{"id":303955,"date":"2025-03-19T23:16:00","date_gmt":"2025-03-19T15:16:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=303955"},"modified":"2025-03-19T23:16:00","modified_gmt":"2025-03-19T15:16:00","slug":"%e6%9c%89%e6%9c%9b%e9%87%8d%e5%a1%91%e8%83%83%e7%99%8c%e6%a8%99%e5%87%86%e6%b2%bb%e7%99%82%ef%bc%8c%e5%be%a9%e5%ae%8f%e6%bc%a2%e9%9c%96%e5%89%b5%e6%96%b0%e5%9e%8b%e6%8a%97her2%e5%96%ae%e6%8a%97hlx22","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=303955","title":{"rendered":"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a"},"content":{"rendered":"
\n

\u4e0a\u6d77<\/span>2025\u5e743\u670819\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — 2025\u5e743\u670819\u65e5\uff0c\u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u5ba3\u5e03\uff0c\u516c\u53f8\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff08Orphan Drug Designation, ODD\uff09\uff0c\u7528\u65bc\u80c3\u764c\u7684\u6cbb\u7642\u3002<\/p>\n

\u7372\u5f97FDA \u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u7684\u85e5\u7269\u5c07\u4eab\u6709\u5305\u62ec\u81e8\u5e8a\u8a66\u9a57\u8cbb\u7528\u7684\u7a05\u6536\u62b5\u514d\u3001\u514d\u9664\u65b0\u85e5\u7533\u8acb\u8cbb\u3001\u7372\u6279\u5f8c\u4e03\u5e74\u7684\u5e02\u5834\u7368\u5360\u6b0a\u7b49\u4e00\u7cfb\u5217\u653f\u7b56\u652f\u6301\uff0c\u4ee5\u52a0\u901f\u5176\u958b\u767c\u9032\u7a0b\uff0c\u65e9\u65e5\u60e0\u53ca\u60a3\u8005\u3002HLX22\u6b64\u6b21\u7372\u5f97\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff0c\u662f\u57fa\u65bc\u5176\u5728\u80c3\u764c\u6cbb\u7642\u9818\u57df\u5c55\u73fe\u51fa\u7684\u5de8\u5927\u6f5b\u529b\u3002\u9019\u662fHLX22\u5168\u7403\u591a\u5730\u76f8\u7e7c\u555f\u52d5\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u8a66\u9a57\u5f8c\uff0c\u53d6\u5f97\u7684\u53c8\u4e00\u91cd\u8981\u88e1\u7a0b\u7891\uff0c\u6a19\u5fd7\u8457\u5176\u5728\u5168\u7403\u8303\u570d\u5167\u7684\u958b\u767c\u9032\u7a0b\u9081\u51fa\u95dc\u9375\u4e00\u6b65\u3002<\/p>\n

\u64daGLOBOCAN\u6578\u64da\u986f\u793a\uff0c2022\u5e74\u5168\u7403\u7d04\u6709100\u842c\u80c3\u764c\u65b0\u767c\u75c5\u4f8b\uff0c\u903e66\u842c\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u75be\u75c5\u8ca0\u64d4\u5448\u73fe\u986f\u8457\u5730\u57df\u4e0d\u5e73\u8861[1]<\/sup>\uff0c\u69cb\u6210\u4e86\u4e00\u5927\u5065\u5eb7\u554f\u984c\u3002\u591a\u6578\u80c3\u764c\u60a3\u8005\u65e9\u671f\u75c7\u72c0\u96b1\u533f\uff0c\u78ba\u8a3a\u6642\u5df2\u8655\u65bc\u75be\u75c5\u665a\u671f\uff0c\u7e3d\u9ad4\u9810\u5f8c\u4e0d\u826f\uff0c5\u5e74\u751f\u5b58\u7387\u50c5\u70ba6%[2,3]<\/sup>\u3002\u76e1\u7ba1\u8fd1\u5e74\u4f86\u9776\u5411\u6cbb\u7642\uff08\u5982\u6297HER2\u85e5\u7269\uff09\u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08\u5982\u6297PD-1\/PD-L1\u55ae\u6297\uff09\u5728\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u53d6\u5f97\u4e86\u986f\u8457\u9032\u5c55[4]<\/sup>\uff0c\u4f46\u9452\u65bc\u8a72\u75be\u75c5\u5177\u6709\u9ad8\u5ea6\u5206\u5b50\u7570\u8cea\u6027\uff0c\u4e0d\u540c\u4e9e\u578b\u60a3\u8005\u5c0d\u5316\u7642\u3001\u9776\u5411\u6cbb\u7642\u548c\u514d\u75ab\u6cbb\u7642\u7684\u53cd\u61c9\u5dee\u7570\u986f\u8457[5]<\/sup>\uff0c\u80c3\u764c\u7684\u6574\u9ad4\u6cbb\u7642\u4ecd\u5b58\u5728\u5de8\u5927\u7684\u672a\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002<\/p>\n

HLX22\u662f\u4e00\u6b3e\u9776\u5411HER2\u7684\u5275\u65b0\u578b\u55ae\u514b\u9686\u6297\u9ad4\u3002\u8207\u50b3\u7d71\u7684HER2\u9776\u5411\u7642\u6cd5\u76f8\u6bd4\uff0cHLX22\u5177\u6709\u5dee\u7570\u5316\u7684\u5206\u5b50\u8a2d\u8a08\u548c\u4f5c\u7528\u6a5f\u5236\uff0c\u53ef\u7d50\u5408\u5728HER2\u7684\u80de\u5916\u4e9e\u7d50\u69cb\u57dfIV\uff0c\u4f46\u7d50\u5408\u8868\u4f4d\u8207\u66f2\u59a5\u73e0\u55ae\u6297\u6709\u6240\u4e0d\u540c\uff0c\u4f7f\u5f97\u8a72\u7522\u54c1\u80fd\u5920\u8207\u548c\u66f2\u59a5\u73e0\u55ae\u6297\u540c\u6642\u7d50\u5408\u81f3HER2\uff0c\u4fc3\u9032HER2\u4e8c\u805a\u9ad4\uff08HER2\u540c\u6e90\u4e8c\u805a\u9ad4\u53caHER2\/EGFR\u7570\u6e90\u4e8c\u805a\u9ad4\uff09\u7684\u5167\u541e\u548c\u964d\u89e3\uff0c\u9032\u800c\u7522\u751f\u66f4\u5f37\u7684HER2\u53d7\u9ad4\u963b\u65b7\u6548\u679c\u3002\u6b64\u524d\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u7684HER2\u96d9\u9776\u7642\u6cd5\u5df2\u5728HER2\u967d\u6027\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u5c55\u73fe\u51fa\u512a\u7570\u7684\u7642\u6548\uff0c\u4e00\u9805HLX22\u806f\u5408\u6f22\u66f2\u512a\u00ae<\/sup>\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\ufe0f\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae<\/sup>\uff09\u6cbb\u7642HER2\u967d\u6027\u80c3\u764c\u7684II\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-201\uff09\u7d50\u679c\u986f\u793a\uff0c\u5728\u6f22\u66f2\u512a\u00ae<\/sup>\u806f\u7528\u5316\u7642\u7684\u57fa\u790e\u4e0a\u52a0\u5165HLX22\u53ef\u63d0\u9ad8HER2\u967d\u6027G\/GEJ\u764c\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u7684\u751f\u5b58\u671f\u548c\u6297\u816b\u7624\u53cd\u61c9\uff0c\u4e14\u5b89\u5168\u6027\u53ef\u63a7[6-8]<\/sup>\uff0c\u6709\u671b\u91cd\u5851\u665a\u671f\u80c3\u764c\u7684\u4e00\u7dda\u6a19\u51c6\u6cbb\u7642\u3002\u5f15\u9818HER2\u96d9\u9776\u5411\u7642\u6cd5\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u53ca\u5316\u7642\u4e00\u7dda\u6cbb\u7642HER2\u967d\u6027\u665a\u671f\u80c3\u764c\u7684\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-301\uff09\u5df2\u5206\u5225\u7372\u5f97\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u65e5\u672c\u548c\u6fb3\u5927\u5229\u4e9e\u7b49\u5730\u85e5\u76e3\u6a5f\u69cb\u7684\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57\uff08IND\uff09\u8a31\u53ef\uff0c\u4e26\u5b8c\u6210\u5168\u7403\u9996\u4f8b\u60a3\u8005\u7d66\u85e5\u3002<\/p>\n

\u672a\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5c07\u7e7c\u7e8c\u79c9\u6301”\u4ee5\u60a3\u8005\u70ba\u4e2d\u5fc3”\u7684\u7406\u5ff5\uff0c\u52a0\u901f\u63a8\u9032HLX22\u7684\u5168\u7403\u7814\u767c\u5e03\u5c40\uff0c\u65e9\u65e5\u5c07\u9019\u4e00\u5275\u65b0\u7642\u6cd5\u5e36\u7d66\u5168\u7403\u60a3\u8005\u3002\u540c\u6642\uff0c\u516c\u53f8\u4e5f\u5c07\u6301\u7e8c\u6df1\u8015\u816b\u7624\u9818\u57df\uff0c\u63a8\u52d5\u66f4\u591a\u5275\u65b0\u85e5\u7269\u7684\u7814\u767c\uff0c\u5e36\u4f86\u66f4\u591a\u9ad8\u8cea\u91cf\u3001\u53ef\u8ca0\u64d4\u7684\u6cbb\u7642\u9078\u64c7\u3002<\/p>\n

\u53c3\u8003\u6587\u737b<\/b><\/p>\n

[1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35.
[2] Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92.
[3] Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70.
[4] Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022).
[5] Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023).\u00a0
[6] Jin Li<\/span> et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric\/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200\/JCO.2024.42.3_suppl.354
[7] J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric\/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016\/annonc\/annonc1482
[8] Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2.<\/p>\n

\u95dc\u65bc\u5fa9\u5b8f\u6f22\u9716<\/b><\/p>\n

\u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u662f\u4e00\u5bb6\u570b\u969b\u5316\u7684\u5275\u65b0\u751f\u7269\u5236\u85e5\u516c\u53f8\uff0c\u81f4\u529b\u65bc\u70ba\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u53ef\u8ca0\u64d4\u7684\u9ad8\u54c1\u8cea\u751f\u7269\u85e5\uff0c\u7522\u54c1\u8986\u84cb\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u3001\u773c\u79d1\u75be\u75c5\u7b49\u9818\u57df\uff0c\u5df2\u67096\u6b3e\u7522\u54c1\u5728\u4e2d\u570b\u7372\u6279\u4e0a\u5e02\uff0c4\u6b3e\u7522\u54c1\u5728\u570b\u969b\u7372\u6279\u4e0a\u5e02\uff0c4\u500b\u4e0a\u5e02\u7533\u8acb\u5206\u5225\u7372\u4e2d\u570b\u85e5\u76e3\u5c40\u3001\u7f8e\u570bFDA\u548c\u6b50\u76dfEMA\u53d7\u7406\u3002\u81ea2010\u5e74\u6210\u7acb\u4ee5\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5df2\u5efa\u6210\u4e00\u9ad4\u5316\u751f\u7269\u5236\u85e5\u5e73\u53f0\uff0c\u9ad8\u6548\u53ca\u5275\u65b0\u7684\u81ea\u4e3b\u6838\u5fc3\u80fd\u529b\u8cab\u7a7f\u7814\u767c\u3001\u751f\u7522\u53ca\u5546\u696d\u904b\u71df\u5168\u7522\u696d\u93c8\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u5b8c\u5584\u9ad8\u6548\u7684\u5168\u7403\u5275\u65b0\u4e2d\u5fc3\uff0c\u6309\u7167\u570b\u969b\u85e5\u54c1\u751f\u7522\u8cea\u91cf\u7ba1\u7406\u898f\u8303\uff08GMP\uff09\u6a19\u51c6\u9032\u884c\u751f\u7522\u548c\u8cea\u91cf\u7ba1\u63a7\uff0c\u4e0d\u65b7\u592f\u5be6\u4e00\u9ad4\u5316\u7d9c\u5408\u751f\u7522\u5e73\u53f0\uff0c\u5176\u4e2d\uff0c\u516c\u53f8\u5546\u696d\u5316\u751f\u7522\u57fa\u5730\u5df2\u76f8\u7e7c\u7372\u5f97\u4e2d\u570b\u3001\u6b50\u76df\u548c\u7f8e\u570bGMP\u8a8d\u8b49\u3002<\/p>\n

\u5fa9\u5b8f\u6f22\u9716\u524d\u77bb\u6027\u5e03\u5c40\u4e86\u4e00\u500b\u591a\u5143\u5316\u3001\u9ad8\u8cea\u91cf\u7684\u7522\u54c1\u7ba1\u7dda\uff0c\u6db5\u84cb50\u591a\u500b\u5206\u5b50\uff0c\u4e26\u5168\u9762\u63a8\u9032\u57fa\u65bc\u81ea\u6709\u6297PD-1\u55ae\u6297H\u85e5\u6f22\u65af\u72c0\u00ae<\/sup>\u7684\u816b\u7624\u514d\u75ab\u806f\u5408\u7642\u6cd5\u3002\u622a\u81f3\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u7372\u6279\u4e0a\u5e02\u7522\u54c1\u5305\u62ec\u570b\u5167\u9996\u500b\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u5229\u5eb7\u00ae<\/sup>\uff08\u5229\u59a5\u6614\u55ae\u6297\uff09\u3001\u81ea\u4e3b\u7814\u767c\u7684\u4e2d\u7f8e\u6b50\u4e09\u5730\u7372\u6279\u55ae\u6297\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u66f2\u512a\u00ae<\/sup>\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae<\/sup>\uff09\u3001\u6f22\u9054\u9060\u00ae<\/sup>\uff08\u963f\u9054\u6728\u55ae\u6297\uff09\u3001\u6f22\u8c9d\u6cf0\u00ae<\/sup>\uff08\u8c9d\u4f10\u73e0\u55ae\u6297\uff09\u3001\u5168\u7403\u9996\u500b\u7372\u6279\u4e00\u7dda\u6cbb\u7642\u5c0f\u7d30\u80de\u80ba\u764c\u7684\u6297PD-1\u55ae\u6297\u6f22\u65af\u72c0\u00ae<\/sup>\uff08\u65af\u9b6f\u5229\u55ae\u6297\uff0c\u6b50\u76df\u5546\u54c1\u540d\uff1aHetronifly\u00ae<\/sup>\uff09\u4ee5\u53ca\u6f22\u5948\u4f73\u00ae<\/sup>\uff08\u5948\u62c9\u66ff\u5c3c\uff09\u3002\u516c\u53f8\u4ea6\u540c\u6b65\u5c3116\u500b\u7522\u54c1\u5728\u5168\u7403\u8303\u570d\u5167\u958b\u5c5530\u591a\u9805\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c0d\u5916\u6388\u6b0a\u5168\u9762\u8986\u84cb\u6b50\u7f8e\u4e3b\u6d41\u751f\u7269\u85e5\u5e02\u5834\u548c\u773e\u591a\u65b0\u8208\u5e02\u5834\u3002<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u4e0a\u6d772025\u5e743\u670819\u65e5 \/\u7f8e…<\/p>\n","protected":false},"author":16,"featured_media":199219,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[40567],"tags":[],"class_list":["post-303955","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"\n\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831<\/title>\n<meta name=\"description\" content=\"\u4e0a\u6d772025\u5e743\u670819\u65e5 \/\u7f8e\u901a\u793e\/ -- 2025\u5e743\u670819\u65e5\uff0c\u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u5ba3\u5e03\uff0c\u516c\u53f8\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff08Orphan Drug Designation, ODD\uff09\uff0c\u7528\u65bc\u80c3\u764c\u7684\u6cbb\u7642\u3002 \u7372\u5f97FDA \u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u7684\u85e5\u7269\u5c07\u4eab\u6709\u5305\u62ec\u81e8\u5e8a\u8a66\u9a57\u8cbb\u7528\u7684\u7a05\u6536\u62b5\u514d\u3001\u514d\u9664\u65b0\u85e5\u7533\u8acb\u8cbb\u3001\u7372\u6279\u5f8c\u4e03\u5e74\u7684\u5e02\u5834\u7368\u5360\u6b0a\u7b49\u4e00\u7cfb\u5217\u653f\u7b56\u652f\u6301\uff0c\u4ee5\u52a0\u901f\u5176\u958b\u767c\u9032\u7a0b\uff0c\u65e9\u65e5\u60e0\u53ca\u60a3\u8005\u3002HLX22\u6b64\u6b21\u7372\u5f97\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff0c\u662f\u57fa\u65bc\u5176\u5728\u80c3\u764c\u6cbb\u7642\u9818\u57df\u5c55\u73fe\u51fa\u7684\u5de8\u5927\u6f5b\u529b\u3002\u9019\u662fHLX22\u5168\u7403\u591a\u5730\u76f8\u7e7c\u555f\u52d5\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u8a66\u9a57\u5f8c\uff0c\u53d6\u5f97\u7684\u53c8\u4e00\u91cd\u8981\u88e1\u7a0b\u7891\uff0c\u6a19\u5fd7\u8457\u5176\u5728\u5168\u7403\u8303\u570d\u5167\u7684\u958b\u767c\u9032\u7a0b\u9081\u51fa\u95dc\u9375\u4e00\u6b65\u3002 \u64daGLOBOCAN\u6578\u64da\u986f\u793a\uff0c2022\u5e74\u5168\u7403\u7d04\u6709100\u842c\u80c3\u764c\u65b0\u767c\u75c5\u4f8b\uff0c\u903e66\u842c\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u75be\u75c5\u8ca0\u64d4\u5448\u73fe\u986f\u8457\u5730\u57df\u4e0d\u5e73\u8861\uff0c\u69cb\u6210\u4e86\u4e00\u5927\u5065\u5eb7\u554f\u984c\u3002\u591a\u6578\u80c3\u764c\u60a3\u8005\u65e9\u671f\u75c7\u72c0\u96b1\u533f\uff0c\u78ba\u8a3a\u6642\u5df2\u8655\u65bc\u75be\u75c5\u665a\u671f\uff0c\u7e3d\u9ad4\u9810\u5f8c\u4e0d\u826f\uff0c5\u5e74\u751f\u5b58\u7387\u50c5\u70ba6%\u3002\u76e1\u7ba1\u8fd1\u5e74\u4f86\u9776\u5411\u6cbb\u7642\uff08\u5982\u6297HER2\u85e5\u7269\uff09\u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08\u5982\u6297PD-1\/PD-L1\u55ae\u6297\uff09\u5728\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u53d6\u5f97\u4e86\u986f\u8457\u9032\u5c55\uff0c\u4f46\u9452\u65bc\u8a72\u75be\u75c5\u5177\u6709\u9ad8\u5ea6\u5206\u5b50\u7570\u8cea\u6027\uff0c\u4e0d\u540c\u4e9e\u578b\u60a3\u8005\u5c0d\u5316\u7642\u3001\u9776\u5411\u6cbb\u7642\u548c\u514d\u75ab\u6cbb\u7642\u7684\u53cd\u61c9\u5dee\u7570\u986f\u8457\uff0c\u80c3\u764c\u7684\u6574\u9ad4\u6cbb\u7642\u4ecd\u5b58\u5728\u5de8\u5927\u7684\u672a\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002 HLX22\u662f\u4e00\u6b3e\u9776\u5411HER2\u7684\u5275\u65b0\u578b\u55ae\u514b\u9686\u6297\u9ad4\u3002\u8207\u50b3\u7d71\u7684HER2\u9776\u5411\u7642\u6cd5\u76f8\u6bd4\uff0cHLX22\u5177\u6709\u5dee\u7570\u5316\u7684\u5206\u5b50\u8a2d\u8a08\u548c\u4f5c\u7528\u6a5f\u5236\uff0c\u53ef\u7d50\u5408\u5728HER2\u7684\u80de\u5916\u4e9e\u7d50\u69cb\u57dfIV\uff0c\u4f46\u7d50\u5408\u8868\u4f4d\u8207\u66f2\u59a5\u73e0\u55ae\u6297\u6709\u6240\u4e0d\u540c\uff0c\u4f7f\u5f97\u8a72\u7522\u54c1\u80fd\u5920\u8207\u548c\u66f2\u59a5\u73e0\u55ae\u6297\u540c\u6642\u7d50\u5408\u81f3HER2\uff0c\u4fc3\u9032HER2\u4e8c\u805a\u9ad4\uff08HER2\u540c\u6e90\u4e8c\u805a\u9ad4\u53caHER2\/EGFR\u7570\u6e90\u4e8c\u805a\u9ad4\uff09\u7684\u5167\u541e\u548c\u964d\u89e3\uff0c\u9032\u800c\u7522\u751f\u66f4\u5f37\u7684HER2\u53d7\u9ad4\u963b\u65b7\u6548\u679c\u3002\u6b64\u524d\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u7684HER2\u96d9\u9776\u7642\u6cd5\u5df2\u5728HER2\u967d\u6027\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u5c55\u73fe\u51fa\u512a\u7570\u7684\u7642\u6548\uff0c\u4e00\u9805HLX22\u806f\u5408\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\ufe0f\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u6cbb\u7642HER2\u967d\u6027\u80c3\u764c\u7684II\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-201\uff09\u7d50\u679c\u986f\u793a\uff0c\u5728\u6f22\u66f2\u512a\u00ae\u806f\u7528\u5316\u7642\u7684\u57fa\u790e\u4e0a\u52a0\u5165HLX22\u53ef\u63d0\u9ad8HER2\u967d\u6027G\/GEJ\u764c\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u7684\u751f\u5b58\u671f\u548c\u6297\u816b\u7624\u53cd\u61c9\uff0c\u4e14\u5b89\u5168\u6027\u53ef\u63a7\uff0c\u6709\u671b\u91cd\u5851\u665a\u671f\u80c3\u764c\u7684\u4e00\u7dda\u6a19\u51c6\u6cbb\u7642\u3002\u5f15\u9818HER2\u96d9\u9776\u5411\u7642\u6cd5\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u53ca\u5316\u7642\u4e00\u7dda\u6cbb\u7642HER2\u967d\u6027\u665a\u671f\u80c3\u764c\u7684\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-301\uff09\u5df2\u5206\u5225\u7372\u5f97\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u65e5\u672c\u548c\u6fb3\u5927\u5229\u4e9e\u7b49\u5730\u85e5\u76e3\u6a5f\u69cb\u7684\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57\uff08IND\uff09\u8a31\u53ef\uff0c\u4e26\u5b8c\u6210\u5168\u7403\u9996\u4f8b\u60a3\u8005\u7d66\u85e5\u3002 \u672a\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5c07\u7e7c\u7e8c\u79c9\u6301"\u4ee5\u60a3\u8005\u70ba\u4e2d\u5fc3"\u7684\u7406\u5ff5\uff0c\u52a0\u901f\u63a8\u9032HLX22\u7684\u5168\u7403\u7814\u767c\u5e03\u5c40\uff0c\u65e9\u65e5\u5c07\u9019\u4e00\u5275\u65b0\u7642\u6cd5\u5e36\u7d66\u5168\u7403\u60a3\u8005\u3002\u540c\u6642\uff0c\u516c\u53f8\u4e5f\u5c07\u6301\u7e8c\u6df1\u8015\u816b\u7624\u9818\u57df\uff0c\u63a8\u52d5\u66f4\u591a\u5275\u65b0\u85e5\u7269\u7684\u7814\u767c\uff0c\u5e36\u4f86\u66f4\u591a\u9ad8\u8cea\u91cf\u3001\u53ef\u8ca0\u64d4\u7684\u6cbb\u7642\u9078\u64c7\u3002 \u53c3\u8003\u6587\u737b Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022). Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023).\u00a0 Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric\/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200\/JCO.2024.42.3_suppl.354 J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric\/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016\/annonc\/annonc1482 Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. \u95dc\u65bc\u5fa9\u5b8f\u6f22\u9716 \u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u662f\u4e00\u5bb6\u570b\u969b\u5316\u7684\u5275\u65b0\u751f\u7269\u5236\u85e5\u516c\u53f8\uff0c\u81f4\u529b\u65bc\u70ba\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u53ef\u8ca0\u64d4\u7684\u9ad8\u54c1\u8cea\u751f\u7269\u85e5\uff0c\u7522\u54c1\u8986\u84cb\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u3001\u773c\u79d1\u75be\u75c5\u7b49\u9818\u57df\uff0c\u5df2\u67096\u6b3e\u7522\u54c1\u5728\u4e2d\u570b\u7372\u6279\u4e0a\u5e02\uff0c4\u6b3e\u7522\u54c1\u5728\u570b\u969b\u7372\u6279\u4e0a\u5e02\uff0c4\u500b\u4e0a\u5e02\u7533\u8acb\u5206\u5225\u7372\u4e2d\u570b\u85e5\u76e3\u5c40\u3001\u7f8e\u570bFDA\u548c\u6b50\u76dfEMA\u53d7\u7406\u3002\u81ea2010\u5e74\u6210\u7acb\u4ee5\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5df2\u5efa\u6210\u4e00\u9ad4\u5316\u751f\u7269\u5236\u85e5\u5e73\u53f0\uff0c\u9ad8\u6548\u53ca\u5275\u65b0\u7684\u81ea\u4e3b\u6838\u5fc3\u80fd\u529b\u8cab\u7a7f\u7814\u767c\u3001\u751f\u7522\u53ca\u5546\u696d\u904b\u71df\u5168\u7522\u696d\u93c8\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u5b8c\u5584\u9ad8\u6548\u7684\u5168\u7403\u5275\u65b0\u4e2d\u5fc3\uff0c\u6309\u7167\u570b\u969b\u85e5\u54c1\u751f\u7522\u8cea\u91cf\u7ba1\u7406\u898f\u8303\uff08GMP\uff09\u6a19\u51c6\u9032\u884c\u751f\u7522\u548c\u8cea\u91cf\u7ba1\u63a7\uff0c\u4e0d\u65b7\u592f\u5be6\u4e00\u9ad4\u5316\u7d9c\u5408\u751f\u7522\u5e73\u53f0\uff0c\u5176\u4e2d\uff0c\u516c\u53f8\u5546\u696d\u5316\u751f\u7522\u57fa\u5730\u5df2\u76f8\u7e7c\u7372\u5f97\u4e2d\u570b\u3001\u6b50\u76df\u548c\u7f8e\u570bGMP\u8a8d\u8b49\u3002 \u5fa9\u5b8f\u6f22\u9716\u524d\u77bb\u6027\u5e03\u5c40\u4e86\u4e00\u500b\u591a\u5143\u5316\u3001\u9ad8\u8cea\u91cf\u7684\u7522\u54c1\u7ba1\u7dda\uff0c\u6db5\u84cb50\u591a\u500b\u5206\u5b50\uff0c\u4e26\u5168\u9762\u63a8\u9032\u57fa\u65bc\u81ea\u6709\u6297PD-1\u55ae\u6297H\u85e5\u6f22\u65af\u72c0\u00ae\u7684\u816b\u7624\u514d\u75ab\u806f\u5408\u7642\u6cd5\u3002\u622a\u81f3\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u7372\u6279\u4e0a\u5e02\u7522\u54c1\u5305\u62ec\u570b\u5167\u9996\u500b\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u5229\u5eb7\u00ae\uff08\u5229\u59a5\u6614\u55ae\u6297\uff09\u3001\u81ea\u4e3b\u7814\u767c\u7684\u4e2d\u7f8e\u6b50\u4e09\u5730\u7372\u6279\u55ae\u6297\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u3001\u6f22\u9054\u9060\u00ae\uff08\u963f\u9054\u6728\u55ae\u6297\uff09\u3001\u6f22\u8c9d\u6cf0\u00ae\uff08\u8c9d\u4f10\u73e0\u55ae\u6297\uff09\u3001\u5168\u7403\u9996\u500b\u7372\u6279\u4e00\u7dda\u6cbb\u7642\u5c0f\u7d30\u80de\u80ba\u764c\u7684\u6297PD-1\u55ae\u6297\u6f22\u65af\u72c0\u00ae\uff08\u65af\u9b6f\u5229\u55ae\u6297\uff0c\u6b50\u76df\u5546\u54c1\u540d\uff1aHetronifly\u00ae\uff09\u4ee5\u53ca\u6f22\u5948\u4f73\u00ae\uff08\u5948\u62c9\u66ff\u5c3c\uff09\u3002\u516c\u53f8\u4ea6\u540c\u6b65\u5c3116\u500b\u7522\u54c1\u5728\u5168\u7403\u8303\u570d\u5167\u958b\u5c5530\u591a\u9805\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c0d\u5916\u6388\u6b0a\u5168\u9762\u8986\u84cb\u6b50\u7f8e\u4e3b\u6d41\u751f\u7269\u85e5\u5e02\u5834\u548c\u773e\u591a\u65b0\u8208\u5e02\u5834\u3002\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pingtungtimes.com.tw\/?p=303955\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u4e0a\u6d772025\u5e743\u670819\u65e5 \/\u7f8e\u901a\u793e\/ -- 2025\u5e743\u670819\u65e5\uff0c\u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u5ba3\u5e03\uff0c\u516c\u53f8\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff08Orphan Drug Designation, ODD\uff09\uff0c\u7528\u65bc\u80c3\u764c\u7684\u6cbb\u7642\u3002 \u7372\u5f97FDA \u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u7684\u85e5\u7269\u5c07\u4eab\u6709\u5305\u62ec\u81e8\u5e8a\u8a66\u9a57\u8cbb\u7528\u7684\u7a05\u6536\u62b5\u514d\u3001\u514d\u9664\u65b0\u85e5\u7533\u8acb\u8cbb\u3001\u7372\u6279\u5f8c\u4e03\u5e74\u7684\u5e02\u5834\u7368\u5360\u6b0a\u7b49\u4e00\u7cfb\u5217\u653f\u7b56\u652f\u6301\uff0c\u4ee5\u52a0\u901f\u5176\u958b\u767c\u9032\u7a0b\uff0c\u65e9\u65e5\u60e0\u53ca\u60a3\u8005\u3002HLX22\u6b64\u6b21\u7372\u5f97\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff0c\u662f\u57fa\u65bc\u5176\u5728\u80c3\u764c\u6cbb\u7642\u9818\u57df\u5c55\u73fe\u51fa\u7684\u5de8\u5927\u6f5b\u529b\u3002\u9019\u662fHLX22\u5168\u7403\u591a\u5730\u76f8\u7e7c\u555f\u52d5\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u8a66\u9a57\u5f8c\uff0c\u53d6\u5f97\u7684\u53c8\u4e00\u91cd\u8981\u88e1\u7a0b\u7891\uff0c\u6a19\u5fd7\u8457\u5176\u5728\u5168\u7403\u8303\u570d\u5167\u7684\u958b\u767c\u9032\u7a0b\u9081\u51fa\u95dc\u9375\u4e00\u6b65\u3002 \u64daGLOBOCAN\u6578\u64da\u986f\u793a\uff0c2022\u5e74\u5168\u7403\u7d04\u6709100\u842c\u80c3\u764c\u65b0\u767c\u75c5\u4f8b\uff0c\u903e66\u842c\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u75be\u75c5\u8ca0\u64d4\u5448\u73fe\u986f\u8457\u5730\u57df\u4e0d\u5e73\u8861\uff0c\u69cb\u6210\u4e86\u4e00\u5927\u5065\u5eb7\u554f\u984c\u3002\u591a\u6578\u80c3\u764c\u60a3\u8005\u65e9\u671f\u75c7\u72c0\u96b1\u533f\uff0c\u78ba\u8a3a\u6642\u5df2\u8655\u65bc\u75be\u75c5\u665a\u671f\uff0c\u7e3d\u9ad4\u9810\u5f8c\u4e0d\u826f\uff0c5\u5e74\u751f\u5b58\u7387\u50c5\u70ba6%\u3002\u76e1\u7ba1\u8fd1\u5e74\u4f86\u9776\u5411\u6cbb\u7642\uff08\u5982\u6297HER2\u85e5\u7269\uff09\u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08\u5982\u6297PD-1\/PD-L1\u55ae\u6297\uff09\u5728\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u53d6\u5f97\u4e86\u986f\u8457\u9032\u5c55\uff0c\u4f46\u9452\u65bc\u8a72\u75be\u75c5\u5177\u6709\u9ad8\u5ea6\u5206\u5b50\u7570\u8cea\u6027\uff0c\u4e0d\u540c\u4e9e\u578b\u60a3\u8005\u5c0d\u5316\u7642\u3001\u9776\u5411\u6cbb\u7642\u548c\u514d\u75ab\u6cbb\u7642\u7684\u53cd\u61c9\u5dee\u7570\u986f\u8457\uff0c\u80c3\u764c\u7684\u6574\u9ad4\u6cbb\u7642\u4ecd\u5b58\u5728\u5de8\u5927\u7684\u672a\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002 HLX22\u662f\u4e00\u6b3e\u9776\u5411HER2\u7684\u5275\u65b0\u578b\u55ae\u514b\u9686\u6297\u9ad4\u3002\u8207\u50b3\u7d71\u7684HER2\u9776\u5411\u7642\u6cd5\u76f8\u6bd4\uff0cHLX22\u5177\u6709\u5dee\u7570\u5316\u7684\u5206\u5b50\u8a2d\u8a08\u548c\u4f5c\u7528\u6a5f\u5236\uff0c\u53ef\u7d50\u5408\u5728HER2\u7684\u80de\u5916\u4e9e\u7d50\u69cb\u57dfIV\uff0c\u4f46\u7d50\u5408\u8868\u4f4d\u8207\u66f2\u59a5\u73e0\u55ae\u6297\u6709\u6240\u4e0d\u540c\uff0c\u4f7f\u5f97\u8a72\u7522\u54c1\u80fd\u5920\u8207\u548c\u66f2\u59a5\u73e0\u55ae\u6297\u540c\u6642\u7d50\u5408\u81f3HER2\uff0c\u4fc3\u9032HER2\u4e8c\u805a\u9ad4\uff08HER2\u540c\u6e90\u4e8c\u805a\u9ad4\u53caHER2\/EGFR\u7570\u6e90\u4e8c\u805a\u9ad4\uff09\u7684\u5167\u541e\u548c\u964d\u89e3\uff0c\u9032\u800c\u7522\u751f\u66f4\u5f37\u7684HER2\u53d7\u9ad4\u963b\u65b7\u6548\u679c\u3002\u6b64\u524d\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u7684HER2\u96d9\u9776\u7642\u6cd5\u5df2\u5728HER2\u967d\u6027\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u5c55\u73fe\u51fa\u512a\u7570\u7684\u7642\u6548\uff0c\u4e00\u9805HLX22\u806f\u5408\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\ufe0f\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u6cbb\u7642HER2\u967d\u6027\u80c3\u764c\u7684II\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-201\uff09\u7d50\u679c\u986f\u793a\uff0c\u5728\u6f22\u66f2\u512a\u00ae\u806f\u7528\u5316\u7642\u7684\u57fa\u790e\u4e0a\u52a0\u5165HLX22\u53ef\u63d0\u9ad8HER2\u967d\u6027G\/GEJ\u764c\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u7684\u751f\u5b58\u671f\u548c\u6297\u816b\u7624\u53cd\u61c9\uff0c\u4e14\u5b89\u5168\u6027\u53ef\u63a7\uff0c\u6709\u671b\u91cd\u5851\u665a\u671f\u80c3\u764c\u7684\u4e00\u7dda\u6a19\u51c6\u6cbb\u7642\u3002\u5f15\u9818HER2\u96d9\u9776\u5411\u7642\u6cd5\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u53ca\u5316\u7642\u4e00\u7dda\u6cbb\u7642HER2\u967d\u6027\u665a\u671f\u80c3\u764c\u7684\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-301\uff09\u5df2\u5206\u5225\u7372\u5f97\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u65e5\u672c\u548c\u6fb3\u5927\u5229\u4e9e\u7b49\u5730\u85e5\u76e3\u6a5f\u69cb\u7684\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57\uff08IND\uff09\u8a31\u53ef\uff0c\u4e26\u5b8c\u6210\u5168\u7403\u9996\u4f8b\u60a3\u8005\u7d66\u85e5\u3002 \u672a\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5c07\u7e7c\u7e8c\u79c9\u6301"\u4ee5\u60a3\u8005\u70ba\u4e2d\u5fc3"\u7684\u7406\u5ff5\uff0c\u52a0\u901f\u63a8\u9032HLX22\u7684\u5168\u7403\u7814\u767c\u5e03\u5c40\uff0c\u65e9\u65e5\u5c07\u9019\u4e00\u5275\u65b0\u7642\u6cd5\u5e36\u7d66\u5168\u7403\u60a3\u8005\u3002\u540c\u6642\uff0c\u516c\u53f8\u4e5f\u5c07\u6301\u7e8c\u6df1\u8015\u816b\u7624\u9818\u57df\uff0c\u63a8\u52d5\u66f4\u591a\u5275\u65b0\u85e5\u7269\u7684\u7814\u767c\uff0c\u5e36\u4f86\u66f4\u591a\u9ad8\u8cea\u91cf\u3001\u53ef\u8ca0\u64d4\u7684\u6cbb\u7642\u9078\u64c7\u3002 \u53c3\u8003\u6587\u737b Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022). Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023).\u00a0 Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric\/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200\/JCO.2024.42.3_suppl.354 J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric\/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016\/annonc\/annonc1482 Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. \u95dc\u65bc\u5fa9\u5b8f\u6f22\u9716 \u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u662f\u4e00\u5bb6\u570b\u969b\u5316\u7684\u5275\u65b0\u751f\u7269\u5236\u85e5\u516c\u53f8\uff0c\u81f4\u529b\u65bc\u70ba\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u53ef\u8ca0\u64d4\u7684\u9ad8\u54c1\u8cea\u751f\u7269\u85e5\uff0c\u7522\u54c1\u8986\u84cb\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u3001\u773c\u79d1\u75be\u75c5\u7b49\u9818\u57df\uff0c\u5df2\u67096\u6b3e\u7522\u54c1\u5728\u4e2d\u570b\u7372\u6279\u4e0a\u5e02\uff0c4\u6b3e\u7522\u54c1\u5728\u570b\u969b\u7372\u6279\u4e0a\u5e02\uff0c4\u500b\u4e0a\u5e02\u7533\u8acb\u5206\u5225\u7372\u4e2d\u570b\u85e5\u76e3\u5c40\u3001\u7f8e\u570bFDA\u548c\u6b50\u76dfEMA\u53d7\u7406\u3002\u81ea2010\u5e74\u6210\u7acb\u4ee5\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5df2\u5efa\u6210\u4e00\u9ad4\u5316\u751f\u7269\u5236\u85e5\u5e73\u53f0\uff0c\u9ad8\u6548\u53ca\u5275\u65b0\u7684\u81ea\u4e3b\u6838\u5fc3\u80fd\u529b\u8cab\u7a7f\u7814\u767c\u3001\u751f\u7522\u53ca\u5546\u696d\u904b\u71df\u5168\u7522\u696d\u93c8\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u5b8c\u5584\u9ad8\u6548\u7684\u5168\u7403\u5275\u65b0\u4e2d\u5fc3\uff0c\u6309\u7167\u570b\u969b\u85e5\u54c1\u751f\u7522\u8cea\u91cf\u7ba1\u7406\u898f\u8303\uff08GMP\uff09\u6a19\u51c6\u9032\u884c\u751f\u7522\u548c\u8cea\u91cf\u7ba1\u63a7\uff0c\u4e0d\u65b7\u592f\u5be6\u4e00\u9ad4\u5316\u7d9c\u5408\u751f\u7522\u5e73\u53f0\uff0c\u5176\u4e2d\uff0c\u516c\u53f8\u5546\u696d\u5316\u751f\u7522\u57fa\u5730\u5df2\u76f8\u7e7c\u7372\u5f97\u4e2d\u570b\u3001\u6b50\u76df\u548c\u7f8e\u570bGMP\u8a8d\u8b49\u3002 \u5fa9\u5b8f\u6f22\u9716\u524d\u77bb\u6027\u5e03\u5c40\u4e86\u4e00\u500b\u591a\u5143\u5316\u3001\u9ad8\u8cea\u91cf\u7684\u7522\u54c1\u7ba1\u7dda\uff0c\u6db5\u84cb50\u591a\u500b\u5206\u5b50\uff0c\u4e26\u5168\u9762\u63a8\u9032\u57fa\u65bc\u81ea\u6709\u6297PD-1\u55ae\u6297H\u85e5\u6f22\u65af\u72c0\u00ae\u7684\u816b\u7624\u514d\u75ab\u806f\u5408\u7642\u6cd5\u3002\u622a\u81f3\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u7372\u6279\u4e0a\u5e02\u7522\u54c1\u5305\u62ec\u570b\u5167\u9996\u500b\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u5229\u5eb7\u00ae\uff08\u5229\u59a5\u6614\u55ae\u6297\uff09\u3001\u81ea\u4e3b\u7814\u767c\u7684\u4e2d\u7f8e\u6b50\u4e09\u5730\u7372\u6279\u55ae\u6297\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u3001\u6f22\u9054\u9060\u00ae\uff08\u963f\u9054\u6728\u55ae\u6297\uff09\u3001\u6f22\u8c9d\u6cf0\u00ae\uff08\u8c9d\u4f10\u73e0\u55ae\u6297\uff09\u3001\u5168\u7403\u9996\u500b\u7372\u6279\u4e00\u7dda\u6cbb\u7642\u5c0f\u7d30\u80de\u80ba\u764c\u7684\u6297PD-1\u55ae\u6297\u6f22\u65af\u72c0\u00ae\uff08\u65af\u9b6f\u5229\u55ae\u6297\uff0c\u6b50\u76df\u5546\u54c1\u540d\uff1aHetronifly\u00ae\uff09\u4ee5\u53ca\u6f22\u5948\u4f73\u00ae\uff08\u5948\u62c9\u66ff\u5c3c\uff09\u3002\u516c\u53f8\u4ea6\u540c\u6b65\u5c3116\u500b\u7522\u54c1\u5728\u5168\u7403\u8303\u570d\u5167\u958b\u5c5530\u591a\u9805\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c0d\u5916\u6388\u6b0a\u5168\u9762\u8986\u84cb\u6b50\u7f8e\u4e3b\u6d41\u751f\u7269\u85e5\u5e02\u5834\u548c\u773e\u591a\u65b0\u8208\u5e02\u5834\u3002\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pingtungtimes.com.tw\/?p=303955\" \/>\n<meta property=\"og:site_name\" content=\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/pingtungnews\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-19T15:16:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png\" \/>\n<meta name=\"author\" content=\"\u7f8e\u901a\u793e\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005:\" \/>\n\t<meta name=\"twitter:data1\" content=\"\u7f8e\u901a\u793e\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9810\u4f30\u95b1\u8b80\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 \u5206\u9418\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"NewsArticle\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955\"},\"author\":{\"name\":\"\u7f8e\u901a\u793e\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\"},\"headline\":\"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\",\"datePublished\":\"2025-03-19T15:16:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955\"},\"wordCount\":232,\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"articleSection\":[\"\u7f8e\u901a\u793e\"],\"inLanguage\":\"zh-TW\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955\",\"name\":\"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"datePublished\":\"2025-03-19T15:16:00+00:00\",\"description\":\"\u4e0a\u6d772025\u5e743\u670819\u65e5 \\\/\u7f8e\u901a\u793e\\\/ -- 2025\u5e743\u670819\u65e5\uff0c\u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u5ba3\u5e03\uff0c\u516c\u53f8\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff08Orphan Drug Designation, ODD\uff09\uff0c\u7528\u65bc\u80c3\u764c\u7684\u6cbb\u7642\u3002 \u7372\u5f97FDA \u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u7684\u85e5\u7269\u5c07\u4eab\u6709\u5305\u62ec\u81e8\u5e8a\u8a66\u9a57\u8cbb\u7528\u7684\u7a05\u6536\u62b5\u514d\u3001\u514d\u9664\u65b0\u85e5\u7533\u8acb\u8cbb\u3001\u7372\u6279\u5f8c\u4e03\u5e74\u7684\u5e02\u5834\u7368\u5360\u6b0a\u7b49\u4e00\u7cfb\u5217\u653f\u7b56\u652f\u6301\uff0c\u4ee5\u52a0\u901f\u5176\u958b\u767c\u9032\u7a0b\uff0c\u65e9\u65e5\u60e0\u53ca\u60a3\u8005\u3002HLX22\u6b64\u6b21\u7372\u5f97\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff0c\u662f\u57fa\u65bc\u5176\u5728\u80c3\u764c\u6cbb\u7642\u9818\u57df\u5c55\u73fe\u51fa\u7684\u5de8\u5927\u6f5b\u529b\u3002\u9019\u662fHLX22\u5168\u7403\u591a\u5730\u76f8\u7e7c\u555f\u52d5\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u8a66\u9a57\u5f8c\uff0c\u53d6\u5f97\u7684\u53c8\u4e00\u91cd\u8981\u88e1\u7a0b\u7891\uff0c\u6a19\u5fd7\u8457\u5176\u5728\u5168\u7403\u8303\u570d\u5167\u7684\u958b\u767c\u9032\u7a0b\u9081\u51fa\u95dc\u9375\u4e00\u6b65\u3002 \u64daGLOBOCAN\u6578\u64da\u986f\u793a\uff0c2022\u5e74\u5168\u7403\u7d04\u6709100\u842c\u80c3\u764c\u65b0\u767c\u75c5\u4f8b\uff0c\u903e66\u842c\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u75be\u75c5\u8ca0\u64d4\u5448\u73fe\u986f\u8457\u5730\u57df\u4e0d\u5e73\u8861\uff0c\u69cb\u6210\u4e86\u4e00\u5927\u5065\u5eb7\u554f\u984c\u3002\u591a\u6578\u80c3\u764c\u60a3\u8005\u65e9\u671f\u75c7\u72c0\u96b1\u533f\uff0c\u78ba\u8a3a\u6642\u5df2\u8655\u65bc\u75be\u75c5\u665a\u671f\uff0c\u7e3d\u9ad4\u9810\u5f8c\u4e0d\u826f\uff0c5\u5e74\u751f\u5b58\u7387\u50c5\u70ba6%\u3002\u76e1\u7ba1\u8fd1\u5e74\u4f86\u9776\u5411\u6cbb\u7642\uff08\u5982\u6297HER2\u85e5\u7269\uff09\u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08\u5982\u6297PD-1\\\/PD-L1\u55ae\u6297\uff09\u5728\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u53d6\u5f97\u4e86\u986f\u8457\u9032\u5c55\uff0c\u4f46\u9452\u65bc\u8a72\u75be\u75c5\u5177\u6709\u9ad8\u5ea6\u5206\u5b50\u7570\u8cea\u6027\uff0c\u4e0d\u540c\u4e9e\u578b\u60a3\u8005\u5c0d\u5316\u7642\u3001\u9776\u5411\u6cbb\u7642\u548c\u514d\u75ab\u6cbb\u7642\u7684\u53cd\u61c9\u5dee\u7570\u986f\u8457\uff0c\u80c3\u764c\u7684\u6574\u9ad4\u6cbb\u7642\u4ecd\u5b58\u5728\u5de8\u5927\u7684\u672a\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002 HLX22\u662f\u4e00\u6b3e\u9776\u5411HER2\u7684\u5275\u65b0\u578b\u55ae\u514b\u9686\u6297\u9ad4\u3002\u8207\u50b3\u7d71\u7684HER2\u9776\u5411\u7642\u6cd5\u76f8\u6bd4\uff0cHLX22\u5177\u6709\u5dee\u7570\u5316\u7684\u5206\u5b50\u8a2d\u8a08\u548c\u4f5c\u7528\u6a5f\u5236\uff0c\u53ef\u7d50\u5408\u5728HER2\u7684\u80de\u5916\u4e9e\u7d50\u69cb\u57dfIV\uff0c\u4f46\u7d50\u5408\u8868\u4f4d\u8207\u66f2\u59a5\u73e0\u55ae\u6297\u6709\u6240\u4e0d\u540c\uff0c\u4f7f\u5f97\u8a72\u7522\u54c1\u80fd\u5920\u8207\u548c\u66f2\u59a5\u73e0\u55ae\u6297\u540c\u6642\u7d50\u5408\u81f3HER2\uff0c\u4fc3\u9032HER2\u4e8c\u805a\u9ad4\uff08HER2\u540c\u6e90\u4e8c\u805a\u9ad4\u53caHER2\\\/EGFR\u7570\u6e90\u4e8c\u805a\u9ad4\uff09\u7684\u5167\u541e\u548c\u964d\u89e3\uff0c\u9032\u800c\u7522\u751f\u66f4\u5f37\u7684HER2\u53d7\u9ad4\u963b\u65b7\u6548\u679c\u3002\u6b64\u524d\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u7684HER2\u96d9\u9776\u7642\u6cd5\u5df2\u5728HER2\u967d\u6027\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u5c55\u73fe\u51fa\u512a\u7570\u7684\u7642\u6548\uff0c\u4e00\u9805HLX22\u806f\u5408\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\ufe0f\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u6cbb\u7642HER2\u967d\u6027\u80c3\u764c\u7684II\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-201\uff09\u7d50\u679c\u986f\u793a\uff0c\u5728\u6f22\u66f2\u512a\u00ae\u806f\u7528\u5316\u7642\u7684\u57fa\u790e\u4e0a\u52a0\u5165HLX22\u53ef\u63d0\u9ad8HER2\u967d\u6027G\\\/GEJ\u764c\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u7684\u751f\u5b58\u671f\u548c\u6297\u816b\u7624\u53cd\u61c9\uff0c\u4e14\u5b89\u5168\u6027\u53ef\u63a7\uff0c\u6709\u671b\u91cd\u5851\u665a\u671f\u80c3\u764c\u7684\u4e00\u7dda\u6a19\u51c6\u6cbb\u7642\u3002\u5f15\u9818HER2\u96d9\u9776\u5411\u7642\u6cd5\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u53ca\u5316\u7642\u4e00\u7dda\u6cbb\u7642HER2\u967d\u6027\u665a\u671f\u80c3\u764c\u7684\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-301\uff09\u5df2\u5206\u5225\u7372\u5f97\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u65e5\u672c\u548c\u6fb3\u5927\u5229\u4e9e\u7b49\u5730\u85e5\u76e3\u6a5f\u69cb\u7684\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57\uff08IND\uff09\u8a31\u53ef\uff0c\u4e26\u5b8c\u6210\u5168\u7403\u9996\u4f8b\u60a3\u8005\u7d66\u85e5\u3002 \u672a\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5c07\u7e7c\u7e8c\u79c9\u6301\\\"\u4ee5\u60a3\u8005\u70ba\u4e2d\u5fc3\\\"\u7684\u7406\u5ff5\uff0c\u52a0\u901f\u63a8\u9032HLX22\u7684\u5168\u7403\u7814\u767c\u5e03\u5c40\uff0c\u65e9\u65e5\u5c07\u9019\u4e00\u5275\u65b0\u7642\u6cd5\u5e36\u7d66\u5168\u7403\u60a3\u8005\u3002\u540c\u6642\uff0c\u516c\u53f8\u4e5f\u5c07\u6301\u7e8c\u6df1\u8015\u816b\u7624\u9818\u57df\uff0c\u63a8\u52d5\u66f4\u591a\u5275\u65b0\u85e5\u7269\u7684\u7814\u767c\uff0c\u5e36\u4f86\u66f4\u591a\u9ad8\u8cea\u91cf\u3001\u53ef\u8ca0\u64d4\u7684\u6cbb\u7642\u9078\u64c7\u3002 \u53c3\u8003\u6587\u737b Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022). Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023).\u00a0 Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric\\\/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200\\\/JCO.2024.42.3_suppl.354 J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric\\\/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016\\\/annonc\\\/annonc1482 Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. \u95dc\u65bc\u5fa9\u5b8f\u6f22\u9716 \u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u662f\u4e00\u5bb6\u570b\u969b\u5316\u7684\u5275\u65b0\u751f\u7269\u5236\u85e5\u516c\u53f8\uff0c\u81f4\u529b\u65bc\u70ba\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u53ef\u8ca0\u64d4\u7684\u9ad8\u54c1\u8cea\u751f\u7269\u85e5\uff0c\u7522\u54c1\u8986\u84cb\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u3001\u773c\u79d1\u75be\u75c5\u7b49\u9818\u57df\uff0c\u5df2\u67096\u6b3e\u7522\u54c1\u5728\u4e2d\u570b\u7372\u6279\u4e0a\u5e02\uff0c4\u6b3e\u7522\u54c1\u5728\u570b\u969b\u7372\u6279\u4e0a\u5e02\uff0c4\u500b\u4e0a\u5e02\u7533\u8acb\u5206\u5225\u7372\u4e2d\u570b\u85e5\u76e3\u5c40\u3001\u7f8e\u570bFDA\u548c\u6b50\u76dfEMA\u53d7\u7406\u3002\u81ea2010\u5e74\u6210\u7acb\u4ee5\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5df2\u5efa\u6210\u4e00\u9ad4\u5316\u751f\u7269\u5236\u85e5\u5e73\u53f0\uff0c\u9ad8\u6548\u53ca\u5275\u65b0\u7684\u81ea\u4e3b\u6838\u5fc3\u80fd\u529b\u8cab\u7a7f\u7814\u767c\u3001\u751f\u7522\u53ca\u5546\u696d\u904b\u71df\u5168\u7522\u696d\u93c8\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u5b8c\u5584\u9ad8\u6548\u7684\u5168\u7403\u5275\u65b0\u4e2d\u5fc3\uff0c\u6309\u7167\u570b\u969b\u85e5\u54c1\u751f\u7522\u8cea\u91cf\u7ba1\u7406\u898f\u8303\uff08GMP\uff09\u6a19\u51c6\u9032\u884c\u751f\u7522\u548c\u8cea\u91cf\u7ba1\u63a7\uff0c\u4e0d\u65b7\u592f\u5be6\u4e00\u9ad4\u5316\u7d9c\u5408\u751f\u7522\u5e73\u53f0\uff0c\u5176\u4e2d\uff0c\u516c\u53f8\u5546\u696d\u5316\u751f\u7522\u57fa\u5730\u5df2\u76f8\u7e7c\u7372\u5f97\u4e2d\u570b\u3001\u6b50\u76df\u548c\u7f8e\u570bGMP\u8a8d\u8b49\u3002 \u5fa9\u5b8f\u6f22\u9716\u524d\u77bb\u6027\u5e03\u5c40\u4e86\u4e00\u500b\u591a\u5143\u5316\u3001\u9ad8\u8cea\u91cf\u7684\u7522\u54c1\u7ba1\u7dda\uff0c\u6db5\u84cb50\u591a\u500b\u5206\u5b50\uff0c\u4e26\u5168\u9762\u63a8\u9032\u57fa\u65bc\u81ea\u6709\u6297PD-1\u55ae\u6297H\u85e5\u6f22\u65af\u72c0\u00ae\u7684\u816b\u7624\u514d\u75ab\u806f\u5408\u7642\u6cd5\u3002\u622a\u81f3\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u7372\u6279\u4e0a\u5e02\u7522\u54c1\u5305\u62ec\u570b\u5167\u9996\u500b\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u5229\u5eb7\u00ae\uff08\u5229\u59a5\u6614\u55ae\u6297\uff09\u3001\u81ea\u4e3b\u7814\u767c\u7684\u4e2d\u7f8e\u6b50\u4e09\u5730\u7372\u6279\u55ae\u6297\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u3001\u6f22\u9054\u9060\u00ae\uff08\u963f\u9054\u6728\u55ae\u6297\uff09\u3001\u6f22\u8c9d\u6cf0\u00ae\uff08\u8c9d\u4f10\u73e0\u55ae\u6297\uff09\u3001\u5168\u7403\u9996\u500b\u7372\u6279\u4e00\u7dda\u6cbb\u7642\u5c0f\u7d30\u80de\u80ba\u764c\u7684\u6297PD-1\u55ae\u6297\u6f22\u65af\u72c0\u00ae\uff08\u65af\u9b6f\u5229\u55ae\u6297\uff0c\u6b50\u76df\u5546\u54c1\u540d\uff1aHetronifly\u00ae\uff09\u4ee5\u53ca\u6f22\u5948\u4f73\u00ae\uff08\u5948\u62c9\u66ff\u5c3c\uff09\u3002\u516c\u53f8\u4ea6\u540c\u6b65\u5c3116\u500b\u7522\u54c1\u5728\u5168\u7403\u8303\u570d\u5167\u958b\u5c5530\u591a\u9805\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c0d\u5916\u6388\u6b0a\u5168\u9762\u8986\u84cb\u6b50\u7f8e\u4e3b\u6d41\u751f\u7269\u85e5\u5e02\u5834\u548c\u773e\u591a\u65b0\u8208\u5e02\u5834\u3002\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955#breadcrumb\"},\"inLanguage\":\"zh-TW\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955#primaryimage\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"contentUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"width\":\"3000\",\"height\":\"1990\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=303955#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u9996\u9801\",\"item\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\",\"name\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"description\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831PingtungTimes\uff0c\u6700\u95dc\u5fc3\u5728\u5730\u7684\u5a92\u9ad4\",\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-TW\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\",\"name\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"contentUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"width\":150,\"height\":150,\"caption\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/pingtungnews\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\",\"name\":\"\u7f8e\u901a\u793e\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"caption\":\"\u7f8e\u901a\u793e\"},\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?author=16\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","description":"\u4e0a\u6d772025\u5e743\u670819\u65e5 \/\u7f8e\u901a\u793e\/ -- 2025\u5e743\u670819\u65e5\uff0c\u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u5ba3\u5e03\uff0c\u516c\u53f8\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff08Orphan Drug Designation, ODD\uff09\uff0c\u7528\u65bc\u80c3\u764c\u7684\u6cbb\u7642\u3002 \u7372\u5f97FDA \u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u7684\u85e5\u7269\u5c07\u4eab\u6709\u5305\u62ec\u81e8\u5e8a\u8a66\u9a57\u8cbb\u7528\u7684\u7a05\u6536\u62b5\u514d\u3001\u514d\u9664\u65b0\u85e5\u7533\u8acb\u8cbb\u3001\u7372\u6279\u5f8c\u4e03\u5e74\u7684\u5e02\u5834\u7368\u5360\u6b0a\u7b49\u4e00\u7cfb\u5217\u653f\u7b56\u652f\u6301\uff0c\u4ee5\u52a0\u901f\u5176\u958b\u767c\u9032\u7a0b\uff0c\u65e9\u65e5\u60e0\u53ca\u60a3\u8005\u3002HLX22\u6b64\u6b21\u7372\u5f97\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff0c\u662f\u57fa\u65bc\u5176\u5728\u80c3\u764c\u6cbb\u7642\u9818\u57df\u5c55\u73fe\u51fa\u7684\u5de8\u5927\u6f5b\u529b\u3002\u9019\u662fHLX22\u5168\u7403\u591a\u5730\u76f8\u7e7c\u555f\u52d5\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u8a66\u9a57\u5f8c\uff0c\u53d6\u5f97\u7684\u53c8\u4e00\u91cd\u8981\u88e1\u7a0b\u7891\uff0c\u6a19\u5fd7\u8457\u5176\u5728\u5168\u7403\u8303\u570d\u5167\u7684\u958b\u767c\u9032\u7a0b\u9081\u51fa\u95dc\u9375\u4e00\u6b65\u3002 \u64daGLOBOCAN\u6578\u64da\u986f\u793a\uff0c2022\u5e74\u5168\u7403\u7d04\u6709100\u842c\u80c3\u764c\u65b0\u767c\u75c5\u4f8b\uff0c\u903e66\u842c\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u75be\u75c5\u8ca0\u64d4\u5448\u73fe\u986f\u8457\u5730\u57df\u4e0d\u5e73\u8861\uff0c\u69cb\u6210\u4e86\u4e00\u5927\u5065\u5eb7\u554f\u984c\u3002\u591a\u6578\u80c3\u764c\u60a3\u8005\u65e9\u671f\u75c7\u72c0\u96b1\u533f\uff0c\u78ba\u8a3a\u6642\u5df2\u8655\u65bc\u75be\u75c5\u665a\u671f\uff0c\u7e3d\u9ad4\u9810\u5f8c\u4e0d\u826f\uff0c5\u5e74\u751f\u5b58\u7387\u50c5\u70ba6%\u3002\u76e1\u7ba1\u8fd1\u5e74\u4f86\u9776\u5411\u6cbb\u7642\uff08\u5982\u6297HER2\u85e5\u7269\uff09\u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08\u5982\u6297PD-1\/PD-L1\u55ae\u6297\uff09\u5728\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u53d6\u5f97\u4e86\u986f\u8457\u9032\u5c55\uff0c\u4f46\u9452\u65bc\u8a72\u75be\u75c5\u5177\u6709\u9ad8\u5ea6\u5206\u5b50\u7570\u8cea\u6027\uff0c\u4e0d\u540c\u4e9e\u578b\u60a3\u8005\u5c0d\u5316\u7642\u3001\u9776\u5411\u6cbb\u7642\u548c\u514d\u75ab\u6cbb\u7642\u7684\u53cd\u61c9\u5dee\u7570\u986f\u8457\uff0c\u80c3\u764c\u7684\u6574\u9ad4\u6cbb\u7642\u4ecd\u5b58\u5728\u5de8\u5927\u7684\u672a\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002 HLX22\u662f\u4e00\u6b3e\u9776\u5411HER2\u7684\u5275\u65b0\u578b\u55ae\u514b\u9686\u6297\u9ad4\u3002\u8207\u50b3\u7d71\u7684HER2\u9776\u5411\u7642\u6cd5\u76f8\u6bd4\uff0cHLX22\u5177\u6709\u5dee\u7570\u5316\u7684\u5206\u5b50\u8a2d\u8a08\u548c\u4f5c\u7528\u6a5f\u5236\uff0c\u53ef\u7d50\u5408\u5728HER2\u7684\u80de\u5916\u4e9e\u7d50\u69cb\u57dfIV\uff0c\u4f46\u7d50\u5408\u8868\u4f4d\u8207\u66f2\u59a5\u73e0\u55ae\u6297\u6709\u6240\u4e0d\u540c\uff0c\u4f7f\u5f97\u8a72\u7522\u54c1\u80fd\u5920\u8207\u548c\u66f2\u59a5\u73e0\u55ae\u6297\u540c\u6642\u7d50\u5408\u81f3HER2\uff0c\u4fc3\u9032HER2\u4e8c\u805a\u9ad4\uff08HER2\u540c\u6e90\u4e8c\u805a\u9ad4\u53caHER2\/EGFR\u7570\u6e90\u4e8c\u805a\u9ad4\uff09\u7684\u5167\u541e\u548c\u964d\u89e3\uff0c\u9032\u800c\u7522\u751f\u66f4\u5f37\u7684HER2\u53d7\u9ad4\u963b\u65b7\u6548\u679c\u3002\u6b64\u524d\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u7684HER2\u96d9\u9776\u7642\u6cd5\u5df2\u5728HER2\u967d\u6027\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u5c55\u73fe\u51fa\u512a\u7570\u7684\u7642\u6548\uff0c\u4e00\u9805HLX22\u806f\u5408\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\ufe0f\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u6cbb\u7642HER2\u967d\u6027\u80c3\u764c\u7684II\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-201\uff09\u7d50\u679c\u986f\u793a\uff0c\u5728\u6f22\u66f2\u512a\u00ae\u806f\u7528\u5316\u7642\u7684\u57fa\u790e\u4e0a\u52a0\u5165HLX22\u53ef\u63d0\u9ad8HER2\u967d\u6027G\/GEJ\u764c\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u7684\u751f\u5b58\u671f\u548c\u6297\u816b\u7624\u53cd\u61c9\uff0c\u4e14\u5b89\u5168\u6027\u53ef\u63a7\uff0c\u6709\u671b\u91cd\u5851\u665a\u671f\u80c3\u764c\u7684\u4e00\u7dda\u6a19\u51c6\u6cbb\u7642\u3002\u5f15\u9818HER2\u96d9\u9776\u5411\u7642\u6cd5\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u53ca\u5316\u7642\u4e00\u7dda\u6cbb\u7642HER2\u967d\u6027\u665a\u671f\u80c3\u764c\u7684\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-301\uff09\u5df2\u5206\u5225\u7372\u5f97\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u65e5\u672c\u548c\u6fb3\u5927\u5229\u4e9e\u7b49\u5730\u85e5\u76e3\u6a5f\u69cb\u7684\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57\uff08IND\uff09\u8a31\u53ef\uff0c\u4e26\u5b8c\u6210\u5168\u7403\u9996\u4f8b\u60a3\u8005\u7d66\u85e5\u3002 \u672a\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5c07\u7e7c\u7e8c\u79c9\u6301\"\u4ee5\u60a3\u8005\u70ba\u4e2d\u5fc3\"\u7684\u7406\u5ff5\uff0c\u52a0\u901f\u63a8\u9032HLX22\u7684\u5168\u7403\u7814\u767c\u5e03\u5c40\uff0c\u65e9\u65e5\u5c07\u9019\u4e00\u5275\u65b0\u7642\u6cd5\u5e36\u7d66\u5168\u7403\u60a3\u8005\u3002\u540c\u6642\uff0c\u516c\u53f8\u4e5f\u5c07\u6301\u7e8c\u6df1\u8015\u816b\u7624\u9818\u57df\uff0c\u63a8\u52d5\u66f4\u591a\u5275\u65b0\u85e5\u7269\u7684\u7814\u767c\uff0c\u5e36\u4f86\u66f4\u591a\u9ad8\u8cea\u91cf\u3001\u53ef\u8ca0\u64d4\u7684\u6cbb\u7642\u9078\u64c7\u3002 \u53c3\u8003\u6587\u737b Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022). Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023).\u00a0 Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric\/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200\/JCO.2024.42.3_suppl.354 J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric\/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016\/annonc\/annonc1482 Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. \u95dc\u65bc\u5fa9\u5b8f\u6f22\u9716 \u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u662f\u4e00\u5bb6\u570b\u969b\u5316\u7684\u5275\u65b0\u751f\u7269\u5236\u85e5\u516c\u53f8\uff0c\u81f4\u529b\u65bc\u70ba\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u53ef\u8ca0\u64d4\u7684\u9ad8\u54c1\u8cea\u751f\u7269\u85e5\uff0c\u7522\u54c1\u8986\u84cb\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u3001\u773c\u79d1\u75be\u75c5\u7b49\u9818\u57df\uff0c\u5df2\u67096\u6b3e\u7522\u54c1\u5728\u4e2d\u570b\u7372\u6279\u4e0a\u5e02\uff0c4\u6b3e\u7522\u54c1\u5728\u570b\u969b\u7372\u6279\u4e0a\u5e02\uff0c4\u500b\u4e0a\u5e02\u7533\u8acb\u5206\u5225\u7372\u4e2d\u570b\u85e5\u76e3\u5c40\u3001\u7f8e\u570bFDA\u548c\u6b50\u76dfEMA\u53d7\u7406\u3002\u81ea2010\u5e74\u6210\u7acb\u4ee5\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5df2\u5efa\u6210\u4e00\u9ad4\u5316\u751f\u7269\u5236\u85e5\u5e73\u53f0\uff0c\u9ad8\u6548\u53ca\u5275\u65b0\u7684\u81ea\u4e3b\u6838\u5fc3\u80fd\u529b\u8cab\u7a7f\u7814\u767c\u3001\u751f\u7522\u53ca\u5546\u696d\u904b\u71df\u5168\u7522\u696d\u93c8\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u5b8c\u5584\u9ad8\u6548\u7684\u5168\u7403\u5275\u65b0\u4e2d\u5fc3\uff0c\u6309\u7167\u570b\u969b\u85e5\u54c1\u751f\u7522\u8cea\u91cf\u7ba1\u7406\u898f\u8303\uff08GMP\uff09\u6a19\u51c6\u9032\u884c\u751f\u7522\u548c\u8cea\u91cf\u7ba1\u63a7\uff0c\u4e0d\u65b7\u592f\u5be6\u4e00\u9ad4\u5316\u7d9c\u5408\u751f\u7522\u5e73\u53f0\uff0c\u5176\u4e2d\uff0c\u516c\u53f8\u5546\u696d\u5316\u751f\u7522\u57fa\u5730\u5df2\u76f8\u7e7c\u7372\u5f97\u4e2d\u570b\u3001\u6b50\u76df\u548c\u7f8e\u570bGMP\u8a8d\u8b49\u3002 \u5fa9\u5b8f\u6f22\u9716\u524d\u77bb\u6027\u5e03\u5c40\u4e86\u4e00\u500b\u591a\u5143\u5316\u3001\u9ad8\u8cea\u91cf\u7684\u7522\u54c1\u7ba1\u7dda\uff0c\u6db5\u84cb50\u591a\u500b\u5206\u5b50\uff0c\u4e26\u5168\u9762\u63a8\u9032\u57fa\u65bc\u81ea\u6709\u6297PD-1\u55ae\u6297H\u85e5\u6f22\u65af\u72c0\u00ae\u7684\u816b\u7624\u514d\u75ab\u806f\u5408\u7642\u6cd5\u3002\u622a\u81f3\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u7372\u6279\u4e0a\u5e02\u7522\u54c1\u5305\u62ec\u570b\u5167\u9996\u500b\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u5229\u5eb7\u00ae\uff08\u5229\u59a5\u6614\u55ae\u6297\uff09\u3001\u81ea\u4e3b\u7814\u767c\u7684\u4e2d\u7f8e\u6b50\u4e09\u5730\u7372\u6279\u55ae\u6297\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u3001\u6f22\u9054\u9060\u00ae\uff08\u963f\u9054\u6728\u55ae\u6297\uff09\u3001\u6f22\u8c9d\u6cf0\u00ae\uff08\u8c9d\u4f10\u73e0\u55ae\u6297\uff09\u3001\u5168\u7403\u9996\u500b\u7372\u6279\u4e00\u7dda\u6cbb\u7642\u5c0f\u7d30\u80de\u80ba\u764c\u7684\u6297PD-1\u55ae\u6297\u6f22\u65af\u72c0\u00ae\uff08\u65af\u9b6f\u5229\u55ae\u6297\uff0c\u6b50\u76df\u5546\u54c1\u540d\uff1aHetronifly\u00ae\uff09\u4ee5\u53ca\u6f22\u5948\u4f73\u00ae\uff08\u5948\u62c9\u66ff\u5c3c\uff09\u3002\u516c\u53f8\u4ea6\u540c\u6b65\u5c3116\u500b\u7522\u54c1\u5728\u5168\u7403\u8303\u570d\u5167\u958b\u5c5530\u591a\u9805\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c0d\u5916\u6388\u6b0a\u5168\u9762\u8986\u84cb\u6b50\u7f8e\u4e3b\u6d41\u751f\u7269\u85e5\u5e02\u5834\u548c\u773e\u591a\u65b0\u8208\u5e02\u5834\u3002","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pingtungtimes.com.tw\/?p=303955","og_locale":"zh_TW","og_type":"article","og_title":"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","og_description":"\u4e0a\u6d772025\u5e743\u670819\u65e5 \/\u7f8e\u901a\u793e\/ -- 2025\u5e743\u670819\u65e5\uff0c\u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u5ba3\u5e03\uff0c\u516c\u53f8\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff08Orphan Drug Designation, ODD\uff09\uff0c\u7528\u65bc\u80c3\u764c\u7684\u6cbb\u7642\u3002 \u7372\u5f97FDA \u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u7684\u85e5\u7269\u5c07\u4eab\u6709\u5305\u62ec\u81e8\u5e8a\u8a66\u9a57\u8cbb\u7528\u7684\u7a05\u6536\u62b5\u514d\u3001\u514d\u9664\u65b0\u85e5\u7533\u8acb\u8cbb\u3001\u7372\u6279\u5f8c\u4e03\u5e74\u7684\u5e02\u5834\u7368\u5360\u6b0a\u7b49\u4e00\u7cfb\u5217\u653f\u7b56\u652f\u6301\uff0c\u4ee5\u52a0\u901f\u5176\u958b\u767c\u9032\u7a0b\uff0c\u65e9\u65e5\u60e0\u53ca\u60a3\u8005\u3002HLX22\u6b64\u6b21\u7372\u5f97\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff0c\u662f\u57fa\u65bc\u5176\u5728\u80c3\u764c\u6cbb\u7642\u9818\u57df\u5c55\u73fe\u51fa\u7684\u5de8\u5927\u6f5b\u529b\u3002\u9019\u662fHLX22\u5168\u7403\u591a\u5730\u76f8\u7e7c\u555f\u52d5\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u8a66\u9a57\u5f8c\uff0c\u53d6\u5f97\u7684\u53c8\u4e00\u91cd\u8981\u88e1\u7a0b\u7891\uff0c\u6a19\u5fd7\u8457\u5176\u5728\u5168\u7403\u8303\u570d\u5167\u7684\u958b\u767c\u9032\u7a0b\u9081\u51fa\u95dc\u9375\u4e00\u6b65\u3002 \u64daGLOBOCAN\u6578\u64da\u986f\u793a\uff0c2022\u5e74\u5168\u7403\u7d04\u6709100\u842c\u80c3\u764c\u65b0\u767c\u75c5\u4f8b\uff0c\u903e66\u842c\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u75be\u75c5\u8ca0\u64d4\u5448\u73fe\u986f\u8457\u5730\u57df\u4e0d\u5e73\u8861\uff0c\u69cb\u6210\u4e86\u4e00\u5927\u5065\u5eb7\u554f\u984c\u3002\u591a\u6578\u80c3\u764c\u60a3\u8005\u65e9\u671f\u75c7\u72c0\u96b1\u533f\uff0c\u78ba\u8a3a\u6642\u5df2\u8655\u65bc\u75be\u75c5\u665a\u671f\uff0c\u7e3d\u9ad4\u9810\u5f8c\u4e0d\u826f\uff0c5\u5e74\u751f\u5b58\u7387\u50c5\u70ba6%\u3002\u76e1\u7ba1\u8fd1\u5e74\u4f86\u9776\u5411\u6cbb\u7642\uff08\u5982\u6297HER2\u85e5\u7269\uff09\u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08\u5982\u6297PD-1\/PD-L1\u55ae\u6297\uff09\u5728\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u53d6\u5f97\u4e86\u986f\u8457\u9032\u5c55\uff0c\u4f46\u9452\u65bc\u8a72\u75be\u75c5\u5177\u6709\u9ad8\u5ea6\u5206\u5b50\u7570\u8cea\u6027\uff0c\u4e0d\u540c\u4e9e\u578b\u60a3\u8005\u5c0d\u5316\u7642\u3001\u9776\u5411\u6cbb\u7642\u548c\u514d\u75ab\u6cbb\u7642\u7684\u53cd\u61c9\u5dee\u7570\u986f\u8457\uff0c\u80c3\u764c\u7684\u6574\u9ad4\u6cbb\u7642\u4ecd\u5b58\u5728\u5de8\u5927\u7684\u672a\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002 HLX22\u662f\u4e00\u6b3e\u9776\u5411HER2\u7684\u5275\u65b0\u578b\u55ae\u514b\u9686\u6297\u9ad4\u3002\u8207\u50b3\u7d71\u7684HER2\u9776\u5411\u7642\u6cd5\u76f8\u6bd4\uff0cHLX22\u5177\u6709\u5dee\u7570\u5316\u7684\u5206\u5b50\u8a2d\u8a08\u548c\u4f5c\u7528\u6a5f\u5236\uff0c\u53ef\u7d50\u5408\u5728HER2\u7684\u80de\u5916\u4e9e\u7d50\u69cb\u57dfIV\uff0c\u4f46\u7d50\u5408\u8868\u4f4d\u8207\u66f2\u59a5\u73e0\u55ae\u6297\u6709\u6240\u4e0d\u540c\uff0c\u4f7f\u5f97\u8a72\u7522\u54c1\u80fd\u5920\u8207\u548c\u66f2\u59a5\u73e0\u55ae\u6297\u540c\u6642\u7d50\u5408\u81f3HER2\uff0c\u4fc3\u9032HER2\u4e8c\u805a\u9ad4\uff08HER2\u540c\u6e90\u4e8c\u805a\u9ad4\u53caHER2\/EGFR\u7570\u6e90\u4e8c\u805a\u9ad4\uff09\u7684\u5167\u541e\u548c\u964d\u89e3\uff0c\u9032\u800c\u7522\u751f\u66f4\u5f37\u7684HER2\u53d7\u9ad4\u963b\u65b7\u6548\u679c\u3002\u6b64\u524d\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u7684HER2\u96d9\u9776\u7642\u6cd5\u5df2\u5728HER2\u967d\u6027\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u5c55\u73fe\u51fa\u512a\u7570\u7684\u7642\u6548\uff0c\u4e00\u9805HLX22\u806f\u5408\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\ufe0f\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u6cbb\u7642HER2\u967d\u6027\u80c3\u764c\u7684II\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-201\uff09\u7d50\u679c\u986f\u793a\uff0c\u5728\u6f22\u66f2\u512a\u00ae\u806f\u7528\u5316\u7642\u7684\u57fa\u790e\u4e0a\u52a0\u5165HLX22\u53ef\u63d0\u9ad8HER2\u967d\u6027G\/GEJ\u764c\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u7684\u751f\u5b58\u671f\u548c\u6297\u816b\u7624\u53cd\u61c9\uff0c\u4e14\u5b89\u5168\u6027\u53ef\u63a7\uff0c\u6709\u671b\u91cd\u5851\u665a\u671f\u80c3\u764c\u7684\u4e00\u7dda\u6a19\u51c6\u6cbb\u7642\u3002\u5f15\u9818HER2\u96d9\u9776\u5411\u7642\u6cd5\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u53ca\u5316\u7642\u4e00\u7dda\u6cbb\u7642HER2\u967d\u6027\u665a\u671f\u80c3\u764c\u7684\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-301\uff09\u5df2\u5206\u5225\u7372\u5f97\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u65e5\u672c\u548c\u6fb3\u5927\u5229\u4e9e\u7b49\u5730\u85e5\u76e3\u6a5f\u69cb\u7684\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57\uff08IND\uff09\u8a31\u53ef\uff0c\u4e26\u5b8c\u6210\u5168\u7403\u9996\u4f8b\u60a3\u8005\u7d66\u85e5\u3002 \u672a\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5c07\u7e7c\u7e8c\u79c9\u6301\"\u4ee5\u60a3\u8005\u70ba\u4e2d\u5fc3\"\u7684\u7406\u5ff5\uff0c\u52a0\u901f\u63a8\u9032HLX22\u7684\u5168\u7403\u7814\u767c\u5e03\u5c40\uff0c\u65e9\u65e5\u5c07\u9019\u4e00\u5275\u65b0\u7642\u6cd5\u5e36\u7d66\u5168\u7403\u60a3\u8005\u3002\u540c\u6642\uff0c\u516c\u53f8\u4e5f\u5c07\u6301\u7e8c\u6df1\u8015\u816b\u7624\u9818\u57df\uff0c\u63a8\u52d5\u66f4\u591a\u5275\u65b0\u85e5\u7269\u7684\u7814\u767c\uff0c\u5e36\u4f86\u66f4\u591a\u9ad8\u8cea\u91cf\u3001\u53ef\u8ca0\u64d4\u7684\u6cbb\u7642\u9078\u64c7\u3002 \u53c3\u8003\u6587\u737b Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022). Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023).\u00a0 Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric\/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200\/JCO.2024.42.3_suppl.354 J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric\/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016\/annonc\/annonc1482 Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. \u95dc\u65bc\u5fa9\u5b8f\u6f22\u9716 \u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u662f\u4e00\u5bb6\u570b\u969b\u5316\u7684\u5275\u65b0\u751f\u7269\u5236\u85e5\u516c\u53f8\uff0c\u81f4\u529b\u65bc\u70ba\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u53ef\u8ca0\u64d4\u7684\u9ad8\u54c1\u8cea\u751f\u7269\u85e5\uff0c\u7522\u54c1\u8986\u84cb\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u3001\u773c\u79d1\u75be\u75c5\u7b49\u9818\u57df\uff0c\u5df2\u67096\u6b3e\u7522\u54c1\u5728\u4e2d\u570b\u7372\u6279\u4e0a\u5e02\uff0c4\u6b3e\u7522\u54c1\u5728\u570b\u969b\u7372\u6279\u4e0a\u5e02\uff0c4\u500b\u4e0a\u5e02\u7533\u8acb\u5206\u5225\u7372\u4e2d\u570b\u85e5\u76e3\u5c40\u3001\u7f8e\u570bFDA\u548c\u6b50\u76dfEMA\u53d7\u7406\u3002\u81ea2010\u5e74\u6210\u7acb\u4ee5\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5df2\u5efa\u6210\u4e00\u9ad4\u5316\u751f\u7269\u5236\u85e5\u5e73\u53f0\uff0c\u9ad8\u6548\u53ca\u5275\u65b0\u7684\u81ea\u4e3b\u6838\u5fc3\u80fd\u529b\u8cab\u7a7f\u7814\u767c\u3001\u751f\u7522\u53ca\u5546\u696d\u904b\u71df\u5168\u7522\u696d\u93c8\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u5b8c\u5584\u9ad8\u6548\u7684\u5168\u7403\u5275\u65b0\u4e2d\u5fc3\uff0c\u6309\u7167\u570b\u969b\u85e5\u54c1\u751f\u7522\u8cea\u91cf\u7ba1\u7406\u898f\u8303\uff08GMP\uff09\u6a19\u51c6\u9032\u884c\u751f\u7522\u548c\u8cea\u91cf\u7ba1\u63a7\uff0c\u4e0d\u65b7\u592f\u5be6\u4e00\u9ad4\u5316\u7d9c\u5408\u751f\u7522\u5e73\u53f0\uff0c\u5176\u4e2d\uff0c\u516c\u53f8\u5546\u696d\u5316\u751f\u7522\u57fa\u5730\u5df2\u76f8\u7e7c\u7372\u5f97\u4e2d\u570b\u3001\u6b50\u76df\u548c\u7f8e\u570bGMP\u8a8d\u8b49\u3002 \u5fa9\u5b8f\u6f22\u9716\u524d\u77bb\u6027\u5e03\u5c40\u4e86\u4e00\u500b\u591a\u5143\u5316\u3001\u9ad8\u8cea\u91cf\u7684\u7522\u54c1\u7ba1\u7dda\uff0c\u6db5\u84cb50\u591a\u500b\u5206\u5b50\uff0c\u4e26\u5168\u9762\u63a8\u9032\u57fa\u65bc\u81ea\u6709\u6297PD-1\u55ae\u6297H\u85e5\u6f22\u65af\u72c0\u00ae\u7684\u816b\u7624\u514d\u75ab\u806f\u5408\u7642\u6cd5\u3002\u622a\u81f3\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u7372\u6279\u4e0a\u5e02\u7522\u54c1\u5305\u62ec\u570b\u5167\u9996\u500b\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u5229\u5eb7\u00ae\uff08\u5229\u59a5\u6614\u55ae\u6297\uff09\u3001\u81ea\u4e3b\u7814\u767c\u7684\u4e2d\u7f8e\u6b50\u4e09\u5730\u7372\u6279\u55ae\u6297\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u3001\u6f22\u9054\u9060\u00ae\uff08\u963f\u9054\u6728\u55ae\u6297\uff09\u3001\u6f22\u8c9d\u6cf0\u00ae\uff08\u8c9d\u4f10\u73e0\u55ae\u6297\uff09\u3001\u5168\u7403\u9996\u500b\u7372\u6279\u4e00\u7dda\u6cbb\u7642\u5c0f\u7d30\u80de\u80ba\u764c\u7684\u6297PD-1\u55ae\u6297\u6f22\u65af\u72c0\u00ae\uff08\u65af\u9b6f\u5229\u55ae\u6297\uff0c\u6b50\u76df\u5546\u54c1\u540d\uff1aHetronifly\u00ae\uff09\u4ee5\u53ca\u6f22\u5948\u4f73\u00ae\uff08\u5948\u62c9\u66ff\u5c3c\uff09\u3002\u516c\u53f8\u4ea6\u540c\u6b65\u5c3116\u500b\u7522\u54c1\u5728\u5168\u7403\u8303\u570d\u5167\u958b\u5c5530\u591a\u9805\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c0d\u5916\u6388\u6b0a\u5168\u9762\u8986\u84cb\u6b50\u7f8e\u4e3b\u6d41\u751f\u7269\u85e5\u5e02\u5834\u548c\u773e\u591a\u65b0\u8208\u5e02\u5834\u3002","og_url":"https:\/\/pingtungtimes.com.tw\/?p=303955","og_site_name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","article_publisher":"https:\/\/www.facebook.com\/pingtungnews","article_published_time":"2025-03-19T15:16:00+00:00","og_image":[{"url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","type":"","width":"","height":""}],"author":"\u7f8e\u901a\u793e","twitter_card":"summary_large_image","twitter_image":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","twitter_misc":{"\u4f5c\u8005:":"\u7f8e\u901a\u793e","\u9810\u4f30\u95b1\u8b80\u6642\u9593":"1 \u5206\u9418"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"NewsArticle","@id":"https:\/\/pingtungtimes.com.tw\/?p=303955#article","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=303955"},"author":{"name":"\u7f8e\u901a\u793e","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/person\/683b937f29ec1537972f6c41e22a2cf3"},"headline":"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a","datePublished":"2025-03-19T15:16:00+00:00","mainEntityOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=303955"},"wordCount":232,"publisher":{"@id":"https:\/\/pingtungtimes.com.tw\/#organization"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=303955#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","articleSection":["\u7f8e\u901a\u793e"],"inLanguage":"zh-TW"},{"@type":"WebPage","@id":"https:\/\/pingtungtimes.com.tw\/?p=303955","url":"https:\/\/pingtungtimes.com.tw\/?p=303955","name":"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=303955#primaryimage"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=303955#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","datePublished":"2025-03-19T15:16:00+00:00","description":"\u4e0a\u6d772025\u5e743\u670819\u65e5 \/\u7f8e\u901a\u793e\/ -- 2025\u5e743\u670819\u65e5\uff0c\u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u5ba3\u5e03\uff0c\u516c\u53f8\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff08Orphan Drug Designation, ODD\uff09\uff0c\u7528\u65bc\u80c3\u764c\u7684\u6cbb\u7642\u3002 \u7372\u5f97FDA \u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u7684\u85e5\u7269\u5c07\u4eab\u6709\u5305\u62ec\u81e8\u5e8a\u8a66\u9a57\u8cbb\u7528\u7684\u7a05\u6536\u62b5\u514d\u3001\u514d\u9664\u65b0\u85e5\u7533\u8acb\u8cbb\u3001\u7372\u6279\u5f8c\u4e03\u5e74\u7684\u5e02\u5834\u7368\u5360\u6b0a\u7b49\u4e00\u7cfb\u5217\u653f\u7b56\u652f\u6301\uff0c\u4ee5\u52a0\u901f\u5176\u958b\u767c\u9032\u7a0b\uff0c\u65e9\u65e5\u60e0\u53ca\u60a3\u8005\u3002HLX22\u6b64\u6b21\u7372\u5f97\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\uff0c\u662f\u57fa\u65bc\u5176\u5728\u80c3\u764c\u6cbb\u7642\u9818\u57df\u5c55\u73fe\u51fa\u7684\u5de8\u5927\u6f5b\u529b\u3002\u9019\u662fHLX22\u5168\u7403\u591a\u5730\u76f8\u7e7c\u555f\u52d5\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u8a66\u9a57\u5f8c\uff0c\u53d6\u5f97\u7684\u53c8\u4e00\u91cd\u8981\u88e1\u7a0b\u7891\uff0c\u6a19\u5fd7\u8457\u5176\u5728\u5168\u7403\u8303\u570d\u5167\u7684\u958b\u767c\u9032\u7a0b\u9081\u51fa\u95dc\u9375\u4e00\u6b65\u3002 \u64daGLOBOCAN\u6578\u64da\u986f\u793a\uff0c2022\u5e74\u5168\u7403\u7d04\u6709100\u842c\u80c3\u764c\u65b0\u767c\u75c5\u4f8b\uff0c\u903e66\u842c\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u75be\u75c5\u8ca0\u64d4\u5448\u73fe\u986f\u8457\u5730\u57df\u4e0d\u5e73\u8861\uff0c\u69cb\u6210\u4e86\u4e00\u5927\u5065\u5eb7\u554f\u984c\u3002\u591a\u6578\u80c3\u764c\u60a3\u8005\u65e9\u671f\u75c7\u72c0\u96b1\u533f\uff0c\u78ba\u8a3a\u6642\u5df2\u8655\u65bc\u75be\u75c5\u665a\u671f\uff0c\u7e3d\u9ad4\u9810\u5f8c\u4e0d\u826f\uff0c5\u5e74\u751f\u5b58\u7387\u50c5\u70ba6%\u3002\u76e1\u7ba1\u8fd1\u5e74\u4f86\u9776\u5411\u6cbb\u7642\uff08\u5982\u6297HER2\u85e5\u7269\uff09\u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08\u5982\u6297PD-1\/PD-L1\u55ae\u6297\uff09\u5728\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u53d6\u5f97\u4e86\u986f\u8457\u9032\u5c55\uff0c\u4f46\u9452\u65bc\u8a72\u75be\u75c5\u5177\u6709\u9ad8\u5ea6\u5206\u5b50\u7570\u8cea\u6027\uff0c\u4e0d\u540c\u4e9e\u578b\u60a3\u8005\u5c0d\u5316\u7642\u3001\u9776\u5411\u6cbb\u7642\u548c\u514d\u75ab\u6cbb\u7642\u7684\u53cd\u61c9\u5dee\u7570\u986f\u8457\uff0c\u80c3\u764c\u7684\u6574\u9ad4\u6cbb\u7642\u4ecd\u5b58\u5728\u5de8\u5927\u7684\u672a\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002 HLX22\u662f\u4e00\u6b3e\u9776\u5411HER2\u7684\u5275\u65b0\u578b\u55ae\u514b\u9686\u6297\u9ad4\u3002\u8207\u50b3\u7d71\u7684HER2\u9776\u5411\u7642\u6cd5\u76f8\u6bd4\uff0cHLX22\u5177\u6709\u5dee\u7570\u5316\u7684\u5206\u5b50\u8a2d\u8a08\u548c\u4f5c\u7528\u6a5f\u5236\uff0c\u53ef\u7d50\u5408\u5728HER2\u7684\u80de\u5916\u4e9e\u7d50\u69cb\u57dfIV\uff0c\u4f46\u7d50\u5408\u8868\u4f4d\u8207\u66f2\u59a5\u73e0\u55ae\u6297\u6709\u6240\u4e0d\u540c\uff0c\u4f7f\u5f97\u8a72\u7522\u54c1\u80fd\u5920\u8207\u548c\u66f2\u59a5\u73e0\u55ae\u6297\u540c\u6642\u7d50\u5408\u81f3HER2\uff0c\u4fc3\u9032HER2\u4e8c\u805a\u9ad4\uff08HER2\u540c\u6e90\u4e8c\u805a\u9ad4\u53caHER2\/EGFR\u7570\u6e90\u4e8c\u805a\u9ad4\uff09\u7684\u5167\u541e\u548c\u964d\u89e3\uff0c\u9032\u800c\u7522\u751f\u66f4\u5f37\u7684HER2\u53d7\u9ad4\u963b\u65b7\u6548\u679c\u3002\u6b64\u524d\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u7684HER2\u96d9\u9776\u7642\u6cd5\u5df2\u5728HER2\u967d\u6027\u80c3\u764c\u7684\u6cbb\u7642\u4e2d\u5c55\u73fe\u51fa\u512a\u7570\u7684\u7642\u6548\uff0c\u4e00\u9805HLX22\u806f\u5408\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\ufe0f\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u6cbb\u7642HER2\u967d\u6027\u80c3\u764c\u7684II\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-201\uff09\u7d50\u679c\u986f\u793a\uff0c\u5728\u6f22\u66f2\u512a\u00ae\u806f\u7528\u5316\u7642\u7684\u57fa\u790e\u4e0a\u52a0\u5165HLX22\u53ef\u63d0\u9ad8HER2\u967d\u6027G\/GEJ\u764c\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u7684\u751f\u5b58\u671f\u548c\u6297\u816b\u7624\u53cd\u61c9\uff0c\u4e14\u5b89\u5168\u6027\u53ef\u63a7\uff0c\u6709\u671b\u91cd\u5851\u665a\u671f\u80c3\u764c\u7684\u4e00\u7dda\u6a19\u51c6\u6cbb\u7642\u3002\u5f15\u9818HER2\u96d9\u9776\u5411\u7642\u6cd5\uff0cHLX22\u806f\u5408\u66f2\u59a5\u73e0\u55ae\u6297\u53ca\u5316\u7642\u4e00\u7dda\u6cbb\u7642HER2\u967d\u6027\u665a\u671f\u80c3\u764c\u7684\u570b\u969b\u591a\u4e2d\u5fc3III\u671f\u81e8\u5e8a\u7814\u7a76\uff08HLX22-GC-301\uff09\u5df2\u5206\u5225\u7372\u5f97\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u65e5\u672c\u548c\u6fb3\u5927\u5229\u4e9e\u7b49\u5730\u85e5\u76e3\u6a5f\u69cb\u7684\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57\uff08IND\uff09\u8a31\u53ef\uff0c\u4e26\u5b8c\u6210\u5168\u7403\u9996\u4f8b\u60a3\u8005\u7d66\u85e5\u3002 \u672a\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5c07\u7e7c\u7e8c\u79c9\u6301\"\u4ee5\u60a3\u8005\u70ba\u4e2d\u5fc3\"\u7684\u7406\u5ff5\uff0c\u52a0\u901f\u63a8\u9032HLX22\u7684\u5168\u7403\u7814\u767c\u5e03\u5c40\uff0c\u65e9\u65e5\u5c07\u9019\u4e00\u5275\u65b0\u7642\u6cd5\u5e36\u7d66\u5168\u7403\u60a3\u8005\u3002\u540c\u6642\uff0c\u516c\u53f8\u4e5f\u5c07\u6301\u7e8c\u6df1\u8015\u816b\u7624\u9818\u57df\uff0c\u63a8\u52d5\u66f4\u591a\u5275\u65b0\u85e5\u7269\u7684\u7814\u767c\uff0c\u5e36\u4f86\u66f4\u591a\u9ad8\u8cea\u91cf\u3001\u53ef\u8ca0\u64d4\u7684\u6cbb\u7642\u9078\u64c7\u3002 \u53c3\u8003\u6587\u737b Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022). Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023).\u00a0 Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric\/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200\/JCO.2024.42.3_suppl.354 J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric\/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016\/annonc\/annonc1482 Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. \u95dc\u65bc\u5fa9\u5b8f\u6f22\u9716 \u5fa9\u5b8f\u6f22\u9716\uff082696.HK\uff09\u662f\u4e00\u5bb6\u570b\u969b\u5316\u7684\u5275\u65b0\u751f\u7269\u5236\u85e5\u516c\u53f8\uff0c\u81f4\u529b\u65bc\u70ba\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u53ef\u8ca0\u64d4\u7684\u9ad8\u54c1\u8cea\u751f\u7269\u85e5\uff0c\u7522\u54c1\u8986\u84cb\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u3001\u773c\u79d1\u75be\u75c5\u7b49\u9818\u57df\uff0c\u5df2\u67096\u6b3e\u7522\u54c1\u5728\u4e2d\u570b\u7372\u6279\u4e0a\u5e02\uff0c4\u6b3e\u7522\u54c1\u5728\u570b\u969b\u7372\u6279\u4e0a\u5e02\uff0c4\u500b\u4e0a\u5e02\u7533\u8acb\u5206\u5225\u7372\u4e2d\u570b\u85e5\u76e3\u5c40\u3001\u7f8e\u570bFDA\u548c\u6b50\u76dfEMA\u53d7\u7406\u3002\u81ea2010\u5e74\u6210\u7acb\u4ee5\u4f86\uff0c\u5fa9\u5b8f\u6f22\u9716\u5df2\u5efa\u6210\u4e00\u9ad4\u5316\u751f\u7269\u5236\u85e5\u5e73\u53f0\uff0c\u9ad8\u6548\u53ca\u5275\u65b0\u7684\u81ea\u4e3b\u6838\u5fc3\u80fd\u529b\u8cab\u7a7f\u7814\u767c\u3001\u751f\u7522\u53ca\u5546\u696d\u904b\u71df\u5168\u7522\u696d\u93c8\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u5b8c\u5584\u9ad8\u6548\u7684\u5168\u7403\u5275\u65b0\u4e2d\u5fc3\uff0c\u6309\u7167\u570b\u969b\u85e5\u54c1\u751f\u7522\u8cea\u91cf\u7ba1\u7406\u898f\u8303\uff08GMP\uff09\u6a19\u51c6\u9032\u884c\u751f\u7522\u548c\u8cea\u91cf\u7ba1\u63a7\uff0c\u4e0d\u65b7\u592f\u5be6\u4e00\u9ad4\u5316\u7d9c\u5408\u751f\u7522\u5e73\u53f0\uff0c\u5176\u4e2d\uff0c\u516c\u53f8\u5546\u696d\u5316\u751f\u7522\u57fa\u5730\u5df2\u76f8\u7e7c\u7372\u5f97\u4e2d\u570b\u3001\u6b50\u76df\u548c\u7f8e\u570bGMP\u8a8d\u8b49\u3002 \u5fa9\u5b8f\u6f22\u9716\u524d\u77bb\u6027\u5e03\u5c40\u4e86\u4e00\u500b\u591a\u5143\u5316\u3001\u9ad8\u8cea\u91cf\u7684\u7522\u54c1\u7ba1\u7dda\uff0c\u6db5\u84cb50\u591a\u500b\u5206\u5b50\uff0c\u4e26\u5168\u9762\u63a8\u9032\u57fa\u65bc\u81ea\u6709\u6297PD-1\u55ae\u6297H\u85e5\u6f22\u65af\u72c0\u00ae\u7684\u816b\u7624\u514d\u75ab\u806f\u5408\u7642\u6cd5\u3002\u622a\u81f3\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u7372\u6279\u4e0a\u5e02\u7522\u54c1\u5305\u62ec\u570b\u5167\u9996\u500b\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u5229\u5eb7\u00ae\uff08\u5229\u59a5\u6614\u55ae\u6297\uff09\u3001\u81ea\u4e3b\u7814\u767c\u7684\u4e2d\u7f8e\u6b50\u4e09\u5730\u7372\u6279\u55ae\u6297\u751f\u7269\u985e\u4f3c\u85e5\u6f22\u66f2\u512a\u00ae\uff08\u66f2\u59a5\u73e0\u55ae\u6297\uff0c\u7f8e\u570b\u5546\u54c1\u540d\uff1aHERCESSI\u2122\uff0c\u6b50\u6d32\u5546\u54c1\u540d\uff1aZercepac\u00ae\uff09\u3001\u6f22\u9054\u9060\u00ae\uff08\u963f\u9054\u6728\u55ae\u6297\uff09\u3001\u6f22\u8c9d\u6cf0\u00ae\uff08\u8c9d\u4f10\u73e0\u55ae\u6297\uff09\u3001\u5168\u7403\u9996\u500b\u7372\u6279\u4e00\u7dda\u6cbb\u7642\u5c0f\u7d30\u80de\u80ba\u764c\u7684\u6297PD-1\u55ae\u6297\u6f22\u65af\u72c0\u00ae\uff08\u65af\u9b6f\u5229\u55ae\u6297\uff0c\u6b50\u76df\u5546\u54c1\u540d\uff1aHetronifly\u00ae\uff09\u4ee5\u53ca\u6f22\u5948\u4f73\u00ae\uff08\u5948\u62c9\u66ff\u5c3c\uff09\u3002\u516c\u53f8\u4ea6\u540c\u6b65\u5c3116\u500b\u7522\u54c1\u5728\u5168\u7403\u8303\u570d\u5167\u958b\u5c5530\u591a\u9805\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c0d\u5916\u6388\u6b0a\u5168\u9762\u8986\u84cb\u6b50\u7f8e\u4e3b\u6d41\u751f\u7269\u85e5\u5e02\u5834\u548c\u773e\u591a\u65b0\u8208\u5e02\u5834\u3002","breadcrumb":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=303955#breadcrumb"},"inLanguage":"zh-TW","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pingtungtimes.com.tw\/?p=303955"]}]},{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/pingtungtimes.com.tw\/?p=303955#primaryimage","url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","contentUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","width":"3000","height":"1990"},{"@type":"BreadcrumbList","@id":"https:\/\/pingtungtimes.com.tw\/?p=303955#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u9996\u9801","item":"https:\/\/pingtungtimes.com.tw\/"},{"@type":"ListItem","position":2,"name":"\u6709\u671b\u91cd\u5851\u80c3\u764c\u6a19\u51c6\u6cbb\u7642\uff0c\u5fa9\u5b8f\u6f22\u9716\u5275\u65b0\u578b\u6297HER2\u55ae\u6297HLX22\u7372\u7f8e\u570bFDA\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a"}]},{"@type":"WebSite","@id":"https:\/\/pingtungtimes.com.tw\/#website","url":"https:\/\/pingtungtimes.com.tw\/","name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","description":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831PingtungTimes\uff0c\u6700\u95dc\u5fc3\u5728\u5730\u7684\u5a92\u9ad4","publisher":{"@id":"https:\/\/pingtungtimes.com.tw\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pingtungtimes.com.tw\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-TW"},{"@type":"Organization","@id":"https:\/\/pingtungtimes.com.tw\/#organization","name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","url":"https:\/\/pingtungtimes.com.tw\/","logo":{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/logo\/image\/","url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","contentUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","width":150,"height":150,"caption":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/pingtungnews"]},{"@type":"Person","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/person\/683b937f29ec1537972f6c41e22a2cf3","name":"\u7f8e\u901a\u793e","image":{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","caption":"\u7f8e\u901a\u793e"},"url":"https:\/\/pingtungtimes.com.tw\/?author=16"}]}},"_links":{"self":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts\/303955","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=303955"}],"version-history":[{"count":0,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts\/303955\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/media\/199219"}],"wp:attachment":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=303955"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=303955"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=303955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}