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1\uff08ROS1\uff09\u967d\u6027\u665a\u671fNSCLC\u7684\u95dc\u9375\u7814\u7a76\u5728\u4e2d\u570b\u5927\u9678\u5b8c\u6210\u60a3\u8005\u62db\u52df\u4ee5\u53canofazinlimab\u8207LENVIMA<sup>\u00ae <\/sup>(lenvatinib)\u806f\u5408\u7642\u6cd5\u7528\u65bc\u4e00\u7dda\u665a\u671f\u809d\u7d30\u80de\u764c\uff08HCC\uff09\u7684\u5168\u7403III\u671f\u8a66\u9a57\u7684\u81e8\u5e8a\u7814\u7a76\u7a69\u6b65\u63a8\u9032<\/li>\n<li>\u65bc\u5168\u7403\u5b78\u8853\u6703\u8b70\uff08\u5982ESMO\u4e16\u754c\u80c3\u8178\u9053\u816b\u7624\u5927\u6703\uff08ESMO GI\u5927\u6703\uff09\u5c55\u793a\u6216\u65bc\u9802\u5c16\u91ab\u5b78\u671f\u520a\uff08\u5982\u300a\u81e8\u5e8a\u816b\u7624\u5b78\u96dc\u5fd7\u300b\u3001\u300aNature 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\u6211\u5011\u7e7c\u7e8c\u8207\u570b\u85e5\u63a7\u80a1\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u570b\u85e5\u63a7\u80a1\uff09\u9032\u884c\u6230\u7565\u5408\u4f5c\uff0c\u4e26\u8207\u4e0a\u6d77\u91ab\u85e5\u96c6\u5718\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u4e0a\u6d77\u91ab\u85e5\uff09\u5efa\u7acb\u65b0\u5408\u4f5c\u4f19\u4f34\u95dc\u7cfb\uff0c\u4ee5\u64f4\u5927\u666e\u5409\u83ef<sup>\u00ae<\/sup>\uff08\u666e\u62c9\u66ff\u5c3c\uff09\u3001\u6cf0\u5409\u83ef<sup>\u00ae<\/sup>\uff08\u963f\u4f10\u66ff\u5c3c\uff09\u53ca\u62d3\u8212\u6c83<sup>\u00ae<\/sup>\uff08\u827e\u4f0f\u5c3c\u5e03\uff09\u65bc\u91ab\u9662\u53ca\u85e5\u5e97\u7684\u5206\u92b7\u8303\u570d\u3002\u622a\u81f3\u672c\u516c\u544a\u65e5\u671f\uff0c\u6cf0\u5409\u83ef<sup>\u00ae<\/sup>\uff08\u963f\u4f10\u66ff\u5c3c\uff09\u3001\u666e\u5409\u83ef<sup>\u00ae<\/sup>\uff08\u666e\u62c9\u66ff\u5c3c\uff09\u53ca\u62d3\u8212\u6c83<sup>\u00ae<\/sup>\uff08\u827e\u4f0f\u5c3c\u5e03\uff09\u5df2\u5b8c\u6210\u7d04300\u5bb6\u91ab\u9662\u53ca\u76f4\u9054\u60a3\u8005\u5c08\u696d\u85e5\u623f\uff08DTP\uff09\u5217\u540d\uff0c\u8f032022\u5e74\u7684\u7d04220\u5bb6\u9032\u4e00\u6b65\u63d0\u5347\u3002<\/p>\n<p><b>\u2022<\/b><b>\u00a0\u00a0\u00a0\u00a0\u00a0 \u5c0d\u60a3\u8005\u9032\u884c\u6301\u7e8c\u6559\u80b2\u53ca\u652f\u6301\u4ee5\u63d0\u9ad8\u4f9d\u5f9e\u53caDOT<\/b><\/p>\n<p>\u6211\u5011\u901a\u904e\u7dda\u4e0a\u60a3\u8005\u793e\u5340\u53ca\u7dda\u4e0b\u6559\u80b2\u6d3b\u52d5\u4e0d\u65b7\u52aa\u529b\u70ba\u60a3\u8005\u63d0\u4f9b\u652f\u6301\uff0c\u4ee5\u63d0\u9ad8\u60a3\u8005\u4f9d\u5f9e\u6027\u53caDOT\u3002\u622a\u81f3\u672c\u516c\u544a\u65e5\u671f\uff0c\u6211\u5011\u7684\u7dda\u4e0a\u5e73\u53f0\u64c1\u6709\u903e8,000\u540d\u8a02\u95b1\u8005\uff0c\u4e26\u5df2\u81ea\u555f\u52d5\u6642\u767c\u5e03\u8d85\u904e330\u500b\u60a3\u8005\u6545\u4e8b\u53ca\u8cc7\u8a0a\u3002\u6211\u5011\u5df2\u8209\u8fa6\u7d04200\u6b21\u60a3\u8005\u6559\u80b2\u6d3b\u52d5\uff0c\u8986\u84cb20,000\u540d\u6f5b\u5728\u60a3\u8005\u3002<\/p>\n<p><b>\u2022<\/b><b>\u00a0\u00a0\u00a0\u00a0\u00a0 \u8207\u8f1d\u745e\u5c31\u8212\u683c\u5229\u55ae\u6297\u5728\u4e2d\u570b\u7684\u5546\u696d\u5316\u9032\u884c\u5408\u4f5c<\/b><\/p>\n<p>&#8211;\u00a0 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<b>\u8212\u683c\u5229\u55ae\u6297<\/b>\uff08CS1001\uff0cPD-L1\u6297\u9ad4\uff09\uff0c\u65b0\u9069\u61c9\u75c7\u6b63\u5728\u5be9\u8a55\u4e2d\u4e26\u6b63\u64f4\u5c55\u81f3\u6b50\u6d32\u53ca\u82f1\u570b\u3002<\/p>\n<p>&#8211;\u00a0 <b>IV\u671fNSCLC\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li>\u5728\u5927\u4e2d\u83ef\u5340\u4ee5\u5916\u7684\u5e02\u5834\uff0cIV\u671fNSCLC\u9069\u61c9\u75c7\u7684\u4e0a\u5e02\u8a31\u53ef\u7533\u8acb\uff08MAA\uff09\u6b63\u5728\u591a\u500b\u570b\u5bb6\u53ca\u5730\u5340\u7684\u76e3\u7ba1\u6a5f\u69cb\u5be9\u8a55\u30022023\u5e742\u6708\u53ca2022\u5e7412\u6708\uff0c\u8212\u683c\u5229\u55ae\u6297\u806f\u5408\u5316\u7642\u4e00\u7dda\u6cbb\u7642\u8f49\u79fb\u6027NSCLC\u60a3\u8005\u7684MAA\u7372EMA\u53ca\u82f1\u570b\u85e5\u54c1\u548c\u91ab\u7642\u4fdd\u5065\u7528\u54c1\u7ba1\u7406\u5c40\uff08MHRA\uff09\u53d7\u7406\u3002\u76ee\u524d\uff0c\u6b64\u9069\u61c9\u75c7\u6b63\u5728\u96d9\u65b9\u5be9\u8a55\u4e2d\u30022023\u5e747\u6708\uff0c\u6211\u5011\u6536\u5230\u4f86\u81ea\u6b50\u76dfEMA\u5c31\u6b64\u9069\u61c9\u75c7\u9032\u884cGCP\u6aa2\u67e5\u7684\u901a\u77e5\u3002<\/li>\n<li>2023\u5e746\u6708\uff0c\u6211\u5011\u5ba3\u5e03IV\u671fNSCLC\u60a3\u8005\u7684\u6ce8\u518a\u6027GEMSTONE-302\u7814\u7a76\u7684\u7e3d\u751f\u5b58\u671f\u671f\u4e2d\u5206\u6790\u7d50\u679c\u5df2\u5728\u4e16\u754c\u77e5\u540d\u7684\u816b\u7624\u5b78\u671f\u520a\uff0d\u300aNature Cancer\u300b\u4e0a\u767c\u5e03\u3002<\/li>\n<\/ul>\n<p>&#8211;\u00a0 <b>GC\/GEJ\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li>2023\u5e742\u6708\uff0c\u8212\u683c\u5229\u55ae\u6297\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027GC\/GEJ\u60a3\u8005\u7684NDA\u7372\u570b\u5bb6\u85e5\u76e3\u5c40\u53d7\u7406\u3002<\/li>\n<\/ul>\n<p>&#8211;\u00a0 <b>ESCC\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li>2023\u5e744\u6708\uff0c\u8212\u683c\u5229\u55ae\u6297\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u3001\u5fa9\u767c\u6216\u8f49\u79fb\u6027ESCC\u60a3\u8005\u7684NDA\u7372\u570b\u5bb6\u85e5\u76e3\u5c40\u53d7\u7406\u3002<\/li>\n<li>2023\u5e741\u6708\uff0c\u6211\u5011\u5ba3\u5e03\u8212\u683c\u5229\u55ae\u6297\u4e00\u7dda\u6cbb\u7642\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u3001\u5fa9\u767c\u6216\u8f49\u79fb\u6027ESCC\u7684GEMSTONE-304\u7814\u7a76\u9054\u5230\u4e3b\u8981\u7814\u7a76\u7d42\u9ede\u3002\u8207\u5b89\u6170\u5291\u806f\u5408\u5316\u7642\u76f8\u6bd4\uff0c\u8212\u683c\u5229\u55ae\u6297\u806f\u5408\u5316\u7642\u660e\u986f\u6539\u5584PFS\u548cOS\uff0c\u5dee\u7570\u5177\u6709\u7d71\u8a08\u5b78\u986f\u8457\u6027\u8207\u81e8\u5e8a\u610f\u7fa9\u3002\u8a72\u7814\u7a76\u7684\u8a73\u7d30\u6578\u64da\u5df2\u65bc2023\u5e746\u6708\u5728ESMO GI\u5927\u6703\u4e0a\u9032\u884c\u4e86\u516c\u5e03\u3002<\/li>\n<\/ul>\n<p>&#8211;\u00a0 <b>R\/R ENKTL\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li>2023\u5e743\u6708\uff0cR\/R ENKTL\u60a3\u8005\u7684\u6ce8\u518a\u6027GEMSTONE-201\u7814\u7a76\u7684\u7d50\u679c\u767c\u5e03\u65bc\u9802\u7d1a\u816b\u7624\u5b78\u671f\u520a\uff0d\u300a\u81e8\u5e8a\u816b\u7624\u5b78\u96dc\u5fd7\u300b\u3002<\/li>\n<\/ul>\n<p><b>\u2022<\/b><b>\u00a0\u00a0\u00a0\u00a0\u00a0 \u666e\u62c9\u66ff\u5c3c\uff08CS3009\uff0cRET\u6291\u5236\u5291\uff09<\/b><\/p>\n<p>&#8211;\u00a0 2023\u5e741\u6708\uff0c\u4e2d\u570b\u53f0\u7063\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\uff08TFDA\uff09\u6279\u51c6\u5176\u7528\u65bc\u6cbb\u7642\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027RET\u878d\u5408\u967d\u6027NSCLC\u3001\u665a\u671f\u6216\u8f49\u79fb\u6027RET\u7a81\u8b8aMTC\u53caRET\u878d\u5408\u967d\u6027TC\u60a3\u8005\u7684NDA\u3002<\/p>\n<p>&#8211;\u00a0 2023\u5e746\u6708\uff0c\u570b\u5bb6\u85e5\u76e3\u5c40\u6279\u51c6\u5176\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u5148\u524d\u672a\u63a5\u53d7\u7cfb\u7d71\u6cbb\u7642\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027RET\u878d\u5408\u967d\u6027NSCLC\u60a3\u8005\u7684\u64f4\u5c55\u9069\u61c9\u75c7\u3002<\/p>\n<p>&#8211;\u00a0 2023\u5e746\u6708\uff0cRET\u878d\u5408\u967d\u6027NSCLC\u4e2d\u570b\u60a3\u8005\u7684I\/II\u671f ARROW\u8a66\u9a57\u7684\u6700\u65b0\u7d50\u679c\u767c\u8868\u65bc\u300aCancer\u300b\u3002<\/p>\n<p><b>\u2022<\/b><b>\u00a0\u00a0\u00a0\u00a0\u00a0 CS5001 (LCB71\u3001ROR1 ADC)<\/b><\/p>\n<p>&#8211;\u00a0 \u672c\u6f5b\u5728\u540c\u985e\u6700\u512a\uff08BIC\uff09ROR1 ADC\u7684FIH\u5168\u7403\u8a66\u9a57\u7684\u5291\u91cf\u905e\u589e\u90e8\u5206\u5df2\u8fc5\u901f\u63a8\u9032\u5230\u7f8e\u570b\u53ca\u6fb3\u5927\u5229\u4e9e\u5291\u91cf\u905e\u589e\u90e8\u5206\u7684\u60a3\u8005\u62db\u52df\u968e\u6bb5\uff0c\u4e26\u986f\u793a\u51fa\u826f\u597d\u7684\u5b89\u5168\u6027\u53ca\u8010\u53d7\u6027\u3002\u6b64\u570b\u969b\u591a\u4e2d\u5fc3\u81e8\u5e8a\u8a66\u9a57\u76ee\u524d\u5df2\u64f4\u5c55\u81f3\u5305\u62ec\u4e2d\u570b\uff0c\u5f9e\u800c\u9032\u4e00\u6b65\u52a0\u901f\u8a72\u7522\u54c1\u7684\u958b\u767c\u3002\u4f5c\u70ba\u81e8\u5e8a\u958b\u767c\u4e2d\u9032\u5c55\u6700\u5feb\u7684ROR1 ADC\u4e4b\u4e00\uff0cCS5001\u5c0d\u65bc\u5404\u7a2e\u60e1\u6027\u8840\u6db2\u53ca\u5be6\u9ad4\u816b\u7624\u6709\u6cbb\u7642\u6f5b\u529b\u3002<\/p>\n<p>&#8211;\u00a0 CS5001\u6709\u8a31\u591a\u5dee\u7570\u6027\u7279\u5f81\uff0c\u5305\u62ec\u5c08\u6709\u7684\u4f4d\u9ede\u7279\u7570\u6027\u5076\u806f\u3001\u816b\u7624\u9078\u64c7\u6027\u53ef\u5207\u5272\u9023\u63a5\u5b50\u53ca\u524d\u85e5\u6280\u8853\u3002\u8207\u53c3\u6bd4ROR1 ADC\u76f8\u6bd4\u8f03\uff0cCS5001\u5df2\u65bc\u5957\u7d30\u80de\u6dcb\u5df4\u7624\u53ca\u4e09\u9670\u6027\u4e73\u817a\u764c\u7570\u7a2e\u79fb\u690d\u6a21\u578b\u986f\u793a\u51faBIC\u6f5b\u529b\u3002\u6b64\u5916\uff0cCS5001\u5728\u9ad4\u5916\u5171\u57f9\u990a\u7cfb\u7d71\u986f\u793a\u51fa\u65c1\u89c0\u8005\u6548\u61c9\uff0c\u8868\u660eROR1\u7570\u8cea\u6027\/\u4f4e\u8868\u9054\u7684\u5be6\u9ad4\u7624\u4ea6\u53ef\u80fd\u53d7\u76ca\u30022023\u5e743\u6708\uff0c\u6211\u5011\u65bc\u7b2c13 \u5c46\u4e16\u754c ADC\u502b\u6566\u5927\u6703\uff08\u4e16\u754c ADC \u502b\u6566\uff09\u4e0a\u4ee5\u53e3\u982d\u532f\u5831\u5f62\u5f0f\u5c55\u793aCS5001\u7684\u8f49\u5316\u6578\u64da\u3002<\/p>\n<p>&#8211;\u00a0 \u6b64\u5916\uff0c\u70ba\u78ba\u4fdd\u751f\u7269\u6a19\u8a18\u7269\u9a45\u52d5\u60a3\u8005\u7684\u9078\u64c7\u4e43\u57fa\u65bc\u816b\u7624ROR1\u8868\u9054\uff0c\u6211\u5011\u5df2\u8b58\u5225\u6709\u6f5b\u529b\u7684\u5019\u9078ROR1\u6297\u9ad4\u514b\u9686\u7528\u65bc\u514d\u75ab\u7d44\u5316\uff08IHC\uff09\uff0c\u4ee5\u652f\u6301\u672a\u4f86\u6709\u95dc\u7cbe\u51c6\u6cbb\u7642\u85e5\u7269\u7684\u5de5\u4f5c\u3002<\/p>\n<p><b>\u2022<\/b><b>\u00a0\u00a0\u00a0\u00a0 \u827e\u4f0f\u5c3c\u5e03\uff08CS3010\uff0cIDH1\u6291\u5236\u5291\uff09<\/b><\/p>\n<p>&#8211;\u00a0 2023\u5e741\u6708\uff0c\u6211\u5011\u5b8c\u6210\u4e86\u827e\u4f0f\u5c3c\u5e03\u5728R\/R AML\u60a3\u8005\u7684\u4e2d\u570b\u6a4b\u63a5\u7814\u7a76\u3002<\/p>\n<p>&#8211;\u00a0 2023\u5e745\u6708\uff0c\u6211\u5011\u8207CDE\u5c31\u827e\u4f0f\u5c3c\u5e03\u7528\u65bcR\/R AML\u7684\u5b8c\u5168\u6279\u51c6\u7684\u76e3\u7ba1\u9014\u5f91\u9054\u6210\u4e00\u81f4\u4e14\u6b63\u5728\u51c6\u5099\u7533\u8acb\u6750\u6599\u3002<\/p>\n<p><b>\u2022<\/b><b>\u00a0\u00a0\u00a0\u00a0\u00a0 \u963f\u4f10\u66ff\u5c3c\uff08CS3007\uff0cKIT\/PDGFRA\u6291\u5236\u5291\uff09<\/b><\/p>\n<p>&#8211;\u00a0 2023\u5e745\u6708\uff0c\u6211\u5011\u7684\u5408\u4f5c\u4f19\u4f34Blueprint Medicines\u5c31\u8a72\u7522\u54c1\u7528\u65bc\u6cbb\u7642\u6210\u4eba\u60f0\u6027\u7cfb\u7d71\u6027\u80a5\u5927\u7d30\u80de\u589e\u591a\u75c7\u53d6\u5f97\u4f86\u81ea\u7f8e\u570b\u98df\u54c1\u548c\u85e5\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684NDA\u6279\u51c6\u3002<\/p>\n<p>&#8211;\u00a0 2023\u5e746\u6708\uff0c\u6211\u5011\u65bc2023\u5e74\u7f8e\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703\uff08ASCO\uff09\u5e74\u6703\u4e0a\u516c\u5e03\u4e86\u963f\u4f10\u66ff\u5c3c\u7528\u65bc\u6cbb\u7642\u665a\u671f\u80c3\u8178\u9053\u9593\u8cea\u7624\u60a3\u8005\u7684\u65b0\u6578\u64da\u3002<\/p>\n<p><b>\u2022<\/b>\u00a0<b>\u6d1b\u62c9\u66ff\u5c3c\uff08<\/b><b>ALK\/ROS-1\u6291\u5236\u5291\uff09<\/b><\/p>\n<p>&#8211;\u00a0 \u6211\u5011\u6b63\u8207\u8f1d\u745e\u5408\u4f5c\u5728\u5927\u4e2d\u83ef\u5340\u806f\u5408\u958b\u767c\u6d1b\u62c9\u66ff\u5c3c\uff0c\u4e26\u91dd\u5c0dROS1\u967d\u6027\u665a\u671fNSCLC\u60a3\u8005\u9032\u884c\u95dc\u9375\u7814\u7a76\u30022023\u5e746\u6708\uff0c\u6211\u5011\u5c31\u8a72\u9805\u7814\u7a76\u5b8c\u6210\u4e86\u60a3\u8005\u5165\u7d44\u3002<\/p>\n<p><b>III.\u00a0 \u5229\u7528\u591a\u7a2e\u5275\u65b0\u6e20\u9053\u5efa\u7acb\u7814\u7a76\u7ba1\u7dda<\/b><\/p>\n<p>\u7cbe\u51c6\u6cbb\u7642\u85e5\u7269\u53ca\u514d\u75ab\u816b\u7624\u85e5\u7269\u806f\u5408\u6cbb\u7642\u4ecd\u7136\u662f\u6211\u5011\u7684\u6230\u7565\u91cd\u9ede\u3002\u5c07\u7d30\u80de\u6bd2\u6027\u85e5\u7269\u7cbe\u78ba\u5730\u8f38\u9001\u5230\u816b\u7624\u7684\u6297\u9ad4\u5076\u806f\u85e5\u7269\uff0c\u4ee5\u53ca\u53ef\u5275\u9020\u65b0\u751f\u7269\u5b78\u4e14\u81ea\u8eab\u7d44\u5408\u7684\u591a\u7279\u7570\u6027\u751f\u7269\u5236\u54c1\u4ee3\u8868\u5169\u7a2e\u65e9\u671f\u958b\u767c\u7684\u77ed\u671f\u6a21\u5f0f\u3002<\/p>\n<p>2023\u5e74\u4e0a\u534a\u5e74\uff0c\u6211\u5011\u5df2\u901a\u904e\u82e5\u5e72\u8209\u63aa\u53d6\u5f97\u91cd\u5927\u9032\u5c55\uff1a<\/p>\n<ul type=\"disc\">\n<li><b>\u540c\u985e\u9996\u5275\uff08<\/b><b>FIC\uff09ADCs\uff1a<\/b>\u5169\u9805\u540c\u985e\u9996\u5275ADC\u9805\u76ee\u6b63\u5728\u5411\u81e8\u5e8a\u524d\u5019\u9078\u85e5\u7269\uff08PCC\uff09\u968e\u6bb5\u63a8\u9032\uff0c\u5176\u4e2d\u5305\u62ec\u91c7\u7528\u5167\u90e8\u6a5f\u5668\u5b78\u7fd2\u751f\u7269\u4fe1\u606f\u7b97\u6cd5\u78ba\u5b9a\u4e00\u7a2e\u65b0\u578b\u816b\u7624\u76f8\u95dc\u6297\u539f\uff0c\u8a72\u6297\u539f\u5728\u591a\u7a2e\u5927\u578b\u816b\u7624\u9069\u61c9\u75c7\u4e2d\u5747\u6709\u8868\u9054\u3002\u540c\u6642\u5019\u9078\u6297\u9ad4\u5df2\u9078\u5b9a\uff0c\u4e26\u4e14\u5171\u8edb\u5148\u5c0e\u5206\u5b50\u5c55\u73fe\u51fa\u4ee4\u4eba\u9f13\u821e\u7684\u9ad4\u5916\u6548\u529b\u53ca\u9ad4\u5167\u7642\u6548\u3002\u9810\u671f\u5c07\u65bc2024\u5e74\u62162025\u5e74\u63d0\u4ea4\u81e8\u5e8a\u7814\u7a76\u7528\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\uff08IND\uff09\u3002<\/li>\n<li><b>\u514d\u75ab\u816b\u7624\u591a\u7279\u7570\u6027\u6297\u9ad4\uff1a<\/b>\u00a0CS2009\u70ba\u91dd\u5c0dPD-1\u3001VEGF\u52a0\u53e6\u4e00\u500b\u514d\u75ab\u816b\u7624\u9776\u9ede\u7684\u4e09\u7279\u7570\u6027\u5206\u5b50\uff0c\u6b63\u8655\u65bc\u7d30\u80de\u682a\u958b\u767c\u968e\u6bb5\u3002\u9810\u8a08\u5c07\u57282024\u5e74\u63d0\u4ea4IND\u3002\u6b64\u5916\uff0c\u53e6\u5169\u9805\u514d\u75ab\u816b\u7624\u591a\u7279\u7570\u6027\u9805\u76ee\u6b63\u5206\u5225\u8655\u65bcIND\u7533\u5831\u8a66\u9a57\u968e\u6bb5\u53caPCC\u7504\u9078\u968e\u6bb5\u3002<\/li>\n<li><b>\u7d30\u80de\u7a7f\u900f\u6cbb\u7642\u5e73\u53f0\uff1a<\/b>\u8a31\u591a\u773e\u6240\u5468\u77e5\u7684\u816b\u7624\u5b78\u9776\u9ede\u662f\u76ee\u524d\u7684\u6cbb\u7642\u65b9\u6cd5\u8a8d\u70ba\u4e0d\u53ef\u6210\u85e5\u7684\u7d30\u80de\u5167\u86cb\u767d\u3002\u6211\u5011\u6b63\u5728\u91dd\u5c0d\u8a72\u7b49\u96e3\u6cbb\u6027\u9776\u9ede\u958b\u767c\u4e00\u7a2e\u5c08\u6709\u7684\u7d30\u80de\u7a7f\u900f\u6cbb\u7642\u5e73\u53f0\u3002\u8a72\u5e73\u53f0\u7684\u958b\u767c\u5df2\u53d6\u5f97\u91cd\u5927\u9032\u5c55\uff0c\u5177\u6709\u5ee3\u6cdb\u7684\u91dd\u5c0d\u816b\u7624\u53ca\u5176\u4ed6\u75be\u75c5\u7684\u6cbb\u7642\u6f5b\u529b\u3002\u8fc4\u4eca\u70ba\u6b62\uff0c\u6211\u5011\u4f7f\u7528\u8a72\u5e73\u53f0\u7372\u5f97\u4e86\u4e09\u7a2e\u6cbb\u7642\u65b9\u5f0f\u7684\u9ad4\u5916\u6982\u5ff5\u9a57\u8b49\uff0c\u4e26\u767c\u73fe\u985e\u4f3c\u85e5\u7269\u7684\u9ad4\u5167\u85e5\u4ee3\u52d5\u529b\u5b78\u7279\u6027\u53ca\u816b\u7624\u751f\u7269\u5206\u5e03\u3002<\/li>\n<\/ul>\n<p><b>IV.\u00a0\u00a0 \u6230\u7565\u95dc\u7cfb\u4fc3\u9032\u5546\u696d\u5316\u6d3b\u52d5\u53ca\u7ba1\u7dda\u958b\u767c<\/b><\/p>\n<p>\u6211\u5011\u4e0d\u65b7\u767c\u5c55\u8207\u6df1\u5316\u548c\u5168\u7403\u4e3b\u8981\u6230\u7565\u5408\u4f5c\u4f19\u4f34\u7684\u95dc\u7cfb\uff0c\u64f4\u5c55\u5df2\u4e0a\u5e02\u53ca\u665a\u671f\u85e5\u7269\u7684\u5546\u696d\u5316\uff0c\u978f\u56fa\u6211\u5011\u6f5b\u5728\u540c\u985e\u9996\u5275\/\u540c\u985e\u6700\u512a\u7684\u65e9\u671f\u7522\u54c1\u7ba1\u7dda\uff0c\u7372\u53d6\u66f4\u591a\u80fd\u5920\u52a0\u5f37\u6211\u5011\u7814\u767c\u5be6\u529b\u7684\u6280\u8853\u3002<\/p>\n<p>Blueprint Medicines\u65bc2023\u5e742\u670822\u65e5\u5ba3\u5e03\uff0c\u5176\u5c07\u81ea\u7f85\u6c0f\u91cd\u65b0\u7372\u5f97\u666e\u62c9\u66ff\u5c3c\u7684\u5168\u7403\u5546\u696d\u5316\u53ca\u958b\u767c\u6b0a\uff08\u4e0d\u5305\u62ec\u5927\u4e2d\u83ef\u5340\uff09\u3002\u6709\u95dc\u6b0a\u5229\u904e\u6e21\u5c07\u9810\u8a08\u65bc2024\u5e742\u6708\u751f\u6548\uff0c\u4e14Blueprint Medicines\u5df2\u555f\u52d5\u666e\u62c9\u66ff\u5c3c\u5728\u5927\u4e2d\u83ef\u5340\u4ee5\u5916\u5730\u5340\u7684\u91cd\u65b0\u5408\u4f5c\u9032\u7a0b\u3002\u6211\u5011\u73fe\u6b63\u8207\u7f85\u6c0f\u53caBlueprint Medicines\u5408\u4f5c\u91c7\u53d6\u5fc5\u8981\u63aa\u65bd\uff0c\u4ee5\u78ba\u4fdd\u53ef\u70ba\u5927\u4e2d\u83ef\u5340\u60a3\u8005\u6301\u7e8c\u4f9b\u61c9\u666e\u62c9\u66ff\u5c3c\u3002<\/p>\n<p>\u6839\u64da\u6211\u5011\u8207\u6c5f\u8607\u6046\u745e\u91ab\u85e5\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5c31\u6297CTLA-4 \u55ae\u514b\u9686\u6297\u9ad4(CS1002)\u5efa\u7acb\u7684\u5408\u4f5c\u95dc\u7cfb\uff0c\u6046\u745e\u6b63\u5728\u9032\u884c\u95dc\u65bcCS1002\u806f\u5408\u7642\u6cd5\u7528\u65bc\u6cbb\u7642\u665a\u671f\u5be6\u9ad4\u7624\uff08\u5305\u62ecHCC\u53caNSCLC\uff09\u7684Ib\/II\u671f\u8a66\u9a57\u3002<\/p>\n<p>\u96a8\u8457\u57fa\u77f3\u85e5\u696d\u8207EQRx\u5c31\u8212\u683c\u5229\u55ae\u6297\u53canofazinlimab\u8a02\u7acb\u7684\u6388\u6b0a\u5354\u8b70\u65bc2023\u5e745\u67089\u65e5\u7d42\u6b62\uff0c\u6211\u5011\u91cd\u65b0\u7372\u5f97\u8212\u683c\u5229\u55ae\u6297\u53canofazinlimab\u65bc\u5927\u4e2d\u83ef\u5340\u4ee5\u5916\u5730\u5340\u7684\u958b\u767c\u53ca\u5546\u696d\u5316\u6b0a\u5229\u3002\u6709\u95dc\u6b0a\u5229\u904e\u6e21\u5df2\u65bc2023\u5e748\u6708\u5b8c\u6210\u3002\u6211\u5011\u76ee\u524d\u6b63\u4e3b\u5c0e\u914d\u5408EMA\u53ca\u82f1\u570bMHRA\u5c0d\u8212\u683c\u5229\u55ae\u6297\u9032\u884cMAA\u5be9\u67e5\u7684\u76e3\u7ba1\u6d41\u7a0b\u3002\u7d42\u6b62\u8a72\u6388\u6b0a\u5354\u8b70\u5c07\u4e0d\u6703\u5f71\u97ff\u5148\u524d\u81eaEQRx\u6536\u53d6\u7684\u9810\u4ed8\u6b3e\u53ca\u88e1\u7a0b\u7891\u4ed8\u6b3e\u3002\u6211\u5011\u76ee\u524d\u6b63\u5728\u5c0b\u6c42\u8212\u683c\u5229\u55ae\u6297\u53canofazinlimab\u65bc\u5927\u4e2d\u83ef\u5340\u4ee5\u5916\u5730\u5340\u7684\u6f5b\u5728\u5408\u4f5c\u3002<\/p>\n<p><b>V.\u00a0\u00a0\u00a0 \u5176\u4ed6\u696d\u52d9\u9032\u5c55<\/b><\/p>\n<p><b>\u751f\u7522\u3002<\/b>\u6211\u5011\u4ea6\u6b63\u5728\u9032\u884c\u591a\u6b3e\u9032\u53e3\u7522\u54c1\u7684\u6280\u8853\u8f49\u79fb\uff0c\u9810\u8a08\u5c07\u964d\u4f4e\u6210\u672c\uff0c\u63d0\u9ad8\u6211\u5011\u7522\u54c1\u7684\u9577\u671f\u76c8\u5229\u80fd\u529b\u3002\u5177\u9ad4\u800c\u8a00\uff0c\u6709\u95dc\u963f\u4f10\u66ff\u5c3c\u7684\u6280\u8853\u8f49\u79fb\u7533\u8acb\u6b63\u5728CDE\u5be9\u6838\u4e2d\u3002\u540c\u6642\uff0c\u666e\u62c9\u66ff\u5c3c\u7684\u6280\u8853\u8f49\u79fb\u6b63\u5728\u9806\u5229\u9032\u884c\u4e14\u5df2\u555f\u52d5\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3002<\/p>\n<p><b>\u672a\u4f86\u53ca\u9858\u666f<\/b><\/p>\n<p>\u6211\u5011\u6b63\u81f4\u529b\u65bc\u5e36\u4f86\u591a\u500b\u91cd\u5927\u81e8\u5e8a\u53ca\u5546\u696d\u9032\u5c55\uff0c\u4ee5\u4fc3\u9032\u6211\u5011\u5728\u672a\u4f86\u5341\u4e8c\u500b\u6708\u7684\u589e\u9577\u3002<\/p>\n<p>\u672a\u4f86\u5341\u4e8c\u500b\u6708\u7684\u9810\u671f\u9032\u5c55\u660e\u7d30\u5982\u4e0b\uff1a<\/p>\n<p><b>\u5546\u696d\u9032\u5c55<\/b><\/p>\n<p>\u6211\u5011\u7684\u5546\u696d\u5718\u968a\u6b63\u5728\u52aa\u529b\u52a0\u5feb\u64f4\u5927\u7522\u54c1\u7684\u6f5b\u5728\u5e02\u5834\u4e26\u6700\u5927\u9650\u5ea6\u5730\u767c\u63ee\u5176\u5546\u696d\u6f5b\u529b\uff0c\u4e3b\u8981\u8457\u91cd\u4ee5\u4e0b\u65b9\u9762\uff1a<\/p>\n<ul type=\"disc\">\n<li>\u901a\u904e\u6700\u5927\u5316\u90e8\u7f72\u6548\u7387\u53ca\u5229\u7528\u6578\u5b57\u5e73\u53f0\u63d0\u9ad8\u5e02\u5834\u8986\u84cb\u7387<\/li>\n<li>\u901a\u904e\u8207\u8a3a\u65b7\u516c\u53f8\u3001\u884c\u696d\u5354\u6703\uff08\u5982\u570b\u5bb6\u75c5\u7406\u8cea\u63a7\u4e2d\u5fc3\uff09\u3001\u60a3\u8005\u5e73\u53f0\u53ca\u5927\u6578\u64da\u516c\u53f8\u7684\u6df1\u5ea6\u5408\u4f5c\uff0c\u63d0\u9ad8\u8a3a\u65b7\u7387\u548c\u7cbe\u51c6\u7387<\/li>\n<li>\u901a\u904e\u7d0d\u5165\u6307\u5357\u3001\u8209\u8fa6\u5b78\u8853\u6d3b\u52d5\u53ca\u958b\u5c55\u7372\u6279\u5f8c\u7684\u81e8\u5e8a\u9805\u76ee\uff0c\u805a\u7126\u81e8\u5e8a\u5dee\u7570\u5316\u548c\u5b89\u5168\u6027\uff0c\u63d0\u9ad8\u54c1\u724c\u5f71\u97ff\u529b\u53ca\u79d1\u5b78\u9818\u5c0e\u529b<\/li>\n<li>\u6301\u7e8c\u63a8\u9032\u91ab\u9662\u53caDTP\u5217\u540d\u4f86\u52a0\u5f37\u53ef\u53ca\u6027<\/li>\n<li>\u901a\u904e\u512a\u5316\u5b9a\u50f9\u7b56\u7565\u53ca\u5546\u696d\u4fdd\u96aa\/\u5275\u65b0\u652f\u4ed8\u8a08\u5283\uff0c\u63d0\u9ad8\u53ef\u8ca0\u64d4\u6027<\/li>\n<li>\u901a\u904e\u60a3\u8005\u96c6\u9ad4\u53c3\u8207\u3001\u6559\u80b2\u6703\u8b70\u53ca\u5f8c\u7e8c\u5229\u7528\u6578\u5b57\u5e73\u53f0\uff0c\u52a0\u5f37\u60a3\u8005\u6559\u80b2\u53ca\u652f\u6301<\/li>\n<\/ul>\n<p><b>\u7814\u767c<\/b><\/p>\n<p><b>\u9810\u671f<\/b><b>NDA\u6279\u51c6\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li>\u8212\u683c\u5229\u55ae\u6297\uff1a2023\u5e74\u5e95\u524d\u5728\u4e2d\u570b\u5927\u9678\u7372\u5f97R\/R ENKTL\u7684NDA\u6279\u51c6<\/li>\n<li>\u8212\u683c\u5229\u55ae\u6297\uff1a2024\u5e74\u4e0a\u534a\u5e74\u5728\u6b50\u76df\u7372\u5f97\u7528\u65bc\u4e00\u7dda\u6cbb\u7642IV\u671fNSCLC\u7684MAA\u6279\u51c6<\/li>\n<li>\u8212\u683c\u5229\u55ae\u6297\uff1a2024\u5e74\u4e0a\u534a\u5e74\u5728\u82f1\u570b\u7372\u5f97\u7528\u65bc\u4e00\u7dda\u6cbb\u7642IV\u671fNSCLC\u7684MAA\u6279\u51c6<\/li>\n<li>\u8212\u683c\u5229\u55ae\u6297\uff1a2023\u5e74\u5e95\u62162024\u5e74\u4e0a\u534a\u5e74\u5728\u4e2d\u570b\u5927\u9678\u7372\u5f97\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u665a\u671fGC\/GEJ\u7684NDA\u6279\u51c6<\/li>\n<li>\u8212\u683c\u5229\u55ae\u6297\uff1a2023\u5e74\u5e95\u62162024\u5e74\u4e0a\u534a\u5e74\u5728\u4e2d\u570b\u5927\u9678\u7372\u5f97\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u665a\u671fESCC\u7684NDA\u6279\u51c6<\/li>\n<\/ul>\n<p><b>\u9810\u671f<\/b><b>NDA\u7533\u8acb\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li>\u6d1b\u62c9\u66ff\u5c3c\uff1a2024\u5e74\u5728\u4e2d\u570b\u5927\u9678\u5c31ROS1\u967d\u6027\u665a\u671fNSCLC\u63d0\u4ea4\u88dc\u5145NDA\u7533\u8acb<\/li>\n<\/ul>\n<p><b>\u9810\u671f\u4e3b\u8981\u7814\u7a76\u7d50\u679c\u767c\u5e03\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li>\u8212\u683c\u5229\u55ae\u6297\uff1a2023\u5e74\u7b2c\u4e09\u5b63\u5ea6\u767c\u5e03\u8212\u683c\u5229\u55ae\u6297\u806f\u5408\u5316\u7642\u4e00\u7dda\u6cbb\u7642\u665a\u671fGC\/GEJ\u60a3\u8005\u7684GEMSTONE-303\u7814\u7a76\u9810\u8a2d\u7684\u7e3d\u751f\u5b58\u671f\u6700\u7d42\u5206\u6790\u4e3b\u8981\u7814\u7a76\u7d50\u679c<\/li>\n<li>Nofazinlimab\uff1a2024\u5e74\u7b2c\u4e00\u5b63\u5ea6\u767c\u5e03nofazinlimab\u806f\u5408LENVIMA<sup>\u00ae<\/sup>(lenvatinib)\u4e00\u7dda\u6cbb\u7642\u665a\u671fHCC\u60a3\u8005III\u671f\u5168\u7403\u8a66\u9a57\u4e3b\u8981\u7814\u7a76\u7d50\u679c<\/li>\n<\/ul>\n<p><b>\u65e9\u671f\u81e8\u5e8a\u9805\u76ee\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li><span id=\"spanHghlt9346\">CS5001\uff1a2023\u5e74\u5e95\u66f4\u65b0\u81e8\u5e8a\u5b89\u5168\u6027\u53ca\u6709\u6548\u6027\u7684\u6578\u64da\u53ca\u65bc2024\u5e74\u4e0a\u534a\u5e74\u5728\u5927\u6703\u5c55\u793a\u6578\u64da<\/span><\/li>\n<\/ul>\n<p><b>\u8ca1\u52d9\u6458\u8981<\/b><\/p>\n<p><b>\u570b\u969b\u8ca1\u52d9\u5831\u544a\u51c6\u5247\u8a08\u91cf\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li><b>\u6536\u5165<\/b>\u622a\u81f32023\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u70ba\u4eba\u6c11\u5e632.615\u5104\u5143\uff0c\u5305\u62ec\u85e5\u54c1\u92b7\u552e\u6536\u5165\u4eba\u6c11\u5e632.469\u5104\u5143\uff08\u5305\u62ec\u963f\u4f10\u66ff\u5c3c\u3001\u666e\u62c9\u66ff\u5c3c\u53ca\u827e\u4f0f\u5c3c\u5e03\uff09\u53ca\u8212\u683c\u5229\u55ae\u6297\u7279\u8a31\u6b0a\u4f7f\u7528\u8cbb\u6536\u5165\u4eba\u6c11\u5e631,462\u842c\u5143\uff0c\u8f03\u622a\u81f32022\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u7684\u85e5\u54c1\u92b7\u552e\u6536\u5165\u4eba\u6c11\u5e631.614\u5104\u5143\uff0c\u589e\u52a0\u4e86\u4eba\u6c11\u5e638,550\u842c\u5143\u621653%\u53ca\u8f03\u622a\u81f32022\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u7684\u7279\u8a31\u6b0a\u4f7f\u7528\u8cbb\u6536\u5165\u4eba\u6c11\u5e631,310\u842c\u5143\uff0c\u589e\u52a0\u4eba\u6c11\u5e63152\u842c\u5143\u621611%\u3002<\/li>\n<li><b>\u7814\u767c\u958b\u652f<\/b>\u622a\u81f32023\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u70ba\u4eba\u6c11\u5e631.868\u5104\u5143\uff0c\u8f03\u622a\u81f32022\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u7684\u7814\u767c\u958b\u652f\u6e1b\u5c11\u4eba\u6c11\u5e637,980\u842c\u5143\uff0c\u4e3b\u8981\u7531\u65bc\u88e1\u7a0b\u7891\u8cbb\u7528\u53ca\u7b2c\u4e09\u65b9\u5408\u7d04\u6210\u672c\u4ee5\u53ca\u96c7\u54e1\u6210\u672c\u6e1b\u5c11\u6240\u81f4\u3002<\/li>\n<li><b>\u884c\u653f\u958b\u652f<\/b>\u622a\u81f32023\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u70ba\u4eba\u6c11\u5e638,920\u842c\u5143\uff0c\u8f03\u622a\u81f32022\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u7684\u884c\u653f\u958b\u652f1.348\u5104\u5143\u6e1b\u5c11\u4e86\u4eba\u6c11\u5e634,560\u842c\u5143\uff0c\u4e3b\u8981\u7531\u65bc\u96c7\u54e1\u6210\u672c\u6e1b\u5c11\u6240\u81f4\u3002<\/li>\n<li><b>\u92b7\u552e\u53ca\u5e02\u5834\u63a8\u5ee3\u958b\u652f<\/b>\u622a\u81f32023\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u70ba\u4eba\u6c11\u5e631.314\u5104\u5143\uff0c\u8f03\u622a\u81f32022\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u92b7\u552e\u53ca\u5e02\u5834\u63a8\u5ee3\u958b\u652f\u4eba\u6c11\u5e631.464\u5104\u5143\u6e1b\u5c11\u4e861,500\u842c\u5143\uff0c\u4e3b\u8981\u6b78\u56e0\u65bc\u96c7\u54e1\u6210\u672c\u53ca\u5c08\u696d\u8cbb\u7528\u6e1b\u5c11\u6240\u81f4\u3002<\/li>\n<li><b>\u671f\u5167\u8667\u640d<\/b>\u622a\u81f32023\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u70ba\u4eba\u6c11\u5e632.092\u5104\u5143\uff0c\u8f03\u622a\u81f32022\u5e746\u670830\u65e5\u6b62\u516d\u500b\u6708\u7684\u671f\u5167\u8667\u640d\u4eba\u6c11\u5e633.616\u5104\u5143\u6e1b\u5c11\u4e86\u4eba\u6c11\u5e631.524\u5104\u5143\u621642%\uff0c\u4e3b\u8981\u6b78\u56e0\u65bc\u7814\u767c\u958b\u652f\u6e1b\u5c11\u53ca\u96c7\u54e1\u6210\u672c\u6e1b\u5c11\u6240\u81f4\u3002<\/li>\n<\/ul>\n<p><b>\u975e\u570b\u969b\u8ca1\u52d9\u5831\u544a\u51c6\u5247\u8a08\u91cf\uff1a<\/b><\/p>\n<ul 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