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\u00a0<\/p>\n

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– \u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\uff09\uff1a\u806f\u5408\u6c1f\u5c3f\u5627\u5576\u53ca\u542b\u9251\u5316\u7642\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u4e0d\u53ef\u5207\u9664\u5c40\u90e8\u665a\u671f\u3001\u5fa9\u767c\u6216\u8f49\u79fb\u6027ESCC\u60a3\u8005\u7684\u65b0\u9069\u61c9\u75c7\u5728\u4e2d\u570b\u5927\u9678\u4e0a\u5e02\u3002<\/p>\n

– \u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\uff09\uff1a\u55ae\u85e5\u6cbb\u7642R\/R ENKTL\u60a3\u8005\u7684\u65b0\u9069\u61c9\u75c7\u5728\u4e2d\u570b\u5927\u9678\u4e0a\u5e02\u3002<\/p>\n

– \u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\uff09\uff1a\u806f\u5408\u5316\u7642\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027GC\/GEJC\u60a3\u8005\u7684\u65b0\u9069\u61c9\u75c7\u5728\u4e2d\u570b\u5927\u9678\u4e0a\u5e02\u3002<\/p>\n

\u5236\u5b9a\u4e00\u7cfb\u5217\u65b9\u6cd5\uff0c\u63d0\u9ad8\u6211\u5011\u85e5\u54c1\u7684\u53ef\u53ca\u6027\u53ca\u53ef\u8ca0\u64d4\u6027 <\/p>\n

– \u6211\u5011\u5df2\u66f4\u65b0\u4e0a\u5e02\u7522\u54c1\u7684\u5b9a\u50f9\u7b56\u7565\u3002\u5177\u9ad4\u800c\u8a00\uff0c\u6cf0\u5409\u83ef\u00ae\uff08\u963f\u4f10\u66ff\u5c3c\uff09\u5df2\u88ab\u7d0d\u5165\u4e2d\u570b\u570b\u5bb6\u57fa\u672c\u91ab\u7642\u4fdd\u96aa\u3001\u5de5\u50b7\u4fdd\u96aa\u548c\u751f\u80b2\u4fdd\u96aa\u85e5\u54c1\u76ee\u9304\uff082023\u5e74\uff09\uff08\u570b\u5bb6\u91ab\u4fdd\u76ee\u9304\uff09\uff0c\u7528\u65bc\u6cbb\u7642\u651c\u5e36PDGFRA\u5916\u986f\u5b5018\u7a81\u8b8a\uff08\u5305\u62ecPDGFRA D842V\u7a81\u8b8a\uff09\u7684\u4e0d\u53ef\u5207\u9664\u6216\u8f49\u79fb\u6027\u80c3\u8178\u9053\u9593\u8cea\u7624\uff08GIST\uff09\u6210\u4eba\u60a3\u8005\u3002<\/p>\n

– \u66f4\u65b0\u666e\u5409\u83ef\u00ae\uff08\u666e\u62c9\u66ff\u5c3c\uff09\u53ca\u62d3\u8212\u6c83\u00ae\uff08\u827e\u4f0f\u5c3c\u5e03\uff09\u60a3\u8005\u63f4\u52a9\u9805\u76ee\uff08PAP\uff09\u8a08\u5283\u4ee5\u70ba\u4e00\u4e9b\u652f\u4ed8\u80fd\u529b\u4f4e\u7684\u60a3\u8005\u964d\u4f4e\u9580\u6abb\u4e26\u63d0\u5347\u50f9\u683c\u7af6\u722d\u529b\u3002<\/p>\n

\u5efa\u7acb\u5ee3\u6cdb\u7684\u884c\u696d\u548c\u5b78\u8853\u8a8d\u77e5\u5ea6\uff0c\u6a39\u7acb\u54c1\u724c\u548c\u79d1\u5b78\u9818\u5c0e\u529b <\/p>\n

– \u666e\u5409\u83ef\u00ae\uff08\u666e\u62c9\u66ff\u5c3c\uff09\u3001\u6cf0\u5409\u83ef\u00ae\uff08\u963f\u4f10\u66ff\u5c3c\uff09\u53ca\u62d3\u8212\u6c83\u00ae\uff08\u827e\u4f0f\u5c3c\u5e03\uff09\u5df2\u7d0d\u516521\u9805\u4e2d\u570b\u570b\u5bb6\u6307\u5357\uff0c\u7528\u65bc\u591a\u500b\u6cbb\u7642\u9818\u57df\u7684\u6aa2\u6e2c\u53ca\u6cbb\u7642\uff0c\u6bd4\u5982NSCLC\u3001TC\u3001GIST\u3001\u7cfb\u7d71\u6027\u80a5\u5927\u7d30\u80de\u589e\u751f\u75c7\uff08SM\uff09\u53ca\u6025\u6027\u9ad3\u7cfb\u767d\u8840\u75c5\uff08AML\uff09\u7b49\u3002\u7279\u5225\u662f\uff0c\u4e2d\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703\uff08CSCO\uff09\u975e\u5c0f\u7d30\u80de\u80ba\u764c\u8a3a\u7642\u6307\u5357\uff082023\u5e74\u7248\uff09\u3001CSCO\u80c3\u8178\u9053\u9593\u8cea\u7624\u8a3a\u7642\u6307\u5357\uff082022\u5e74\u7248\uff09\u3001\u4e2d\u570b\u6210\u4eba\u7cfb\u7d71\u6027\u80a5\u5927\u7d30\u80de\u589e\u591a\u75c7\u8a3a\u7642\u6307\u5357\uff082022\u5e74\u7248\uff09\u53ca\u4e2d\u570b\u6297\u764c\u5354\u6703\uff08CACA\uff09\u8840\u6db2\u816b\u7624\u6307\u5357\uff082022\u5e74\u7248\uff09\u7b49\u3002<\/p>\n

– \u6211\u5011\u7e7c\u7e8c\u8207\u7814\u7a76\u8005\u5408\u4f5c\u9032\u884c\u4e0a\u5e02\u5f8c\u81e8\u5e8a\u9805\u76ee\uff0c\u5982\u7814\u7a76\u8005\u767c\u8d77\u7684\u8a66\u9a57\uff08IIT\uff09\u548c\u771f\u5be6\u4e16\u754c\u7684\u7814\u7a76\uff08RWS\uff09\uff0c\u4ee5\u65bc\u591a\u500b\u764c\u75c7\u9069\u61c9\u75c7\u4e2d\u751f\u6210\u66f4\u591a\u6578\u64da\u3002\u4f8b\u5982\uff0c\u4e00\u9805\u591a\u4e2d\u5fc3RWS\u8a55\u4f30\u4e86\u6cf0\u5409\u83ef\u00ae\uff08\u963f\u4f10\u66ff\u5c3c\uff09\u5728\u4e2d\u570bGIST\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u53ca\u7642\u6548\uff1b\u53e6\u4e00\u9805IIT\u65e8\u5728\u7814\u7a76\u6cf0\u5409\u83ef\u00ae\uff08\u963f\u4f10\u66ff\u5c3c\uff09\u5c0d\u65bc\u6cbb\u7642\u651c\u5e36\u6709KIT D816\u6216N822\u7a81\u8b8a\u7684R\/R \u6838\u5fc3\u7d50\u5408\u56e0\u5b50\uff08CBF\uff09-AML\u60a3\u8005\u7684\u7642\u6548\u53ca\u5b89\u5168\u6027\u3002<\/p>\n

\u8207\u8f1d\u745e\u5c31\u8212\u683c\u5229\u55ae\u6297\u5728\u4e2d\u570b\u7684\u5546\u696d\u5316\u9032\u884c\u5408\u4f5c <\/p>\n

– \u6211\u5011\u6b63\u8207\u5408\u4f5c\u5925\u4f34\u8f1d\u745e\u5c55\u958b\u5bc6\u5207\u5408\u4f5c\uff0c\u4ee5\u63a8\u9032\u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\uff09\u5728\u4e2d\u570b\u5927\u9678\u7684\u5546\u696d\u5316\u3002<\/p>\n

– 2023\u5e74\uff0c\u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\uff09\u4f5c\u70baIII\u671fNSCLC\u7684\u6cbb\u7642\u65b9\u6848\u5728CSCO\u975e\u5c0f\u7d30\u80de\u80ba\u764c\u6cbb\u7642\u6307\u5357\uff082023\u5e74\u7248\uff09\u53caCSCO\u514d\u75ab\u6cbb\u7642\u6307\u5357\uff082023\u5e74\u7248\uff09\u4e2d\u5df2\u5347\u7d1a\u81f3\u4e00\u7d1a\u63a8\u85a6\u3002\u6b64\u5916\uff0c\u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\uff09\u7528\u65bc\u6cbb\u7642III\u671fNSCLC\u4ea6\u5df2\u7372\u7d0d\u5165\u4e2d\u83ef\u91ab\u5b78\u6703\u81e8\u5e8a\u5be6\u8e10\u6307\u5357\uff082023\u5e74\u7248\uff09\u3002<\/p>\n

\u00a0<\/p>\n

II. \u4e0d\u65b7\u767c\u5c55\u7684\u7ba1\u7dda\u7684\u81e8\u5e8a\u9032\u5c55<\/p>\n

\u8a73\u60c5\u5982\u4e0b\uff1a<\/p>\n

CS5001 (LCB71\uff0cROR1 ADC)<\/p>\n

– \u672c\u6f5b\u5728\u540c\u985e\u6700\u512a\uff08BIC\uff09ROR1 ADC\u7684FIH\u5168\u7403\u8a66\u9a57\u5df2\u8fc5\u901f\u63a8\u9032\u5230\u7f8e\u570b\u3001\u6fb3\u5927\u5229\u4e9e\u53ca\u4e2d\u570b\u5291\u91cf\u905e\u589e\u90e8\u5206\u7684\u60a3\u8005\u62db\u52df\u968e\u6bb5\u3002<\/p>\n

– 2023\u5e7412\u670820\u65e5\uff0c\u6211\u5011\u5831\u544a\u4e86\u6b63\u5728\u9032\u884c\u7684FIH\u8a66\u9a57\u65e9\u671f\u968e\u6bb5\u7684\u521d\u6b65\u7d50\u679c\uff0c\u7576\u6642\u5df2\u5b8c\u6210\u7b2c7\u7d1a\u5291\u91cf\u6c34\u5e73\u7684\u5b89\u5168\u6027\u8a55\u4f30\u53ca\u6b63\u5728\u9032\u884c\u7642\u6548\u8a55\u4f30\u3002CS5001\u5c55\u73fe\u4e86\u826f\u597d\u7684\u8010\u53d7\u6027\u548c\u5b89\u5168\u6027\uff0c\u4e26\u5728\u5be6\u9ad4\u7624\u548c\u6dcb\u5df4\u7624\u4e2d\u986f\u793a\u51fa\u826f\u597d\u7684\u6297\u816b\u7624\u6d3b\u6027\u3002CS5001\u662f\u8fc4\u4eca\u70ba\u6b62\u6240\u5831\u544a\u7b2c\u4e00\u500b\u5c0d\u5be6\u9ad4\u7624\u5177\u6709\u81e8\u5e8a\u6297\u816b\u7624\u6d3b\u6027\u7684ROR1 ADC\u3002<\/p>\n

– \u622a\u81f3\u672c\u516c\u544a\u65e5\u671f\uff0c\u6211\u5011\u5df2\u5c07\u5291\u91cf\u6c34\u5e73\u905e\u589e\u81f3\u7b2c9\u7d1a\u3002\u6211\u5011\u672a\u89c0\u5bdf\u5230\u5291\u91cf\u9650\u5236\u6027\u6bd2\u6027\uff08DLT\uff09\uff1b\u4e14\u5c1a\u672a\u9054\u5230\u6700\u5927\u8010\u53d7\u5291\u91cf\uff08MTD\uff09\u3002\u5728\u672a\u8003\u616eROR1\u72c0\u6cc1\u7684\u60c5\u6cc1\u4e0b\u5165\u7d44\u53ca\u63a5\u53d7\u5927\u91cf\u5148\u524d\u6cbb\u7642\u7684\u6dcb\u5df4\u7624\u6216\u5be6\u9ad4\u7624\u60a3\u8005\u4e2d\uff0c\u96a8\u8457\u5291\u91cf\u6c34\u5e73\u589e\u52a0\uff0cCS5001\u4fdd\u6301\u826f\u597d\u7684\u8010\u53d7\u6027\uff1b\u672a\u89c0\u5bdf\u5230\u7b2c4\u81f35\u7d1a\u6cbb\u7642\u76f8\u95dc\u4e0d\u826f\u4e8b\u4ef6\u3002CS5001\u7684\u85e5\u4ee3\u52d5\u529b\u5b78\uff08PK\uff09\u7279\u5fb5\u7b26\u5408\u9810\u671f\uff0c\u4e26\u986f\u793aADC\u5177\u6709\u512a\u7570\u7684\u7a69\u5b9a\u6027\u3002\u6211\u5011\u5f9e\u7b2c5\u7d1a\u5291\u91cf\u6c34\u5e73\u958b\u59cb\u89c0\u5bdf\u5230\u4ee4\u4eba\u9f13\u821e\u7684\u6297\u816b\u7624\u6d3b\u6027\uff0c\u5305\u62ec\u665a\u671f\u5be6\u9ad4\u7624\uff08\u5982\u80ba\u764c\u53ca\u80f0\u817a\u764c\uff09\u53ca\u6dcb\u5df4\u7624\uff08\u5982\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u53ca\u7030\u6f2b\u6027\u5927B \u7d30\u80de\u6dcb\u5df4\u7624\uff08DLBCL\uff09\uff09\u7684\u90e8\u5206\u53ca\u5b8c\u5168\u7de9\u89e3\u3002\u6211\u5011\u9810\u8a08\u5c07\u65bc2024\u5e74\u4e0a\u534a\u5e74\u78ba\u5b9aCS5001\u7684\u521d\u6b65\u63a8\u85a62\u671f\u5291\u91cf\uff08RP2D\uff09\uff0c\u4e26\u8a08\u5283\u65bc2024\u5e74\u5e95\u524d\u555f\u52d5\u8a3b\u518a\u6027Ib\/II\u671f\u8a66\u9a57\u3002\u96a8\u8457\u5291\u91cf\u589e\u52a0\u904e\u7a0b\u4e2d\u6240\u7a4d\u7d2f\u7684\u6578\u64da\u8d8a\u4f86\u8d8a\u8c50\u5bcc\uff0c\u6211\u5011\u8a08\u5283\u65bc2024\u5e74\u5728\u570b\u969b\u5b78\u8853\u6703\u8b70(\u5305\u62ecASCO\u3001ESMO\u53ca\u7f8e\u570b\u8840\u6db2\u5b78\u6703\u5e74\u6703\uff08ASH\uff09\uff09\u4e0a\u9032\u884c\u591a\u6b21\u532f\u5831\u3002<\/p>\n

– CS5001\u6709\u8a31\u591a\u5dee\u7570\u6027\u7279\u5fb5\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\u6bd4\u5177\u6709\u55ae\u7532\u57fa\u6fb3\u745e\u4ed6\u6c40E\uff08MMAE\uff09\u6bd2\u7d20\u7684ROR1 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\u754cADC\u502b\u6566\u5927\u6703\uff08\u4e16\u754cADC\u502b\u6566\uff09\u4e0a\u4ee5\u53e3\u982d\u532f\u5831\u5f62\u5f0f\u5c55\u793aCS5001\u7684\u8f49\u5316\u6578\u64da\u3002<\/p>\n

– \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\u6e96\u6cbb\u7642\u85e5\u7269\u7684\u5de5\u4f5c\u3002<\/p>\n

\u8212\u683c\u5229\u55ae\u6297\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

– IV\u671fNSCLC\uff1a\u00a0<\/p>\n

\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\u7531\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\u7372\u6b50\u76dfEMA\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\u7531\u96d9\u65b9\u5be9\u8a55\u30022023\u5e747\u6708\uff0c\u6211\u5011\u6536\u5230\u4f86\u81ea\u6b50\u76dfEMA\u5c31\u6b64\u9069\u61c9\u75c7\u9032\u884cGCP\u6aa2\u67e5\u7684\u901a\u77e5\u30022023\u5e7410\u6708\uff0c\u6211\u5011\u6536\u5230MHRA\u767c\u51fa\u7684\u7b2c80\u5929\u7684\u9032\u4e00\u6b65\u8cc7\u6599\u8981\u6c42\uff08RFI\uff09\uff0c\u7576\u4e2d\u4e26\u7121\u4efb\u4f55\u7121\u6cd5\u89e3\u6c7a\u7684\u554f\u984c\u30022023\u5e7412\u6708\uff0c\u6211\u5011\u6536\u5230EMA\u767c\u51fa\u7684\u7b2c180\u5929\u672a\u6c7a\u554f\u984c\u6e05\u55ae\uff08LoOI\uff09\uff0c\u8868\u660e\u6240\u6709\u554f\u984c\u5df2\u65bc\u524d\u5e7e\u8f2a\u6e9d\u901a\u4e2d\u5f97\u5230\u59a5\u5584\u89e3\u6c7a\u30022024\u5e742\u6708\uff0c\u6211\u5011\u5b8c\u6210\u4e86EMA\u5728\u5169\u500b\u7814\u7a76\u4e2d\u5fc3\u53caCRO\u7684GCP\u6aa2\u67e5\u3002 2023\u5e746\u6708\uff0c\u6211\u5011\u5ba3\u4f48\u5c0d\u65bcIV\u671fNSCLC\u60a3\u8005\u7684\u8a3b\u518a\u6027 GEMSTONE-302 \u7814\u7a76\u7684\u7e3d\u751f\u5b58\u671f\uff08OS\uff09\u671f\u4e2d\u5206\u6790\u7d50\u679c\u5df2\u5728\u4e16\u754c\u77e5\u540d\u7684\u816b\u7624\u5b78\u671f\u520a\uff0d\u300aNature Cancer\u300b\u4e0a\u767c\u8868\u3002 <\/p>\n

– GC\/GEJC\uff1a\u00a0<\/p>\n

2024\u5e743\u6708\uff0c\u8212\u683c\u5229\u55ae\u6297\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027GC\/GEJC (CPS\u22655)\u60a3\u8005\u7684NDA\u7372\u570b\u5bb6\u85e5\u76e3\u5c40\u6279\u51c6\u3002 2023\u5e742\u6708\uff0c\u8212\u683c\u5229\u55ae\u6297\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027GC\/GEJC (CPS\u22655)\u60a3\u8005\u7684NDA\u7372\u570b\u5bb6\u85e5\u76e3\u5c40\u53d7\u7406\u3002 2023\u5e7410\u6708\uff0cGEMSTONE-303\u7814\u7a76\u4e2d\u7684\u9810\u8a2d\u7121\u9032\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u548cOS\u6700\u7d42\u5206\u6790\u4e3b\u8981\u7814\u7a76\u7d50\u679c\u88ab\u63a5\u6536\u70ba\u91cd\u78c5\u6458\u8981\uff08LBA\uff09\uff0c\u4e26\u5728ESMO\u5927\u6703\uff082023\u5e74\uff09\u4e0a\u4ee5\u53e3\u982d\u532f\u5831\u5f62\u5f0f\u5c55\u793a\u3002\u8207\u5b89\u6170\u5291\u806f\u5408\u5316\u7642\u76f8\u6bd4\uff0c\u8212\u683c\u5229\u55ae\u6297\u806f\u5408\u5316\u7642\u986f\u8457\u6539\u5584 PFS\u548cOS\uff0c\u6b64\u5dee\u7570\u5177\u6709\u7d71\u8a08\u5b78\u986f\u8457\u6027\u8207\u81e8\u5e8a\u610f\u7fa9\u3002 <\/p>\n

– ESCC\uff1a\u00a0<\/p>\n

2023\u5e7412\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\u6279\u51c6\u3002 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 2023\u5e741\u6708\uff0c\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\u5584 PFS\u548cOS\uff0c\u6b64\u5dee\u7570\u5177\u6709\u7d71\u8a08\u5b78\u986f\u8457\u6027\u8207\u81e8\u5e8a\u610f\u7fa9\u3002\u6211\u5011\u65bc2023\u5e746\u6708\u5728ESMO GI\u5927\u6703\u4e0a\u516c\u4f48\u4e86\u8a72\u7814\u7a76\u7684\u8a73\u7d30\u7d50\u679c\u3002 2024\u5e742\u6708\uff0c\u8a3b\u518a\u6027GEMSTONE-304\u7814\u7a76\u7684PFS\u6700\u7d42\u5206\u6790\u7d50\u679c\u53caOS\u671f\u4e2d\u5206\u6790\u7d50\u679c\u520a\u767c\u65bc\u9802\u5c16\u91ab\u5b78\u671f\u520a\u2014\u300aNature Medicine\u300b\u3002 <\/p>\n

– R\/R ENKTL\uff1a\u00a0<\/p>\n

2023\u5e7410\u6708\uff0c\u8212\u683c\u5229\u55ae\u6297\u7528\u65bc\u55ae\u85e5\u6cbb\u7642R\/R ENKTL\u60a3\u8005\u7684NDA\u7372\u570b\u5bb6\u85e5\u76e3\u5c40\u6279\u51c6\u3002 2023\u5e743\u6708\uff0c R\/R ENKTL\u60a3\u8005\u7684\u8a3b\u518a\u6027GEMSTONE-201\u7814\u7a76\u7684\u7d50\u679c\u767c\u8868\u65bc\u9802\u7d1a\u816b\u7624\u5b78\u671f\u520a\uff0d\u300a\u81e8\u5e8a\u816b\u7624\u5b78\u96dc\u8a8c\u300b\u3002 2023\u5e7412\u6708\uff0c\u6211\u5011\u5728\u6709\u95dcR\/R ENKTL\u9069\u61c9\u75c7\u8a3b\u518a\u9014\u5f91\u7684B\u985e\u54a8\u8a62\u65b9\u9762\u8207\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u9054\u6210\u5354\u8b70\u3002 <\/p>\n

Nofazinlimab\uff08CS1003\uff0cPD-1\u6297\u9ad4\uff09<\/p>\n

– 2024\u5e743\u6708\uff0c\u5b8c\u6210\u4e86nofazinlimab\u806f\u5408LENVIMA\u00ae\u00a0(lenvatinib)\u4e00\u7dda\u6cbb\u7642\u4e0d\u53ef\u5207\u9664\u6216\u8f49\u79fb\u6027HCC\u60a3\u8005\u7684\u5168\u7403III\u671f\u8a66\u9a57\u7684\u9810\u8a2d\u671f\u4e2d\u5206\u6790\uff1b\u6211\u5011\u4e26\u7121\u89c0\u5bdf\u5230\u65b0\u589e\u6216\u610f\u5916\u5b89\u5168\u6027\u4fe1\u865f\uff1b\u7368\u7acb\u6578\u64da\u76e3\u5bdf\u59d4\u54e1\u6703\uff08iDMC\uff09\u5efa\u8b70\u5728\u4e0d\u4fee\u6539\u65b9\u6848\u7684\u60c5\u6cc1\u4e0b\u9032\u884c\u6301\u7e8c\u96a8\u8a2a\uff0c\u76f4\u81f3OS\u6700\u7d42\u8a55\u4f30\u3002<\/p>\n

– 2023\u5e749\u6708\uff0c nofazinlimab\u7528\u65bc\u6cbb\u7642\u665a\u671f\u5be6\u9ad4\u7624\u60a3\u8005\u7684FIH\u8a66\u9a57(CS1003-101)\u7d50\u679c\u5df2\u767c\u8868\u65bc\u9ad8\u5f15\u7528\u7387\u7684\u671f\u520a\u300a\u82f1\u570b\u764c\u75c7\u96dc\u8a8c\u300b(British Journal of Cancer)\u3002<\/p>\n

\u666e\u62c9\u66ff\u5c3c\uff08CS3009\uff0cRET\u6291\u5236\u5291\uff09<\/p>\n

– 2023\u5e741\u6708\uff0c\u666e\u62c9\u66ff\u5c3c\u7528\u65bc\u6cbb\u7642\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027RET\u878d\u5408\u967d\u6027NSCLC\u3001\u665a\u671f\u6216\u8f49\u79fb\u6027 RET\u7a81\u8b8aMTC\u53caRET\u878d\u5408\u967d\u6027TC\u60a3\u8005\u7684NDA\u7372\u4e2d\u570b\u53f0\u7063\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\uff08TFDA\uff09\u6279\u51c6\u3002<\/p>\n

– 2023\u5e746\u6708\uff0c\u666e\u62c9\u66ff\u5c3c\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\u7684NDA\u7372\u570b\u5bb6\u85e5\u76e3\u5c40\u6279\u51c6\u3002<\/p>\n

– 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

\u963f\u4f10\u66ff\u5c3c\uff08CS3007\uff0cKIT\/PDGFRA\u6291\u5236\u5291\uff09<\/p>\n

– 2023\u5e745\u6708\uff0c\u6211\u5011\u7684\u5408\u4f5c\u5925\u4f34Blueprint Medicines Corporation\uff08Blueprint Medicines\uff09\u5c31\u8a72\u7522\u54c1\u5728\u7f8e\u570b\u7372\u5f97\u4f86\u81ea\u7f8e\u570b\u98df\u54c1\u548c\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u6279\u51c6\uff0c\u5c07\u5176\u7528\u65bc\u6cbb\u7642\u60f0\u6027\u7cfb\u7d71\u6027\u80a5\u5927\u7d30\u80de\u589e\u591a\u75c7\uff08ISM\uff09\u6210\u4eba\u60a3\u8005\u3002<\/p>\n

– 2023\u5e7412\u6708\uff0c\u6211\u5011\u7684\u5408\u4f5c\u5925\u4f34Blueprint Medicines\u7372\u5f97\u4f86\u81ea EMA\u7684\u6279\u51c6\uff0c\u6388\u4e88\u5176\u53ef\u7528\u65bc\u6cbb\u7642\u5728\u7cfb\u7d71\u6cbb\u7642\u4e2d\u51fa\u73fe\u4e2d\u91cd\u5ea6\u75c7\u72c0\u63a7\u5236\u4e0d\u5145\u5206\u7684\u60f0\u6027\u7cfb\u7d71\u6027\u80a5\u5927\u7d30\u80de\u589e\u591a\u75c7\u6210\u4eba\u60a3\u8005\u3002\u8fc4\u4eca\u70ba\u6b62\uff0c\u963f\u4f10\u66ff\u5c3c\u662f\u6b50\u6d32\u9996\u500b\u4ea6\u662f\u552f\u4e00\u7372\u6279\u51c6\u7528\u65bc\u6cbb\u7642\u60f0\u6027\u7cfb\u7d71\u6027\u80a5\u5927\u7d30\u80de\u589e\u591a\u75c7\u60a3\u8005\u7684\u7642\u6cd5\u3002<\/p>\n

– 2023\u5e746\u6708\uff0c\u963f\u4f10\u66ff\u5c3c\u7528\u65bc\u6cbb\u7642\u665a\u671fGIST\u60a3\u8005\u7684\u65b0\u6578\u64da\u5728\u7f8e\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703\u5e74\u6703\uff082023\u5e74\uff09\u4e0a\u767c\u8868\u3002<\/p>\n

– 2023\u5e7411\u6708\uff0c\u963f\u4f10\u66ff\u5c3c\u6cbb\u7642\u665a\u671fGIST\u7684\u5168\u74031\u671fNAVIGATOR\u53ca\u4e2d\u570b\u6a4b\u63a51\/2\u671f(CS3007-101)\u7814\u7a76\u7684\u4e8b\u5f8c\u6578\u64da\u5206\u6790\u5728\u77e5\u540d\u816b\u7624\u5b78\u671f\u520a\u300aClinical Cancer Research\u300b\u767c\u8868\u3002<\/p>\n

\u827e\u4f0f\u5c3c\u5e03\uff08CS3010\uff0cIDH1\u6291\u5236\u5291\uff09<\/p>\n

– 2023\u5e7412\u6708\uff0c\u827e\u4f0f\u5c3c\u5e03\u7528\u65bc\u6cbb\u7642R\/R AML\u7684\u5e38\u898f\u6279\u51c6\u800c\u63d0\u4ea4\u7684\u88dc\u5145\u8cc7\u6599\u7372\u570b\u5bb6\u85e5\u76e3\u5c40\u53d7\u7406\u3002<\/p>\n

– 2023\u5e745\u6708\uff0c\u827e\u4f0f\u5c3c\u5e03\u7528\u65bc\u6cbb\u7642R\/R AML\u7684\u5e38\u898f\u6279\u51c6\u7684\u76e3\u7ba1\u9014\u5f91\u8207\u85e5\u54c1\u5be9\u8a55\u4e2d\u5fc3\u9054\u6210\u4e00\u81f4\u3002<\/p>\n

– 2023\u5e741\u6708\uff0c\u5b8c\u6210\u827e\u4f0f\u5c3c\u5e03\u5728R\/R AML\u60a3\u8005\u7684\u4e2d\u570b\u6a4b\u63a5\u7814\u7a76\u3002<\/p>\n

\u6d1b\u62c9\u66ff\u5c3c\uff08ALK\/ROS-1\u6291\u5236\u5291\uff09<\/p>\n

– \u6211\u5011\u6b63\u91dd\u5c0d\u5148\u524d\u7d93\u514b\u5511\u66ff\u5c3c\u53ca\u542b\u9251\u5316\u7642\u5f8c\u7684ROS1 \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\u30022024\u5e742\u6708\uff0c\u8a72\u95dc\u9375\u7814\u7a76\u9054\u5230\u4e3b\u8981\u7d42\u9ede\uff0c\u6211\u5011\u6b63\u5728\u8207\u85e5\u54c1\u5be9\u8a55\u4e2d\u5fc3\u53ca\u8f1d\u745e\u5c31\u65bc2024\u5e74\u5728\u4e2d\u570b\u5927\u9678\u63d0\u4ea4ROS1\u967d\u6027\u665a\u671fNSCLC\u7684pre-NDA\/NDA\u9032\u884c\u8a0e\u8ad6\u3002<\/p>\n

\u00a0<\/p>\n

III. \u5229\u7528\u591a\u7a2e\u5275\u65b0\u6e20\u9053\u5efa\u7acb\u7814\u7a76\u7ba1\u7dda<\/p>\n

\u7cbe\u6e96\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\u7684ADC\uff0c\u4ee5\u53ca\u53ef\u5275\u9020\u65b0\u751f\u7269\u5b78\u53ca\u7d44\u5408\u7684\u591a\u7279\u7570\u6027\u751f\u7269\u88fd\u54c1\u4ee3\u8868\u5169\u7a2e\u65e9\u671f\u958b\u767c\u7684\u77ed\u671f\u6a21\u5f0f\u3002<\/p>\n

2023\u5e74\uff0c\u6211\u5011\u5df2\u901a\u904e\u82e5\u5e72\u8209\u63aa\u53d6\u5f97\u91cd\u5927\u9032\u5c55\uff1a<\/p>\n

\u540c\u985e\u9996\u5275\/\u540c\u985e\u6700\u512a\uff08FIC\/BIC\uff09ADC\uff1a\u5169\u500b\u540c\u985e\u9996\u5275ADC\u9805\u76ee\u6b63\u5728\u5411\u5b8c\u6210\u81e8\u5e8a\u5019\u9078\u5206\u5b50\u7684\u7be9\u9078\u968e\u6bb5\u63a8\u9032\u3002\u5176\u4e2d\u4e00\u500b\u91dd\u5c0d\u591a\u7a2e\u9ad8\u767c\u816b\u7624\u9069\u61c9\u75c7\u4e26\u63a1\u7528\u5167\u90e8\u6a5f\u5668\u5b78\u7fd2\u751f\u7269\u4fe1\u606f\u5b78\u7b97\u6cd5\u8b58\u5225\u7684\u65b0\u578b\u816b\u7624\u76f8\u95dc\u6297\u539f\u7684ADC\u9805\u76eeCS5006\u9810\u8a08\u5c07\u65bc2024\u5e74\u4e0a\u534a\u5e74\u5b8c\u6210\u81e8\u5e8a\u524d\u5019\u9078\u5206\u5b50\u7684\u7be9\u9078\u3002\u53e6\u5916\uff0c\u53e6\u4e00\u540c\u985e\u9996\u5275GPCR-x ADC CS5005\u7684\u5148\u5c0e\u6297\u9ad4\u5df2\u9078\u5b9a\u3002\u5171\u8edb\u5148\u5c0e\u5206\u5b50\u5728\u9ad4\u5916\u53ca\u9ad4\u5167\u5747\u8868\u73fe\u51fa\u4ee4\u4eba\u9f13\u821e\u7684\u7642\u6548\uff1b\u9810\u8a08\u8a72\u5169\u7a2e\u540c\u985e\u9996\u5275ADC\u5c07\u65bc\u4e8c\u96f6\u4e8c\u4e94\u5e74\u63d0\u4ea4\u76f8\u95dc\u8a3b\u518a\u6027\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\uff08IND\uff09\u3002\u6b64\u5916\uff0cCS5007\uff08\u9810\u8a08\u5c07\u6210\u70ba\u540c\u985e\u6700\u512a\u7279\u7570\u6027ADC\uff09\u53ca\u5176\u76f8\u61c9\u7684\u7279\u7570\u6027\u6297\u9ad4CS2011\uff0c\u6b63\u5728\u5411\u81e8\u5e8a\u524d\u5019\u9078\u85e5\u7269\u968e\u6bb5\u63a8\u9032\u3002CS5007\uff08CS2011\uff09\u9776\u5411\u7d93\u904e\u9a57\u8b49\u7684\u9776\u9ede\uff0c\u5177\u6709\u7d93\u8b49\u5be6\u7684\u540c\u6e90\u6709\u6548\u6027\u3002\u9810\u8a08\u5c07\u65bc2024\u5e74\u4e0a\u534a\u5e74\u5b8c\u6210\u95dc\u9375\u7684\u96d9\u7279\u7570\u6027\u6297\u9ad4\u5019\u9078\u5206\u5b50\u7684\u7be9\u9078\uff0c\u4e14\u9810\u8a08\u5c07\u65bc2024\u5e74\u5e95\u5ba3\u4f48\u8a72\u96d9\u7279\u7570\u6027ADC\u5b8c\u6210\u81e8\u5e8a\u524d\u5019\u9078\u85e5\u7269\u7684\u7be9\u9078\u3002
\n\u514d\u75ab\u816b\u7624\u591a\u7279\u7570\u6027\u6297\u9ad4\uff1aCS2009\u70ba\u91dd\u5c0dPD-1\u3001VEGFa\u53caCTLA-4\u9776\u9ede\u7684\u4e09\u7279\u7570\u6027\u5206\u5b50\uff0c\u6b63\u8655\u65bc\u7d30\u80de\u682a\u958b\u767c\u968e\u6bb5\uff0c\u4e14\u76f8\u95dcIND\u9810\u8a08\u65bc2024\u5e74\u63d0\u4ea4\u3002\u9019\u662f\u4e00\u7a2e\u6f5b\u5728\u7684\u540c\u985e\u9996\u5275\u4e0b\u4e00\u4ee3\u816b\u7624\u514d\u75ab\u9aa8\u67b6\u7522\u54c1\uff0c\u5176\u9776\u5411\u816b\u7624\u5fae\u74b0\u5883\u4e2d\u7684\u4e09\u500b\u95dc\u9375\u514d\u75ab\u6291\u5236\u9014\u5f91\uff0c\u4e26\u53ef\u52a0\u6df1\u57fa\u65bcPD-(L)1\u7642\u6cd5\u6cbb\u7642\u9ad8\u767c\u816b\u7624\u985e\u578b\uff08\u5305\u62ecNSCLC\u53caHCC\uff09\u7684\u7642\u6548\u3002
\n\u7d30\u80de\u7a7f\u900f\u6cbb\u7642\u5e73\u53f0\uff1a\u8a31\u591a\u773e\u6240\u5468\u77e5\u7684\u816b\u7624\u5b78\u9776\u9ede\u662f\u73fe\u6709\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\u91dd\u5c0d\u816b\u7624\u53ca\u5176\u4ed6\u75be\u75c5\u7684\u5ee3\u6cdb\u6cbb\u7642\u6f5b\u529b\u3002 <\/p>\n

\u00a0<\/p>\n

IV. \u6230\u7565\u95dc\u4fc2\u4fc3\u9032\u5546\u696d\u5316\u6d3b\u52d5\u53ca\u7ba1\u7dda\u958b\u767c<\/p>\n

\u6211\u5011\u4e0d\u65b7\u767c\u5c55\u8207\u6df1\u5316\u8207\u5168\u7403\u4e3b\u8981\u6230\u7565\u5408\u4f5c\u5925\u4f34\uff08\u5305\u62ec\u4e2d\u570b\u7684\u5408\u4f5c\u5925\u4f34\uff09\u7684\u95dc\u4fc2\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\u5206\u5b50\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

2023\u5e7411\u6708\uff0c\u6211\u5011\u8207\u4e09\u751f\u88fd\u85e5\u5c31nofazinlimab\u9054\u6210\u5728\u4e2d\u570b\u5927\u9678\u7684\u6230\u7565\u5408\u4f5c\uff0c\u4e26\u6388\u4e88\u4e09\u751f\u88fd\u85e5\u5728\u4e2d\u570b\u5927\u9678\u958b\u767c\u3001\u8a3b\u518a\u3001\u751f\u7522\u548c\u5546\u696d\u5316nofazinlimab\u7684\u7368\u5bb6\u6b0a\u5229\u3002\u8a72\u5408\u4f5c\u5925\u4f34\u95dc\u4fc2\u5c07\u52a0\u5febnofazinlimab\u7684CMC\u958b\u767c\u53ca\u5546\u696d\u5316\u3002<\/p>\n

2023\u5e7411\u6708\uff0c\u6211\u5011\u8207\u827e\u529b\u65af\u5728\u4e2d\u570b\u5c31\u666e\u62c9\u66ff\u5c3c\u7684\u63a8\u5ee3\u53ca\u4e0a\u5e02\u9054\u6210\u5546\u696d\u5408\u4f5c\u5925\u4f34\u95dc\u4fc2\u3002\u8a72\u4ea4\u6613\u5c07\u666e\u62c9\u66ff\u5c3c\u7d0d\u5165\u827e\u529b\u65af\u7684\u9ad8\u5ea6\u5354\u540c\u80ba\u764c\u696d\u52d9\u90e8\uff0c\u4e26\u4f7f\u666e\u62c9\u66ff\u5c3c\u53d7\u76ca\u65bc\u827e\u529b\u65af\u66f4\u6210\u719f\u7684\u5546\u696d\u5718\u968a\u53ca\u66f4\u5927\u7684\u5e02\u5834\u8986\u84cb\u7bc4\u570d\uff0c\u540c\u6642\u4f7f\u57fa\u77f3\u85e5\u696d\u80fd\u5920\u6e1b\u5c11\u8207\u666e\u62c9\u66ff\u5c3c\u5546\u696d\u5316\u76f8\u95dc\u7684\u7d93\u71df\u8cbb\u7528\u53ca\u904b\u71df\u6210\u672c\uff0c\u5f9e\u800c\u63d0\u9ad8\u6574\u9ad4\u76c8\u5229\u80fd\u529b\u3002<\/p>\n

2023\u5e7412\u6708\uff0c\u6211\u5011\u5c07\u827e\u4f0f\u5c3c\u5e03\u5728\u5927\u4e2d\u83ef\u5340\u53ca\u65b0\u52a0\u5761\u7684\u6b0a\u5229\u8f49\u8b93\u4e88\u5168\u7403\u8a31\u53ef\u8b49\u6301\u6709\u4eba\u65bd\u7dad\u96c5\uff0c\u8f49\u8b93\u50f9\u6700\u591a\u70ba5\u5343\u842c\u7f8e\u5143\uff08\u5305\u62ec\u9996\u4ed8\u6b3e4400\u842c\u7f8e\u5143\uff08\u8f49\u8b93\u827e\u4f0f\u5c3c\u5e03\u696d\u52d9\uff09\uff09\u3002\u6b64\u9805\u9ad8\u589e\u503c\u4ea4\u6613\u4f7f\u57fa\u77f3\u85e5\u696d\u80fd\u5920\u6536\u56de\u5176\u5c0d\u8a72\u8cc7\u7522\u7684\u521d\u59cb\u6295\u8cc7\uff0c\u4e26\u8b8a\u73fe\u8a72\u696d\u52d9\u7684\u672a\u4f86\u6f5b\u5728\u73fe\u91d1\u6d41\u3002<\/p>\n

\u6839\u64da\u6211\u5011\u8207\u6c5f\u8607\u6046\u745e\u91ab\u85e5\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u6046\u745e\uff09\u5c31\u6297CTLA-4 \u55ae\u514b\u9686\u6297\u9ad4 (CS1002)\u5efa\u7acb\u7684\u5408\u4f5c\u95dc\u4fc2\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\u76ee\u524d\uff0c\u8a72\u8a66\u9a57\u6b63\u5728\u9806\u5229\u62db\u52df\u60a3\u8005\u30022024\u5e741\u6708\uff0c\u6046\u745e\u5c31\u8a55\u4f30CS1002(SHR-8068)\u806f\u5408adebrelimab\u53ca\u5316\u7642\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u665a\u671f\u6216\u8f49\u79fb\u6027\u975e\u9c57\u72c0NSCLC\u60a3\u8005\u7684\u7642\u6548\u53d6\u5f97\u570b\u5bb6\u85e5\u76e3\u5c40\u7684 IND\u6279\u51c6\u3002<\/p>\n

\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\u9996\u4ed8\u6b3e\u53ca\u91cc\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\u6a5f\u6703\u3002<\/p>\n

\u00a0<\/p>\n

V. \u5176\u4ed6\u696d\u52d9\u9032\u5c55<\/p>\n

\u751f\u7522\uff1a\u6211\u5011\u4e5f\u6b63\u5728\u9032\u884c\u591a\u6b3e\u9032\u53e3\u7522\u54c1\u7684\u6280\u8853\u8f49\u79fb\uff0c\u9019\u5c07\u6709\u52a9\u65bc\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\u5728\u85e5\u54c1\u5be9\u8a55\u4e2d\u5fc3\u5be9\u6838\u4e2d\u3002\u540c\u6642\uff0c\u666e\u62c9\u66ff\u5c3c\u7684\u6280\u8853\u8f49\u79fb\uff08\u5305\u62ec\u751f\u7522\u53ca\u81e8\u5e8a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\uff09\u5df2\u6210\u529f\u5b8c\u6210\uff0c\u7533\u8acb\u8cc7\u6599\u5df2\u63d0\u4ea4\u4e88CDE\u3002<\/p>\n

\u00a0<\/p>\n

\u672a\u4f86\u53ca\u9858\u666f<\/p>\n

\u5c55\u671b\u672a\u4f86\uff0c\u6211\u5011\u5c07\u7e7c\u7e8c\u63a8\u9032\u5275\u65b0\u7ba1\u7dda\u85e5\u7269\uff0c\u4e26\u6700\u5927\u9650\u5ea6\u5730\u767c\u63ee\u6210\u719f\u85e5\u7269\u7684\u5546\u696d\u50f9\u503c\u3002<\/p>\n

\u9810\u671f\u7684\u8fd1\u671f\u50ac\u5316\u5291\u7d30\u7bc0\u8f09\u5217\u5982\u4e0b\uff1a<\/p>\n

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