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\u4e0a\u6d772021\u5e747\u67082\u65e5 \/\u7f8e\u901a\u793e\/ —  \u8fd1\u65e5\uff0c\u4e0a\u6d77\u827e\u529b\u65af\u533b\u836f\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0“\u827e\u529b\u65af”\uff0c\u80a1\u7968\u4ee3\u7801\uff1a688578\uff09\u4e0e\u7f8e\u56fdArriVent Biopharma, Inc.\uff08\u4ee5\u4e0b\u7b80\u79f0“ArriVent” \uff09\u5171\u540c\u5ba3\u5e03\uff0c\u53cc\u65b9\u5c31\u827e\u529b\u65af\u81ea\u4e3b\u7814\u53d1\u7684\u7532\u78fa\u9178\u4f0f\u7f8e\u66ff\u5c3c\uff08\u5546\u54c1\u540d\uff1a\u827e\u5f17\u6c99®<\/sup>\uff0c\u4ee5\u4e0b\u7b80\u79f0“\u4f0f\u7f8e\u66ff\u5c3c” \uff09\u8fbe\u6210\u6d77\u5916\u72ec\u5bb6\u6388\u6743\u5408\u4f5c\u534f\u8bae\u3002<\/p>\n

\u6839\u636e\u534f\u8bae\u6761\u6b3e\uff0cArriVent\u5c06\u83b7\u5f97\u4f0f\u7f8e\u66ff\u5c3c\u5728\u6d77\u5916\uff08\u5168\u7403\u9664\u4e2d\u56fd\u5927\u9646\u53ca\u6e2f\u6fb3\u53f0\u5730\u533a\uff09\u7684\u72ec\u5bb6\u5f00\u53d1\u53ca\u5546\u4e1a\u5316\u8bb8\u53ef\u6743\u3002\u827e\u529b\u65af\u5c06\u4fdd\u7559\u4f0f\u7f8e\u66ff\u5c3c\u5728\u4e2d\u56fd\u5927\u9646\u53ca\u6e2f\u6fb3\u53f0\u5730\u533a\u7684\u5f00\u53d1\u53ca\u5546\u4e1a\u5316\u6240\u6709\u6743\u3002\u8be5\u9879\u5408\u4f5c\u4e2d\uff0c\u827e\u529b\u65af\u5c06\u83b7\u5f974,000\u4e07\u7f8e\u5143\u9996\u4ed8\u6b3e\u53caArriVent\u516c\u53f8\u7684\u90e8\u5206\u80a1\u6743\uff0c\u53ef\u9ad8\u8fbe7.65\u4ebf\u7f8e\u5143\u7684\u6ce8\u518c\u548c\u9500\u552e\u91cc\u7a0b\u7891\u4ed8\u6b3e\uff0c\u4ee5\u53ca\u53ef\u9ad8\u8fbe\u4e24\u4f4d\u6570\u7684\u9500\u552e\u63d0\u6210\u3002<\/p>\n

\u4f0f\u7f8e\u66ff\u5c3c\u662f\u827e\u529b\u65af\u72ec\u7acb\u7814\u53d1\u5e76\u62e5\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u56fd\u5bb61\u7c7b\u65b0\u836f\uff0c\u4eca\u5e74<\/strong>3\u67083\u65e5<\/strong>\u5728\u56fd\u5185\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08EGFR\uff09\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\uff08TKI\uff09\u6cbb\u7597\u65f6\u6216\u6cbb\u7597\u540e\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55\uff0c\u5e76\u4e14\u7ecf\u68c0\u6d4b\u786e\u8ba4\u5b58\u5728EGFR T790M\u7a81\u53d8\u9633\u6027\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u6210\u4eba\u60a3\u8005\u3002<\/p>\n

\u5728\u7b2c\u4e09\u4ee3EGFR-TKI\u540c\u7c7b\u836f\u7269\u4e2d\uff0c\u4f0f\u7f8e\u66ff\u5c3c\u5728\u56db\u4e2a\u65b9\u9762<\/strong>\u663e\u793a\u72ec\u7279\u6027\u3002<\/p>\n

\u9996\u5148\uff0c\u56e0\u5176\u4e3b\u8981\u6d3b\u6027\u4ee3\u8c22\u4ea7\u7269AST5902\u4e0e\u539f\u578b\u836fAST2818\u5747\u53ef\u5f3a\u6548\u6291\u5236EGFR\u654f\u611f\u7a81\u53d8\u548cT790M\u8010\u836f\u7a81\u53d8\uff0c\u4f0f\u7f8e\u66ff\u5c3c\u5177\u6709\u53cc\u6d3b\u6027<\/strong>[i]<\/sup><\/strong><\/strong>\u3002<\/p>\n

\u5176\u6b21\uff0c\u4f0f\u7f8e\u66ff\u5c3c\u53ea\u5bf9EGFR\u654f\u611f\u7a81\u53d8\u8d77\u4f5c\u7528\uff0c\u5bf9\u91ce\u751f\u578bEGFR\u51e0\u4e4e\u65e0\u6291\u5236\u4f5c\u7528\uff0c \u56e0\u6b64\u5177\u6709\u9ad8\u9009\u62e9\u6027<\/strong>\uff0c\u7531\u6b64\u5e26\u6765\u66f4\u9ad8\u7684\u5b89\u5168\u6027<\/strong>\uff0c\u5373\u4f0f\u7f8e\u66ff\u5c3c\u7684\u4e0e\u836f\u7269\u76f8\u5173\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u5c11\u3002\u5728\u4f0f\u7f8e\u66ff\u5c3c\u7684\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76\u4e2d\uff0c\u5404\u9879>\/=3<\/span>\u7ea7\u53ef\u80fd\u7684\u836f\u7269\u76f8\u5173\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7387\u5747<1.5%[ii]<\/sup><\/strong><\/strong>\u3002<\/p>\n

\u53e6\u5916\uff0c\u4f0f\u7f8e\u66ff\u5c3c\u5177\u6709\u5f3a\u6548\u7f29\u7624\u7684\u7279\u6027<\/strong>\u3002\u4e00\u9879\u5355\u81c2\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u663e\u793a\uff0c\u4f0f\u7f8e\u66ff\u5c3c\u5bf9EGFR T790M\u7a81\u53d8\u9633\u6027\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027NSCLC\u60a3\u8005\u6cbb\u7597\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u8fbe74.1%\u3002\u8be5\u7814\u7a76\u7ed3\u679c\u520a\u767b\u4e8e\u4eca\u5e743\u670827\u65e5\uff0c\u520a\u767b\u4e8e\u5168\u7403\u77e5\u540d\u533b\u5b66\u671f\u520a\u300a\u67f3\u53f6\u5200•\u547c\u5438\u533b\u5b66\u300b[ii]<\/strong><\/sup>\u3002<\/p>\n

\u6700\u540e\uff0c\u4f0f\u7f8e\u66ff\u5c3c\u6cbb\u7597\u80ba\u764c\u8111\u8f6c\u79fb<\/strong>\u60a3\u8005\u7684\u7597\u6548\u975e\u5e38\u7a81\u51fa\u3002\u5728\u4eca\u5e74\u53ec\u5f00\u7684\u7b2c21\u5c4a\u4e16\u754c\u80ba\u764c\u5927\u4f1a\u4e0a\u516c\u5e03\u7684\u7814\u7a76\u7ed3\u679c\u663e\u793a\uff0c\u4f0f\u7f8e\u66ff\u5c3c\u6cbb\u7597\u8111\u8f6c\u79fb\u80bf\u7624\u75c5\u7076\u7684ORR\uff08CNS ORR\uff09\u4e3a60.0%\uff0c\u800c160mg\u4f0f\u7f8e\u66ff\u5c3c\u7ec4\u7684CNS ORR\u8fbe\u523084.6%\uff0cCNS\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09100%<\/strong>\uff0c\u7597\u6548\u5177\u6709\u4e34\u5e8a\u610f\u4e49[iii]<\/sup><\/strong><\/strong>\u3002<\/p>\n

“ArriVent\u81f4\u529b\u4e8e\u63a8\u52a8\u50cf\u4f0f\u7f8e\u66ff\u5c3c\u8fd9\u6837\u6709\u6f5c\u529b\u6210\u4e3a\u540c\u7c7b\u6700\u4f73\uff08<\/strong>Best-in-class\uff09<\/strong>\u7684\u521b\u65b0\u836f\u8d70\u5411\u5168\u7403\uff0c\u6ee1\u8db3\u4e34\u5e8a\u5c1a\u672a\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\uff0c\u63d0\u4f9b\u533b\u751f\u65b0\u7684\u6cbb\u7597\u9009\u62e9\uff0c\u9020\u798f\u5168\u7403\u60a3\u8005\u3002”\u7f8e\u56fdArriVent Biopharma<\/span>\u521b\u59cb\u4eba\u3001\u8463\u4e8b\u957f\u517c\u9996\u5e2d\u6267\u884c\u5b98\u59da\u6b63\u5f6c\u535a\u58eb<\/span>\u8868\u793a\uff0c“\u6211\u4eec\u975e\u5e38\u8363\u5e78\u80fd\u4e0e\u827e\u529b\u65af\u8fd9\u6837\u4e00\u5bb6\u5177\u6709\u5f3a\u5927\u81ea\u4e3b\u7814\u53d1\u5b9e\u529b\u7684\u521b\u65b0\u578b\u5236\u836f\u4f01\u4e1a\u5efa\u7acb\u5408\u4f5c\u5173\u7cfb\u3002”<\/span><\/p>\n

\u53e6\u636eArriVent\u5b98\u65b9\u65b0\u95fb\u7a3f\u4ecb\u7ecd\uff0cArriVent\u8ba1\u5212\u5728\u5e74\u5e95\u524d\u5411\u7f8e\u56fdFDA\u63d0\u4ea4\u7814\u7a76\u6027\u65b0\u836f\u7533\u8bf7\uff08IND\uff09\uff0c\u4ee5\u8fdb\u4e00\u6b65\u5f00\u53d1\u4f0f\u7f8e\u66ff\u5c3c\u7528\u4e8eEGFR\u7a81\u53d8\u578bNSCLC\u548c\u5176\u5b83\u5b9e\u4f53\u7624\u9002\u5e94\u75c7\uff0c\u5e76\u4e14\u63a2\u7d22\u4f0f\u7f8e\u66ff\u5c3c\u7684\u5168\u7403\u5f00\u53d1\u673a\u4f1a\u3002<\/p>\n

\u4f0f\u7f8e\u66ff\u5c3c\u4e00\u7ebf\u6cbb\u7597<\/strong>\u5177\u6709EGFR\u5916\u663e\u5b5019\u7f3a\u5931\u6216\u5916\u663e\u5b5021\uff08L858R\uff09\u7f6e\u6362\u7a81\u53d8\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027NSCLC\u6210\u4eba\u60a3\u8005\u7684\u6cbb\u7597\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff08FURLONG\uff09\u5df2\u8fdb\u5165\u6570\u636e\u5206\u6790\u9636\u6bb5\uff0c\u9884\u8ba1\u4eca\u5e74\u5728\u56fd\u5185\u9012\u4ea4\u4e0a\u5e02\u7533\u8bf7\uff0c\u6709\u671b\u4e8e2022\u5e74\u83b7\u6279\u3002\u6b64\u5916\uff0c\u4f0f\u7f8e\u66ff\u5c3c\u7528\u4e8eEGFR\u7a81\u53d8\u9633\u6027\u7684II-IIIA\u671fNSCLC\u60a3\u8005\u672f\u540e\u8f85\u52a9\u6cbb\u7597<\/strong>\u7684\u56fd\u5185III\u671f\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76\uff08FORWARD\uff09\u4e5f\u4e8e\u4eca\u5e744\u6708\u5728\u56fd\u5185\u6b63\u5f0f\u542f\u52a8\uff0c\u8fdb\u5165\u4e34\u5e8a\u5165\u7ec4\u9636\u6bb5\u3002\u6b64\u5916\uff0c\u827e\u529b\u65af\u4e5f\u5728\u79ef\u6781\u63a2\u7d22\u4f0f\u7f8e\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u5176\u5b83EGFR\u9776\u70b9\u7a81\u53d8NSCLC\u7684\u6f5c\u529b\u3002<\/p>\n

\u4f5c\u4e3a\u4e00\u5bb6\u521b\u65b0\u9a71\u52a8\u578b\u836f\u4f01\uff0c\u827e\u529b\u65af\u4ee5\u5168\u7403\u533b\u836f\u5e02\u573a\u672a\u88ab\u6ee1\u8db3\u7684\u4e34\u5e8a\u9700\u6c42\u4e3a\u5bfc\u5411\uff0c\u4ee5\u5f00\u53d1\u51fa\u9996\u521b\u836f\u7269\u548c\u540c\u7c7b\u6700\u4f73\u836f\u7269\u4e3a\u76ee\u6807\uff0c\u81f4\u529b\u4e8e\u7814\u53d1\u548c\u751f\u4ea7\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u3001\u5b89\u5168\u3001\u6709\u6548\u3001\u60e0\u53ca\u5927\u4f17\u7684\u521b\u65b0\u836f\u7269\u3002\u827e\u529b\u65af\u8463\u4e8b\u957f\u675c\u9526\u8c6a<\/span>\u6307\u51fa\uff0c\u827e\u529b\u65af\u81ea\u521b\u7acb\u4e4b\u521d\u5c31\u5df2\u7acb\u4e0b\u8ba9\u5168\u7403\u60a3\u8005\u7528\u4e0a\u4e2d\u56fd\u65b0\u836f\u597d\u836f\u7684\u613f\u666f\u76ee\u6807\u3002 “\u6211\u4eec\u975e\u5e38\u9ad8\u5174\u80fd\u4e0eArriVent\u5c31\u4f0f\u7f8e\u66ff\u5c3c\u6d77\u5916\u6388\u6743\u4ee5\u53ca\u672a\u6765\u591a\u5c42\u9762\u3001\u5168\u65b9\u4f4d\u7684\u6218\u7565\u5408\u4f5c\u8fbe\u6210\u534f\u8bae\uff0c\u8fd9\u662f\u827e\u529b\u65af\u5f00\u542f\u5168\u7403\u5316\u8fdb\u7a0b\u3001\u52a0\u901f\u521b\u65b0\u4e4b\u65c5\u7684\u4e00\u4e2a\u91cd\u5927\u91cc\u7a0b\u7891<\/strong>\u3002”<\/span>\u675c\u9526\u8c6a\u8868\u793a\u3002<\/p>\n

 <\/p>\n

\n\n\n\n\n\n
\n

[i]<\/sup> Yuankai Shi, et al., Safety, Clinical Activity, and Pharmacokinetics of Alflutinib (AST2818) in Patients With Advanced NSCLC With EGFR T790M Mutation, Journal of Thoracic Oncology, January, 2020 https:\/\/doi.org\/10.1016\/j.jtho.2020.01.010<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[ii]<\/sup> Yuankai Shi,Xingsheng Hu,Shucai Zhang, et al. Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. Lancet Respir Med. Published on March 26, 2021. DOI: https:\/\/doi.org\/10.1016\/S2213-2600(20)30455-0<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[iii]<\/sup> Y. Shi et al.,  CNS Efficacy of AST2818 in Patients with T790M-Positive Advanced NSCLC: Data from a Phase I-II Dose-Expansion Study, 2020 WCLC, Abstract 3286<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

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“\u6211\u4eec\u975e\u5e38\u9ad8\u5174\u80fd\u4e0eArriVent\u5c31\u4f0f\u7f8e\u66ff\u5c3c\u6d77\u5916\u6388\u6743\u4ee5\u53ca\u672a\u6765\u591a\u5c42\u9762\u3001\u5168\u65b9\u4f4d\u7684\u6218\u7565\u5408\u4f5c\u8fbe\u6210\u534f\u8bae\uff0c\u8fd9\u662f\u827e\u529b\u65af\u5f00\u542f\u5168\u7403\u5316\u8fdb\u7a0b\u3001\u52a0\u901f\u521b\u65b0\u4e4b\u65c5\u7684\u4e00\u4e2a\u91cd\u5927\u91cc\u7a0b\u7891\u3002”\u675c\u9526\u8c6a\u8868\u793a\u3002   [i] Yuankai Shi, et al., Safety, Clinical Activity, and Pharmacokinetics of Alflutinib (AST2818) in Patients With Advanced NSCLC With EGFR T790M Mutation, Journal of Thoracic Oncology, January, 2020… Read 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