{"id":24048,"date":"2021-03-24T19:50:00","date_gmt":"2021-03-24T12:50:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2021032419500024048"},"modified":"2021-03-24T21:39:52","modified_gmt":"2021-03-24T13:39:52","slug":"%e5%98%89%e5%92%8c%e7%94%9f%e7%89%a9%e5%8f%91%e5%b8%832020%e5%b9%b4%e5%ba%a6%e4%b8%9a%e7%bb%a9","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2021032419500024048","title":{"rendered":"\u5609\u548c\u751f\u7269\u53d1\u5e032020\u5e74\u5ea6\u4e1a\u7ee9"},"content":{"rendered":"<p><p><b>&nbsp;&#8211; <i>\u5728\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff0c\u4e34\u5e8a\u5f00\u53d1<\/i><i>, <\/i><i>\u4e0a\u5e02\u7533\u8bf7\uff0c\u5546\u4e1a\u5316\uff0c\u5546\u52a1\u62d3\u5c55\uff0c\u548c\u8d22\u52a1\u7b49\u65b9\u9762\u53d6\u5f97\u5feb\u901f\u3001\u5168\u9762\u7684\u53d1\u5c55\u3002<\/i><\/b><\/p>\n<ul type=\"disc\">\n<li><i><i><b>\u4e0a\u5e02\u7533\u8bf7<\/b><\/i> <i>&#8211; <\/i><i>\u6770\u6d1b\u5229\u5355\u6297\u6ce8\u5c04\u6db2<\/i><i>(Geptanolimab<\/i><i>\uff0c<\/i><i>GB226) <\/i><i>\u5916\u5468<\/i><i>T<\/i><i>\u7ec6\u80de\u6dcb\u5df4\u7624\u9002\u5e94\u75c7\u83b7\u4f18\u5148\u5ba1\u8bc4\uff0c\u4e0e\u82f1\u592b\u5229\u897f\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f<\/i><i>(GB242)<\/i><i>\u5df2\u9012\u4ea4\u4e0a\u5e02\u7533\u8bf7<\/i><i>(NDA)<\/i><\/i> <\/li>\n<li><i><b>\u4e34\u5e8a\u5f00\u53d1<\/b><\/i> <i>\u2013 3<\/i><i>\u4e2a\u4ea7\u54c1<\/i><i>(GB224<\/i><i>\uff0c<\/i><i>GB221<\/i><i>\uff0c<\/i><i>GB242)<\/i><i>\u7684\u5173\u952e\u4e34\u5e8a\u6ce8\u518c\u8bd5\u9a8c\u5df2\u7ecf\u5b8c\u6210\uff0c<\/i><i>GB491(Lerociclib)<\/i><i>\u7ec6\u80de\u5468\u671f\u86cb\u767d\u4f9d\u8d56\u6027\u6fc0\u9176<\/i><i>4\/6<\/i><i>\u6291\u5236\u5242\u9488\u5bf9<\/i><i>HR+\/HER2-<\/i><i>\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u4e00\u7ebf\u4e8c\u7ebf\u6865\u63a5\u8bd5\u9a8c\u5df2\u88ab\u8bb8\u53ef\uff0c<\/i><i>GB261<\/i><i>\uff08<\/i><i>CD20\/CD3<\/i><i>\uff09\u53cc\u7279\u5f02\u6027\u6297\u4f53\u7684\u9996\u6b21\u4eba\u4f53\u8bd5\u9a8c\uff08<\/i><i>FIH<\/i><i>\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u4e8e<\/i><i>2021<\/i><i>\u5e74<\/i><i>3<\/i><i>\u6708\u5728\u6fb3\u5927\u5229\u4e9a\u9012\u4ea4<\/i> <\/li>\n<li><i><b>\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7<\/b><\/i> <i>&#8211; 8<\/i><i>\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u88ab\u6279\u51c6\uff0c<\/i><i>2<\/i><i>\u4e2a\u6b63\u5728\u5ba1\u6279\uff0c<\/i><i>3<\/i><i>\u4e2a\u53cc\u7279\u5f02\u6297\u4f53\u8fdb\u5165\u4e34\u5e8a\u8bd5\u9a8c\u7533\u62a5\u51c6\u5907\uff08<\/i><i>IND-enabling<\/i><i>\uff09\u9636\u6bb5<\/i> <\/li>\n<li><i><b>\u5546\u4e1a\u5316<\/b><\/i> <i>\u2013 <\/i><i>\u5546\u4e1a\u5316\u56e2\u961f\u7a33\u6b65\u5efa\u7acb\uff0c\u5173\u952e\u5c97\u4f4d\u5df2\u5b8c\u6210\u4f18\u79c0\u7ba1\u7406\u4eba\u5458\u7684\u52a0\u5165\uff1b\u4e0e\u4e2d\u56fd<\/i><i>(<\/i><i>\u4e0a\u6d77<\/i><i>)<\/i><i>\u81ea\u7531\u8d38\u6613\u8bd5\u9a8c\u533a\u4e34\u6e2f\u7279\u533a\u7ba1\u7406\u5c40\u7b7e\u7f72\u6295\u8d44\u534f\u8bae<\/i> <\/li>\n<li><i><b>\u5546\u52a1\u62d3\u5c55<\/b><\/i> <i>\u2013 <\/i><i>\u4ece<\/i><i>G1 Therapeutics<\/i><i>\u5f15\u8fdb<\/i><i>HR+\/HER2-<\/i><i>\u4e73\u817a\u764c\u6cbb\u7597\u836f\u7269<\/i><i>GB491(Lerociclib)<\/i><i>\uff0c\u5e76\u4ece<\/i><i>ImmuneSensor<\/i><i>\u5f15\u8fdb<\/i><i>GB492 (STING agonist)<\/i><i>\u7684\u6388\u6743\u8bb8\u53ef\u3002<\/i> <\/li>\n<li><i><b>\u8d22\u52a1<\/b><\/i><i> \u2013 2020<\/i><i>\u5e74<\/i><i>5<\/i><i>\u6708\u83b7\u5f97<\/i><i>B<\/i><i>\u8f6e\u878d\u8d44<\/i><i>1.6<\/i><i>\u4ebf\u7f8e\u5143\uff0c<\/i><i>10<\/i><i>\u6708\u5728\u6e2f\u4ea4\u6240\u4e3b\u677f\u4e0a\u5e02\uff0c\u6210\u529f\u7b79\u8d44<\/i><i>4<\/i><i>\u4ebf\u7f8e\u5143<\/i><\/li>\n<\/ul>\n<p><i><b>&#8211; \u66f4\u591a\u8fdb\u5c55\u5c06\u63a5\u8e35\u800c\u81f3<\/b><\/i><\/p>\n<ul type=\"disc\">\n<li><i>GB261 (CD20\/CD3) \u2013 2021<\/i><i>\u5e74<\/i><i>3<\/i><i>\u5b63\u5ea6\u6fb3\u5927\u5229\u4e9a\u4e34\u5e8a\u8bd5\u9a8c\u9996\u4f4d\u60a3\u8005\u5165\u7ec4<\/i><i>, 2022<\/i><i>\u5e74\u4e0a\u534a\u5e74\u83b7\u5f97\u521d\u6b65<\/i><i>POC<\/i><i>\u6570\u636e<\/i> <\/li>\n<li><i>GB<\/i><i>491(Lerociclib)<\/i><i>\u7ec6\u80de\u5468\u671f\u86cb\u767d\u4f9d\u8d56\u6027\u6fc0\u9176<\/i><i>4\/6<\/i><i>\u6291\u5236\u5242<\/i><i>(CDK4\/6) \u2013 2021<\/i><i>\u5e74<\/i><i>4<\/i><i>\u5b63\u5ea6<\/i><i>HR+\/HER2-<\/i><i>\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u4e00\u7ebf\u4e8c\u7ebf<\/i><i>III<\/i><i>\u671f\u4e34\u5e8a\u8bd5\u9a8c\u9996\u4f4d\u60a3\u8005\u5165\u7ec4\uff0c<\/i><i>2023<\/i><i>\u5e74<\/i><i>2<\/i><i>\u5b63\u5ea6\u8fbe\u5230\u4e8c\u7ebf\u7684\u4e2d\u671f\u5206\u6790\u8282\u70b9<\/i> <\/li>\n<li><i>GB226 (Geptanolimab) \u2013 2021<\/i><i>\u5e74<\/i><i>3<\/i><i>\u5b63\u5ea6\u590d\u53d1\u6216\u96be\u6cbb\u6027\u5916\u5468<\/i><i>T<\/i><i>\u7ec6\u80de\u6dcb\u5df4\u7624\u9002\u5e94\u75c7\u4e0a\u5e02\u83b7\u6279<\/i>&nbsp; <\/li>\n<li><i>GB242 (<\/i><i>\u82f1\u592b\u5229\u897f\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f<\/i><i>) \u2013 2022<\/i><i>\u5e74\u4e0a\u534a\u5e74\u83b7\u6279\u4e0a\u5e02<\/i><\/li>\n<\/ul>\n<p>\u4e0a\u6d772021\u5e743\u670824\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; \u5609\u548c\u751f\u7269\u836f\u4e1a\uff08\u5f00\u66fc\uff09\u63a7\u80a1\u6709\u9650\u516c\u53f8\uff08\u7b80\u79f0\u201c\u5609\u548c\u751f\u7269\u201d\u6216\u201c\u516c\u53f8\u201d\uff0c\u80a1\u7968\u4ee3\u7801\uff1a6998.HK\uff09\u516c\u5e032020\u5e74\u5ea6\u4e1a\u7ee9\uff0c\u5206\u4eab\u516c\u53f8\u57282020\u5e74\u5ea6\u7684\u8d22\u52a1\u4e1a\u7ee9\u3001\u4e1a\u52a1\u8fdb\u5c55\u7b49\u65b9\u9762\u7684\u4eae\u70b9\u3002<\/p>\n<p>2020\u5e74\u662f\u5609\u548c\u751f\u7269\u539a\u79ef\u8584\u53d1\u3001\u9510\u610f\u8fdb\u53d6\u7684\u4e00\u5e74\u3002\u8fd9\u4e00\u5e74\uff0c\u516c\u53f8\u5728\u4e34\u5e8a\u8bd5\u9a8c\u3001\u7ba1\u7ebf\u62d3\u5c55\u3001\u4ea7\u54c1\u5546\u4e1a\u5316\u7b79\u5907\u3001\u751f\u4ea7\u57fa\u5730\u5efa\u8bbe\u7b49\u65b9\u9762\u5747\u53d6\u5f97\u91cd\u5927\u8fdb\u5c55\u3002<\/p>\n<p>\u7acb\u8db3\u4e2d\u56fd\uff0c\u670d\u52a1\u5168\u7403\u3002\u5609\u548c\u751f\u7269\u81f4\u529b\u4e8e\u6210\u4e3a\u53d1\u73b0\u3001\u7814\u7a76\u3001\u5f00\u53d1\u3001\u751f\u4ea7\u548c\u5546\u4e1a\u5316\u521b\u65b0\u7597\u6cd5\u7684\u751f\u7269\u5236\u836f\u5f15\u64ce\uff0c\u5e76\u7740\u529b\u6253\u9020\u4e3a<b>\u5168\u4ef7\u503c\u94fe\u3001\u5168\u4ea7\u4e1a\u94fe\u7684\u751f\u7269\u5236\u836f\u521b\u65b0\u4e00\u4f53\u5316\u516c\u53f8<\/b><b>\u3002<\/b>\u4e3a\u4e86\u5b9e\u73b0\u8fd9\u4e00\u4f7f\u547d\uff0c\u516c\u53f8\u6301\u7eed\u62d3\u5c55\u521b\u65b0\u6e20\u9053\uff0c\u4ee5\u6ee1\u8db3\u4e2d\u56fd\u548c\u5168\u7403\u66f4\u6709\u5438\u5f15\u529b\u548c\u672a\u88ab\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002\u540c\u65f6\u901a\u8fc7\u5236\u5b9a\u548c\u6267\u884c\u6574\u5408\u6218\u7565\uff0c\u6700\u5927\u5316\u73b0\u6709\u4e1a\u52a1\u7ec4\u5408\u3002<\/p>\n<p><b>\u52a0\u901f\u63a8\u8fdb\u65d7\u4e0b\u65b0\u578b\u53cc\u7279\u5f02\u6027<\/b><b>\/<\/b><b>\u4e09\u7279\u5f02\u6027\u5019\u9009\u4ea7\u54c1\u8fdb\u5165\u4e34\u5e8a\u9636\u6bb5\uff1a<\/b><\/p>\n<p>\u5609\u548c\u751f\u7269\u5c06\u7ee7\u7eed\u4e13\u6ce8\u4e8e\u53d1\u5c55\u516c\u53f8\u4f4d\u4e8e\u4e0a\u6d77\u548c\u65e7\u91d1\u5c71\u7684\u4e24\u4e2a\u7814\u53d1\u5e73\u53f0\u7684\u65e9\u671f\u7814\u53d1\u4ea7\u54c1\u7ba1\u7ebf\u3002\u5176\u4e2d\uff0c\u4f4d\u4e8e\u7f8e\u56fd\u65e7\u91d1\u5c71\u7684Ab Therapeutics Inc.\u91c7\u7528\u6388\u6743\u521b\u65b0\u6280\u672f\u901a\u8fc7\u8ba1\u7b97\u673a\u8f85\u52a9\u8bbe\u8ba1\u8fdb\u884c\u663e\u8457\u5dee\u5f02\u5316\u7684\u9776\u5411\u80bf\u7624\u591a\u9776\u70b9\u7684\u6cbb\u7597\u7528\u53cc\u6297\u548c\u4e09\u6297\u7684\u5f00\u53d1\u548c\u4f18\u5316\uff0c\u4ee5\u6ee1\u8db3\u672a\u88ab\u6ee1\u8db3\u7684\u4e34\u5e8a\u9700\u6c42\u3002<\/p>\n<p>\u76ee\u524d\uff0c\u6211\u4eec\u5df2\u7ecf\u62e5\u6709\u591a\u79cd\u53cc\u7279\u5f02\u6027\/\u4e09\u7279\u5f02\u6027\u6297\u4f53\u5019\u9009\u836f\u7269\uff0c\u5176\u4e2d\u5305\u62ecCD20\/CD3\uff08GB261\uff09\u3001PD-L1\/CD55\uff08GB262\uff09\u3001EGFR\/c-Met\/c-Met\uff08GB263T\uff09\u3001Claudin 18.2\/CD3\uff08GB264\uff09\u7b49\u5907\u53d7\u5173\u6ce8\u7684\u5019\u9009\u836f\u7269\uff0c\u5728\u5168\u7403\u8303\u56f4\u5185\u4ef7\u503c\u76ee\u524d\u5c1a\u6ca1\u6709\u4e00\u79cd\u836f\u7269\u83b7\u5f97\u6279\u51c6\u3002\u8fd9\u56db\u9879\u5019\u9009\u836f\u7269\u5df2\u7ecf\u63d0\u4ea42021\u5e74\u5ea6\u7f8e\u56fd\u764c\u75c7\u7814\u7a76\u534f\u4f1a\u5e74\u4f1a\uff08AACR\uff09\uff0c\u5e76\u5168\u90e8\u88ab\u5217\u4e3a\u201cLate Breaking Abstracts\u201d\u3002&nbsp;<\/p>\n<p>\u5609\u548c\u751f\u7269\u5728\u5927\u5206\u5b50\u836f\u7269\u9886\u57df\u6df1\u8015\u5341\u4f59\u5e74\uff0c\u4f9d\u6258\u591a\u5e74\u5355\u514b\u9686\u6297\u4f53\u7814\u53d1\u7ecf\u9a8c\u4ee5\u53ca\u81ea\u8eab\u5b8c\u5584\u7684CMC\uff08\u5316\u5b66\u3001\u751f\u4ea7\u548c\u8d28\u91cf\u63a7\u5236\uff09\u80fd\u529b\uff0c\u5728\u77ed\u65f6\u95f4\u5185\u5feb\u901f\u6253\u9020\u4e86\u9ad8\u6548\u7684\u65b0\u578b\u53cc\u7279\u5f02\u6027\u53ca\u591a\u7279\u5f02\u6027\u6297\u4f53\u5f00\u53d1\u5e73\u53f0\u3002\u81ea2019\u5e74\u5e95\u4f18\u9009\u83b7\u5f97GB261\u76ee\u7684\u6c28\u57fa\u9178\u5e8f\u5217\u540e\uff0c\u5609\u548c\u751f\u7269\u572816\u4e2a\u6708\u5185\u5b8c\u6210\u4e86\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u6240\u9700\u8981\u7684\u5de5\u4f5c\uff0c\u5305\u62ec\u7ec6\u80de\u682a\u53ca\u7ec6\u80de\u57f9\u517b\u5de5\u827a\u5f00\u53d1\u3001\u7eaf\u5316\u5de5\u827a\u5f00\u53d1\u3001\u5904\u65b9\u53ca\u5236\u5242\u5de5\u827a\u5f00\u53d1\u3001\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u3001GLP\u6bd2\u7406\u6279\u6b21\u53ca\u4e34\u5e8a\u6279\u6b21\u7684\u751f\u4ea7\u53ca\u653e\u884c\u3001\u53cc\u6297\u7ed3\u6784\u4e0e\u529f\u80fd\u8868\u5f81\u3001ICH\u7a33\u5b9a\u6027\u8003\u5bdf\u542f\u52a8\u7b49\u4e00\u7cfb\u5217\u4e34\u5e8a\u7533\u62a5\u6240\u9700\u8981\u7684\u836f\u5b66\u5de5\u4f5c\u3002\u5e76\u4e0e\u533b\u5b66\u3001\u6ce8\u518c\u7b49\u591a\u4e2a\u56e2\u961f\u5408\u4f5c\uff0c\u5b8c\u6210\u6b63\u5f0f\u6bd2\u7406\u8bd5\u9a8c\uff0cFIH\u8bd5\u9a8c\u65b9\u6848\u8bbe\u8ba1\u4e0e\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u8d44\u6599\u51c6\u5907\u3002<\/p>\n<p>\u516c\u53f8\u5df2\u7ecf\u4e8e2021\u5e743\u6708\u5728\u6fb3\u5927\u5229\u4e9a\u63d0\u4ea4\u4e86CD20\/CD3\u53cc\u7279\u5f02\u6027\u6297\u4f53(GB261)\u7684\u9996\u6b21\u4eba\u4f53\u8bd5\u9a8c\uff08FIH\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff0c\u7528\u4e8eB\u7ec6\u80de\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\uff08B-NHL\uff09\u60a3\u8005\u7684\u6cbb\u7597\u3002\u5e76\u8ba1\u5212\u57286 &#8211; 12\u4e2a\u6708\u5185\u5411NMPA\u548cFDA\u63d0\u4ea4\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff0c\u5c06GB261\u5728\u5168\u7403\u8fdb\u884c\u5f00\u53d1\uff0c\u4e5f\u4e3a\u540e\u7eed\u7684\u6297\u4f53\u5019\u9009\u836f\u7269\u4ee5\u53ca\u5176\u5b83\u81ea\u4e3b\u7814\u53d1\u7684\u521b\u65b0\u836f\u7269\u6253\u4e0b\u5168\u7403\u4e34\u5e8a\u5f00\u53d1\u7684\u57fa\u7840\u3002<\/p>\n<p><b>\u52a0\u5feb\u4e3b\u8981\u5019\u9009\u4ea7\u54c1\u7684\u6ce8\u518c\u5ba1\u6279<\/b><\/p>\n<p>\u5609\u548c\u751f\u7269\u65d7\u4e0b\u6770\u6d1b\u5229\u5355\u6297\u6ce8\u5c04\u6db2\uff08Geptanolimab\uff0cGB226)\u5c06\u57282021\u5e743\u5b63\u5ea6\u83b7\u6279\u4e0a\u5e02\uff0c\u4f5c\u4e3a<b>\u5168\u7403\u9996\u4e2a\u5916\u5468<\/b><b>T<\/b><b>\u7ec6\u80de\u6dcb\u5df4\u7624\u9002\u5e94\u75c7\u7684<\/b><b>PD-1<\/b><b>\u4ea7\u54c1<\/b>\u4e3a\u60a3\u8005\u5e26\u6765\u5b89\u5168\u3001\u9ad8\u8d28\u91cf\u7684\u6cbb\u7597\u83b7\u76ca\u3002\u540c\u65f6\uff0c\u6211\u4eec\u6b63\u5728\u7ee7\u7eed\u63a2\u7d22\u6770\u6d1b\u5229\u5355\u6297\u6ce8\u5c04\u6db2\uff08Geptanolimab\uff0cGB226)\u5728\u5176\u4ed6\u9002\u5e94\u75c7\u4e2d\u7684\u5e94\u7528\uff0c\u4ee5\u53ca\u65b0\u7684\u8054\u5408\u6cbb\u7597\u6f5c\u529b\uff0c\u5305\u62ec\u5176\u4e0eGB492(STING\u6fc0\u52a8\u5242)\u7684\u8054\u5408\u6cbb\u7597\uff0c\u4ee5\u60e0\u53ca\u66f4\u591a\u533b\u7597\u9700\u6c42\u5c1a\u672a\u5f97\u5230\u6ee1\u8db3\u7684\u4e2d\u56fd\u60a3\u8005\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u5609\u548c\u751f\u7269GB491\uff08Lerociclib\uff09\u7ec6\u80de\u5468\u671f\u86cb\u767d\u4f9d\u8d56\u6027\u6fc0\u91764\/6\u6291\u5236\u5242\uff08CDK4\/6\uff09\u4e8e2021\u5e743\u6708\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u4e34\u5e8a\u8bd5\u9a8c\u9ed8\u793a\u8bb8\u53ef\uff0c\u4ee5\u53ca\u533b\u5b66\u4f26\u7406\u59d4\u5458\u4f1a\uff08IRB\uff09\u7684\u6279\u51c6\uff0c\u6b63\u5f0f\u542f\u52a8\u4e00\u7ebf\u8054\u5408\u6765\u66f2\u5511\u6cbb\u7597\u65e2\u5f80\u672a\u7ecf\u8fc7\u7cfb\u7edf\u6027\u6297\u80bf\u7624\u6cbb\u7597\u7684HR\u9633\u6027\u3001HER2\u9634\u6027\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001Ib\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u548c\u4e8c\u7ebf\u8054\u5408\u6c1f\u7ef4\u53f8\u7fa4\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u5185\u5206\u6ccc\u6cbb\u7597\u540e\u75be\u75c5\u8fdb\u5c55\u7684HR\u9633\u6027\u3001HER2\u9634\u6027\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001Ib\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002&nbsp;<\/p>\n<p>\u5609\u548c\u751f\u7269\u65d7\u4e0bGB492\uff08IMSA101\uff09\u5e72\u6270\u7d20\u57fa\u56e0\u523a\u6fc0\u56e0\u5b50\uff08Stimulator of interferon genes\uff0cSTING\uff09\u6fc0\u52a8\u5242\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u6b63\u5f0f\u53d7\u7406\uff0c\u5c06\u5f00\u5c55\u5355\u836f\u4ee5\u53ca\u4e0e\u91cd\u7ec4\u6297PD-1\/L1\u4eba\u6e90\u5316\u5355\u514b\u9686\u6297\u4f53\u8054\u5408\u5728\u665a\u671f\u96be\u6cbb\u6027\u6076\u6027\u80bf\u7624\u53d7\u8bd5\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684I\/IIa\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n<p>\u81ea\u8eab\u514d\u75ab\u9886\u57df\u6cbb\u7597\u836f\u7269\u82f1\u592b\u5229\u897f\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f(GB242)\u7684\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\u4ea6\u88abNMPA\u53d7\u7406\uff0c\u76ee\u524d\u6b63\u5728\u5ba1\u8bc4\u4e2d\uff0c\u9884\u8ba1\u5c06\u57282022\u5e74\u4e0a\u534a\u5e74\u83b7\u6279\u4e0a\u5e02\u3002&nbsp;<\/p>\n<p>\u5728\u4e73\u817a\u764c\u9886\u57df\u7684\u4ea7\u54c1\u7ec4\u5408\u65b9\u9762\uff0c\u6211\u4eec\u8ba1\u5212\u57282021\u5e744\u5b63\u5ea6\uff0c\u5411NMPA\u9012\u4ea4Coprelotamab (GB221) HER2+ \u4e73\u817a\u764c\u6cbb\u7597\u7684\u4e0a\u5e02\u7533\u8bf7\u3002<\/p>\n<p><b>\u52a0\u5f3a\u5e76\u5b8c\u5584\u7ba1\u7406\u56e2\u961f\u3001\u4e3a\u5546\u4e1a\u5316\u505a\u5168\u9762\u51c6\u5907<\/b><\/p>\n<p>\u5609\u548c\u751f\u7269\u7684\u7ba1\u7406\u56e2\u961f\u6210\u5458\u5e73\u5747\u62e5\u6709\u8d85\u8fc715\u5e74\u7684\u884c\u4e1a\u7ecf\u9a8c\uff0c\u5e76\u62e5\u6709\u826f\u597d\u7684\u4ece\u4e1a\u8bb0\u5f55\uff0c\u662f\u8de8\u8d8a\u7814\u7a76\u53d1\u73b0\u3001\u4e34\u5e8a\u5f00\u53d1\u3001\u5236\u9020\u3001\u6cd5\u89c4\u4e8b\u52a1\u3001\u5546\u4e1a\u5316\u548c\u878d\u8d44\u7b49\u4e13\u4e1a\u77e5\u8bc6\u7684\u5747\u8861\u7ec4\u5408\u3002<\/p>\n<p>2021\u5e741\u6708\uff0c\u97e9\u6dd1\u534e\u535a\u58eb\u52a0\u5165\u516c\u53f8\uff0c\u62c5\u4efb\u96c6\u56e2\u9996\u5e2d\u79d1\u5b66\u5b98\u3002\u97e9\u535a\u58eb\u5728\u514d\u75ab\u5b66\u3001\u764c\u75c7\u514d\u75ab\u6cbb\u7597\u3001\u80bf\u7624\u5b66\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u53ca\u708e\u75c7\u7b49\u9886\u57df\u62e5\u6709\u8d85\u8fc725\u5e74\u7684\u836f\u7269\u53d1\u73b0\u53ca\u5b66\u672f\u7814\u7a76\u7ecf\u9a8c\u3002&nbsp;\u5979\u5c06\u5f15\u9886\u5609\u548c\u751f\u7269\u7684\u5185\u90e8\u7814\u53d1\uff0c\u52a0\u901f\u5c06\u516c\u53f8\u5efa\u7acb\u6210\u4e3a\u4e00\u4e2a\u4e16\u754c\u7ea7\u7684\u521b\u65b0\u5f15\u64ce\u3002<\/p>\n<p>2020\u5e747\u6708\uff0c\u9648\u6587\u5fb7\u5148\u751f\u52a0\u5165\u516c\u53f8\uff0c\u62c5\u4efb\u9996\u5e2d\u8fd0\u8425\u5b98\u3002\u9648\u6587\u5fb7\u5148\u751f\u62e5\u6709\u8d85\u8fc720\u5e74\u7684\u751f\u7269\u5236\u836f\u884c\u4e1a\u7ecf\u9a8c\uff0c\u8d1f\u8d23\u5609\u548c\u751f\u7269\u7684\u5546\u4e1a\u5316\u8fd0\u8425\u3002<\/p>\n<p>\u4e3a\u51c6\u5907\u65b0\u836f\u7684\u4e0a\u5e02\uff0c\u5609\u548c\u751f\u7269\u6b63\u5728\u7a33\u6b65\u5efa\u7acb\u5546\u4e1a\u5316\u56e2\u961f\uff0c\u5e76\u5236\u5b9a\u5546\u4e1a\u7b56\u7565\uff0c\u4ee5\u652f\u6301GB226\u57282021\u5e74\u7684\u4e0a\u5e02\u4ee5\u53ca\u672a\u6765\u5176\u4ed6\u65b0\u4ea7\u54c1\u7684\u6210\u529f\u4e0a\u5e02\u3002\u76ee\u524d\uff0c\u5173\u952e\u5c97\u4f4d\u5df2\u5b8c\u6210\u4f18\u79c0\u7ba1\u7406\u56e2\u961f\u4eba\u5458\u7684\u52a0\u5165\u3002<\/p>\n<p>2020\u5e7412\u6708\uff0c\u5546\u4e1a\u5316\u56e2\u961f\u4ee3\u8868\u5609\u548c\u751f\u7269\u4eae\u76f82020\u4e2d\u56fd\u80bf\u7624\u9632\u6cbb\u8054\u76df\u5e74\u4f1a\uff0c\u4ecb\u7ecd\u516c\u53f8\u4ee5\u53caGB226 r\/r PTCL\u7814\u7a76\u6210\u679c\u3002\u540c\u65f6\uff0c\u5546\u4e1a\u5316\u56e2\u961f\u4e00\u76f4\u5728\u4e0eGB226\u836f\u7269\u7ecf\u6d4e\u5b66\u7814\u7a76\u7684\u4e13\u5bb6\u5b66\u8005\u5bc6\u5207\u5408\u4f5c\uff0c\u4e3a\u4ea7\u54c1\u4e0a\u5e02\u548c\u53c2\u4e0e\u56fd\u5bb6\u533b\u4fdd\u76ee\u5f55(NRDL)\u8c08\u5224\u505a\u51c6\u5907\u3002<\/p>\n<p>2020\u5e7411\u6708\uff0c\u5609\u548c\u751f\u7269\u4f4d\u4e8e\u4e91\u5357\u7701\u7389\u6eaa\u751f\u4ea7\u57fa\u5730\u5b8c\u6210\u4e86GB226 NDA\u7684\u6ce8\u518c\u751f\u4ea7\u73b0\u573a\u6838\u67e5\u548cGMP\u7b26\u5408\u6027\u68c0\u67e5\uff0c\u5e76\u987a\u5229\u901a\u8fc7\u4e86\u68c0\u9a8c\u3002\u914d\u5408GB226\u53ca\u66f4\u591a\u521b\u65b0\u836f\u7269\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u516c\u53f8\u4e0e\u4e2d\u56fd(\u4e0a\u6d77)\u81ea\u7531\u8d38\u6613\u8bd5\u9a8c\u533a\u4e34\u6e2f\u7279\u533a\u7ba1\u7406\u5c40\u4e8e2021\u5e742\u6708\u7b7e\u7f72\u6295\u8d44\u534f\u8bae\uff0c\u5c06\u5728\u4e0a\u6d77\u4e34\u6e2f\u7279\u533a\u5efa\u8bbe\u5360\u57304.3\u4e07\u591a\u5e73\u65b9\u7c73\u7684\u5546\u4e1a\u751f\u4ea7\u8bbe\u65bd\u3002<\/p>\n<p><b>\u8d22\u52a1\u6458\u8981<\/b><\/p>\n<ul type=\"disc\">\n<li>\u62a5\u544a\u671f\u5185\u603b\u6536\u76ca\u4e3a\u4eba\u6c11\u5e011,030\u4e07\u5143\uff0c\u4e3b\u8981\u6765\u81ea\u6839\u636e\u6309\u670d\u52a1\u6536\u8d39\u5408\u7ea6\u5411\u5ba2\u6237\u63d0\u4f9b\u7814\u7a76\u53ca\u5236\u9020\u670d\u52a1\u3002 <\/li>\n<li>\u62a5\u544a\u671f\u5185\u7814\u53d1\u5f00\u652f\u4e3a\u4eba\u6c11\u5e016.966\u4ebf\u5143\uff0c\u622a\u81f32019\u5e7412\u670831\u65e5\u7684\u5e74\u5ea6\u7814\u53d1\u5f00\u652f\u4e3a\u4eba\u6c11\u5e014.388\u4ebf\u5143\u3002\u76f8\u5173\u652f\u51fa\u4e3b\u8981\u5f52\u56e0\u4e8e(i)\u8fdb\u884c\u4e2d\u7684\u4e34\u5e8a\u8bd5\u9a8c\u5f00\u652f\u589e\u52a0\u4ee5\u53ca(ii)\u5458\u5de5\u85aa\u916c\u548c\u76f8\u5173\u798f\u5229\u6210\u672c\u3002 <\/li>\n<li>\u62a5\u544a\u671f\u5185\u5168\u9762\u4e8f\u635f\u603b\u989d\u4e3a\u4eba\u6c11\u5e0130.328\u4ebf\u5143\u3002\u5176\u4e2d\u622a\u6b622019\u5e7412\u670831\u65e5\u4e8f\u635f\u603b\u989d\u4e3a5.23\u4ebf\u5143\u3002\u8fd9\u4e3b\u8981\u662f\u56e0\u4e3a\u6839\u636e\u9999\u6e2f\u8d22\u52a1\u62a5\u544a\u51c6\u5219(\u201cHKFRS\u201d)\uff0c <\/li>\n<li>\u4f18\u5148\u80a1\u4e8e\u516c\u53f8\u9996\u6b21\u516c\u5f00\u53d1\u552e\uff08IPO\uff09\u4e2d\u8f6c\u6362\u4e3a\u666e\u901a\u80a1\u540e\uff0c\u672c\u96c6\u56e2\u5c31\u4f18\u5148\u80a1\u516c\u5141\u4ef7\u503c\u4e8f\u635f\u51c0\u989d\u9020\u6210\u975e\u7ecf\u5e38\u6027\u4e8f\u635f\u4eba\u6c11\u5e0119.338\u4ebf\u5143\u3002 <\/li>\n<li>\u6839\u636e\u975e\u9999\u6e2f\u8d22\u52a1\u62a5\u544a\u51c6\u5219\u8ba1\u91cf\uff0c\u672c\u62a5\u544a\u671f\u5185\u7ecf\u8c03\u6574\u4e8f\u635f(1)\u4e3a\u4eba\u6c11\u5e016.546\u4ebf\u5143\u3002<\/li>\n<\/ul>\n<p>\u7ecf\u8c03\u6574\u4e8f\u635f\u51c0\u989d\u6309\u7167\u62a5\u544a\u671f\u5185\u4e8f\u635f\u6263\u9664&nbsp;(i) \u4f18\u5148\u80a1\u7684\u516c\u5141\u4ef7\u503c\u4e8f\u635f\uff0c&nbsp;(ii) \u4ee5\u80a1\u4efd\u4e3a\u57fa\u7840\u7684\u4ed8\u6b3e\u5f00\u652f\uff0c&nbsp;(iii) \u6c47\u5151\u4e8f\u635f\u51c0\u989d&nbsp;\u53ca&nbsp;(iv) \u4e0a\u5e02\u5f00\u652f\u3002&nbsp;<\/p>\n<p><b>\u5173\u4e8e\u5609\u548c\u751f\u7269<\/b><\/p>\n<p>\u5609\u548c\u751f\u7269\u836f\u4e1a\uff08\u7b80\u79f0\u201c\u5609\u548c\u751f\u7269\u201d\uff0c\u80a1\u7968\u4ee3\u7801\uff1a6998.HK\uff09\u6210\u7acb\u4e8e2007\u5e74\uff0c\u662f\u4e00\u5bb6\u521b\u65b0\u9a71\u52a8\u578b\u751f\u7269\u5236\u836f\u516c\u53f8\uff1b\u76ee\u524d\u5df2\u62e5\u6709\u5f3a\u5927\u7684\u4ea7\u54c1\u7ba1\u7ebf\uff0c\u6db5\u76d6\u5168\u7403\u524d\u4e09\u5927\u80bf\u7624\u9776\u6807\uff08\u4e73\u817a\u764c\u3001\u80ba\u764c\u3001\u80c3\u80a0\u9053\u80bf\u7624\uff09\u3002<\/p>\n<p>\u7acb\u8db3\u4e2d\u56fd\u3001\u5e03\u5c40\u5168\u7403\uff0c\u5609\u548c\u751f\u7269\u7740\u529b\u6253\u9020<b>\u5168\u4ef7\u503c\u94fe\u3001\u5168\u4ea7\u4e1a\u94fe\u7684\u751f\u7269\u5236\u836f\u521b\u65b0\u4e00\u4f53\u5316\u516c\u53f8<\/b>\u3002\u4f4d\u4e8e\u7f8e\u56fd\u65e7\u91d1\u5c71\u7684<b>\u62e5\u6709\u5168\u7403\u524d\u6cbf\u521b\u65b0\u6280\u672f\u7684\u5f3a\u5927\u53cc<\/b><b>\/<\/b><b>\u591a\u7279\u5f02\u6027\u6297\u4f53\u7814\u53d1\u5e73\u53f0<\/b>\uff0c\u91c7\u7528\u8ba1\u7b97\u673a\u8f85\u52a9\u6280\u672f\u8fdb\u884c\u663e\u8457\u5dee\u5f02\u5316\u53cc\u9776\u70b9\u53ca\u591a\u9776\u70b9\u5355\u514b\u9686\u6297\u4f53\u7684\u5f00\u53d1\u548c\u4f18\u5316\u3002\u4f4d\u4e8e\u4e2d\u56fd\u4e0a\u6d77<b>\u4e1a\u754c\u9886\u5148\u7684<\/b><b>CMC<\/b><b>\uff08\u5316\u5b66\u3001\u751f\u4ea7\u548c\u8d28\u91cf\u63a7\u5236\uff09\u5de5\u827a\u6280\u672f\u7814\u53d1\u4e2d\u5fc3<\/b>\uff0c\u62e5\u6709\u56fd\u9645\u5148\u8fdb\u7684\u5de5\u827a\u6d41\u7a0b\u5f00\u53d1\u80fd\u529b\u3001\u4e34\u5e8a\u524d\u53ca\u4e34\u5e8a\u7528\u836f\u751f\u4ea7\u80fd\u529b\uff0c\u5f3a\u5927\u5b8c\u5584\u7684\u5206\u6790\u68c0\u6d4b\u80fd\u529b\u548c\u5b8c\u5907\u7684\u8d28\u91cf\u4f53\u7cfb\u3002\u4f4d\u4e8e\u4e2d\u56fd\u4e91\u5357\u7389\u6eaa\u7684<b>\u5546\u4e1a\u5316<\/b><b>GMP<\/b><b>\u751f\u4ea7\u57fa\u5730<\/b>\u4e8e2016\u5e74\u5efa\u6210\u3001\u9a8c\u8bc1\u5e76\u6295\u4ea7\uff0c\u62e5\u6709\u9886\u5148\u7684\u9ad8\u8868\u8fbe\u91cf\u8fde\u7eed\u704c\u6d41\u57f9\u517b\u6280\u672f\uff08~20g\/L\uff09\u3001\u81ea\u4e3b\u7814\u53d1\u57f9\u517b\u57fa\u3001\u9ad8\u6210\u672c\u6548\u76ca\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u80fd\u529b\u548c\u4e00\u652f\u9ad8\u5ea6\u6ee1\u8db3GMP\u5408\u89c4\u6027\u7684\u6280\u672f\u56e2\u961f\uff0c\u9ad8\u6548\u5b9e\u73b0\u5609\u548c\u4ea7\u54c1\u7ebfIII\u671f\u4e34\u5e8a\u53ca\u5173\u952e\u4e34\u5e8a\u7814\u7a76\u7528\u836f\u751f\u4ea7\u3001\u4e0a\u5e02\u5de5\u827a\u9a8c\u8bc1\u53ca\u6700\u7ec8\u4e0a\u5e02\u4ea7\u54c1\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u3002<\/p>\n<p>\u5609\u548c\u751f\u7269\u73b0\u670910\u4f59\u4e2a\u5728\u7814\u4ea7\u54c1\u5904\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u6216\u8005\u4e34\u5e8a\u7533\u62a5\u9636\u6bb5\u3002\u5176\u4e2d\u6770\u6d1b\u5229\u5355\u6297\u6ce8\u5c04\u6db2\u65b0\u836f\uff08\u7814\u53d1\u4ee3\u53f7\uff1aGB226\uff09\u4e0a\u5e02\u7533\u8bf7&nbsp;(NDA) \u5df2\u88ab\u56fd\u5bb6\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3&nbsp;(CDE) \u6388\u4e88\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff0c\u5e76\u5df2\u6210\u529f\u901a\u8fc7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u836f\u54c1\u6ce8\u518c\u751f\u4ea7\u73b0\u573a\u6838\u67e5\uff0c\u8ba1\u5212\u4e8e2021\u5e74\u5b9e\u73b0\u5546\u4e1a\u5316\uff0c\u4f5c\u4e3a<b>\u5168\u7403\u9996\u4e2a\u5916\u5468<\/b><b>T<\/b><b>\u7ec6\u80de\u6dcb\u5df4\u7624\u9002\u5e94\u75c7\u7684<\/b><b>PD-1<\/b><b>\u4ea7\u54c1<\/b>\u4e3a\u60a3\u8005\u5e26\u6765\u5b89\u5168\u3001\u9ad8\u8d28\u91cf\u7684\u6cbb\u7597\u83b7\u76ca\u3002\u6ce8\u5c04\u7528\u82f1\u592b\u5229\u897f\u5355\u6297\uff08\u7814\u53d1\u4ee3\u53f7\uff1aGB242\uff09\u4e0a\u5e02\u7533\u8bf7\u4ea6\u88abCDE\u53d7\u7406\uff0c\u76ee\u524d\u6b63\u5728\u8fdb\u884c\u5ba1\u8bc4\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp;&#8211; \u5728\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff0c\u4e34\u5e8a\u5f00\u53d1, \u4e0a\u5e02\u7533\u8bf7\uff0c\u5546\u4e1a\u5316\uff0c\u5546\u52a1\u62d3\u5c55\uff0c\u548c\u8d22\u52a1\u7b49\u65b9\u9762\u53d6\u5f97\u5feb\u901f\u3001\u5168\u9762\u7684\u53d1\u5c55\u3002 \u4e0a\u5e02\u7533\u8bf7 &#8211; \u6770\u6d1b\u5229\u5355\u6297\u6ce8\u5c04\u6db2(Geptanolimab\uff0cGB226) \u5916\u5468T\u7ec6\u80de\u6dcb\u5df4\u7624\u9002\u5e94\u75c7\u83b7\u4f18\u5148\u5ba1\u8bc4\uff0c\u4e0e\u82f1\u592b\u5229\u897f\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f(GB242)\u5df2\u9012\u4ea4\u4e0a\u5e02\u7533\u8bf7(NDA) \u4e34\u5e8a\u5f00\u53d1 \u2013 3\u4e2a\u4ea7\u54c1(GB224\uff0cGB221\uff0cGB242)\u7684\u5173\u952e\u4e34\u5e8a\u6ce8\u518c\u8bd5\u9a8c\u5df2\u7ecf\u5b8c\u6210\uff0cGB491(Lerociclib)\u7ec6\u80de\u5468\u671f\u86cb\u767d\u4f9d\u8d56\u6027\u6fc0\u91764\/6\u6291\u5236\u5242\u9488\u5bf9HR+\/HER2-\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u4e00\u7ebf\u4e8c\u7ebf\u6865\u63a5\u8bd5\u9a8c\u5df2\u88ab\u8bb8\u53ef\uff0cGB261\uff08CD20\/CD3\uff09\u53cc\u7279\u5f02\u6027\u6297\u4f53\u7684\u9996\u6b21\u4eba\u4f53\u8bd5\u9a8c\uff08FIH\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u4e8e2021\u5e743\u6708\u5728\u6fb3\u5927\u5229\u4e9a\u9012\u4ea4 \u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7 &#8211; 8\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u88ab\u6279\u51c6\uff0c2\u4e2a\u6b63\u5728\u5ba1\u6279\uff0c3\u4e2a\u53cc\u7279\u5f02\u6297\u4f53\u8fdb\u5165\u4e34\u5e8a\u8bd5\u9a8c\u7533\u62a5\u51c6\u5907\uff08IND-enabling\uff09\u9636\u6bb5 \u5546\u4e1a\u5316 \u2013 \u5546\u4e1a\u5316\u56e2\u961f\u7a33\u6b65\u5efa\u7acb\uff0c\u5173\u952e\u5c97\u4f4d\u5df2\u5b8c\u6210\u4f18\u79c0\u7ba1\u7406\u4eba\u5458\u7684\u52a0\u5165\uff1b\u4e0e\u4e2d\u56fd(\u4e0a\u6d77)\u81ea\u7531\u8d38\u6613\u8bd5\u9a8c\u533a\u4e34\u6e2f\u7279\u533a\u7ba1\u7406\u5c40\u7b7e\u7f72\u6295\u8d44\u534f\u8bae \u5546\u52a1\u62d3\u5c55 \u2013 \u4eceG1 Therapeutics\u5f15\u8fdbHR+\/HER2-\u4e73\u817a\u764c\u6cbb\u7597\u836f\u7269GB491(Lerociclib)\uff0c\u5e76\u4eceImmuneSensor\u5f15\u8fdbGB492 (STING agonist)\u7684\u6388\u6743\u8bb8\u53ef\u3002 \u8d22\u52a1 \u2013 2020\u5e745\u6708\u83b7\u5f97B\u8f6e\u878d\u8d441.6\u4ebf\u7f8e\u5143\uff0c10\u6708\u5728\u6e2f\u4ea4\u6240\u4e3b\u677f\u4e0a\u5e02\uff0c\u6210\u529f\u7b79\u8d444\u4ebf\u7f8e\u5143 &#8211; \u66f4\u591a\u8fdb\u5c55\u5c06\u63a5\u8e35\u800c\u81f3 GB261 (CD20\/CD3) \u2013 2021\u5e743\u5b63\u5ea6\u6fb3\u5927\u5229\u4e9a\u4e34\u5e8a\u8bd5\u9a8c\u9996\u4f4d\u60a3\u8005\u5165\u7ec4, 2022\u5e74\u4e0a\u534a\u5e74\u83b7\u5f97\u521d\u6b65POC\u6570\u636e GB491(Lerociclib)\u7ec6\u80de\u5468\u671f\u86cb\u767d\u4f9d\u8d56\u6027\u6fc0\u91764\/6\u6291\u5236\u5242(CDK4\/6) \u2013 2021\u5e744\u5b63\u5ea6HR+\/HER2-\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u4e00\u7ebf\u4e8c\u7ebfIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u9996\u4f4d\u60a3\u8005\u5165\u7ec4\uff0c2023\u5e742\u5b63\u5ea6\u8fbe\u5230\u4e8c\u7ebf\u7684\u4e2d\u671f\u5206\u6790\u8282\u70b9 GB226 (Geptanolimab) \u2013 2021\u5e743\u5b63\u5ea6\u590d\u53d1\u6216\u96be\u6cbb\u6027\u5916\u5468T\u7ec6\u80de\u6dcb\u5df4\u7624\u9002\u5e94\u75c7\u4e0a\u5e02\u83b7\u6279&nbsp; GB242 (\u82f1\u592b\u5229\u897f\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f) \u2013 2022\u5e74\u4e0a\u534a\u5e74\u83b7\u6279\u4e0a\u5e02 \u4e0a\u6d772021\u5e743\u670824\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; 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