{"id":2151,"date":"2026-09-14T14:26:52","date_gmt":"2026-09-14T06:26:52","guid":{"rendered":"https:\/\/www.millibuff.com\/?p=2151"},"modified":"2026-09-14T14:28:46","modified_gmt":"2026-09-14T06:28:46","slug":"%e5%b0%8f%e7%89%9b%e6%b4%9e%e5%af%9f-%e6%8b%9c%e8%80%b3hyrnuo%e8%8e%b7%e6%89%b9%e3%80%81biohaven%e6%9a%82%e5%81%9c%e3%80%81solstice%e8%9e%8d%e8%b5%842-25%e4%ba%bf%ef%bc%9a%e4%b8%b4%e5%ba%8a%e5%bc%80","status":"publish","type":"post","link":"https:\/\/www.millibuff.com\/?p=2151","title":{"rendered":"\u5c0f\u725b\u6d1e\u5bdf | \u62dc\u8033Hyrnuo\u83b7\u6279\u3001Biohaven\u6682\u505c\u3001Solstice\u878d\u8d442.25\u4ebf\uff1a\u4e34\u5e8a\u5f00\u53d1\u6b63\u5728\u6210\u4e3aBiotech\u7684\u7b2c\u4e00\u9053\u98ce\u63a7"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h5 class=\"wp-block-heading\">\u4e00\u3001\u62dc\u8033 <a><\/a><a>Hyrnuo <\/a>\u83b7 FDA \u4e00\u7ebf\u52a0\u901f\u6279\u51c6\uff1a\u786e\u8bc1\u6027\u8bd5\u9a8c\u662f\u4e0b\u4e00\u573a\u786c\u4ed7<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\"><a><\/a><a>2026<\/a>\u5e749\u67089\u65e5, FDA\u52a0\u901f\u6279\u51c6\u62dc\u8033\u53e3\u670d TKI \u836f\u7269 Hyrnuo\uff08sevabertinib\uff09\u6269\u5927\u9002\u5e94\u75c7\uff0c\u7528\u4e8e\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u975e\u9cde\u72b6 NSCLC \u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597\uff0c\u524d\u63d0\u662f\u80bf\u7624\u643a\u5e26 HER2 \u916a\u6c28\u9178\u6fc0\u9176\u57df\u6fc0\u6d3b\u7a81\u53d8<strong><sup>[1]<\/sup><\/strong>\u3002\u8be5\u51b3\u5b9a\u57fa\u4e8e I\/II \u671f SOHO-01 \u8bd5\u9a8c\uff1a\u5728\u4e00\u7ec4\u672a\u63a5\u53d7\u8fc7\u6cbb\u7597\u7684\u60a3\u8005\uff08N=69\uff09\u4e2d\uff0c\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u8fbe\u5230 75%\uff08\u5176\u4e2d\u5b8c\u5168\u7f13\u89e3 6%\u3001\u90e8\u5206\u7f13\u89e3 70%\uff09\uff0c73% \u7684\u7f13\u89e3\u8005\u6301\u7eed\u65f6\u95f4\u8d85\u8fc7\u516d\u4e2a\u6708<strong><sup>[1]<\/sup><\/strong>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>SOHO-01 <\/strong><strong>\u8bd5\u9a8c\uff08\u672a\u7ecf\u6cbb\u961f\u5217\uff0c<\/strong><strong>N=69<\/strong><strong>\uff09<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5ba2\u89c2\u7f13\u89e3\u7387\uff08<\/strong><strong>ORR<\/strong><strong>\uff09\uff5c<\/strong>75%\uff08\u5176\u4e2d\u5b8c\u5168\u7f13\u89e3 6%\u3001\u90e8\u5206\u7f13\u89e3 70%\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff5c<\/strong>73% \u7684\u7f13\u89e3\u8005\u7ef4\u6301\u81f3\u5c11 6 \u4e2a\u6708<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>HER2 <\/strong><strong>\u7a81\u53d8\u5360\u6bd4\uff5c<\/strong>\u665a\u671f NSCLC \u60a3\u8005\u7684 2% \u81f3 4%<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u786e\u8bc1\u6027\u8bd5\u9a8c\uff5c<\/strong>III \u671f SOHO-02\uff08NCT06452277\uff09\u6b63\u5728\u8fdb\u884c\u4e2d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6279\u51c6\u8def\u5f84\u4e3a\u52a0\u901f\u6279\u51c6\uff0c\u9644\u6761\u4ef6\u53d6\u51b3\u4e8e\u786e\u8bc1\u6027\u8bd5\u9a8c\u7ed3\u679c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">HER2 \u7a81\u53d8\u4ec5\u5360\u665a\u671f NSCLC \u60a3\u8005\u7684 2% \u81f3 4%\u3002\u62dc\u8033\u4e0e\u52c3\u6797\u683c\u6bb7\u683c\u7ff0\u7684 Hernexeos\uff08zongertinib\uff09\u5df2\u5728\u8be5\u7ec6\u5206\u9886\u57df\u5f62\u6210\u76f4\u63a5\u7ade\u4e89\u2014\u2014\u540e\u8005\u4e8e 2026 \u5e74 2 \u6708 26 \u65e5\u7387\u5148\u83b7\u5f97\u4e00\u7ebf\u52a0\u901f\u6279\u51c6\uff0c\u5176 Beamion LUNG-1 \u8bd5\u9a8c\u5728\u672a\u7ecf\u6cbb\u961f\u5217\uff08N=72\uff09\u4e2d\u62a5\u544a ORR 76%<strong><sup>[2]<\/sup><\/strong>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u52a0\u901f\u6279\u51c6\u4e0d\u662f\u7ec8\u70b9\uff0c\u800c\u662f\u786e\u8bc1\u6027 III \u671f\u8bd5\u9a8c\u7684\u5f00\u59cb\u3002\u5bf9\u4e8e\u5c0f\u4eba\u7fa4\u7cbe\u51c6\u9776\u70b9\uff0c\u771f\u6b63\u7684\u6311\u6218\u5728\u4e8e\uff1a\u5982\u4f55\u5feb\u901f\u7b5b\u9009 HER2 \u7a81\u53d8\u60a3\u8005\u3001\u5982\u4f55\u5728\u591a\u4e2d\u5fc3\u7ade\u4e89\u4e2d\u5b8c\u6210\u5165\u7ec4\u3001\u5982\u4f55\u751f\u6210\u7b26\u5408 FDA \u8981\u6c42\u7684\u786e\u8bc1\u6027\u6570\u636e\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5c24\u5176\u5f53\u540c\u4e00\u9002\u5e94\u75c7\u5df2\u6709\u7ade\u54c1\u83b7\u6279\uff0c\u786e\u8bc1\u6027\u8bd5\u9a8c\u7684\u5bf9\u7167\u7ec4\u9009\u62e9\u3001\u7ec8\u70b9\u8bbe\u8ba1\u3001\u5165\u7ec4\u901f\u5ea6\u548c\u771f\u5b9e\u4e16\u754c\u6570\u636e\u6536\u96c6\u7b56\u7565\uff0c\u90fd\u4f1a\u76f4\u63a5\u5f71\u54cd\u9002\u5e94\u75c7\u80fd\u5426\u5b88\u4f4f\u3002\u5feb\u901a\u9053\u5e26\u6765\u7684\u65f6\u95f4\u4f18\u52bf\uff0c\u4e5f\u6709\u88ab\u540e\u7eed\u786e\u8bc1\u6027\u8bd5\u9a8c\u7684\u6267\u884c\u96be\u5ea6\u62b5\u6d88\u7684\u53ef\u80fd\u3002<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">\u4e8c\u3001Biohaven \u766b\u75eb\u836f\u906d FDA \u90e8\u5206\u4e34\u5e8a\u6682\u505c\uff1a\u975e\u4e34\u5e8a\u4fe1\u53f7\u5982\u4f55\u51fb\u7a7f III \u671f\u65f6\u95f4\u7ebf<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\"><a><\/a><a>2026<\/a>\u5e749\u67084\u65e5, FDA \u5bf9 Biohaven \u7684 Kv7 \u94be\u901a\u9053\u6fc0\u52a8\u5242 BHV-7000\uff08opakalim\uff09\u65bd\u52a0\u90e8\u5206\u4e34\u5e8a\u6682\u505c\uff0c\u6682\u505c\u5728 RISE 2 \u548c RISE 3 \u4e24\u9879\u5c40\u7076\u6027\u766b\u75eb\u5173\u952e\u8bd5\u9a8c\u4e2d\u5165\u7ec4\u65b0\u60a3\u8005\u3002\u539f\u56e0\u662f FDA \u5728\u556e\u9f7f\u52a8\u7269\u8bd5\u9a8c\u4e2d\u53d1\u73b0\u4e00\u79cd\u4ee3\u8c22\u7269\uff0c\u9700\u8bc4\u4f30\u5176\u4eba\u7c7b\u98ce\u9669\uff0c\u8981\u6c42\u5b8c\u6210\u989d\u5916\u975e\u4e34\u5e8a\u7814\u7a76<strong><sup>[3]<\/sup><\/strong>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u90e8\u5206\u4e34\u5e8a\u6682\u505c\u7684\u5f71\u54cd\u9762<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5df2\u5165\u7ec4\u60a3\u8005\uff5c<\/strong>600 \u4f59\u540d\u60a3\u8005\u7ee7\u7eed\u7ed9\u836f\uff0c\u4e0d\u53d7\u5f71\u54cd<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>RISE 3<\/strong><strong>\uff5c<\/strong>\u5165\u7ec4\u5df2\u4e8e 2026 \u5e74 6 \u6708\u5b8c\u6210\uff0c\u9876\u7ebf\u6570\u636e\u4ecd\u8ba1\u5212\u4e0b\u534a\u5e74\u8bfb\u51fa<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>RISE 2<\/strong><strong>\uff5c<\/strong>\u5165\u7ec4\u5c1a\u672a\u5b8c\u6210\uff0c\u6570\u636e\u8bfb\u51fa\u5927\u6982\u7387\u5ef6\u8fdf<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u80a1\u4ef7\u53cd\u5e94\uff5c<\/strong>\u6d88\u606f\u516c\u5e03\u540e\u80a1\u4ef7\u76d8\u524d\u4e0b\u8dcc\u8d85\u8fc7 13%<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5df2\u968f\u673a\u5165\u7ec4\u7684 600 \u4f59\u540d\u60a3\u8005\u7ee7\u7eed\u7ed9\u836f\uff0cRISE 3 \u5165\u7ec4\u5df2\u4e8e 2026 \u5e74 6 \u6708\u5b8c\u6210\uff0c\u9876\u7ebf\u6570\u636e\u4ecd\u8ba1\u5212\u4e8e\u4e0b\u534a\u5e74\u8bfb\u51fa\uff1b\u4f46 RISE 2 \u5165\u7ec4\u5c1a\u672a\u5b8c\u6210\uff0c\u6570\u636e\u8bfb\u51fa\u5927\u6982\u7387\u5ef6\u8fdf\u3002\u6d88\u606f\u516c\u5e03\u540e\uff0cBiohaven \u80a1\u4ef7\u76d8\u524d\u4e0b\u8dcc\u8d85\u8fc7 13%\u3002\u8fd9\u662f Biohaven \u4e00\u5e74\u5185\u7b2c\u4e8c\u6b21\u91cd\u5927\u76d1\u7ba1\u632b\u6298\u3002\u66f4\u503c\u5f97\u5173\u6ce8\u7684\u662f\uff0cSK Biopharmaceuticals \u4e8e 8 \u6708 26 \u65e5\u521a\u83b7\u5f97\u8be5 Kv7 \u5e73\u53f0\u5168\u7403\u8bb8\u53ef\uff08\u603b\u989d\u6700\u9ad8 7.95 \u4ebf\u7f8e\u5143\uff09\uff0c\u800c SK \u5df2\u8868\u793a 4 \u4ebf\u7f8e\u5143\u9996\u4ed8\u6b3e\u5c06\u7b49\u5f85 FDA \u6682\u505c\u89e3\u9664\u540e\u518d\u652f\u4ed8<strong><sup>[3,4]<\/sup><\/strong>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u975e\u4e34\u5e8a\u6bd2\u7406\u4fe1\u53f7\u7684\u5ef6\u8fdf\u66b4\u9732\uff0c\u53ef\u80fd\u5728\u6700\u5173\u952e\u7684\u4e34\u5e8a\u9636\u6bb5\u9020\u6210\u4e25\u91cd\u65f6\u95f4\u635f\u5931\uff0c\u5e76\u76f4\u63a5\u51b2\u51fb licensing \u4ea4\u6613\u4f30\u503c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u90e8\u5206\u4e34\u5e8a\u6682\u505c\u671f\u95f4\uff0c\u5df2\u5165\u7ec4\u60a3\u8005\u7684\u7ee7\u7eed\u7ed9\u836f\u3001\u5b89\u5168\u6027\u968f\u8bbf\u3001DSMB \u5ba1\u67e5\u3001\u836f\u7269\u8b66\u6212\u548c\u76d1\u7ba1\u6c9f\u901a\uff0c\u90fd\u662f\u9ad8\u5f3a\u5ea6\u7684\u4e34\u5e8a\u8fd0\u8425\u5de5\u4f5c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9 CNS \u836f\u7269\u800c\u8a00\uff0c\u975e\u4e34\u5e8a\u5230\u4e34\u5e8a\u7684\u8f6c\u5316\u3001\u4ee3\u8c22\u7269\u5b89\u5168\u6027\u8bc4\u4f30\u3001\u98ce\u9669\u63a7\u5236\u8ba1\u5212\uff0c\u5fc5\u987b\u524d\u7f6e\u5230 III \u671f\u542f\u52a8\u4e4b\u524d\u3002\u76d1\u7ba1\u5c3d\u8c03\u4e5f\u4e0d\u80fd\u6b62\u4e8e\u5df2\u6709\u4e34\u5e8a\u6570\u636e\uff0c\u975e\u4e34\u5e8a\u6570\u636e\u7684\u5b8c\u6574\u6027\u540c\u6837\u662f\u4ea4\u6613\u51b3\u7b56\u7684\u5173\u952e\u53d8\u91cf\u3002<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">\u4e09\u3001\u82f1\u56fd\u56de\u6263\u7387\u4e0e\u7f8e\u82f1\u534f\u8bae\uff1a\u5b9a\u4ef7\u653f\u7b56\u6b63\u5728\u53cd\u5411\u5f71\u54cd\u7814\u53d1\u6295\u5165\u4e0e\u8bd5\u9a8c\u5e03\u5c40<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">2025 \u5e74 9 \u6708\u82f1\u56fd\u5c06\u65b0\u54c1\u724c\u836f\u54c1\u7684 NHS \u56de\u6263\u7387\u4ece 15.5% \u63d0\u9ad8\u81f3 31.3%\uff08\u9002\u7528\u4e8e\u4e0b\u534a\u5e74\u7684\u6cd5\u5b9a\u65b9\u6848\uff09\uff0c\u5f15\u53d1\u963f\u65af\u5229\u5eb7\u3001\u9ed8\u6c99\u4e1c\u7b49\u836f\u4f01\u6682\u505c\u6216\u64a4\u51fa\u82f1\u56fd\u7814\u53d1\u6295\u8d44<strong><sup>[5]<\/sup><\/strong>\u3002\u4e00\u5e74\u540e\uff0c\u5c40\u9762\u51fa\u73b0\u6709\u9650\u7f13\u548c\uff1a\u82f1\u56fd\u4e0e\u7f8e\u56fd\u8fbe\u6210\u534f\u8bae\uff0c\u7f8e\u56fd\u8fdb\u53e3\u5904\u65b9\u836f\u4e09\u5e74\u5185\u8c41\u514d\u5173\u7a0e\uff0c\u6362\u53d6\u82f1\u56fd\u4e3a\u65b0\u836f\u652f\u4ed8\u9ad8\u51fa 25% \u7684\u4ef7\u683c\uff1b\u540c\u65f6\u82f1\u56fd\u653f\u5e9c\u4e8e 2025 \u5e74 12 \u6708 10 \u65e5\u5ba3\u5e03\uff0c2026 \u5e74\u65b0\u836f NHS \u56de\u6263\u7387\uff08VPAG \u65b9\u6848\uff09\u4e0b\u8c03\u81f3 14.5%<strong><sup>[6,7]<\/sup><\/strong>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u653f\u7b56\u8109\u7edc<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a><strong>2025 <\/strong><\/a><strong>\u5e74<\/strong><strong> 9 <\/strong><strong>\u6708\uff5c<\/strong>\u6cd5\u5b9a\u65b9\u6848\u56de\u6263\u7387\u7531 15.5% \u5347\u81f3 31.3%\uff08\u5168\u5e74\u5e73\u5747 23.4%\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2025 <\/strong><strong>\u5e74<\/strong><strong> 12 <\/strong><strong>\u6708<\/strong><strong> 1 <\/strong><strong>\u65e5\uff5c<\/strong>\u7f8e\u82f1\u8fbe\u6210\u836f\u54c1\u534f\u8bae\uff1a<a>\u7f8e\u56fd\u4e09\u5e74\u5185\u4e0d\u5bf9\u82f1\u56fd\u836f\u54c1\u52a0\u5f81\u5173\u7a0e\uff0c\u82f1\u56fd\u5219\u7b54\u5e94\u8ba9\u82f1\u56fd\u56fd\u5bb6\u533b\u7597\u670d\u52a1\u4f53\u7cfb<\/a> (NHS) \u4e70\u65b0\u836f\u65f6\u591a\u638f\u7ea6 25% \u7684\u94b1, \u5373\u66f4\u591a\u6b64\u524d\u56e0\u201c\u8fc7\u4e8e\u6602\u8d35\u201d\u800c\u88ab\u62d2\u7edd\u7684\u65b0\u836f\uff0c\u73b0\u5728\u6709\u673a\u4f1a\u8fdb\u5165NHS\u7684\u62a5\u9500\u8303\u56f4\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2025 <\/strong><strong>\u5e74<\/strong><strong> 12 <\/strong><strong>\u6708<\/strong><strong> 10 <\/strong><strong>\u65e5\uff5c<\/strong>\u82f1\u56fd\u5ba3\u5e03 2026 \u5e74 \u81ea\u613f\u65b9\u6848\uff08VPAG\uff09 \u65b0\u836f\u56de\u6263\u7387\u4e0b\u8c03\u81f3 14.5%\uff082025 \u5e74\u4e3a 22.9%\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u963f\u65af\u5229\u5eb7\u968f\u5373\u5ba3\u5e03\u91cd\u542f\u5251\u6865 2 \u4ebf\u82f1\u9551\u5efa\u8bbe\u9879\u76ee\uff0cCEO Pascal Soriot \u660e\u786e\u5c06\u6b64\u5f52\u56e0\u4e8e\u7f8e\u82f1\u836f\u54c1\u534f\u8bae<strong><sup>[6]<\/sup><\/strong>\u3002\u4f46\u9ed8\u6c99\u4e1c\u81f3\u4eca\u672a\u786e\u8ba4\u7acb\u573a\u53d8\u5316\uff0c\u793c\u6765\u4ec5\u8868\u793a\u6ce8\u610f\u5230\u79ef\u6781\u4fe1\u53f7<strong><sup>[6]<\/sup><\/strong>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b9a\u4ef7\u4e0e\u51c6\u5165\u6b63\u5728\u53cd\u5411\u5f71\u54cd\u7814\u53d1\u6295\u5165\u4e0e\u8bd5\u9a8c\u5e03\u5c40\u3002\u5bf9\u4e8e\u8ba1\u5212\u51fa\u6d77\u7684\u4e2d\u56fd\u521b\u65b0\u836f\u4f01\uff0c\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5730\u70b9\u9009\u62e9\u3001\u6ce8\u518c\u8def\u5f84\u548c\u4e0a\u5e02\u987a\u5e8f\uff0c\u9700\u8981\u66f4\u65e9\u7eb3\u5165\u5b9a\u4ef7\u4e0e\u51c6\u5165\u53d8\u91cf\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u82f1\u56fd\u5e02\u573a\u7684\u56de\u64a4\u4e0e\u6709\u9650\u56de\u6696\u8bf4\u660e\uff0c\u5355\u4e00\u5e02\u573a\u7684\u653f\u7b56\u8ba9\u6b65\u672a\u5fc5\u8db3\u4ee5\u626d\u8f6c\u5168\u7403\u7814\u53d1\u9884\u7b97\u7684\u96c6\u4e2d\u8d8b\u52bf\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e34\u5e8a\u5f00\u53d1\u7b56\u7565\u4e2d\uff0cNHS \u51c6\u5165\u3001<a><\/a><a>HTA <\/a>\u8bc1\u636e\u8981\u6c42\uff08\u62a5\u9500\u51c6\u5165\u8bc4\u4f30\uff09\u3001\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u751f\u6210\uff0c\u5e94\u4e0e\u6ce8\u518c\u7533\u62a5\u540c\u6b65\u8bbe\u8ba1\uff0c\u800c\u4e0d\u662f\u7b49\u5230\u4e0a\u5e02\u540e\u518d\u8865\u8bfe\u3002<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">\u56db\u3001Solstice Oncology \u643a 2.25 \u4ebf\u7f8e\u5143\u4eae\u76f8\uff1a\u65b0\u8f85\u52a9\u80bf\u7624\u8bd5\u9a8c\u6210\u5dee\u5f02\u5316\u9a8c\u8bc1\u573a<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">\u4eca\u65e5\uff0c\u65b0\u6210\u7acb\u7684\u764c\u75c7\u751f\u7269\u6280\u672f\u516c\u53f8 Solstice Oncology \u4ee5 2.25 \u4ebf\u7f8e\u5143 A \u8f6e\u878d\u8d44\u7ed3\u675f\u9690\u8eab\u6a21\u5f0f\uff0c\u7531 RA Capital Management \u9886\u6295\u3002\u8d44\u91d1\u5c06\u7528\u4e8e\u63a8\u8fdb\u4ece\u4e2d\u56fd\u548c\u94c2\u533b\u836f\uff08Harbour BioMed\uff09\u5f15\u8fdb\u7684\u4e0b\u4e00\u4ee3 CTLA-4 \u6297\u4f53 porustobart\uff0c\u5f00\u5c55\u4e00\u9879 II \u671f\u65b0\u8f85\u52a9\u6cbb\u7597\u8bd5\u9a8c\uff0c\u9488\u5bf9\u5fae\u536b\u661f\u7a33\u5b9a\u578b\uff08MSS\uff09II-III \u671f\u7ed3\u80a0\u764c\uff0c\u8054\u5408\u9ed8\u6c99\u4e1c Keytruda \u4f7f\u7528\uff0c\u9884\u8ba1 2026 \u5e74\u7b2c\u56db\u5b63\u5ea6\u5f00\u59cb\u5165\u7ec4\uff0c2027 \u5e74\u4e0b\u534a\u5e74\u8bfb\u51fa\u6570\u636e<strong><sup>[8]<\/sup><\/strong>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4ea4\u6613\u4e0e\u8bd5\u9a8c\u8bbe\u8ba1<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u9776\u4eba\u7fa4\uff5c<\/strong>\u5fae\u536b\u661f\u7a33\u5b9a\u578b\uff08MSS\uff09II-III \u671f\u7ed3\u80a0\u764c<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u8054\u5408\u7528\u836f\uff5c<\/strong>\u9ed8\u6c99\u4e1c Keytruda\uff08\u5e15\u535a\u5229\u73e0\u5355\u6297\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5165\u7ec4\u8ba1\u5212\uff5c<\/strong>2026 \u5e74\u7b2c\u56db\u5b63\u5ea6\u5f00\u59cb\uff0c2027 \u5e74\u4e0b\u534a\u5e74\u8bfb\u51fa\u6570\u636e<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u8bb8\u53ef\u5bf9\u4ef7\uff5c<\/strong>\u7ea6 1.05 \u4ebf\u7f8e\u5143\uff08\u542b 5000 \u4e07\u9996\u4ed8\u6b3e\u3001500 \u4e07\u8fd1\u671f\u73b0\u91d1\u3001\u8d85 5000 \u4e07\u80a1\u6743\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u91cc\u7a0b\u7891\uff5c<\/strong>\u6700\u9ad8\u7ea6 11 \u4ebf\u7f8e\u5143\u5f00\u53d1\u3001\u76d1\u7ba1\u53ca\u5546\u4e1a\u91cc\u7a0b\u7891<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ib <\/strong><strong>\u671f\u6570\u636e\uff5c<\/strong>\u5ba2\u89c2\u7f13\u89e3\u7387 30%\uff087\/23\uff09\uff0c\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4 8.4 \u4e2a\u6708<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u548c\u94c2\u533b\u836f\u5df2\u5728 Ib \u671f\u8bd5\u9a8c\u4e2d\u89c2\u5bdf\u5230 30% \u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff087\/23\uff09\uff0c\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4 8.4 \u4e2a\u6708\u3002\u4ea4\u6613\u7ed3\u6784\u65b9\u9762\uff0cSolstice \u6295\u8d44\u65b9\u4ee5\u7ea6 1.05 \u4ebf\u7f8e\u5143\u4ece\u548c\u94c2\u83b7\u5f97\u8bb8\u53ef\uff08\u542b 5000 \u4e07\u7f8e\u5143\u9996\u4ed8\u6b3e\u3001500 \u4e07\u7f8e\u5143\u8fd1\u671f\u73b0\u91d1\u4ed8\u6b3e\u53ca\u8d85 5000 \u4e07\u7f8e\u5143\u80a1\u6743\uff09\uff0c\u548c\u94c2\u8fd8\u53ef\u83b7\u5f97\u6700\u9ad8\u7ea6 11 \u4ebf\u7f8e\u5143\u5f00\u53d1\u3001\u76d1\u7ba1\u53ca\u5546\u4e1a\u91cc\u7a0b\u7891\u4ed8\u6b3e<strong><sup>[8,9]<\/sup><\/strong>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MSS \u7ed3\u80a0\u764c\u5bf9\u73b0\u6709\u514d\u75ab\u68c0\u67e5\u70b9\u6291\u5236\u5242\u666e\u904d\u4e0d\u654f\u611f\uff0c\u65b0\u8f85\u52a9\u573a\u666f\u8054\u5408 Keytruda\uff0c\u672c\u8d28\u662f\u5728\u80bf\u7624\u5c1a\u672a\u5e7f\u6cdb\u8f6c\u79fb\u65f6\u91cd\u5efa\u514d\u75ab\u5e94\u7b54\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u7c7b\u8bd5\u9a8c\u8bbe\u8ba1\u590d\u6742\uff1a\u9700\u8981\u7cbe\u51c6\u7684\u672f\u524d\u5206\u671f\u3001\u9ad8\u6548\u7684\u4e2d\u5fc3\u7b5b\u9009\u3001\u4e25\u683c\u7684\u514d\u75ab\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u7ba1\u7406\uff0c\u4ee5\u53ca\u65b0\u8f85\u52a9\u7ec8\u70b9\u4e0e\u751f\u5b58\u7ec8\u70b9\u7684\u6865\u63a5\u7b56\u7565\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CTLA-4 \u6bd2\u6027\u7ba1\u7406\u3001\u624b\u672f\u7a97\u53e3\u671f\u3001\u75c5\u7406\u5b66\u7ec8\u70b9\uff08\u5982 pCR\u3001MRD\uff09\u7684\u6807\u51c6\u5316\uff0c\u90fd\u662f\u6267\u884c\u96be\u70b9\u3002\u4e2d\u56fd\u8d44\u4ea7\u53cd\u5411\u8f93\u51fa\uff0c\u4e34\u5e8a\u6267\u884c\u80fd\u529b\u662f\u4f30\u503c\u5151\u73b0\u7684\u5173\u952e\u4e00\u73af\u3002<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">\u7efc\u5408\u89c2\u5bdf\uff1a\u4e34\u5e8a\u5f00\u53d1\uff0c\u6b63\u5728\u6210\u4e3a\u4e0d\u786e\u5b9a\u73af\u5883\u4e2d\u7684\u786e\u5b9a\u6027\u6765\u6e90<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">\u56db\u6761\u52a8\u6001\u6307\u5411\u540c\u4e00\u4e2a\u4e3b\u9898\uff1a\u76d1\u7ba1\u3001\u8d44\u672c\u4e0e\u5b9a\u4ef7\u7684\u4e0d\u786e\u5b9a\u6027\uff0c\u90fd\u5728\u5411\u4e34\u5e8a\u5f00\u53d1\u73af\u8282\u4f20\u5bfc\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u56db\u6761\u7ebf\u7d22\uff0c\u4e00\u4e2a\u53d8\u91cf<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u52a0\u901f\u6279\u51c6\uff5c<\/strong>\u9700\u8981\u786e\u8bc1\u6027\u8bd5\u9a8c\u5151\u73b0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u975e\u4e34\u5e8a\u4fe1\u53f7\uff5c<\/strong>\u53ef\u80fd\u51fb\u7a7f III \u671f\u65f6\u95f4\u7ebf<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5b9a\u4ef7\u653f\u7b56\uff5c<\/strong>\u53cd\u5411\u5f71\u54cd\u7814\u53d1\u6295\u5165\u4e0e\u8bd5\u9a8c\u5e03\u5c40<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e2d\u56fd\u8d44\u4ea7\u53cd\u5411\u8f93\u51fa\uff5c<\/strong>\u4e34\u5e8a\u6267\u884c\u51b3\u5b9a\u4f30\u503c<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u7533\u529e\u65b9\u800c\u8a00\uff0c\u79d1\u5b66\u521b\u610f\u53ea\u662f\u8d77\u70b9\u3002\u628a\u79d1\u5b66\u521b\u610f\u8f6c\u5316\u4e3a\u53ef\u6ce8\u518c\u3001\u53ef\u5546\u4e1a\u5316\u6570\u636e\u7684\u4e34\u5e8a\u6267\u884c\u80fd\u529b\uff0c\u624d\u662f\u7a7f\u8d8a\u5468\u671f\u7684\u6838\u5fc3\u7ade\u4e89\u529b\u3002<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">\u53c2\u8003\u6587\u732e<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">[1] Bayer. U.S. FDA grants accelerated approval to Bayer&#8217;s targeted therapy sevabertinib as a first-line treatment option for adults with HER2-mutant non-small cell lung cancer. Press release. September 9, 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[2] Boehringer Ingelheim. FDA approves HERNEXEOS, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option. Press release. February 26, 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[3] BioSpace. Biohaven takes another hit as FDA pauses enrollment in pivotal trials for embattled epilepsy drug. September 10, 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[4] Businesskorea. SK Biopharma Presses Ahead with Opakalim License Deal Despite FDA Hold. September 11, 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[5] Fierce Pharma. Pharmas to face higher drug rebates in UK despite government&#8217;s tweak to proposal. 2025.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[6] Fierce Pharma. AstraZeneca restarts \u00a3300M investment in UK, but Merck not budging. April 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[7] UK Department of Health and Social Care. Innovative medicines supported as rebate rate falls by a third. December 10, 2025.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[8] BioSpace. Solstice rises with $225M to develop next-gen CTLA-4 drug from China. September 9, 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[9] Harbour BioMed. Harbour BioMed Partner, Solstice Oncology, announces $225 Million Series A Financing to Advance Porustobart, a Neoadjuvant Immuno-Oncology Therapy. September 9, 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u64b0\u7a3f\uff1a\u90d1\u53f6\u654f<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u8fc7\u53bb 48 \u5c0f\u65f6\uff0c\u884c\u4e1a\u5a92\u4f53\u63a5\u8fde\u62a5\u9053\u4e86\u56db\u6761\u770b\u4f3c\u72ec\u7acb\u7684\u6d88\u606f\uff1a\u62dc\u8033 HER2 \u80ba\u764c\u836f\u83b7 FDA \u4e00\u7ebf\u52a0\u901f\u6279\u51c6\u3001Biohaven \u766b\u75eb\u836f\u906d FDA \u90e8\u5206\u4e34\u5e8a\u6682\u505c\u3001\u82f1\u56fd\u836f\u54c1\u56de\u6263\u7387\u8c03\u6574\u540e\u963f\u65af\u5229\u5eb7\u91cd\u542f\u5251\u6865\u6295\u8d44\u3001Solstice Oncology \u643a 2.25 \u4ebf\u7f8e\u5143\u5f15\u8fdb\u4e2d\u56fd CTLA-4 \u6297\u4f53\u3002<br \/>\n\u8868\u9762\u770b\uff0c\u8fd9\u662f\u76d1\u7ba1\u3001\u5b9a\u4ef7\u3001\u8d44\u672c\u4e8b\u4ef6\u3002\u4f46\u5bf9\u4e34\u5e8a\u5f00\u53d1\u4ece\u4e1a\u8005\u800c\u8a00\uff0c\u5b83\u4eec\u5171\u540c\u6307\u5411\u4e00\u4e2a\u4e8b\u5b9e\uff1a\u4e34\u5e8a\u7b56\u7565\u4e0e\u6267\u884c\u6548\u7387\uff0c\u6b63\u5728\u76f4\u63a5\u51b3\u5b9a\u4e00\u6b3e\u836f\u7684\u5546\u4e1a\u547d\u8fd0\u3002<\/p>\n","protected":false},"author":1,"featured_media":2152,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[147],"tags":[35,86,15,32],"class_list":["post-2151","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-147","tag-35","tag-86","tag-15","tag-32"],"_links":{"self":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/2151","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2151"}],"version-history":[{"count":2,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/2151\/revisions"}],"predecessor-version":[{"id":2155,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/2151\/revisions\/2155"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/media\/2152"}],"wp:attachment":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2151"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2151"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}