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\u201cNMPA\u6279\u51c6\u5fb7\u742a\u5f00\u5c55\u8fd9\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5177\u6709\u975e\u5e38\u91cd\u8981\u7684\u610f\u4e49\uff0c\u5f25\u6f2b\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u60a3\u8005\u7684\u6cbb\u7597\u624b\u6bb5\u6709\u9650\uff0c\u8fd9\u5c06\u662f\u4e00\u4e2a\u5168\u65b0\u7684\u3001\u4f18\u5316\u7684\u53e3\u670d\u7597\u6cd5\uff0c\u201d\u5fb7\u742a\u533b\u836f\u521b\u59cb\u4eba\u3001\u8463\u4e8b\u957f\u517c\u9996\u5e2d\u6267\u884c\u5b98\u6885\u5efa\u660e\u535a\u58eb\u8868\u793a\u3002\u201c\u4f5c\u4e3a2021\u5e74\u6211\u4eec\u53c2\u52a0\u7684\u9996\u4e2a\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4e5f\u662f\u5fb7\u742a\u5168\u7403\u5316\u53d1\u5c55\u7684\u4f18\u52bf\u4f53\u73b0\u3002\u6211\u4eec\u5c06\u540c\u6d77\u5916\u5408\u4f5c\u4f19\u4f34\u65e0\u7f1d\u5bf9\u63a5\uff0c\u63a8\u8fdb\u8bd5\u9a8c\u5728\u4e2d\u56fd\u7684\u5f00\u5c55\u3002\u201d<\/p>\n

\u5173\u4e8e<\/b>ATG-<\/b>010\uff08<\/b>selinexor\uff0c<\/b>XPOVIO®<\/sup>\uff09<\/b><\/p>\n

ATG-010\uff08selinexor\uff0cXPOVIO®<\/sup>\uff09\u662f\u540c\u7c7b\u9996\u6b3e\u4e14\u552f\u4e00\u4e00\u6b3e\u53e3\u670d\u578b\u9009\u62e9\u6027\u6838\u8f93\u51fa\u6291\u5236\u5242\uff08SINE\uff09\uff0c<\/span>\u7531Karyopharm Therapeutics Inc.\uff08\u7eb3\u65af\u8fbe\u514b\u80a1\u7968\u4ee3\u7801\uff1aKPTI\uff09\u5f00\u53d1\u3002\u5fb7\u742a\u533b\u836f\u4e0eKaryopharm\u8fbe\u6210\u72ec\u5bb6\u5408\u4f5c\u548c\u6388\u6743\uff0c\u83b7\u5f97\u4e86ATG-010\u5728\u591a\u4e2a\u4e9a\u592a\u5e02\u573a\u5305\u62ec\u5927\u4e2d\u534e\u533a\u3001\u97e9\u56fd\u3001\u6fb3\u5927\u5229\u4e9a\u3001\u65b0\u897f\u5170\u548c\u4e1c\u76df\u56fd\u5bb6\u7684\u72ec\u5bb6\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u6743\u76ca\u3002<\/p>\n

2019\u5e747\u6708\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6selinexor\uff08XPOVIO®<\/sup>\uff09\u8054\u5408\u4f4e\u5242\u91cf\u5730\u585e\u7c73\u677e\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u96be\u6cbb\u6027\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff08rrMM\uff09\u60a3\u8005\u3002<\/span>2020\u5e746\u6708\uff0c\u7f8e\u56fdFDA\u518d\u6b21\u6279\u51c6selinexor\uff08XPOVIO®<\/sup>\uff09\u4f5c\u4e3a\u5355\u836f\u53e3\u670d\u7597\u6cd5\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u96be\u6cbb\u6027\u5f25\u6f2b\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\uff08rrDLBCL\uff09\u60a3\u8005\u30022020\u5e7412\u6708\uff0c\u7f8e\u56fdFDA\u6279\u51c6\u4e86selinexor\uff08XPOVIO®<\/sup>\uff09\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u6b21\u6cbb\u7597\u7684\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\u3002Selinexor\uff08XPOVIO®<\/sup>\uff09\u7684\u4e00\u9879\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08MAA\uff09\u5df2\u7ecf\u9012\u4ea4\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\uff0c\u8981\u6c42\u6709\u6761\u4ef6\u5730\u6279\u51c6selinexor\uff08XPOVIO®<\/sup>\uff09\u7528\u4e8errMM\u3002Selinexor\uff08XPOVIO®<\/sup>\uff09\u662f\u76ee\u524d\u9996\u6b3e\u4e14\u552f\u4e00\u4e00\u6b3e\u88ab\u7f8e\u56fdFDA\u6279\u51c6\u7684\u53e3\u670dSINE\u5316\u5408\u7269\uff0c\u53ef\u7528\u4e8e\u6cbb\u7597\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u548c\u5f25\u6f2b\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u3002\u6b64\u5916\uff0cselinexor\uff08XPOVIO®<\/sup>\uff09\u9488\u5bf9\u591a\u4e2a\u5b9e\u4f53\u80bf\u7624\u9002\u5e94\u75c7\u5f00\u5c55\u4e86\u591a\u9879\u4e2d\u671f\u548c\u540e\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5305\u62ec\u8102\u80aa\u8089\u7624\u548c\u5b50\u5bab\u5185\u819c\u764c\u30022020\u5e7411\u6708\uff0c\u5fb7\u742a\u533b\u836f\u5408\u4f5c\u4f19\u4f34Karyopharm\u57282020\u5e74\u7ed3\u7f14\u7ec4\u7ec7\u80bf\u7624\u5b66\u5e74\u4f1a\uff08CTOS 2020\uff09\u4e0a\u62a5\u544a\u4e863\u671fSEAL\u8bd5\u9a8c\u7684\u79ef\u6781\u6570\u636e\u3002SEAL\u662f\u4e00\u9879\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u4ea4\u53c9\u8bd5\u9a8c\uff0c\u65e8\u5728\u6bd4\u8f83\u53e3\u670d\u5355\u836fselinexor\uff08XPOVIO®<\/sup>\uff09\u4e0e\u5b89\u6170\u5242\u5728\u8102\u80aa\u8089\u7624\u60a3\u8005\u4e2d\u7684\u7597\u6548\u3002\u53e6\u5916\uff0cKaryopharm\u8fd1\u671f\u516c\u5e03\u4e86selinexor\uff08XPOVIO®<\/sup>\uff09\u7528\u4e8e\u6cbb\u7597\u5b50\u5bab\u5185\u819c\u764c\u60a3\u8005\u76843\u671fSIENDO\u8bd5\u9a8c\u5df2\u5b8c\u6210\u8ba1\u5212\u7684\u4e2d\u671f\u65e0\u6548\u6027\u5206\u6790\uff0c\u6570\u636e\u5b89\u5168\u76d1\u67e5\u59d4\u5458\u4f1a\uff08DSMB\uff09\u63a8\u8350SIENDO\u8bd5\u9a8c\u65e0\u9700\u4f5c\u4efb\u4f55\u4fee\u6539\u6309\u8ba1\u5212\u7ee7\u7eed\u8fdb\u884c\u3002SIENDO\u8bd5\u9a8c\u7684\u9996\u8981\u6570\u636e\u7ed3\u679c\u9884\u8ba1\u57282021\u5e74\u4e0b\u534a\u5e74\u516c\u5e03\u3002<\/p>\n

\u5173\u4e8e\u5fb7\u742a\u533b\u836f<\/b><\/p>\n

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\u524d\u77bb\u6027\u58f0\u660e<\/b><\/p>\n

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\n\n\n\n
\n

* XPORT-DLBCL-030\u7814\u7a76\u7531Karyopharm Therapeutics Inc.\u53d1\u8d77\uff1bXPOVIO®<\/sup>\u4e3aKaryopharm Therapeutics Inc.\u6ce8\u518c\u5546\u6807\uff1bR-GDP\uff1a\u5229\u59a5\u6614\u5355\u6297\u3001\u5409\u897f\u4ed6\u6ee8\u3001\u5730\u585e\u7c73\u677e\u548c\u987a\u94c2\u3002<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

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