\u4e0a\u6d772022\u5e743\u670810\u65e5 \/\u7f8e\u901a\u793e\/ — \u4e91\u9876\u65b0\u8000\uff08HKEX 1952.HK\uff09\u4eca\u65e5\u5ba3\u5e03\uff0c\u5176\u6388\u6743\u5408\u4f5c\u4f19\u4f34 Venatorx Pharmaceuticals \u5f00\u5c55\u7684 CERTAIN-1 \u7814\u7a76\u53d6\u5f97\u4e86\u79ef\u6781\u7ed3\u679c\uff0cCERTAIN-1 \u662f\u4e00\u9879\u5173\u952e\u6027\u5168\u7403 3 \u671f\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30\u5934\u5b62\u5421\u809f-Taniborbactam\uff0c\u4e00\u79cd\u5904\u4e8e\u7814\u7a76\u9636\u6bb5\u7684\u65b0\u836f\uff0c\u76f8\u6bd4\u7f8e\u7f57\u57f9\u5357\u4f5c\u4e3a\u6210\u4eba\u590d\u6742\u6027\u5c3f\u8def\u611f\u67d3 (cUTI) \u5305\u62ec\u6025\u6027\u80be\u76c2\u80be\u708e\u4f4f\u9662\u60a3\u8005\u7684\u4e00\u79cd\u6f5c\u5728\u6cbb\u7597\u836f\u7269\u3002<\/p>\n
\u8be5 CERTAIN-1 \u8bd5\u9a8c\u5168\u7403\u8303\u56f4\uff08\u5305\u62ec\u4e2d\u56fd\uff09\u5171\u5165\u7ec4661\u4f8b\u6210\u4eba\u60a3\u8005\uff0c\u4ed6\u4eec\u4ee52:1\u7684\u6bd4\u4f8b\u968f\u673a\u63a5\u53d7\u5934\u5b62\u5421\u809f- taniborbactam \u6bcf8\u5c0f\u65f62.5\u514b\u6216\u7f8e\u7f57\u57f9\u5357\u6bcf8\u5c0f\u65f61\u514b \uff0c\u5171\u7ed9\u836f7\u5929\uff08\u83cc\u8840\u75c7\u60a3\u8005\u6700\u591a\u7ed9\u836f14\u5929\uff09\u3002\u7814\u7a76\u8fbe\u5230\u4e86\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\uff0c\u5373\u8bc4\u4ef7\u7597\u6548\u5224\u5b9a (TOC) \u8bbf\u89c6\u5728\u5fae\u751f\u7269\u5b66\u610f\u5411\u6cbb\u7597 (microITT) \u4eba\u7fa4\u4e2d\u590d\u5408\u4e34\u5e8a\u548c\u5fae\u751f\u7269\u5b66\u7597\u6548\uff0c\u5934\u5b62\u5421\u809f- taniborbactam \u6cbb\u7597\u7ec4\u4e3a70.0%\uff0c\u7f8e\u7f57\u57f9\u5357\u6cbb\u7597\u7ec4\u4e3a58.0%\uff08\u6cbb\u7597\u5dee\u5f0211.9\uff1b95% CI\uff0c2.4\uff0c21.6\uff09\u5934\u5b62\u5421\u809f-Taniborbactam \u4e0e\u7f8e\u7f57\u57f9\u5357\u7ec4\u76f8\u6bd4\u5728\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u8fbe\u5230\u7edf\u8ba1\u5b66\u975e\u52a3\u6548\u6027 (NI)\uff0c\u3002\u8fdb\u4e00\u6b65\u8fdb\u884c\u9884\u5148\u8bbe\u5b9a\u7684\u4f18\u6548\u6027\u68c0\u9a8c\uff0c\u5934\u5b62\u5421\u809f- taniborbactam \u663e\u793a\u5728TOC \u8bbf\u89c6\u65f6\u590d\u5408\u7ec8\u70b9\u4f18\u6548\u6027\u4e8e\u7f8e\u7f57\u57f9\u5357\u5e76\u4e14\u5728\u540e\u671f\u968f\u8bbf\uff08\u7b2c 28-35 \u5929\uff09\u8bbf\u89c6\u65f6\uff0c\u5934\u5b62\u5421\u809f-taniborbactam \u7684\u8fd9\u4e00\u4f18\u6548\u6027\u4ecd\u5f97\u4ee5\u6301\u7eed\u3002<\/p>\n
\u5934\u5b62\u5421\u809f- taniborbactam \u6cbb\u7597\u7ec4\u548c\u7f8e\u7f57\u57f9\u5357\u6cbb\u7597\u7ec4\u5206\u522b\u67092.0%\u548c1.8%\u7684\u60a3\u8005\u53d1\u751f\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6 (TEAE)\u3002\u8fd9\u4e24\u4e2a\u6cbb\u7597\u7ec4\u5747\u6709\u4f4e\u6bd4\u4f8b\u60a3\u8005\u51fa\u73b0\u56e0 TEAE \u800c\u5bfc\u81f4\u7684\u63d0\u524d\u505c\u836f\uff08\u5934\u5b62\u5421\u809f- taniborbactam \u6cbb\u7597\u7ec4\u4e3a3.0%\uff1b\u7f8e\u7f57\u57f9\u5357\u6cbb\u7597\u7ec4\u4e3a0.9%\uff09\u3002\u5728\u7814\u7a76\u671f\u95f4\uff0c\u5934\u5b62\u5421\u809f-taniborbactam \u6cbb\u7597\u7ec4\u51fa\u73b01\u4f8b\u6b7b\u4ea1\u4e8b\u4ef6\uff0c\u7814\u7a76\u8005\u5224\u65ad\u5176\u4e0e\u7814\u7a76\u6cbb\u7597\u65e0\u5173\u3002\u5b8c\u6574\u7684 CERTAIN-1 \u7814\u7a76\u7ed3\u679c\u5c06\u5728\u5373\u5c06\u53ec\u5f00\u7684\u5b66\u672f\u4f1a\u8bae\u4e0a\u516c\u5e03\u3002<\/p>\n
\u4e91\u9876\u65b0\u8000\u901a\u8fc7\u4e0e Venatorx Pharmaceuticals \u7684\u5408\u4f5c\u5171\u540c\u5f00\u53d1\u5934\u5b62\u5421\u809f-taniborbactam\u3002\u6839\u636e\u4e0e Venatorx Pharmaceuticals \u7b7e\u8ba2\u7684\u72ec\u5bb6\u8bb8\u53ef\u534f\u8bae\uff0c\u4e91\u9876\u65b0\u8000\u6709\u6743\u5728\u5927\u4e2d\u534e\u533a\u3001\u97e9\u56fd\u3001\u5370\u5ea6\u5c3c\u897f\u4e9a\u3001\u9a6c\u6765\u897f\u4e9a\u3001\u83f2\u5f8b\u5bbe\u3001\u6cf0\u56fd\u3001\u65b0\u52a0\u5761\u548c\u8d8a\u5357\u8fdb\u884c\u5934\u5b62\u5421\u809f-taniborbactam \u7684\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u6d3b\u52a8\u3002<\/p>\n
Venatorx \u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98 Christopher J. Burns \u535a\u58eb\u8868\u793a\uff1a\u201c\u8fd9\u4e9b\u6570\u636e\u8868\u660e\u5934\u5b62\u5421\u809f-taniborbactam \u4e0e\u6807\u51c6\u6cbb\u7597\u76f8\u6bd4\u6709\u7740\u663e\u8457\u63d0\u9ad8\u53ef\u80fd\u6027\uff0c\u4ece\u800c\u53ef\u4e3a\u5168\u7403\u536b\u751f\u5de5\u4f5c\u63d0\u4f9b\u6709\u529b\u652f\u6301\u4ee5\u5bf9\u6297\u6297\u83cc\u836f\u7269\u8010\u836f\u6027\u611f\u67d3\u3002\u5934\u5b62\u5421\u809f-taniborbactam \uff0c\u7ecf\u8fc7 FDA \u6279\u51c6\u540e\u53ef\u80fd\u4e3a\u8010\u836f\u6027\u7ec6\u83cc\u611f\u67d3\u98ce\u9669\u8f83\u9ad8\u7684\u60a3\u8005\u63d0\u4f9b\u4e86\u4e00\u79cd\u65b0\u7684\u6cbb\u7597\u9009\u62e9\uff0c\u751a\u81f3\u5305\u62ec\u90a3\u4e9b\u4e34\u5e8a\u5e7f\u6cdb\u4f7f\u7528\u7684\u78b3\u9752\u9709\u70ef\u7c7b\u6297\u83cc\u836f\u7269\u7684\u8010\u836f\u7ec6\u83cc\u611f\u67d3\u3002\u6211\u4eec\u8981\u611f\u8c22\u53c2\u52a0\u8bd5\u9a8c\u7684\u60a3\u8005\u3001\u53c2\u4e0e\u7814\u7a76\u7684\u4e34\u5e8a\u7814\u7a76\u8005\uff0c\u4ee5\u53ca\u6211\u4eec\u7684\u5458\u5de5\u548c\u5408\u4f5c\u4f19\u4f34\u5982\u4e91\u9876\u65b0\u8000\uff0c\u611f\u8c22\u4ed6\u4eec\u575a\u5b9a\u4e0d\u79fb\u7684\u652f\u6301\u548c\u4e3a\u4e16\u754c\u5404\u5730\u60a3\u8005\u5e26\u6765\u633d\u6551\u751f\u547d\u7597\u6cd5\u7684\u51b3\u5fc3\u3002\u6211\u4eec\u8ba1\u5212\u5728\u4eca\u5e74\u665a\u4e9b\u65f6\u5019\u5411 FDA \u63d0\u4ea4\u5c06\u5934\u5b62\u5421\u809f- taniborbactam \u7528\u4e8e\u6210\u4eba cUTI \u7684\u4f4f\u9662\u60a3\u8005\u6cbb\u7597\u7684\u65b0\u836f\u7533\u8bf7\u3002\u201d<\/p>\n
\u4e91\u9876\u65b0\u8000\u611f\u67d3\u75c5\u9886\u57df\u9996\u5e2d\u533b\u5b66\u5b98\u6731\u7166\u8868\u793a\uff0c\u201c\u6211\u4eec\u5f88\u9ad8\u5174\u770b\u5230\u8fd9\u4e00\u5173\u952e\u6027\u5168\u74033\u671f\u7814\u7a76\u53d6\u5f97\u4e86\u4ee4\u4eba\u632f\u594b\u7684\u7ed3\u679c\uff0c\u5e76\u671f\u5f85\u5c06\u8fd9\u79cd\u836f\u7269\u5c3d\u5feb\u5e26\u7ed9\u4e9a\u6d32\u60a3\u8005\u3002\u6211\u4eec\u5c06\u7ee7\u7eed\u81f4\u529b\u4e8e\u4e3a\u4e2d\u56fd\u548c\u4e9a\u6d32\u5176\u4ed6\u5730\u533a\u5b58\u5728\u8feb\u5207\u9700\u6c42\u7684\u4e25\u91cd\u4f20\u67d3\u75c5\u60a3\u8005\u5f00\u53d1\u65b0\u7684\u7597\u6cd5\u3002\u201d<\/p>\n
\u5173\u4e8e\u5934\u5b62\u5421\u809f\u548c<\/b>Taniborbactam<\/b><\/p>\n
\u5934\u5b62\u5421\u809f\uff0c\u4e00\u4e2a\u7b2c\u56db\u4ee3\u5934\u5b62\u83cc\u7d20\uff0c\u662f\u4e00\u79cd\u5e7f\u6cdb\u4f7f\u7528\u7684 \u03b2-\u5185\u9170\u80fa\u7c7b (BL)\u6297\u83cc\u836f\u7269\uff0c\u5728\u5bf9\u6297\u654f\u611f\u9769\u5170\u9634\u6027\u548c\u9769\u5170\u9633\u6027\u83cc\u65b9\u9762\u5df2\u6709\u4e8c\u5341\u591a\u5e74\u7684\u5e94\u7528\u5386\u53f2\uff0c\u4e34\u5e8a\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5747\u5df2\u5f97\u5230\u8bc1\u5b9e\u3002Taniborbactam (\u5316\u5408\u7269\u4ee3\u53f7 VNRX-5133)\u662f\u4e00\u79cd \u03b2-\u5185\u9170\u80fa\u9176\u6291\u5236\u5242 (BLI)\uff0c\u4e0e\u5934\u5b62\u5421\u809f\u8054\u5408\u4f7f\u7528\u65f6\u53ef\u4e3a\u7531\u96be\u6cbb\u6027\u8010\u836f\u6027\u9769\u5170\u6c0f\u9634\u6027\u83cc\uff0c\u5c24\u5176\u662f\u8010\u78b3\u9752\u9709\u70ef\u7c7b\u80a0\u6746\u83cc (CRE) \u548c\u8010\u78b3\u9752\u9709\u70ef\u7c7b\u94dc\u7eff\u5047\u5355\u80de\u83cc (CRPA)\u5f15\u8d77\u7684\u4e25\u91cd\u7ec6\u83cc\u611f\u67d3\u60a3\u8005\u53ef\u80fd\u63d0\u4f9b\u4e00\u79cd\u6f5c\u5728\u7684\u6cbb\u7597\u9009\u62e9\u3002\u5176\u4e2d\u8bb8\u591a\u5fae\u751f\u7269\u4e5f\u5177\u6709\u591a\u91cd\u8010\u836f\u6027(MDR) \uff0c\u8fd9\u8fdb\u4e00\u6b65\u9650\u5236\u4e86\u6cbb\u7597\u9009\u62e9\u3002\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u5df2\u6388\u4e88\u5934\u5b62\u5421\u809f-taniborbactam \u5408\u683c\u6cbb\u7597\u611f\u67d3\u75c5\u4ea7\u54c1 (QIDP) \u79f0\u53f7\u548c\u5feb\u901f\u901a\u9053\u5ba1\u8bc4\u8d44\u683c\u3002<\/p>\n
\u5173\u4e8e\u590d\u6742\u6027\u5c3f\u8def\u611f\u67d3\uff08<\/b>cUTI<\/b>\uff09<\/b><\/p>\n
cUTI\uff08\u5305\u62ec\u6025\u6027\u80be\u76c2\u80be\u708e\uff09\u662f\u6307\u4ece\u8180\u80f1\u4e0a\u884c\u7684\u5c3f\u8def\u611f\u67d3\uff0c\u4f34\u6709\u53d1\u70e7\u3001\u5bd2\u6218\u3001\u4e0d\u9002\u3001\u8170\u808b\u75bc\u75db\u3001\u80cc\u75db\u548c\/\u6216\u808b\u690e\u89d2\u75bc\u75db\u6216\u89e6\u75db\u7b49\u5c40\u90e8\u6216\u5168\u8eab\u4f53\u5f81\u53ca\u75c7\u72b6\uff0c\u6613\u611f\u56e0\u7d20\u901a\u5e38\u4e3a\u6ccc\u5c3f\u7cfb\u7edf\u5b58\u5728\u529f\u80fd\u6216\u89e3\u5256\u5f02\u5e38\u6216\u5bfc\u5c3f\u3002\u83cc\u8840\u75c7\uff0c\u53ef\u7ee7\u53d1\u4e8e\u6025\u6027\u5168\u8eab\u6027\u611f\u67d3\u4f8b\u5982cUTI\uff0c\u5e76\u53ef\u5bfc\u81f4\u91cd\u5927\u5408\u5e76\u75c7\u4ee5\u53ca\u6b7b\u4ea1\u3002<\/p>\n
\u5173\u4e8e<\/b>CERTAIN-1<\/b><\/p>\n
CERTAIN-1\u662f\u4e00\u9879\u5168\u7403\u6027\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u6d3b\u6027\u5bf9\u7167\u3001\u975e\u52a3\u6548\u60273\u671f\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30\u5934\u5b62\u5421\u809f- taniborbactam\u4e0e\u7f8e\u7f57\u57f9\u5357\u76f8\u6bd4\u6cbb\u7597cUTI\u6210\u4eba\u60a3\u8005\uff08\u5305\u62ec\u6025\u6027\u80be\u76c2\u80be\u708e\u60a3\u8005\uff09\u7684\u7597\u6548\u3001\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u3002\u8be5\u8bd5\u9a8c\u5171\u5165\u7ec4661\u540d\u6210\u4eba\u60a3\u8005\uff0c\u4ed6\u4eec\u4ee52:1\u7684\u6bd4\u4f8b\u968f\u673a\u63a5\u53d7\u5934\u5b62\u5421\u809f- taniborbactam \u6bcf8\u5c0f\u65f62.5\u514b\u6216\u7f8e\u7f57\u57f9\u5357\u6bcf8\u5c0f\u65f61\u514b\uff0c\u5171\u7ed9\u836f7\u5929\uff08\u83cc\u8840\u75c7\u60a3\u8005\u6700\u591a\u7ed9\u836f14\u5929\uff09\u3002\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u8bc4\u4f30\u4e86\u7f8e\u56fd FDA \u548c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u6307\u5357\u89c4\u5b9a\u7684\u5fae\u751f\u7269\u5b66\u610f\u5411\u6cbb\u7597 (microITT) \u4eba\u7fa4\u5728\u7597\u6548\u5224\u5b9a(TOC) \u8bbf\u89c6\uff08\u7b2c 19-23 \u5929\uff09\u65f6\u7684\u590d\u5408\u4e34\u5e8a\u548c\u5fae\u751f\u7269\u5b66\u7597\u6548\uff08\u5373\u7ec6\u83cc\u6839\u9664\uff09\u3002<\/p>\n
\u5173\u4e8e<\/b>Venatorx Pharmaceuticals, Inc.<\/b><\/p>\n
Venatorx Pharmaceuticals \u662f\u4e00\u5bb6\u79c1\u8425\u7684\u4e34\u5e8a\u9636\u6bb5\u5236\u836f\u516c\u53f8\uff0c\u4e13\u6ce8\u4e8e\u6539\u5584\u591a\u91cd\u8010\u836f\u7ec6\u83cc\u611f\u67d3\u548c\u96be\u6cbb\u6027\u75c5\u6bd2\u611f\u67d3\u60a3\u8005\u3002Venatorx \u7684\u4e3b\u8981\u9879\u76ee\u5934\u5b62\u5421\u809f- taniborbactam \u662f\u4e00\u79cd\u5904\u4e8e\u4e34\u5e8a\u9636\u6bb5\u7684\u9759\u8109\u6ce8\u5c04\u7528\u6297\u83cc\u836f\u7269\uff0c\u5df2\u5728\u590d\u6742\u6027\u5c3f\u8def\u611f\u67d3\u6210\u4eba\u60a3\u8005\u4e2d\u5b8c\u6210\u4e863\u671f\u7814\u7a76\u3002\u57fa\u4e8e CERTAIN-1 \u5168\u74033\u671f\u4e34\u5e8a\u7814\u7a76\u79ef\u6781\u7684\u7ed3\u679c\uff0c\u8be5\u516c\u53f8\u9884\u8ba1\u5c06\u4e8e2022\u5e74\u7b2c\u56db\u5b63\u5ea6\u5411\u7f8e\u56fdFDA\u63d0\u4ea4\u5934\u5b62\u5421\u809f- taniborbactam \u7684\u65b0\u836f\u7533\u8bf7\u3002\u6709\u5173 Venatorx 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