{"id":6294,"date":"2023-01-12T03:11:18","date_gmt":"2023-01-12T03:11:18","guid":{"rendered":"\/\/smallcapscn.x5view.co\/?p=6294"},"modified":"2023-08-29T17:56:41","modified_gmt":"2023-08-29T17:56:41","slug":"avecho-biotechnology-vitamin-k-injectable-pre-ind-meeting-us-fda","status":"publish","type":"post","link":"https:\/\/smallcapscn.x5view.co\/?p=6294","title":{"rendered":"Avecho Biotechnology \u7684\u7ef4\u751f\u7d20 K \u6ce8\u5c04\u5242\u83b7\u5f97\u7f8e\u56fd FDA \u7684\u9884 IND \u4f1a\u8bae"},"content":{"rendered":"<p>Avecho Biotechnology (ASX: AVE) \u5728\u5168\u7403\u516c\u53f8 Athenex Pharmaceutical \u7684\u9884\u7814\u7a76\u65b0\u836f (pre-IND) \u4f1a\u8bae\u4e0a\u5411\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff09\u63d0\u4ea4\u4e86\u5176\u589e\u5f3a TPM \u7684\u690d\u7269\u7532\u8418\u918c\u6ce8\u5c04\u836f\u7269\u3002<\/p>\n<p>Phytonadione \u7528\u4e8e\u6cbb\u7597\u7531\u7ef4\u751f\u7d20 K \u7f3a\u4e4f\u3001\u5bf9\u67d0\u4e9b\u836f\u7269\u7684\u53cd\u5e94\u6216\u5176\u4ed6\u5bfc\u81f4\u8840\u6db2\u53d8\u7a00\u7684\u533b\u7597\u72b6\u51b5\u7b49\u95ee\u9898\u5f15\u8d77\u7684\u51fa\u8840\u6216\u51dd\u8840\u95ee\u9898\u3002<\/p>\n<p>\u5b83\u901a\u5e38\u4f5c\u4e3a\u9884\u9632\u5242\u5728\u51fa\u751f\u65f6\u7ed9\u4e88\u5a74\u513f\uff0c\u4ee5\u9632\u6b62\u51fa\u8840\u3002<\/p>\n<h2>\u5f00\u53d1\u5de5\u4f5c<\/h2>\n<p>\u6765\u81ea IND \u524d\u4f1a\u8bae\u7684\u53cd\u9988\u5c06\u786e\u5b9a\u5728\u65b0\u836f\u7533\u8bf7\u63d0\u4ea4\u7ed9\u7f8e\u56fd FDA \u8fdb\u884c\u6b63\u5f0f\u5ba1\u67e5\u4e4b\u524d\u5269\u4f59\u7684\u5f00\u53d1\u5de5\u4f5c\u91cf\u3002<\/p>\n<p>\u5982\u679c\u53cd\u9988\u662f\u79ef\u6781\u7684\uff0c\u5e76\u4e14\u8be5\u836f\u7269\u88ab\u8ba4\u4e3a\u5177\u6709\u5546\u4e1a\u53ef\u884c\u6027\uff0cAvecho \u548c Athenex \u5c06\u5728\u5f00\u53d1\u524d\u8fbe\u6210\u8bb8\u53ef\u534f\u8bae\u3002<\/p>\n<h2>Athenex \u5174\u8da3<\/h2>\n<p>Avecho \u9996\u5e2d\u6267\u884c\u5b98 Paul Gavin \u535a\u58eb\u8868\u793a\uff0c\u9f13\u52b1\u516c\u53f8\u5438\u5f15 Athenex \u7684\u5174\u8da3\u3002<\/p>\n<p>\u201cAthenex \u662f\u6211\u4eec\u4ea7\u54c1\u7ec4\u5408\u4e2d\u4f20\u7edf\u4ea7\u54c1\u7684\u77e5\u540d\u5408\u4f5c\u4f19\u4f34\uff0c\u5c24\u5176\u662f\u53ef\u4ee5\u8ba9\u6211\u4eec\u79ef\u6781\u53c2\u4e0e\u7f8e\u56fd FDA \u7684\u4ea7\u54c1\uff0c\u201d\u4ed6\u8bf4\u3002<\/p>\n<p>\u201c\u4e00\u65e6 TPM \u7684\u5168\u90e8\u529f\u80fd\u548c\u7f8e\u56fd\u690d\u7269\u8418\u4e8c\u916e\u5546\u4e1a\u5316\u7684\u53ef\u884c\u6027\u5f97\u5230\u786e\u7acb\uff0c\u6211\u4eec\u5e0c\u671b\u8fd9\u5c06\u6210\u4e3a\u6211\u4eec\u5f00\u53d1\u548c[\u5171\u540c]\u589e\u5f3a\u7684\u8bb8\u591a\u6ce8\u5c04\u4ea7\u54c1\u4e2d\u7684\u7b2c\u4e00\u4e2a\u3002\u201d<\/p>\n<p>\u4ed6\u8bf4\uff0cAthenex \u548c Avecho \u8fd8\u5728\u8ba8\u8bba\u9009\u62e9\u4e00\u79cd TPM \u589e\u5f3a\u7684\u4ea7\u54c1\uff0c\u4ee5\u4fbf\u5728\u690d\u7269\u8418\u4e8c\u916e\u4e4b\u540e\u53ef\u80fd\u5728\u7f8e\u56fd\u5546\u4e1a\u5316\uff0cAthenex \u5c06\u62e5\u6709\u8be5\u4ea7\u54c1\u7684\u4f18\u5148\u62d2\u7edd\u6743\u3002<\/p>\n<h2>\u4e0d\u6eb6\u6027\u6cb9<\/h2>\n<p>Phytonadione \u7531\u4e0d\u6eb6\u6027\u6cb9\u7ec4\u6210\uff0c\u9700\u8981\u4e0e\u8d4b\u5f62\u5242\u4e00\u8d77\u914d\u5236\u624d\u80fd\u6eb6\u89e3\u5e76\u4f7f\u5176\u9002\u5408\u6ce8\u5c04\u3002<\/p>\n<p>\u4f17\u6240\u5468\u77e5\uff0c\u8bf8\u5982\u84d6\u9ebb\u6cb9 (Cremophor EL) \u6216\u805a\u5c71\u68a8\u916f\u7b49\u8d4b\u5f62\u5242\u7684\u5b89\u5168\u6027\u5f88\u5dee\uff0c\u4e00\u65e6\u6ce8\u5c04\u901a\u5e38\u4f1a\u4ea7\u751f\u4e0d\u826f\u526f\u4f5c\u7528\u3002<\/p>\n<p>\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u636e\u62a5\u9053 TPM\uff08\u6216\u751f\u80b2\u915a\u78f7\u9178\u916f\u6df7\u5408\u7269\uff09\u5177\u6709\u51fa\u8272\u7684\u5b89\u5168\u6027\uff0c\u5e76\u88ab\u89c6\u4e3a\u66ff\u4ee3\u54c1\u3002<\/p>\n<p>TPM \u91c7\u7528\u4e13\u5229\u5de5\u827a\u4ece\u7ef4\u751f\u7d20 E \u4e2d\u63d0\u53d6\uff0c\u7ecf\u8bc1\u660e\u53ef\u589e\u5f3a\u836f\u7269\u548c\u8425\u517b\u7d20\u7684\u6eb6\u89e3\u5ea6\u4ee5\u53ca\u53e3\u670d\u3001\u771f\u76ae\u548c\u900f\u76ae\u5438\u6536\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Avecho Biotechnology (ASX: AVE) \u5728\u5168\u7403\u516c\u53f8 Athenex Pharmaceutical \u7684\u9884\u7814\u7a76\u65b0\u836f (pre-IND) \u4f1a\u8bae\u4e0a\u5411\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff09\u63d0\u4ea4\u4e86\u5176\u589e\u5f3a TPM \u7684\u690d\u7269\u7532\u8418\u918c\u6ce8\u5c04\u836f\u7269\u3002 Phytonadione \u7528\u4e8e\u6cbb\u7597\u7531\u7ef4\u751f\u7d20 K \u7f3a\u4e4f\u3001\u5bf9\u67d0\u4e9b\u836f\u7269\u7684\u53cd\u5e94\u6216\u5176\u4ed6\u5bfc\u81f4\u8840\u6db2\u53d8\u7a00\u7684\u533b\u7597\u72b6\u51b5\u7b49\u95ee\u9898\u5f15\u8d77\u7684\u51fa\u8840\u6216\u51dd\u8840\u95ee\u9898\u3002 \u5b83\u901a\u5e38\u4f5c\u4e3a\u9884\u9632\u5242\u5728\u51fa\u751f\u65f6\u7ed9\u4e88\u5a74\u513f\uff0c\u4ee5\u9632\u6b62\u51fa\u8840\u3002 \u5f00\u53d1\u5de5\u4f5c \u6765\u81ea IND \u524d\u4f1a\u8bae\u7684\u53cd\u9988\u5c06\u786e\u5b9a\u5728\u65b0\u836f\u7533\u8bf7\u63d0\u4ea4\u7ed9\u7f8e\u56fd FDA \u8fdb\u884c\u6b63\u5f0f\u5ba1\u67e5\u4e4b\u524d\u5269\u4f59\u7684\u5f00\u53d1\u5de5\u4f5c\u91cf\u3002 \u5982\u679c\u53cd\u9988\u662f\u79ef\u6781\u7684\uff0c\u5e76\u4e14\u8be5\u836f\u7269\u88ab\u8ba4\u4e3a\u5177\u6709\u5546\u4e1a\u53ef\u884c\u6027\uff0cAvecho \u548c Athenex \u5c06\u5728\u5f00\u53d1\u524d\u8fbe\u6210\u8bb8\u53ef\u534f\u8bae\u3002 Athenex \u5174\u8da3 Avecho \u9996\u5e2d\u6267\u884c\u5b98 Paul Gavin \u535a\u58eb\u8868\u793a\uff0c\u9f13\u52b1\u516c\u53f8\u5438\u5f15 Athenex \u7684\u5174\u8da3\u3002 \u201cAthenex \u662f\u6211\u4eec\u4ea7\u54c1\u7ec4\u5408\u4e2d\u4f20\u7edf\u4ea7\u54c1\u7684\u77e5\u540d\u5408\u4f5c\u4f19\u4f34\uff0c\u5c24\u5176\u662f\u53ef\u4ee5\u8ba9\u6211\u4eec\u79ef\u6781\u53c2\u4e0e\u7f8e\u56fd FDA \u7684\u4ea7\u54c1\uff0c\u201d\u4ed6\u8bf4\u3002 \u201c\u4e00\u65e6 TPM \u7684\u5168\u90e8\u529f\u80fd\u548c\u7f8e\u56fd\u690d\u7269\u8418\u4e8c\u916e\u5546\u4e1a\u5316\u7684\u53ef\u884c\u6027\u5f97\u5230\u786e\u7acb\uff0c\u6211\u4eec\u5e0c\u671b\u8fd9\u5c06\u6210\u4e3a\u6211\u4eec\u5f00\u53d1\u548c[\u5171\u540c]\u589e\u5f3a\u7684\u8bb8\u591a\u6ce8\u5c04\u4ea7\u54c1\u4e2d\u7684\u7b2c\u4e00\u4e2a\u3002\u201d \u4ed6\u8bf4\uff0cAthenex \u548c Avecho \u8fd8\u5728\u8ba8\u8bba\u9009\u62e9\u4e00\u79cd TPM \u589e\u5f3a\u7684\u4ea7\u54c1\uff0c\u4ee5\u4fbf\u5728\u690d\u7269\u8418\u4e8c\u916e\u4e4b\u540e\u53ef\u80fd\u5728\u7f8e\u56fd\u5546\u4e1a\u5316\uff0cAthenex \u5c06\u62e5\u6709\u8be5\u4ea7\u54c1\u7684\u4f18\u5148\u62d2\u7edd\u6743\u3002 \u4e0d\u6eb6\u6027\u6cb9&hellip; <a class=\"more-link\" href=\"https:\/\/smallcapscn.x5view.co\/?p=6294\">Continue reading <span class=\"screen-reader-text\">Avecho Biotechnology \u7684\u7ef4\u751f\u7d20 K \u6ce8\u5c04\u5242\u83b7\u5f97\u7f8e\u56fd FDA \u7684\u9884 IND \u4f1a\u8bae<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":19212,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[3],"tags":[130],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v17.3 (Yoast SEO v21.0) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Avecho Biotechnology \u7684\u7ef4\u751f\u7d20 K \u6ce8\u5c04\u5242\u83b7\u5f97\u7f8e\u56fd FDA \u7684\u9884 IND \u4f1a\u8bae<\/title>\n<meta name=\"description\" content=\"Avecho Biotechnology (ASX: AVE) \u5728\u5168\u7403\u516c\u53f8 Athenex Pharmaceutical \u7684\u9884\u7814\u7a76\u65b0\u836f (pre-IND) \u4f1a\u8bae\u4e0a\u5411\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff09\u63d0\u4ea4\u4e86\u5176\u589e\u5f3a TPM \u7684\u690d\u7269\u7532\u8418\u918c\u6ce8\u5c04\u836f\u7269\u3002\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Avecho Biotechnology \u7684\u7ef4\u751f\u7d20 K \u6ce8\u5c04\u5242\u83b7\u5f97\u7f8e\u56fd FDA \u7684\u9884 IND \u4f1a\u8bae\" \/>\n<meta property=\"og:description\" content=\"Avecho Biotechnology (ASX: AVE) \u5728\u5168\u7403\u516c\u53f8 Athenex Pharmaceutical \u7684\u9884\u7814\u7a76\u65b0\u836f (pre-IND) \u4f1a\u8bae\u4e0a\u5411\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff09\u63d0\u4ea4\u4e86\u5176\u589e\u5f3a TPM 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