2026-10-27 02:30:53 网络 阅读（124）
鼎晋 (7876-TW) 今 (15) 日宣布，旗下核心产品 760 kDa 长效型 A 型肉毒杆菌素新药 OBI-858，顺利完成 TFDA 核准的皱眉纹重复治疗安全性临床试验最后一位受试者最后一次回诊 (LPLV)，完成所有受试者追踪与资料收集，为未来生物制剂上市许可申请(BLA) 提前建立安全性审查资料。
鼎晋指出，此次试验为 TFDA 核准的开放标示 (Open-Label) 重复治疗安全性临床二期试验，主要评估受试者接受多次施打后的长期安全性与耐受性表现，并同步搜集重复治疗后的疗效相关数据。
鼎晋进一步提到，此类重复治疗安全性资料，与接续规划执行的 2 项双盲随机枢纽性 (Pivatal) 临床三期试验结果，都是即将送件的 BLA 申请的重要审查文件。
除医美适应症，鼎晋也积极布局其他医疗适应症领域，目前已规划在台湾推进中风后痉挛临床试验，同时布局斜颈症、慢性偏头痛、膀胱过动症、多汗症和眼睑痉挛等多项医疗适应症的研究与产品开发。
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"description": "鼎晋今日宣布，旗下核心产品 760 kDa 长效型 A 型肉毒杆菌素新药 OBI-858，顺利完成 TFDA 核准的皱眉纹重复治疗安全性临床试验最后一位受试者最后一次回诊 (LPLV)，完成所有受试者追踪与资料。",
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"content": "<p>鼎晋 (7876-TW) 今 (15) 日宣布，旗下核心产品 760 kDa 长效型 A 型肉毒杆菌素新药 OBI-858，顺利完成 TFDA 核准的皱眉纹重复治疗安全性临床试验最后一位受试者最后一次回诊 (LPLV)，完成所有受试者追踪与资料收集，为未来生物制剂上市许可申请(BLA) 提前建立安全性审查资料。 </p>\n<p style=\"text-align:center;\"><img src=\"https://cimg.cnyes.cool/prod/news/6536026/l/1a4a6c5816c8fa014ebe737f1a54a2e5.jpg\" alt=\"鼎晋肉毒杆菌素新药完成TFDA重复治疗安全性试验 提前建立BLA审查资料\" style=\"width:50%;height:auto;border-radius:6px;margin:15px auto;display:block;\"></p>\n\n\n<p>鼎晋指出，此次试验为 TFDA 核准的开放标示 (Open-Label) 重复治疗安全性临床二期试验，主要评估受试者接受多次施打后的长期安全性与耐受性表现，并同步搜集重复治疗后的疗效相关数据。 </p>\n\n<p>鼎晋进一步提到，此类重复治疗安全性资料，与接续规划执行的 2 项双盲随机枢纽性 (Pivatal) 临床三期试验结果，都是即将送件的 BLA 申请的重要审查文件。 </p>\n\n<p>除医美适应症，鼎晋也积极布局其他医疗适应症领域，目前已规划在台湾推进中风后痉挛临床试验，同时布局斜颈症、慢性偏头痛、膀胱过动症、多汗症和眼睑痉挛等多项医疗适应症的研究与产品开发。 </p>\n<div class=\"related-articles seo-links\">\n <h4>相关阅读</h4>\n <ul>\n <li><a href=\"/new/tw/article-17694.html\" title=\"〈焦点股〉今国光红外线镜头推升营运走高 今涨幅逾2.5%居光学股之冠\">〈焦点股〉今国光红外线镜头推升营运走高 今涨幅逾2.5%居光学股之冠</a></li>\n <li><a href=\"/new/tw/article-8849.html\" title=\"神助手！AI新十大建设Q2秀肌肉 首创法务专属LLM「秒查」消化1年1600万案件\">神助手！AI新十大建设Q2秀肌肉 首创法务专属LLM「秒查」消化1年1600万案件</a></li>\n <li><a href=\"/new/tw/article-7805.html\" title=\"〈台币〉高低价差超过2角震幅大 收在32.375元贬值3分\">〈台币〉高低价差超过2角震幅大 收在32.375元贬值3分</a></li>\n <li><a href=\"/new/tw/article-3868.html\" title=\"盘中速报 - 集中市场加权指数下跌-931.3点至45323.96点，跌幅2.01%\">盘中速报 - 集中市场加权指数下跌-931.3点至45323.96点，跌幅2.01%</a></li>\n <li><a href=\"/new/tw/article-1503.html\" title=\"【超级警讯】六月4大利空→完美风暴成形？风暴下如何卡位 Q3 爆发股？\">【超级警讯】六月4大利空→完美风暴成形？风暴下如何卡位 Q3 爆发股？</a></li>\n <li><a href=\"/new/tw/article-8215.html\" title=\"资料中心电力大革命！大厂扩产倍增背书，BBU引爆HVDC兆元新商机！\">资料中心电力大革命！大厂扩产倍增背书，BBU引爆HVDC兆元新商机！</a></li>\n </ul>\n</div>",
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"createdAt": "2026-07-15T10:36:33.000Z",
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