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亞虹醫藥(688176.SH):海克威®獲開展III期臨牀試驗批准通知書
格隆匯 02-11 15:52

格隆匯2月11日丨亞虹醫藥(688176.SH)公佈,近日公司收到國家藥品監督管理局(NMPA)簽發的藥物臨牀試驗批准通知書

審批結論根據《中華人民共和國藥品管理法》及有關規定,經審查,20211129日受理的 Hexvix® 85mg 符合藥品註冊的有關要求,建議同意此次申請,即:一項比較海克威®聯合藍光膀胱鏡和白光膀胱鏡對膀胱癌檢出率的前瞻性、受試者自身對照的多中心臨牀研究。

該研究是一項前瞻性受試者自身對照的多中心III期臨牀試驗旨在探討海克威®聯合藍光膀胱鏡對比白光膀胱鏡對非肌層浸潤性膀胱癌(NMIBC)(原位(CIS)TaT1)額外檢出率及安全性。公司未來將根據該臨牀試驗進展及有效數據,向國家藥品監督管理局提交產品上市申請。

海克威®是目前全球唯一獲批的輔助膀胱癌診斷或手術的顯影劑類藥物,通過與藍光膀胱鏡的聯合使用可以有效提高 NMIBC 的檢出率(尤其是原位癌的檢出率),使手術切除更完全,從而降低腫瘤複發率。

海克威®已在美國和歐洲許多國家獲得批准。聯合使用海克威®和藍光膀胱鏡作為 NMIBC 管理的方法已被納入全球專家共識指南公司和全資子公司 AsierisMediTech (Hong Kong) Co., Ltd. 2021 1 月與位於挪威奧斯陸的膀胱癌專科公司 Photocure ASAPhotocure, PHO.OL)簽訂《經銷協議》,獲得海克威®中國大陸及台灣地區的獨家註冊及商業化權利。

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