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東曜藥業與兆科眼科附屬公司就TAB014簽訂補充協議書、收到樸欣汀新增適應症補充申請批件
格隆匯3月9日丨東曜藥業公佈,與兆科眼科(6622.HK)之全資附屬兆科廣州已簽訂補充協議書。兆科廣州將作為申請人向中國藥監局(NMPA)就TAB014申請藥品上市許可並負責開展三期臨牀試驗,以及作為TAB014在中國(包括香港和澳門)的整個產品生命週期的藥品上市許可持有人(MAH)。所有臨牀前及臨牀研究數據仍將由兆科廣州及公司共同擁有。在獲得藥品上市許可後,蘇州東曜仍將負責TAB014的商業規模生產,兆科廣州仍將負責TAB014在上述授權區域的商業化及銷售。董事會認為,簽訂本補充協議書有利於加快TAB014在中國的開發、上市及商業化。本集團將繼續充分發揮在抗體藥物商業化生產領域的優勢,為廣大眼病患者製造高品質的藥物,惠及中國眼病患者。公司於同日公佈,近日收到NMPA核准簽發的關於樸欣汀(貝伐珠單抗注射液)新增適應症補充申請批件。本次補充申請是依據NMPA藥品審評中心發佈的《生物類似藥相似性評 價和適應症外推技術指導原則》外推申請原研藥在中國獲批的其他適應 症,分別為:複發性膠質母細胞瘤,上皮性卵巢癌、輸卵管癌或原發性腹膜癌,以及宮頸癌。據此,包含晚期、轉移性或複發性非鱗狀非小細胞肺癌(nsNSCLC)和轉移性結直腸癌(mCRC),樸欣汀共有5項適應症獲批。此次申請獲批將進 一 步擴大樸欣汀的市場空間,滿足更多中 國癌症患者用藥的可及性。
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