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兆科眼科-B(06622.HK)兩項藥品通過國家藥監局藥品註冊現場核查
格隆匯 05-24 07:33

格隆匯5月24日丨兆科眼科-B(06622.HK)發佈公吿,於2021年5月13日,公司的兩項藥品-貝美素噻嗎洛爾滴眼液(在中國用於治療青光眼的潛在首仿藥,為前列腺素類似物與乙型受體阻斷劑的固定劑量複方);及鹽酸依匹斯汀滴眼液(在中國用於治療過敏性結膜炎的潛在首仿藥,具有抗組胺及穩定的肥大細胞雙重作用機制),通過國家藥品監督管理局藥品審評檢查大灣區分中心藥品註冊現場核查,核實上述兩項藥品的研製過程及生產過程中的原始記錄及資料。

公司亦通過廣東省藥監局同步進行的藥品生產品質管制規範(GMP)符合性檢查,確認公司制定了GMP管理框架、核心團隊人員及整套分析儀器、設備和設施、管理完善的文件體系以及正常運作的生產與品質體系。

通過藥品註冊現場核查及GMP符合性是本公司重大里程碑。作為國家藥品監督管理局藥品審評檢查大灣區分中心首個註冊核查的企業,此次檢查結果象徵國家藥監局對公司的藥物研發體系實力及質量管理體系的認可,證明體系能最大限度地降低藥品生產過程中污染、交叉污染以及差錯等風險,確保持續穩定地生產出符合註冊要求的藥品。

董事會認為,通過國家藥品監督管理局藥品註冊現場核查乃公司的重要認證,肯定公司多年來為落實優質生產體系所作的一切努力,而此體系正形成公司的核心優勢之一。

公司已向國家藥監局提交了以上所闡述之兩種仿製藥(貝美素噻嗎洛爾滴眼液及鹽酸依匹斯汀滴眼液)的簡化新藥申請。公司預期在2022年獲得監管批准後開始將該等兩個產品商業化,及預期有關商業化有助本公司與合作伙伴及關鍵意見領袖、眼科醫生及醫院等戰略渠道建立緊密下游聯繫。

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