兆科眼科-B(06622.HK):ACCG通過藥品註冊現場檢查成為本年度通過的第三項GMP檢查
格隆匯9月13日丨兆科眼科-B(06622.HK)發佈公吿,公司一項候選藥阿達帕林鹽酸克林黴素複方凝膠(“ACCG”)已通過國家藥品監督管理局食品藥品審核查驗中心的藥品註冊現場檢查。有關檢查查驗ACCG研發及生產程序的記錄及資料正本。此乃本公司繼2021年5月通過貝美素噻嗎洛爾滴眼液及鹽酸依匹斯汀滴眼液的現場檢查後,於本年度通過的第三項現場檢查,為最終審批ACCG的重要一步。
公司亦已通過廣東省藥品監督管理局對藥品生產質量管理規範(“GMP”)實施情況進行的外用凝膠生產線合規檢查。檢查結果確認公司已落實GMP管理框架、核心團隊、全套分析工具、設備及設施、妥善文件管理系統以及生產及質量系統妥善運作。此亦為公司通過GMP檢查的第二條生產線。
公司與被許可方Lee’s Pharmaceutical International Limited及兆科藥業(廣州)有限公司(統稱為“李氏大藥廠集團”)於2020年10月訂立許可協議,據此,公司同意授予李氏大藥廠集團於大中華地區商業化ACCG的獨家權利,對ACCG進行對外許可。作為代價,李氏大藥廠集團同意於簽訂協議時支付預付款,以及於ACCG於中國的新藥上市申請取得相關監管批准後支付里程碑付款,並與公司分享銷售ACCG所得利潤。
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