四環醫藥(00460.HK)附屬與旺實生物就新冠口服藥氫溴酸氘瑞米德韋片達成藥品委託生產及供貨協議
格隆匯2月8日丨四環醫藥(00460.HK)宣佈,集團旗下子公司吉林四環製藥有限公司(“吉林四環")與上海旺實生物醫藥科技有限公司(“旺實生物")就口服核苷類抗新型冠狀病毒(SARS-CoV-2)1類創新藥氫溴酸氘瑞米德韋片(產品代號:VV116/JT001,商品名:民得維®,“VV116")的生產供應達成合作協議。雙方將密切配合推進VV116在技術轉移、委託生產相關工作。
VV116為上海君實生物醫藥科技股份有限公司(股份代號:1877.HK)下屬控股子公司旺實生物申報的1類創新藥氫溴酸氘瑞米德韋片,並於2023年1月28日經囯家藥品監督管理局應急審評審批,附條件批准上市,該藥被批准用於治療輕中度新型冠狀病毒感染(COVID-19)的成年患者。
根據雙方協議約定及相關藥品管理法規,吉林四環將作為受託生產方配合旺實生物開展產品的工藝優化、質量方法轉移、中試放大、工藝驗證等技術轉移落產及委託生產註冊審批工作。同時,吉林四環作為旺實生物主要委託生產合作方將充分發揮優勢以提供高效、穩定、高產能的市場供應及支持服務。
公吿稱,該次產品委託生產及供貨協議的簽署,不僅促使合作雙方建立雙贏的戰略合作伙伴關係,同時展現了行業對集團高效率、高質量生產能力的認可。集團相信合作雙方將在優勢互補、互惠互利、共同發展的基礎上,進一步推進業務進展,滿足雙方未來發展需求。
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