君實生物(688180.SH):特瑞普利單抗注射液獲得藥品補充申請批准通知書
格隆匯5月10日丨君實生物(688180.SH)公佈,近日,上海君實生物醫藥科技股份有限公司收到國家藥品監督管理局核准簽發的藥品補充申請批准通知書,批准公司全資子公司上海君實生物工程有限公司(簡稱“君實工程”)位於上海臨港的生產基地(簡稱“上海臨港生產基地”)可與公司蘇州吳江生產基地同時負責生產商業化批次的特瑞普利單抗注射液(商品名:拓益®,產品代號:JS001)。
上海臨港生產基地按照CGMP標準建設,其中一期項目產能30,000升。此次獲批後,上海臨港生產基地將具備與蘇州吳江生產基地同時負責生產商業化批次的特瑞普利單抗注射液的資質。
由於規模效應,上海臨港生產基地帶來的產能擴充將使公司獲得更具競爭力的生產成本,並支持更多臨牀試驗加速推出新藥物。根據目前在研產品管線的研發進度,公司計劃進一步擴展生產設施,以提供可與公司日益增長及漸趨成熟的在研藥物相匹配的充足產能,支持公司的業務在未來的持續擴張。
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