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復宏漢霖(02696.HK)就新增2000L生物反應器完成生產許可備案
格隆匯 07-08 17:33

格隆匯 7 月 8日丨復宏漢霖-B(02696.HK)發佈公告,近日,公司全資子公司上海復宏漢霖生物製藥有限公司完成了就於上海市徐彙區生產基地新增四台2,000L生物反應器向上海市藥品監督管理局進行的生產許可新增關鍵設備備案。

為滿足公司已商業化的產品及未來候選藥物陸續進入商業化階段後的市場供貨需求,上海復宏漢霖生物製藥有限公司就於徐匯基地D樓原液南北線分別新增兩台2,000L生物反應器向上海市藥品監督管理局進行生產許可新增關鍵設備備案。

本次生產許可備案完成後,公司的總體商業化產能進一步提升至20,000L,除將提高現階段已商業化產品的產能、保證持續及穩定的市場供應以外,亦將對候選藥物後續的商業化生產提供產能保障。

為滿足產品管線中候選藥物逐步上市的預期需求,公司制定了針對產品開發週期的階段性產能規劃,逐步完善和提升基於健全質量管理體系的大規模生產能力。除徐匯基地產能之外,公司已於上海市松江區啟動松江基地(一)的建設,設計產能為24,000L,包括罐裝製劑線,為松江基地(二)建設投產之前公司的預計生產需求做好準備。

此外,為實現長期產能規劃,總規劃用地面積約200畝的松江基地(二)也已於2019年啟動建設。建設完成後,松江基地(二)將成為集團單克隆抗體生物藥研發、中試及生產基地,這將進一步增強集團在核心業務領域的市場競爭力,並滿足集團生物類似藥、生物創新藥產品的全球商業化生產需求。

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