華潤醫藥(03320.HK)與河南真實生物科技進行戰略合作
格隆匯5月10日丨華潤醫藥(03320.HK)發佈公吿,華潤雙鶴(由公司間接擁有59.99%權益的非全資附屬公司)已於近期與河南真實生物科技有限公司訂立為期10年的戰略合作協議。根據戰略合作協議,華潤雙鶴與河南真實生物科技將在產品研發、生產、經銷以及與經銷直接相關的多個方面、領域拓展合作。
華潤雙鶴與河南真實生物科技亦已訂立委託加工框架協議。河南真實生物科技擁有阿茲夫定片的所有權;申請並取得該藥的藥品註冊證書,為上市許可持有人,擁有生產(自行生產或委託生產)、放行、銷售的權利。根據委託加工框架協議,河南真實生物科技向華潤雙鶴提供阿茲夫定片註冊處方、生產工藝和品質標準等技術資料,以及生產與品質控制所需文件;對華潤雙鶴阿茲夫定片生產全過程進行指導、檢查,確保委託加工生產的所有活動符合藥品GMP要求;決定最終產品的拒絕和放行;對上市後的藥品不良反應事件負責;對上市應用造成的人身損害,承擔先行賠償責任。
華潤雙鶴與河南真實生物科技將根據阿茲夫定片開展臨牀試驗、批准上市應用各階段的實際情況,針對委託加工生產涉及的訂單計劃、結算方式、交貨期限以及品質要求等具體事項,另行簽署委託合同。截至該公吿日期,華潤雙鶴已向北京市藥品監督管理局提交藥品生產許可證C證的核發申請,且申請已獲審批通過。
公吿表示,簽訂戰略合作協議及委託加工框架協議有助於華潤雙鶴與河南真實生物科技在產品研發、生產、經銷以及與經銷直接相關的多個方面、領域拓展合作,提升華潤雙鶴業務發展空間,符合華潤雙鶴未來發展的需要。董事會認為,此次與河南真實生物科技的戰略合作與集團未來發展戰略及經營需求一致,並符合公司及其股東的整體利益。
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