石药(01093.HK)附属淋巴瘤药品内地上市申请获受理
石药集团(01093.HK)公布,公司附属石中奇制药技术的「度恩西布胶囊」(商品名克必妥)的上市申请已获中国国家药品监督管理局受理,并获附条件批准上市及优先审评资格。
集团指,克必妥按照化药5.1类申报,用於治疗既往至少经过两线治疗的复发/难治性滤泡性淋巴瘤成年患者。美国食品药品监督管理局(FDA)已於2018年9月批准该品种上市。集团拥有该产品在中国(包括香港、澳门和台湾地区)开发及商业化的独家许可权。
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