康哲药业：甲氨蝶呤注射液增加类风湿关节炎适应症中国上市许可申请获批

新浪港股08-06

康哲药业（00867）发布公告，甲氨蝶呤注射液（产品）增加适应症的上市许可申请（NDA）已于2024年7月30日获得国家药品监督管理局（NMPA）批准。产品是多种规格的预充式小容量甲氨蝶呤注射剂，获批用于治疗成人活动性类风湿关节炎（RA）。集团于2024年8月5日获得药品注册证书。　　甲氨蝶呤是国际公认治疗类风湿关节炎（RA）的一线首选药物和锚定药物。产品是中国首个以皮下给药方式治疗类风湿关节炎...

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