李氏大药厂(00950.HK)附属婴儿(酉每)缺乏症药物获注册证书并完成首次发货
李氏大药厂(00950.HK)公布,公司全资附属兆科广州开发并生产的苯丁酸钠颗粒(规格:150g/瓶,每1g含苯丁酸钠0.94g)获中国国家药监局的药品注册证书,并已於本公布日期完成首次发货。
苯丁酸钠作为辅助治疗药物,用於氨基甲(酉先)磷酸合成(酉每)缺乏症、鸟氨酸氨甲(酉先)基转移(酉每)缺乏症或精氨基琥珀酸合成(酉每)缺乏症引起的尿素循环异常患者的长期治疗,适用於所有新生儿期(出生28天内)出现完全(酉每)缺乏症的患者,也适用於有高血氨性脑病病史的迟发型(部分(酉每)缺乏症,发生於出生1个月後)患者。兆科广州开发并生产的苯丁酸钠颗粒为国内首仿药物,因用於治疗罕见病且为儿童用药品,被国家药监局药品审评中心纳入优先审评审批品种名单。
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