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中国生物制药(01177.HK)"醋酸阿比特龙片"获药品注册批件
格隆汇 07-17 18:12

格隆汇7月17日丨中国生物制药(01177.HK)公告,公司附属公司正大天晴药业集团股份有限公司开发的抗肿瘤药"醋酸阿比特龙片",已获中华人民共和国国家药品监督管理局颁发药品注册批件,为国内同品种第二家获批。

阿比特龙是CYP17A1(17α-羟化酶和C17,20-裂解酶)的选择性、不可逆甾体类抑制剂,通过抑制酶活性从而阻止睾丸、肾上腺和肿瘤中的睾酮合成,与泼尼松合用,治疗转移性去势抵抗性前列腺癌。作为新一代抗癌药物,醋酸阿比特龙相对同类产品酮康唑有更高的CYP17A1选择性,具有抗癌活性较强、不良反应发生率较低的优势。

醋酸阿比特龙联合治疗方案已被欧美临床指南指定为前列腺癌的一线或二线治疗选择。集团申报的醋酸阿比特龙片处方工艺与原研药保持一致,并通过生物等效性研究,确认与原研药具有一致的安全性和有效性。

醋酸阿比特龙片属于全新作用机制的前列腺癌治疗药物,临床定位明确,应用广泛。集团的醋酸阿比特龙片上市后,将可填补国内现有转移性去势抵抗性前列腺癌治疗的不足,降低患者用药负担,真正惠及患者。

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