荣昌生物-B(09995.HK):注射用维迪西妥单抗(商品名:爱地希®)获得NMPA在中国附条件上市批准
格隆汇6月9日丨荣昌生物-B(09995.HK)发布公告,公司自主研发的新型靶向HER2抗体偶联物(ADC)注射用维迪西妥单抗(RC48,商品名:爱地希®)于2021年6月9日正式获得中国国家药品监督管理局(NMPA)在中国的附条件上市的批准,用于治疗局部晚期或转移性胃癌(包括胃食管结合部腺癌)(GC)。
注射用维迪西妥单抗(RC48,商品名:爱地希®)是集团在继今年3月份获得注射用泰它西普获准在国内上市后的第二款获批上市产品,亦是集团的一项重大里程碑,体现了集团在肿瘤治疗领域的成就,也彰显了我们在生物药领域的强大的自主研发能力,尤其是开发ADC产品的能力。
应公司要求,股份已于2021年6月9日下午3时14分于联交所短暂停止买卖,以待刊发该公告。公司已向联交所申请股份自2021 年6月10日上午9时正起于联交所恢复买卖。
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