迈威生物-B(02493.HK):9MW5211注射液临床试验申请获得国家药监局批准

智通财经
Jul 31
【迈威生物-B(02493.HK):9MW5211注射液临床试验申请获得国家药监局批准】智通财经APP讯,迈威生物-B(02493.HK)发布公告,近日,迈威(上海)生物科技股份有限公司(以下简称“公司”)收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,9MW5211注射液用于原发性胆汁性胆管炎(PBC)适应症的临床试验申请获得批准,此前,其用于炎症性肠病(IBD)适应症的临床试验申请已分别获得国家药品监督管理局批准和 FDA许可,用于多发性硬化(MS)、1型糖尿病(T1DM)和白癜风适应症的临床试验申请已获得国家药品监督管理局批准;公司亦在积极推进其他适应症临床试验申请工作。

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