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和记黄埔表示,中国授予Sovleplenib治疗自身免疫性溶血性贫血的优先审评资格。

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-- 和记黄埔医药(Hutchmed,股票代码:HCM)周三宣布,中国国家药品监督管理局已受理其新药申请,并授予其索维普利尼(sovleplenib)优先审评资格,用于治疗温抗体自身免疫性溶血性贫血。 该公司表示,其申请得到了在中国开展的二/三期临床试验数据的支持。该公司补充道,今年1月,该试验的三期部分达到了主要终点,即治疗5至24周内血红蛋白持续升高。 和记黄埔医药还表示,中国监管机构已于今年3月授予索维普利尼治疗温抗体自身免疫性溶血性贫血的突破性疗法认定。

Price: $13.49, Change: $-0.11, Percent Change: -0.77%

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