和黃醫藥(00013.HK)抑制劑HMPL-523獲納入突破性治療藥物
和黃醫藥(00013.HK)公布,中國國家藥監局藥品審評中心將HMPL-523納入突破性治療藥物品種,用於治療既往接受過至少一種治療的慢性成人原發免疫性血小板減少症患者。
HMPL-523是一種新型、研究性、選擇性的小分子口服Syk抑制劑,和黃醫藥目前擁有HMPL-523在全球範圍內的所有權利。獲納入突破性治療藥物的品種,可在提交新藥上市申請時提出附條件批准申請和優先審評審批申請。
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