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和黃醫藥(00013.HK):索樂匹尼布(sovleplenib)用於治療原發免疫性血小板減少症的中國新藥上市申請獲受理並獲納入優先審批
格隆匯 01-11 08:06

格隆匯1月11日丨和黃醫藥(00013.HK)發佈公吿,索樂匹尼布用於治療成人原發免疫性血小板減少症患者的新藥上市申請已獲中國國家藥品監督管理局受理並予以優先審批。索樂匹尼布是一種開發用於治療血液惡性腫瘤和自身免疫性疾病的新型、高選擇性的口服脾酪氨酸激酶(“Syk”)抑制劑。

和黃醫藥首席執行官兼首席科學官蘇慰國博士表示:“我們很高興開始了索樂匹尼布在中國的新藥上市申請的滾動提交,我們期待將這種創新療法帶向免疫性血小板減少症患者。我們提交的資料包括了在中國成功完成的ESLIM-01 III期研究的數據,該研究證明了索樂匹尼布能為患者帶來持續的應答。成人免疫性血小板減少症會嚴重損害患者的生活品質,患者非常需要新療法。”

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