和黃醫藥(00013.HK):啟動索樂匹尼布(sovleplenib)治療温抗體型自身免疫性溶血性貧血的ESLIM-02中國II/III期研究的註冊階段
格隆匯3月22日丨和黃醫藥(00013.HK)宣佈在中國啟動一項索樂匹尼布治療温抗體型自身免疫性溶血性貧血(wAIHA)成人患者的II/III期研究的註冊階段。
在此之前,該研究的II期概念驗證階段取得了積極的數據,並與中國國家藥品監督管理局(“國家藥監局”)進行了溝通。若研究取得積極結果,其數據有望用於支持於未來提交新藥上市申請。温抗體型自身免疫性溶血性貧血是一種可導致貧血的自身免疫性疾病,治療選擇非常有限。研究III期階段的首名受試者已於2024年3月20日接受首次給藥治療。
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