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歌禮制藥-B(01672.HK):ASC22(恩沃利單抗)用於人類免疫缺陷病毒1型(HIV-1)感染者免疫重建╱功能性治癒的 II期臨試申請獲NMPA批准
格隆匯 11-10 08:03

格隆匯11月10日丨歌禮制藥-B(01672.HK)發佈公吿,ASC22(恩沃利單抗)II期臨牀試驗申請獲中國國家藥品監督管理局(NMPA)批准,用於人類免疫缺陷病毒1型(HIV-1)感染者免疫重建╱功能性治癒的新適應症。

根據披露,ASC22(恩沃利單抗)是一種皮下注射的PD-L1單域抗體,具有重建慢性病毒感染患者病毒特異性免疫應答的潛力。人類免疫缺陷病毒1型(HIV-1)感染者免疫重建╱功能性治癒是繼慢性乙型肝炎功能性治癒後歌禮對ASC22開發的第二個適應症。

據估計,全球約有3,800萬艾滋病感染者,2019年約有69萬人死於艾滋病,且每年約有170萬新發感染者。聯合抗逆轉錄病毒療法(cART)雖然能抑制病毒血症,但無法治癒艾滋病,幾乎所有艾滋病感染者在停止抗逆轉錄病毒療法後,數週或數月內都會出現病毒反彈。

該II期試驗是一項隨機、單盲、安慰劑對照、多中心的中國臨牀試驗,用於評估每4周1次1 mg/kg、2.5 mg/kg ASC22或安慰劑與抗逆轉錄病毒療法聯合治療人類免疫缺陷病毒1型(HIV-1)感染者的安全性和有效性,治療期為12周,治療結束後為12周的隨訪期。 

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