歌禮制藥-B(01672.HK):皮下注射PD-L1抗體ASC22(恩沃利單抗)美國臨牀試驗申請獲批,用於慢性乙型肝炎功能性治癒
格隆匯1月17日丨歌禮制藥-B(01672.HK)發佈公吿,公司的 ASC22(恩沃利單抗)獲美國食品藥品監督管理局(FDA)批准開展臨牀試驗,並啟動全球開發計劃。ASC22是一款用於慢性乙型肝炎功能性治癒的同類第一皮下注射PD-L1抗體。
2020年6月發表的題為“美國慢性乙型肝炎病毒感染率”的最新研究論文顯示,美國約有159萬患者(範圍為125萬-249萬)感染慢性乙型肝炎病毒(HBV)。世界衞生組織(WHO)和美國衞生與公眾服務部(DHHS)均正式提出了消除肝炎的計劃。
ASC22的IIb期試驗(臨牀試驗編號:NCT04465890)是一項隨機、單盲、安慰劑對照、多中心的中國臨牀試驗,用於評估在慢性乙型肝炎患者中24周每2周1次1 mg/kg、2.5 mg/kg ASC22或安慰劑聯合核苷(酸)類似物的安全性和有效性。該試驗中期結果被2021年美國肝病研究協會(AASLD)年會(The Liver Meeting® 2021) 選為最新研究摘要並作口頭報吿,結果顯示在基線乙肝表面抗原≤500 IU/mL的患者中,治療組約19% (3/16)的患者乙肝表面抗原持續消失,而安慰劑組沒有患者實現乙肝表面抗原消失,且在ASC22停藥後沒有出現反彈,顯示乙肝的功能性治癒。
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