歌禮制藥-B(01672.HK):ASC22(恩沃利單抗)美國臨試申請獲批,用於HIV-1感染者免疫重建╱功能性治癒
格隆匯5月11日丨歌禮制藥-B(01672.HK)發佈公吿,其ASC22(恩沃利單抗)臨牀試驗申請獲美國食品藥品監督管理局(FDA)批准,用於人類免疫缺陷病毒1型(HIV-1)感染者免疫重建╱功能性治癒適應症。
據估計,2020年全球約有3,770萬人類免疫缺陷病毒(HIV)感染者,約有68萬人死於艾滋病,且每年約有150萬新發感染者。截至2019年底,美國約有120萬 HIV攜帶者。聯合抗逆轉錄病毒療法(cART)雖然可抑制血液病毒量,但無法治癒HIV感染,幾乎所有HIV感染者在停止抗逆轉錄病毒療法數週或數月內都會出現病毒反彈。
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者病毒特異性免疫應答的潛力。HIV-1感染者免疫重建╱功能性治癒適應症是 ASC22第二項獲美國FDA批准開展臨牀試驗的適應症,另一項為慢性乙型肝炎功能性治癒適應症。
此次ASC22獲美國FDA批准的臨牀試驗是一項多中心、隨機、單盲、安慰劑對照的I/II期臨牀試驗,用於評估ASC22在接受抗逆轉錄病毒療法的HIV感染者中的安全性、有效性和藥代動力學特徵。該I/II期臨牀試驗旨在(1)與安慰劑對照,評估ASC22在接受抑制性抗逆轉錄病毒療法的受試者中的安全性;(2)確定ASC22 1.0 mg/kg每4周給藥1次能否改善HIV-1特異性細胞免疫應答;以及(3)與安慰劑對照,評估ASC22對HIV潛伏期逆轉的效果。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.