歌禮制藥-B(01672.HK):皮下注射PD-L1抗體ASC22(恩沃利單抗)IIa期乙肝試驗取得良好結果
格隆匯 5 月 5日丨歌禮制藥-B(01672.HK)發佈公吿,公司的ASC22(恩沃利單抗)IIa期臨牀試驗取得良好結果。ASC22是全球首創(first-in-class)可皮下注射的PD-L1抗體,用於慢性乙型肝炎(CHB)功能性治癒。
根據披露,ASC22 IIa期臨牀試驗是一項單劑量遞增研究,採用三種皮下給藥劑量(0.3、1.0 和2.5 mg/kg,每種劑量注射三例患者),並進行12周隨訪,以探討ASC22在慢性乙型肝炎患者中的安全性和有效性(ClinicalTrials.gov註冊號:NCT04465890)。該試驗主要療效終點為單次給藥後12周隨訪中的乙肝表面抗原下降。入組的九名慢性乙肝患者的乙肝表面抗原基線中位數為3.0 log10 IU/mL。
該IIa期臨牀試驗數據表明,經過單次給藥ASC22後(分別為0.3, 1.0, 2.5 mg/kg劑量),乙肝表面抗原呈現劑量依賴性下降的趨勢。九名接受ASC22治療的患者中,有八名在12周隨訪結束時表現出一定程度的乙肝表面抗原下降。注射2.5 mg/kg劑量的三名患者中,一名患者在12周隨訪中,乙肝表面抗原最大降幅達1.2 log10 IU/ mL。
ASC22在不同劑量組中均表現出了良好的安全性和耐受性,所有和藥物相關的不良反應均為1級。在12周隨訪中,未觀察到2級或以上不良反應,ASC22單次給藥劑量至2.5 mg/kg,並未影響丙氨酸氨基轉移酶(ALT)和天冬氨酸氨基轉移酶(AST)水平(均低於正常值上限)。
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 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. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.