和譽-B(02256.HK):X4 Pharmaceuticals完成Mavorixafor 4WHIM臨牀3期患者入組
格隆匯11月5日丨和譽-B(02256.HK)發佈公吿,2021年11月3日,和譽醫藥宣佈其合作伙伴X4 Pharmaceuticals已完成其主要候選藥物mavorixafor的註冊性臨牀3期試驗患者入組,用於治療經基因證實的WHIM(疣、低丙種球蛋白血癥、感染和骨髓增生異常綜合症)綜合症患者。這是一種由CXCR4基因功能突變引起的原發性免疫缺陷疾病。31名成人和兒童患者參加了該4WHIM臨牀3期試驗。該試驗將比較每日一次口服劑量的mavorixafor與安慰劑的主要和次要終點,包括臨牀相關的中性粒細胞和淋巴細胞計數、感染和疣發生的頻率和嚴重程度,以及特定的生活質量監測。該試驗最初設計為招募18-28名患者。
這對於缺乏根治療法選擇的眾多WHIM患者來説是一個重大里程碑。4WHIM試驗的最終數據預計將於2022年第四季度公佈。X4預計於2023年第一季度向美國NDA提交新藥申請。此外,集團也期待今年年末X4關於WHIM正在進行的臨牀2期開放性擴展試驗中新的長期數據,以及其它各項研究和臨牀數據。這些數據將可能為mavorixafor提供更廣泛的市場空間。
根據披露,Mavorixafor(ABSK081)是一款全球領先的first-in-class口服CXCR4拮抗劑。和譽醫藥已授權獲得mavorixafor在大中華地區腫瘤及WHIM適應症的商業化權益,並將主導其大中華地區多個腫瘤適應症的臨牀與商業開發,並已逐步開展多項mavorixofor與腫瘤免疫抑制劑或其它藥物聯合治療的臨牀研究。
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.