開拓藥業-B(09939.HK)：GT20029凝膠治療痤瘡中國II期臨牀試驗達到主要終點
格隆匯8月12日丨開拓藥業-B(09939.HK)發佈公告，有關GT20029凝膠治療痤瘡的中國II期臨牀試驗(“該項II期臨牀試驗”)，其已於2024年6月17日完成首例受試者入組。其自主研發的新型靶向雄激素受體(“AR”)的蛋白降解嵌合體(“PROTAC”)化合物GT20029治療痤瘡的該項II期臨牀試驗讀出頂線數據。數據顯示，該項II期臨牀試驗成功達到主要研究終點，結果具有統計學顯著性及臨牀意義，且有效性、安全性和藥代動力學特徵均表現出色，並確定III期臨牀試驗的推薦劑量爲0.5%。詳細的頂線結果資料未來預計在學術期刊或學術會議上予以公佈。
該項II期臨牀試驗是一項多中心、隨機、雙盲、安慰劑對照的研究，選用GT20029 0.5%每天一次(“QD”)和1.0% QD作爲研究藥物給藥劑量，用以評估GT20029治療痤瘡的有效性、安全性和藥代動力學特徵。該項II期臨牀試驗在全國10家中心開展，由復旦大學附屬華山醫院的項蕾紅教授擔任主要研究者。
GT20029作爲公司核心產品之一，是公司基於自有的PROTAC平臺自主開發，有潛力成爲雄激素性脫髮及痤瘡的新一代治療藥物。其自開發以來始終保持領先地位，是全球範圍內首款完成II期臨牀試驗的外用PROTAC化合物。公司正在制定GT20029治療痤瘡的未來臨牀策略，包括開啓治療痤瘡中國III期臨牀試驗，進一步擴大在外用PROTAC領域的先發優勢。
Winlevi®(clascoterone 1%，乳膏劑)是美國食品和藥物管理局(FDA)近40年來批準的首款具有新作用機制(MOA)的痤瘡藥物，用於治療12歲及以上患者的痤瘡。根據 Cosmo Pharmaceuticals N.V.的公開披露，Winlevi®已經成爲美國市場處方量最多的品牌外用痤瘡藥物，自其上市以來，Winlevi®已獲超17,900名醫師開具逾130萬張處方。同AR靶點的痤瘡藥物獲批，表明通過阻斷/降解AR信號通路來治療痤瘡的作用機制已得到驗證。GT20029有望爲皮膚科醫生和患者提供一種創新、安全且有效的新治療選擇。
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.
