綠葉製藥(02186.HK)：創新抗體藥物BA1105在中國獲批進行臨牀試驗
格隆匯10月4日丨綠葉製藥(02186.HK)宣佈，集團附屬公司山東博安生物技術股份有限公司("博安生物")發現和研發的創新抗體BA1105已獲中國國家藥品監督管理局藥品審評中心("CDE")批准進行臨牀試驗。BA1105是重組抗Claudin18.2全人源IgG1型單克隆抗體，用於治療Claudin18.2陽性表達的晚期實體瘤。BA1105此次獲批的臨牀試驗為一項在晚期實體瘤患者中評價安全性、耐受性和藥代動力學特性的I期臨牀研究。
Claudin18.2蛋白是一種參與調控細胞間緊密連接的跨膜蛋白，能持續、穩定地在消化道腫瘤高表達。文獻報道70%胃癌患者、50%胰腺癌患者和30%食管癌患者高表達Claudin18.2，同時Claudin18.2蛋白主要在機體的上皮細胞中表達，具有高度的組織特異性。當上皮組織發生惡性轉化時，細胞極性的紊亂將導致細胞表面的Claudin18.2蛋白表位暴露，Claudin18.2被異常激活，參與腫瘤細胞的增殖分化和遷移。故開發針對Claudin18.2的治療性抗體極具抗癌潛力。
世界衞生組織國際癌症研究機構(IARC) 數據顯示：2020年中國新發癌症中，消化道腫瘤的發病形勢最為嚴峻。以胃癌為例：胃癌是中國發病數量第三高的惡性腫瘤。2020年中國胃癌的新發病例數和死亡病例數分別達到48萬和37萬例左右，佔全球該疾病新發病例和死亡病例的近一半。由於胃癌早期症狀隱匿，大部分患者一經發現已處於中晚期。從現有治療方案來看，HER2陰性的晚期胃癌患者尚缺乏靶向藥物，其生存時間難以有效延長。因此，臨牀需要新的靶點治療藥物，以提升治療效果。
BA1105是重組抗Claudin18.2全人源IgG1型單克隆抗體，通過Fc區引入氨基酸定點突變以增強ADCC效應。本產品體外藥效結果顯示，BA1105可與人Claudin18.2、C1q及不同種屬來源Fc受體結合，對低或高表達Claudin18.2 細胞均有較強結合活性。對於多種不同效應細胞，BA1105均可誘導較強的ADCC活性。體內藥效表明，在野生型和高表達Claudin18.2荷瘤模型中，BA1105單用或聯合化療藥物均顯示了較強的抗腫瘤活性。增強的ADCC效應可以提高BA1105的腫瘤殺傷效力，故本產品有望成為同類治療轉移性胰腺癌和晚期胃癌及食管胃交接部腺癌等潛在獲益癌種的最佳靶向藥物。
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.
