基石藥業-B(02616.HK)多特異性抗體CS2006/NM21-1480在中國IND獲NMPA批准，管線2.0戰略持續深化
格隆匯9月15日丨基石藥業-B(02616.HK)發佈公吿，多特異性抗體CS2006/NM21-1480在中國的臨牀試驗申請(“IND”)獲中國國家藥品監督管理局(“NMPA”)批准。該產品極具同類最優免疫治療骨架分子的潛力，有望成為腫瘤免疫治療領域極有前景的下一代PD-1/PD-L1治療方法。
CS2006/NM21-1480是一種靶向PD-L1、4-1BB和人血清蛋白(“HSA”)的單價三特異性抗體。根據其分子設計，CS2006/NM21-1480僅在與腫瘤細胞表面的免疫檢查點配體PD-L1結合的情況下，才能條件性地誘導免疫共刺激受體4-1BB，激活抗癌T細胞，從而可能避免使用傳統4-1BB激動劑抗體時所觀察到的肝毒性。作為一種潛在同類最優療法，CS2006/NM21-1480可用於單藥治療或與多種療法聯合治療。即將開展的臨牀試驗旨在評估CS2006/NM21-1480在多種晚期實體瘤中國患者中的安全性、藥代動力學特徵及抗腫瘤活性。
相比其他PD-L1/4-1BB雙特異性候選抗體，CS2006/NM21-1480獨特的單價結構設計和對PD-L1的超高親和力，將能夠使腫瘤局部PD-L1和4-1BB雙重作用的潛力最大化，為患者帶來更加廣泛而持久的治療緩解，同時避免全身毒性。此外，通過結合HSA可延長其半衰期，為患者提供更加便利的給藥頻率。因此，CS2006/NM21-1480有望對有PD-L1表達的廣譜腫瘤類型有效，並可能克服對PD-1/PD-L1抗體的原發性和繼發性耐藥。
基石藥業首席科學官謝毅釗博士表示：“我們非常高興看到CS2006/NM21-1480在中國的IND獲得中國NMPA的許可，即將開展臨牀試驗。這是基石藥業管線2.0戰略進程中的重要里程碑。基石藥業聚焦於腫瘤領域新興療法中的全球同類首創、同類最優產品。此次獲批的CS2006/NM21-1480已於2020年4月在美國進入首次人體試驗，目前該研究正在積極進行中。未來，我們將快速推進包括CS2006/NM21-1480在內的多個產品管線的研發進程，為中國乃至全球的患者帶來更多新的治療選擇。”
CS2006/NM21-1480是基石藥業合作伙伴Numab Therapeutics(“Numab”)基於其獨有的λcap™技術和MATCH™平台設計研發，基石藥業與Numab雙方就該候選藥物的開發和商業化簽署一項獨家區域性授權合作協議。根據協議，基石藥業將為CS2006/NM21-1480的研發提供資金直至完成初步Ib期臨牀試驗，同時基石藥業將在大中華區(包括中國大陸、中國香港、中國澳門和中國台灣)、韓國和新加坡擁有獨家開發和商業化的權利。Numab則保留該候選藥物在全球其餘地區的所有權利。在上述提供資助階段完成後，雙方不再有進一步的財務付款義務。
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.
