恆瑞醫藥(01276.HK)：SHR-8068注射液、阿得貝利單抗注射液、貝伐珠單抗注射液臨牀試驗獲批
格隆匯7月31日丨恆瑞醫藥(01276.HK)公告，近日，江蘇恆瑞醫藥股份有限公司(以下簡稱“公司”)子公司蘇州盛迪亞生物醫藥有限公司、上海盛迪醫藥有限公司收到國家藥品監督管理局(以下簡稱“國家藥監局”)覈準簽發關於SHR-8068注射液、阿得貝利單抗注射液、貝伐珠單抗注射液的《藥物臨牀試驗批準通知書》，將於近期開展臨牀試驗。
SHR-8068注射液是公司引進的一款全人源抗CTLA-4單克隆抗體，可增強抗腫瘤免疫效應。目前全球共有兩款同類產品獲批上市，分別是伊匹木單抗和替西木單抗。經查詢，2024年伊匹木單抗和替西木單抗全球銷售額合計約爲32.71億美元。截至目前，SHR-8068注射液相關項目累計研發投入約21,350萬元。
阿得貝利單抗注射液是公司自主研發的人源化抗PD-L1單克隆抗體，能通過特異性結合PD-L1分子從而阻斷導致腫瘤免疫耐受的PD-1/PD-L1通路，重新激活免疫系統的抗腫瘤活性，從而達到治療腫瘤的目的。公司阿得貝利單抗注射液(商品名：艾瑞利)已於2023年3月獲批上市，獲批的適應症爲與卡鉑和依託泊苷聯合用於廣泛期小細胞肺癌患者的一線治療。國外有同類產品Atezolizumab(商品名：Tecentriq)、Avelumab(商品名：Bavencio)和Durvalumab(商品名：Imfinzi)於美國獲批上市銷售，其中Atezolizumab和Durvalumab已在中國獲批上市。國內有康寧傑瑞/思路迪藥業的恩沃利單抗、基石藥業的舒格利單抗和正大天晴藥業的貝莫蘇拜單抗等同類產品獲批上市。經查詢，2024年Atezolizumab、Avelumab和Durvalumab全球銷售額合計約爲96.48億美元。截至目前，阿得貝利單抗注射液相關項目累計研發投入約90,130萬元。
貝伐珠單抗是一種人源化抗VEGF單克隆抗體，由中外製藥和羅氏的子公司基因泰克合作開發，2004年由美國食品藥品監督管理局批準上市，商品名爲Avastin(安維汀)，目前已在中國和全球多個國家上市銷售。公司的貝伐珠單抗注射液已於2021年6月獲批上市，國內目前有多個貝伐珠單抗注射液獲批上市。經查詢，2024年貝伐珠單抗全球銷售額約爲56.55億美元。截至目前，貝伐珠單抗注射液相關項目累計研發投入約34,494萬元。
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.
