恆瑞醫藥(600276.SH):馬來酸吡咯替尼片、阿得貝利單抗注射液、注射用SHR-A1811獲批開展臨牀試驗
格隆匯7月25日丨恆瑞醫藥(600276.SH)公佈,近日,江蘇恆瑞醫藥股份有限公司及子公司上海盛迪醫藥有限公司、蘇州盛迪亞生物醫藥有限公司收到國家藥品監督管理局核准簽發關於馬來酸吡咯替尼片、阿得貝利單抗注射液、注射用SHR-A1811的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。暨獲批開展注射用SHR-A1811聯合吡咯替尼或阿得貝利單抗在HER2異常的晚期非小細胞肺癌受試者中的安全性、耐受性、藥代動力學及有效性的Ⅰb/Ⅱ期臨牀研究。
吡咯替尼是一種小分子、不可逆、泛ErbB受體酪氨酸激酶抑制劑。截至目前,馬來酸吡咯替尼片相關項目累計已投入研發費用約112412萬元。
注射用SHR-A1811可通過與HER2表達的腫瘤細胞結合並內吞,在腫瘤細胞溶酶體內通過蛋白酶剪切釋放毒素,誘導細胞週期阻滯從而誘導腫瘤細胞凋亡。截至目前,注射用SHR-A1811相關項目累計已投入研發費用約14253萬元。
阿得貝利單抗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。截至目前,阿得貝利單抗注射液相關項目累計已投入研發費用約34285萬元。
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.