You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
恆瑞醫藥(600276.SH):SHR-1701注射液兩個新適應症獲批臨牀
格隆匯 06-30 18:05

格隆匯6月30日丨恆瑞醫藥(600276.SH)宣佈,公司子公司蘇州盛迪亞生物醫藥有限公司近日收到國家藥監局核准簽發關於SHR-1701注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

受理號:CXSL2101010;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年4月6日受理的SHR-1701注射液符合藥品註冊的有關要求,同意開展用於腎細胞癌治療的臨牀試驗,具體為:SHR-1701注射液聯合阿昔替尼片對比蘋果酸舒尼替尼膠囊一線治療晚期腎細胞癌的多中心、隨機、對照、開放的Ib/III期臨牀研究(方案編號:SHR-1701-Ib/III-306)。

受理號:CXSL2101025;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年4月12日受理的SHR-1701注射液符合藥品註冊的有關要求,同意開展用於胃癌或胃食管結合部癌治療的臨牀試驗,具體為:SHR-1701聯合化療對比安慰劑聯合化療治療既往未經系統治療的晚期或轉移性胃癌或胃食管結合部癌的隨機、雙盲、多中心III期臨牀研究(SHR-1701-III-307)。

SHR-1701可以促進效應性T細胞的活化,同時還可有效改善腫瘤微環境中的免疫調節作用,最終有效促進免疫系統對於腫瘤細胞的殺傷。經查詢,目前Merck KGaA公司,普米斯生物技術和蘇州創勝集團的同類產品在國內外處於臨牀試驗階段,適應症以晚期惡性腫瘤為主。國內外尚無同類產品獲批上市,亦無相關銷售數據。

截至目前,SHR-1701相關項目累計已投入研發費用約為1.88億元。

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.
uSMART
Wealth Growth Made Easy
Open Account