君實生物(01877.HK):特瑞普利單抗聯合化療一線治療局部晚期或轉移性食管鱗癌的新適應症上市申請獲受理
格隆匯7月29日丨君實生物(01877.HK)公佈,2021年7月29日,公司收到國家藥品監督管理局核准簽發的《受理通知書》,特瑞普利單抗(商品名:拓益®,產品代號:JS001)聯合含鉑化療一線治療局部晚期或轉移性食管鱗癌的新適應症上市申請獲得受理。
公吿顯示,此次新適應症上市申請基於JUPITER-06研究(Clinicaltrials.gov登記號:NCT03829969),該研究是一項隨機、雙盲、安慰劑對照、多中心的III期臨牀研究,由中山大學附屬腫瘤醫院徐瑞華教授擔任主要研究者。根據期中分析結果,獨立數據監察委員會(IDMC)判定該研究兩個主要研究終點無進展生存期和總生存期都達到方案預設的優效界值,結果表明特瑞普利單抗聯合紫杉醇/順鉑一線治療晚期或轉移性食管鱗癌患者,較紫杉醇/順鉑的標準一線治療,可顯著延長患者的無進展生存期和總生存期。
據悉,特瑞普利單抗是中國首個批准上市的以PD-1為靶點的國產單抗藥物,且至今已在中、美等多國開展了覆蓋超過15個適應症的30多項臨牀研究。
截至公吿披露日,特瑞普利單抗已在黏膜黑色素瘤、鼻咽癌、軟組織肉瘤領域獲得FDA授予1項突破性療法認定、1項快速通道認定和3項孤兒藥資格認定。
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.