HUTCHMED and Innovent Announce Regulatory Review Acceptance in China for Fruquintinib and Sintilimab Combination in Advanced Renal Cell Carcinoma Treatment

Reuters

06-05

HUTCHMED and Innovent Announce Regulatory Review Acceptance in China for Fruquintinib and Sintilimab Combination in Advanced Renal Cell Carcinoma Treatment

HUTCHMED (China) Limited and Innovent Biologics, Inc. have jointly announced the acceptance of their New Drug Application (NDA) by the China National Medical Products Administration (NMPA). The application is for the combination of fruquintinib and sintilimab for the treatment of patients with advanced renal cell carcinoma who have not responded to prior treatment with a tyrosine kinase inhibitor. This NDA is backed by data from the FRUSICA-2 study, which demonstrated the efficacy and safety of the drug combination compared to monotherapy options. The announcement underscores both companies' commitment to advancing cancer therapies and enhancing treatment options for patients.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. HUTCHMED (China) Ltd. published the original content used to generate this news brief on June 05, 2025, and is solely responsible for the information contained therein.

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The application is for the combination of fruquintinib and sintilimab for the treatment of patients with advanced renal cell carcinoma who have not responded to prior treatment with a tyrosine kinase inhibitor. This NDA is backed by data from the FRUSICA-2 study, which demonstrated the efficacy and safety of the drug combination compared to monotherapy options. The announcement underscores both companies' commitment to advancing cancer therapies and enhancing treatment options for patients.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. HUTCHMED (China) Ltd. published the original content used to generate this news brief on June 05, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":null,"symbol_name":null,"start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250604:nNDL8P2WdD:1","article_id":"2541909742","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2541909742","pubTimestamp":1749081005,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"HUTCHMED and Innovent Announce Regulatory Review Acceptance in China for Fruquintinib and Sintilimab Combination in Advanced Renal Cell Carcinoma Treatment. HUTCHMED  Limited and Innovent Biologics, Inc. have jointly announced the acceptance of their New Drug Application  by the China National Medical Products Administration . The application is for the combination of fruquintinib and sintilimab for the treatment of patients with advanced renal cell carcinoma who have not responded to prior treatment with a tyrosine kinase inhibitor. This NDA is backed by data from the FRUSICA-2 study, which demonstrated the efficacy and safety of the drug combination compared to monotherapy options. The announcement underscores both companies' commitment to advancing cancer therapies and enhancing treatment options for patients.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{},"translate_title":"和黄医药和信达生物宣布呋喹替尼和信迪利单抗联合治疗晚期肾细胞癌在中国获得监管审查受理","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00013":0.9,"01911":0.9},"content_text":"HUTCHMED and Innovent Announce Regulatory Review Acceptance in China for Fruquintinib and Sintilimab Combination in Advanced Renal Cell Carcinoma Treatment\n    \n\n        HUTCHMED (China) Limited and Innovent Biologics, Inc. have jointly announced the acceptance of their New Drug Application (NDA) by the China National Medical Products Administration (NMPA). The application is for the combination of fruquintinib and sintilimab for the treatment of patients with advanced renal cell carcinoma who have not responded to prior treatment with a tyrosine kinase inhibitor. This NDA is backed by data from the FRUSICA-2 study, which demonstrated the efficacy and safety of the drug combination compared to monotherapy options. The announcement underscores both companies' commitment to advancing cancer therapies and enhancing treatment options for patients.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. HUTCHMED (China) Ltd. published the original content used to generate this news brief on June 05, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"code":"91000000","status":"200"}}}