Gyre Therapeutics Gains CDE Alignment for Hydronidone Conditional Approval NDA in China

Reuters

Jan 05

<a href="https://laohu8.com/S/GYRE">Gyre Therapeutics</a> Gains CDE Alignment for Hydronidone Conditional Approval NDA in China

Gyre Therapeutics Inc. announced that its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd., has completed a Pre-New Drug Application (Pre-NDA) meeting with China's Center for Drug Evaluation $(CDE)$ regarding its anti-fibrotic therapy, Hydronidone. The CDE agreed that Phase 3 clinical data support a conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval. Gyre Pharmaceuticals plans to submit a New Drug Application (NDA) for conditional approval in the first half of 2026 and conduct a confirmatory clinical trial to support full approval in China. Hydronidone previously received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA).

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. Gyre Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9619606-en) on January 05, 2026, and is solely responsible for the information contained therein.

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The CDE agreed that Phase 3 clinical data support a conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval. Gyre Pharmaceuticals plans to submit a New Drug Application (NDA) for conditional approval in the first half of 2026 and conduct a confirmatory clinical trial to support full approval in China. Hydronidone previously received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA).\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>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. Gyre Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9619606-en) on January 05, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00BKPKM429.USD","symbol_name":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260105:nNDLkxgmW:1","article_id":"2601727885","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2601727885","pubTimestamp":1767614413,"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":"Gyre Therapeutics Inc. announced that its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd., has completed a Pre-New Drug Application  meeting with China's Center for Drug Evaluation  regarding its anti-fibrotic therapy, Hydronidone. 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The CDE agreed that Phase 3 clinical data support a conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval. Gyre Pharmaceuticals plans to submit a New Drug Application (NDA) for conditional approval in the first half of 2026 and conduct a confirmatory clinical trial to support full approval in China. Hydronidone previously received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA).\n      \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. Gyre Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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