On March 22, 2026, Gyre Pharmaceuticals Co., Ltd., a majority-owned subsidiary of Gyre Therapeutics, Inc., submitted its New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration for F351 (Hydronidone). This drug is aimed at treating chronic hepatitis B (CHB)-induced liver fibrosis, a significant health concern affecting millions globally. The NDA submission is a critical milestone for Gyre Therapeutics, as it seeks to expand its product offerings and address unmet medical needs in the hepatitis B treatment landscape. The submission will undergo initial formatting and completeness verification, with Gyre Therapeutics planning to collaborate with the CDE to provide any supplementary materials if requested. Following this, the CDE is expected to issue an acceptance number, which will initiate the technical review process. This development is anticipated to have a noticeable positive effect on the company's stock price, as it signifies progress in the company's drug development pipeline and potential market entry for a new treatment option. The successful approval of F351 could enhance Gyre Therapeutics' market position and financial performance, making it a significant event for investors and stakeholders alike.

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