Gyre Therapeutics Announces Submission of New Drug Application for F351 (Hydronidone) for Chronic Hepatitis B-Induced Liver Fibrosis in China

San Diego, CA – March 23, 2026: Gyre Therapeutics, Inc. (NASDAQ: GYRE), a clinical-stage biopharmaceutical company, has announced a major milestone that could have significant implications for shareholders and potentially impact the company’s share price. On March 22, 2026, Gyre Pharmaceuticals Co., Ltd., a majority indirectly owned subsidiary of Gyre Therapeutics, submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its lead product candidate, F351 (Hydronidone). The NDA seeks approval for the treatment of chronic hepatitis B (CHB)-induced liver fibrosis, a serious and widespread liver condition.

Key Points for Investors

• Lead Product Progress: The NDA submission for F351 (Hydronidone) marks a pivotal advancement in Gyre Therapeutics’ pipeline and is the company’s most significant regulatory milestone to date.
• Target Indication: F351 is being developed for the treatment of CHB-induced liver fibrosis—a condition with substantial unmet medical need, particularly in China, where hepatitis B prevalence is high.
• Regulatory Pathway: The application will undergo an initial formatting and completeness verification by the CDE. Gyre Therapeutics plans to cooperate with the CDE and submit supplementary materials if requested.
• Next Steps: Upon satisfactory review of the NDA format and content, the CDE is expected to issue an acceptance number, after which the technical review process will commence. This is a crucial step toward potential market approval in China.

Potential Shareholder Impact & Price Sensitivity

• Significant Catalyst: The NDA submission is a critical, price-sensitive event. Regulatory acceptance and eventual approval could open a major commercial market for Gyre Therapeutics, potentially driving significant revenue growth.
• Risk Factors: The acceptance and review of the NDA by the CDE is a multi-step process. Any requests for additional information or unexpected issues during the review could impact timelines and investor sentiment.
• Market Opportunity: Chronic hepatitis B-induced liver fibrosis represents a sizable market in China. Success in this indication could also set the stage for Gyre Therapeutics to pursue additional regulatory filings in other regions.
• Company’s Status: Gyre Therapeutics is not considered an emerging growth company under current SEC definitions, and its common stock is listed on The Nasdaq Capital Market under the symbol “GYRE.”

Details of the Regulatory Submission

The NDA for F351 (Hydronidone) was submitted on March 22, 2026, by Gyre Pharmaceuticals Co., Ltd., the company’s majority indirectly owned subsidiary. The application targets the treatment of liver fibrosis resulting from chronic hepatitis B, a condition associated with long-term complications, including cirrhosis and liver cancer. Hydronidone is Gyre’s lead drug candidate and the company’s first drug to reach the NDA submission stage, underscoring its commitment to addressing liver diseases with high unmet needs.

The CDE’s review will begin with a check of the application’s format and completeness. Gyre Therapeutics has stated its intention to provide any supplementary materials required by the CDE in a timely manner. If the application passes this initial stage, the CDE will issue an acceptance number, formally initiating the technical review process—a key hurdle toward potential commercial launch in China.

Forward-Looking Statements

The company has cautioned that this announcement contains forward-looking statements, including expectations regarding the acceptance and review of the NDA, the need for supplementary material, and the timing of potential regulatory milestones. Actual outcomes may differ materially due to various risks and uncertainties, including those described in Gyre’s filings with the SEC.

Summary Table

Contact and Company Information

• Company Name: Gyre Therapeutics, Inc.
• Address: 12770 High Bluff Drive, Suite 150, San Diego, CA 92130
• Phone: (858) 567-7770
• Trading Symbol: GYRE
• Exchange: The Nasdaq Capital Market
• Chief Financial Officer: Ruoyu Chen

Disclaimer: This article contains forward-looking statements, including expectations regarding regulatory review and market approval. Actual results may differ materially due to risks and uncertainties referenced in the company’s filings with the SEC. This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own due diligence and consult their financial advisor before making investment decisions.

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