Announcement • May 14
Gyre Pharmaceuticals Co., Ltd. Announces Nmpa Acceptance of New Drug Application for F351 (Hydronidone) for Chb-Induced Liver Fibrosis Treatment Gyre Therapeutics, Inc. announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). The acceptance comes after the NMPA previously granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co. Ltd. (Gyre Pharmaceuticals). This marks the second major product for which Gyre has submitted an NDA to the NMPA, and is a significant milestone for the Company in the commercialization of a new medication for the treatment of CHB-induced liver fibrosis. Priority review was established in China in 2017 to facilitate drug registration and accelerate the development of new drugs with clinical value under the guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval. According to these guidelines, the NMPA will prioritize the review of these applications and allocate additional evaluation resources, which is expected to accelerate the review process. F351 is Gyre’s lead development candidate for the treatment of liver fibrosis that is being developed for two different indications. It is a structurally modified derivative of pirfenidone designed to optimize metabolic properties while targeting the TGF-ß1 signaling pathway, a key mediator of fibrogenesis. Gyre is developing F351 for two primary indications: Chronic hepatitis B (CHB)-associated liver fibrosis in the People’s Republic of China (PRC) and MASH-associated liver fibrosis initially in the United States. In the United States, Gyre has completed a Phase 1 clinical trial in healthy volunteers evaluating F351’s safety, tolerability, and PK. Gyre plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026, and, if the IND becomes effective, to initiate a Phase 2 clinical trial. Liver fibrosis is a condition where healthy tissues in the liver become scarred in response to chronic inflammation. If left untreated, it can progress to cirrhosis—the final, severe stage where extensive scarring permanently distorts the liver’s architecture and significantly impairs its vital functions. Viral hepatitis is estimated to cause up to 50% of fibrosis and 65% of cirrhosis worldwide. Without intervention, liver fibrosis and cirrhosis typically progress from manageable organ damage to systemic, life-threatening liver failure and hepatocellular carcinoma (HCC). No non-viral directed therapy has been shown to reduce fibrosis in viral induced hepatitis. Gyre Pharmaceuticals’ pipeline includes F351 (hydronidone), a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. F351 received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Reported Earnings • May 07
First quarter 2026 earnings: EPS and revenues miss analyst expectations First quarter 2026 results: US$0.095 loss per share (down from US$0.031 profit in 1Q 2025). Revenue: US$22.5m (up 2.1% from 1Q 2025). Net loss: US$8.69m (down 422% from profit in 1Q 2025). Revenue missed analyst estimates by 29%. Earnings per share (EPS) also missed analyst estimates by 36%. Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Announcement • May 06
Gyre Therapeutics, Inc. (NasdaqCM:GYRE) completed the acquisition of Cullgen Inc. Gyre Therapeutics, Inc. (NasdaqCM:GYRE) entered into an agreement to acquire Cullgen Inc. on March 2, 2026. The transaction is valued at approximately $300 million. The new combined entity will continue to be listed on the Nasdaq Capital Market under the ticker “GYRE”.
Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, Ping Zhang, will remain as the Executive Chairman of Gyre. Dr. Ying Luo, is expected to become the President and Chief Executive Officer and a member of the board of directors of Gyre.
The consummation of the Merger is subject to certain closing conditions, including, among other things, (1) approval by the requisite Cullgen stockholders of the adoption and approval of the Merger Agreement and the transactions contemplated thereby, and (2) a filing under The Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, as amended. (3) approval of Gyre board of directors (4) regulatory approvals and other customary closing conditions. The Board of Directors of the Gyre approved the Merger Agreement and the related transactions, and the consummation of the Merger does not require the approval of the Gyre stockholders. The transaction is expected to close early in the second quarter of 2026.
Ryan Murr, Branden Berns and Evan Shepherd of Gibson, Dunn & Crutcher LLP served as legal advisor to Gyre Therapeutics. Moelis & Company LLC is acting as financial advisor to the special committee to Gyre’s Board of Directors. Scott Stanton and Jason McCaffrey of Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. served as legal advisor to Cullgen. Equiniti Trust Company, LLC acted as transfer agent for Gyre Therapeutics, Inc.
Gyre Therapeutics, Inc. (NasdaqCM:GYRE) completed the acquisition of Cullgen Inc. on May 4, 2026. 
