GYRE News & Events

Gyre Therapeutics announced that the Center for Drug Evaluation of China's National Medical Products Administration, or NMPA, has granted priority review status to the New Drug Application for Hydronidone as a treatment for chronic hepatitis B-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus. Gyre, through its majority-owned subsidiary, Gyre Pharmaceuticals Co., plans to submit a formal NDA in the near future.

Reports Q4 revenue $37.2M, consensus $35.44M. "2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China's CDE," said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. "Our planned NDA submission in the first half of 2026 underscores the strength of our Phase 3 data and the constructive progress achieved through regulatory engagement. In addition, we have completed enrollment in our 52-week Phase 3 pirfenidone trial in pneumoconiosis, further strengthening our late-stage respiratory portfolio. We have also incorporated the complete Phase 2 and Phase 3 clinical data from our CHB-associated liver fibrosis program into our U.S. development strategy and expect to submit an IND application in 2026 for MASH-associated liver fibrosis. Finally, we recently announced an agreement to acquire Cullgen, a company with a robust pipeline of degraders, targeting inflammatory diseases and cancers, as well as U.S.-based drug discovery and development capabilities. Collectively, these achievements support the continued advancement of our differentiated pipeline across both China and the United States."

The company anticipates that 2026 will be a transition period, during which it plans to prioritize regulatory activities, including preparation for the planned NDA submission of Hydronidone. In addition, given uncertainties associated with the National Centralized Drug Procurement program and evolving market dynamics, the company expects to moderate promotional activities for Contiva and Etorel.

Gyre Therapeutics (GYRE) announced its agreement to acquire Cullgen, a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader antibody conjugate therapies, in an all-stock transaction valued at approximately $300M. Following the closure of the acquisition, the new combined entity will be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas including inflammatory diseases, cancers, and pain. Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, the interim CEO and Executive Chairman of Gyre, Ping Zhang, will remain as the Executive Chairman. The current CEO of Cullgen, Dr. Ying Luo, is expected to become the President and EO and a member of the board of directors of Gyre. The transaction is expected to close early in the second quarter of 2026, subject to customary closing conditions, including necessary regulatory approvals in the United States. Prior to entering into this transaction, Cullgen's proposed merger with Pulmatrix (PULM) was terminated.