GYRE News & Events

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.

Gyre Therapeutics announced that its majority-owned subsidiary in China, Gyre Pharmaceuticals Co., Ltd., completed a Pre-New Drug Application communication meeting with the Center for Drug Evaluation of China's National Medical Products Administration regarding Hydronidone, the company's first-in-class anti-fibrotic therapy. During the meeting, Gyre Pharmaceuticals and the CDE reached consensus that existing Phase 3 clinical data for Hydronidone, based on histologic improvement in liver fibrosis as measured by the Ishak fibrosis score, are generally supportive of submission of a conditional approval NDA for the treatment of chronic hepatitis B-associated liver fibrosis, including early cirrhosis. The CDE further indicated that Hydronidone meets the criteria for inclusion in China's Priority Review and Approval Program for Innovative Drugs, subject to formal filing, acceptance and regulatory review. The NMPA previously granted Hydronidone Breakthrough Therapy Designation in March 2021, recognizing its potential to address a serious condition with significant unmet medical need. This designation supports eligibility for priority review, which is intended to facilitate an accelerated regulatory review process for innovative therapies. As part of the agreed regulatory pathway, the company plans to conduct an additional confirmatory clinical trial, referred to as a Phase 3c trial in China, designed to evaluate liver-related clinical outcomes to support potential conversion from conditional approval to regular approval. The company currently expects to submit an NDA for conditional approval of Hydronidone in the first half of 2026, subject to final data readiness and applicable regulatory procedures.

FY25 consensus $119/5M. Cites delayed Etorel rollout and government procurement-related uncertainty.

Reports Q3 revenue $30.6M, consensus $32.93M. "Following the positive results from our pivotal Phase 3 trial in the PRC evaluating Hydronidone for the treatment of CHB-associated liver fibrosis, we are working diligently toward our NDA submission and are leveraging Hydronidone's Breakthrough Therapy designation to bring this much-needed therapy to patients in China," said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. "With enrollment now completed in our 52-week Phase 3 trial of pirfenidone for the treatment of pneumoconiosis, we continue to advance our pipeline in China. We are also preparing for U.S. clinical activities and expect to file the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis in 2026, supported by the translation and regulatory-quality review of our China Phase 2 and Phase 3 trial data and an upcoming hepatic impairment study."