Gyre Therapeutics Acquires Cullgen Inc. for $300 Million

By Chris Stiles • Monday, March 02 10:34 • Permanent Link

Gyre Therapeutics, a commercial-stage biopharmaceutical company, has announced its plans to acquire Cullgen Inc., a clinical-stage biopharmaceutical company, in an all-stock transaction valued at approximately $300 million. This acquisition is expected to create a fully integrated biopharmaceutical company with capabilities in the U.S. and China, covering multiple therapeutic areas including inflammatory diseases, cancers, and pain.

Cullgen has developed a portfolio of targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies, with its lead product candidate, CG001419, having completed a phase 1 trial for the treatment of acute post-operative pain. Positive top-line results from the study were released in late 2025, and Cullgen expects to initiate a phase 2 trial in acute pain in bunionectomy patients in the United States pending FDA allowance. CG001419 is also being studied in a phase 1 trial for the treatment of solid tumors.

Additionally, Cullgen's second product candidate, CG009301, is a GSPT1 degrader being studied in a phase 1 trial for the treatment of blood cancers, including relapsed/refractory acute myeloid leukemia, higher-risk myelodysplastic syndrome, and acute lymphoblastic leukemia. Cullgen is also progressing a number of preclinical programs, including next-generation degrader-antibody conjugates.

Following the acquisition, Dr. Ying Luo, the current Chief Executive Officer of Cullgen, is expected to become the President and Chief Executive Officer of Gyre Therapeutics. Dr. Luo expressed excitement about the potential of TPDs and DACs to drive the company's future growth globally.

Gyre Therapeutics, through its majority-owned subsidiary Gyre Pharmaceuticals, recently had a pre-NDA meeting with the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), which supported a conditional approval and priority review eligibility filing for Gyre Pharmaceuticals' anti-liver fibrosis candidate, Hydronidone. Gyre Pharmaceuticals plans to submit an NDA for Hydronidone for conditional approval in the first half of 2026 and conduct a phase 3c confirmatory trial to support full approval in China.

The transaction is expected to close early in the second quarter of 2026, subject to customary closing conditions and necessary regulatory approvals in the United States. Prior to entering into this transaction, Cullgen's proposed merger with Pulmatrix was terminated.

An updated corporate presentation has been posted on both Gyre and Cullgen's respective websites in connection with this announcement.

This acquisition marks a significant development in the biopharmaceutical industry, positioning Gyre Therapeutics to enhance its capabilities and expand its pipeline to address unmet medical needs worldwide. Today the company's shares have moved -0.26% to a price of $7.68. For more information, read the company's full 8-K submission here.

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