Gyre Therapeutics Completes \$300M Acquisition of Cullgen, Forming Integrated US-China Biopharma Powerhouse

Key Highlights for Investors

• Gyre Therapeutics (Nasdaq: GYRE) has closed its acquisition of Cullgen Inc., a clinical-stage biotech focused on targeted protein degraders and degrader-antibody conjugates, in an all-stock transaction valued at approximately \$300 million.
• Cullgen is now a wholly owned subsidiary of Gyre.
• Leadership changes: Dr. Ying Luo, former CEO of Cullgen, is now President, CEO, and a Board member of Gyre. Ping Zhang remains Chairman of the Board.
• The combined company boasts a revenue-generating commercial asset, ETUARY® (pirfenidone capsule), marketed in China for lung fibrosis, and a full pipeline spanning from discovery to Phase 3, focused on fibrosis and inflammatory diseases.
• China innovation engine: Gyre leverages cost-efficient R&D in China for targeted protein degraders and degrader-antibody conjugates.
• Robust late-stage pipeline: Lead candidate F351 (hydronidone) for chronic hepatitis B (CHB)-induced liver fibrosis has received priority review status from China’s CDE and is being considered for expansion into ex-China markets, including the U.S.
• Significant clinical milestones: Phase 3 trial of ETUARY® for pneumoconiosis completed enrollment; Phase 3 study initiated for ETUARY® in radiation-induced lung injury, including patients with or without immune checkpoint inhibitor-related pneumonitis.
• Strategic U.S.-China footprint: Strengthened leadership and operational presence to support global growth.
• Financial and legal advisors: Moelis & Company LLC advised Gyre; Gibson, Dunn & Crutcher LLP (Gyre) and Mintz Levin (Cullgen) acted as legal counsel.

Deal Summary and Strategic Rationale

Gyre Therapeutics has finalized its acquisition of Cullgen Inc., bringing together two biopharmaceutical innovators to create a fully integrated company with operations in both the U.S. and China. This transformative deal not only provides Gyre with a commercial-stage asset (ETUARY®) and a robust, multi-stage R&D pipeline, but also establishes a leading platform for next-generation targeted protein degraders (TPDs) and degrader-antibody conjugates (DACs).

The all-stock transaction is valued at approximately \$300 million, and positions Gyre to capitalize on synergies in early-stage discovery, clinical development, and commercialization across both major markets. The combined company will continue to trade on the Nasdaq under the ticker “GYRE”.

Leadership and Operational Integration

Dr. Ying Luo, who led Cullgen, assumes the roles of President, CEO, and Board member at Gyre, while Ping Zhang remains Chairman. This transition underscores a commitment to leveraging leadership from both entities to drive future growth.

The operational infrastructure spans San Diego headquarters and a strong presence in China, enabling efficient R&D and access to global markets.

Product Portfolio and Development Pipeline

• ETUARY® (pirfenidone capsule): The first treatment approved for idiopathic pulmonary fibrosis (IPF) in China (since 2011), holding a leading market share and now being evaluated in pivotal Phase 3 studies for new indications, including pneumoconiosis and radiation-induced lung injury.
• F351 (hydronidone): Lead clinical candidate for CHB-induced liver fibrosis; recently granted priority review status by the China National Medical Products Administration (NMPA). There is potential for ex-China expansion, including development in the U.S.
• Pipeline Expansion: Additional programs in preclinical and clinical stages, including TPDs and DACs from Cullgen, as well as Gyre’s own development assets for conditions such as COPD, pulmonary arterial hypertension (PAH), acute/chronic liver failure (ALF/ACLF), and more.

Recent Clinical and Regulatory Milestones

• F351: Received priority review status in China for the new drug application (NDA) in March. Plans are underway for development in markets outside China, including the U.S.
• ETUARY®: Completed enrollment in a 52-week Phase 3 trial for pneumoconiosis and dosed the first patient in a new Phase 3 trial for radiation-induced lung injury with or without immune checkpoint inhibitor-related pneumonitis.
• Innovation Engine: The acquisition brings in Cullgen’s portfolio of promising protein degraders and DACs, potentially providing long-term value and a growth catalyst for Gyre.

Shareholder Considerations and Potential Share Price Impact

• Potential price-moving factors:
  • The \$300M all-stock acquisition is immediately transformative, expanding Gyre’s pipeline and commercial presence.
  • Leadership changes and enhanced U.S.-China operational integration signal strategic focus on global expansion.
  • Recent regulatory milestones (priority review for F351, completion of Phase 3 trials) could accelerate time to market for key assets, potentially increasing future revenues.
  • Entry into the targeted protein degrader space via Cullgen acquisition opens up new growth avenues in a hot sector.
  • Any delays, integration risks, or unexpected clinical setbacks could negatively affect value realization from the acquisition.
• Risks: The company cautions investors about potential unknown costs from the acquisition, integration challenges, clinical or regulatory delays, and capital needs for advancing the expanded pipeline.
• Forward-looking statements: The company’s plans and projections are subject to significant risks and uncertainties, as detailed in their SEC filings.

Investor Contacts

Gyre Therapeutics, Inc.
Thomas Eastling, CFO
[email protected]

Investors:
Chuck Padala, Managing Director, LifeSci Advisors
[email protected]

Disclaimer

This article is for informational purposes only and does not constitute investment advice or a solicitation to buy or sell any securities. Forward-looking statements are subject to risks and uncertainties, and actual results may differ materially. Investors should review the company’s regulatory filings and consult with their financial advisors before making investment decisions.

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