Gyre Therapeutics, Inc. filings document a commercial-stage biopharmaceutical issuer with U.S. and China operations, revenue from Gyre Pharmaceuticals, and a pipeline centered on anti-fibrotic therapies and targeted protein degradation assets. Form 8-K reports cover operating results, business updates, CDE/NMPA regulatory disclosures for F351, and clinical-program updates for Hydronidone and pirfenidone.
Proxy and material-event filings describe governance matters, shareholder voting items, material agreements, capital-structure disclosures and the completed Cullgen acquisition, including preferred-stock and common-stock conversion mechanics. The record also includes Regulation FD disclosures addressing commercial products, research spending and pipeline development.
Gyre Therapeutics, Inc. furnished a scientific presentation it will deliver at a conference in Shanghai, outlining its strategy as a fully integrated biopharmaceutical company focused on fibrosis, inflammatory diseases and cancer, including the recently announced acquisition of Cullgen.
The presentation highlights a broad pipeline from discovery to marketed products and a global footprint with headquarters in San Diego and major discovery, development, manufacturing and commercial operations in China. Gyre reports about 740 employees worldwide across R&D, manufacturing, sales and marketing, and G&A functions.
A key focus is CG923308, a CDK2/cyclin E degrader for CCNE1-amplified solid tumors and HR+/HER2- breast cancer resistant to CDK4/6 inhibitors. Preclinical data show potent, selective protein degradation, oral bioavailability in multiple species, strong in vitro and in vivo anti-cancer activity versus Phase 2/3 CDK2 inhibitors, and tolerability in animal models. Cullgen anticipates submitting an Investigational New Drug application for CG923308 in the first quarter of 2027. The presentation is furnished as Exhibit 99.1 under Item 7.01 and is not deemed filed under the Exchange Act.
Gyre Therapeutics, Inc. announced that China’s National Medical Products Administration, through its Center for Drug Evaluation, has accepted a New Drug Application for F351 (hydronidone) to treat chronic hepatitis B-induced liver fibrosis. The NDA was submitted via its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd., and follows the product’s earlier priority review status. F351 is Gyre’s lead liver fibrosis candidate and has also been developed for MASH-associated liver fibrosis, with plans to file a U.S. IND by the end of 2026.
Gyre Therapeutics, Inc. reported Q1 2026 revenue of $22.5 million, slightly above $22.1 million a year earlier, driven mainly by ETUARY, which contributed $21.0 million, or 93.1% of product sales. Newer products Contiva and Etorel added modest but growing contributions.
The company posted a net loss of $9.9 million, compared with net income of $3.7 million in Q1 2025, as selling, R&D, G&A and $2.6 million of transaction costs lifted operating expenses to $31.9 million. Despite the loss, operating cash flow was positive at $3.2 million, and cash and cash equivalents were $37.5 million as of March 31, 2026.
Total assets were $162.0 million and equity $137.0 million. Gyre’s China subsidiary remained the sole revenue source, while U.S. operations focused on Hydronidone development. After quarter-end, Gyre closed an all‑stock acquisition of Cullgen valued at approximately $300 million, bringing a new pipeline under common control accounting.
GYRE Therapeutics, Inc. Chief Executive Officer Luo Ying reported indirect open-market sales of company common stock held by a spouse. On May 5–6, 2026, a total of 10,315 shares of common stock were sold in two transactions at weighted average prices of $8.01 and $8.04 per share. The sales were executed pursuant to a Rule 10b5-1 trading plan adopted on March 13, 2025, indicating they were pre-arranged. Following these transactions, indirect holdings reported as owned through the spouse totaled 2,565,226 shares of common stock.
Gyre Therapeutics, Inc. executive Joshua Benjamin Bergmann, the company’s GC and Corporate Secretary, reported his initial ownership of a stock option in a Form 3 filing. The option gives him the right to buy 47,530 shares of common stock at an exercise price of $8.09 per share.
According to the filing, the option expires on February 27, 2036. One quarter of the option will vest on June 16, 2026, and the remaining three quarters will vest in equal monthly installments over the following three years, as long as he continues serving the company on each vesting date.
GYRE THERAPEUTICS, INC. executive vice president and general manager Jialiang Wang has reported initial holdings of stock options for the company’s common stock. The Form 3 shows options covering 47,530 underlying shares at an exercise price of $5.98 per share expiring on November 12, 2034, 42,777 underlying shares at $2.00 expiring on April 16, 2031, 38,024 underlying shares at $0.93 expiring on January 12, 2030, and 95,060 underlying shares at $0.32 expiring on June 7, 2028, all held directly. A footnote states that one of these options is fully vested, while another vests over time starting on November 13, 2025, subject to continued service.
GYRE THERAPEUTICS, INC. Chief Scientific Officer Xiong Yue reports initial ownership of 2,376,500 shares of Series B Preferred Stock. These shares were received in the merger where a Gyre subsidiary combined with Cullgen Inc., with Cullgen becoming a wholly owned subsidiary effective as of May 4, 2026.
Each share of Series B Preferred Stock will be convertible, following stockholder approval and subject to a Beneficial Ownership Limitation, into five shares of common stock. The Series B Preferred Stock has no expiration date.
GYRE THERAPEUTICS, INC. chief executive officer Luo Ying filed a Form 3 that lists existing equity holdings in the company. The filing shows indirect ownership through a spouse of 2,575,541 shares of common stock, plus multiple stock option awards held both directly and indirectly with exercise prices between $0.32 and $5.98 and expirations from 2028 through 2034.
Gyre Therapeutics investors Songjiang Ma and Yueying Zhu report beneficial ownership of 7,342,131 shares, representing 6.33% of the company’s common stock. Their stake consists of 4,536,047 shares underlying options held by Mr. Ma that are exercisable within 60 days and 2,806,084 shares held directly by Ms. Zhu. The amendment is triggered by a change in Gyre’s shares outstanding following its all-stock acquisition of Cullgen Inc., which was valued at approximately $300 million and added 14,450,527 new shares. Ma and Zhu did not receive additional Gyre securities in the merger. The deal includes Series B Preferred Stock convertible into common shares, subject to a 19.99% issuance cap until stockholders vote on a Conversion Proposal at a meeting scheduled for June 10, 2026.