Welcome to our dedicated page for GYRE THERAPEUTICS SEC filings (Ticker: GYRE), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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. reported that its majority indirectly owned subsidiary, Gyre Pharmaceuticals Co., Ltd., has submitted a New Drug Application to the Center for Drug Evaluation of China’s National Medical Products Administration for F351 (Hydronidone). The NDA seeks approval of Hydronidone as a treatment for chronic hepatitis B–induced liver fibrosis.
The filing explains that the submission will first undergo formatting and completeness checks, after which the company expects an acceptance number before the technical review begins. Gyre notes that forward-looking statements about the NDA process are subject to significant risks and uncertainties described in its prior SEC reports.
Gyre Therapeutics, Inc. files its annual report describing a commercial-stage fibrosis and inflammation franchise built around ETUARY in China and an expanding global pipeline. ETUARY generated $106.1 million sales in 2025, while newer products Etorel and Contiva contributed $4.6 million and $5.5 million, respectively.
The company is advancing lead candidate Hydronidone for liver fibrosis, with a Phase 3 trial in CHB patients in China meeting its primary endpoint and supporting a planned conditional NDA submission in 2026. In the U.S., Gyre is preparing a Phase 2 trial in MASH-related liver fibrosis. Additional assets include F573 for acute liver failure, F230 for pulmonary arterial hypertension, and F528 for COPD. Gyre also signed a Merger Agreement to acquire Cullgen, which would make Cullgen a wholly owned subsidiary if closing conditions are met.
Gyre Therapeutics, Inc. reported that a company representative presented information at an investor conference on March 10, 2026. The discussion included future expectations for revenues, margins, tax deductions, and potential indication expansions related to F351 and ETUARY®, as well as anticipated development timelines and possible efficacy for CG001419.
The company also highlighted potential future licensing opportunities. It emphasized that these are forward-looking statements based on current beliefs and assumptions, and that actual results may differ due to various risks described in its previously filed Annual and Quarterly Reports with the SEC.
Gyre Therapeutics reported full-year 2025 revenue of $116.6 million, up 10.2% year-over-year, driven by ETUARY®, and launches of Contiva® and Etorel®. Fourth-quarter revenue was $37.2 million, up 33.3%.
GAAP net income for 2025 declined to $9.9 million from $17.9 million, while non-GAAP adjusted net income rose to $18.9 million from $16.9 million. In the fourth quarter, Gyre posted a GAAP net loss of $1.4 million but non-GAAP adjusted net income of $4.3 million, reflecting higher operating expenses, especially sales, marketing and stock-based compensation.
The company issued 2026 revenue guidance of $100.5–$111.0 million, implying a 13.8% to 4.8% decline versus 2025 as it treats 2026 as a transition year focused on regulatory work for Hydronidone and moderates promotion for Contiva® and Etorel®. Gyre also agreed to acquire Cullgen in an approximately $300 million all-stock deal, aiming to add a targeted protein degradation pipeline, and advanced Hydronidone and pirfenidone programs toward key regulatory and clinical milestones in China and the United States.
Gyre Therapeutics is acquiring Cullgen in an all‑stock deal valuing Cullgen at approximately $300 million. Cullgen will become a wholly owned subsidiary, bringing a targeted protein degradation and degrader antibody conjugate platform, plus clinical programs in pain, solid tumors and blood cancers, into Gyre’s portfolio.
The merger uses new Series B Convertible Preferred Stock, each share convertible into five common shares after stockholders approve a Conversion Proposal, with issuance capped at 19.99% of Gyre’s pre‑vote common stock and voting power until that approval. Existing Cullgen equity and in‑the‑money options will roll into Gyre equity, and a registration rights agreement requires Gyre to file a resale registration statement shortly after closing. Selected Gyre and Cullgen insiders signed support agreements and staggered 6‑, 12‑ and 18‑month lock‑ups. Two Gyre directors will resign at closing, and Cullgen CEO Ying Luo will become Gyre’s Chief Executive Officer, President and a director. The companies expect the transaction to close early in the second quarter of 2026, subject to customary regulatory and stockholder conditions, including Hart‑Scott‑Rodino review and Cullgen stockholder approval.
Gyre Therapeutics director Zhang Ping reported receiving a new stock option grant for 100,000 shares of the company’s common stock. The option has an exercise price of $7.31 per share and was granted on January 7, 2026. According to the filing, 25% of the option will vest on January 7, 2027, with the remaining 75% vesting in equal monthly installments over the following three years, conditioned on Zhang’s continued service to the company. After this grant, Zhang beneficially owns 100,000 derivative securities (stock options) directly.
Gyre Therapeutics, Inc. disclosed that its Chief Financial Officer, Ruoyu Chen, received a grant of stock options on January 7, 2026. The award is an option to purchase 50,000 shares of Gyre’s common stock at an exercise price of $7.31 per share.
According to the terms, 25% of the option will vest on January 7, 2027, with the remaining portion vesting in equal monthly installments over the following three years, subject to Chen’s continued service with the company through each vesting date. After this grant, Chen holds 50,000 stock options directly.
Gyre Therapeutics (GYRE) filed its Q3 2025 10‑Q, showing higher sales and continued profitability. Revenue rose to $30.6 million from $25.5 million a year ago, driven mainly by ETUARY, with added contributions from newly launched Contiva and Etolel. Operating income reached $6.9 million, and net income was $5.9 million for the quarter.
For the nine months, revenue was $79.4 million and net income $11.2 million. Cash and cash equivalents increased to $40.4 million from $11.8 million at year‑end, supported by $6.6 million of operating cash flow and a May 2025 underwritten offering that raised $23.0 million gross. Total assets were $159.4 million and total equity $137.4 million at quarter‑end.
Customer concentration remained notable, with Sinopharm accounting for roughly half of Q3 revenue and about half of accounts receivable as of quarter‑end. Intangible assets rose with the addition of Etolel technology rights (~$4.9 million), and the company recorded a lower warrant liability. As of October 31, 2025, 96,333,157 common shares were outstanding.
Gyre Therapeutics, Inc. furnished a press release announcing financial results for the three and nine months ended September 30, 2025. The press release is included as Exhibit 99.1 to this Form 8-K.
Consistent with General Instruction B.2, the information in Item 2.02 and Exhibit 99.1 is not deemed filed for purposes of Section 18 of the Exchange Act. Gyre’s common stock trades on The Nasdaq Capital Market under the symbol GYRE. The report was signed by Ping Zhang, Executive Chairman and Interim Chief Executive Officer.
Gyre Therapeutics, Inc. filed a Form 8-K reporting that on September 10, 2025 the company made an updated corporate presentation available on its website and filed that presentation as Exhibit 99.1 to the report. The filing notes the exhibit is dated September 2025 and that the report was signed by Ping Zhang, Executive Chairman and Interim Chief Executive Officer. The 8-K does not include financial results, transaction details, or other operational disclosures; it solely documents the availability and filing of the corporate presentation.