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. is asking stockholders to approve several items at its 2026 virtual annual meeting, including director elections, a non-binding advisory vote on executive pay, ratification of Grant Thornton as auditor and approval of a key share-conversion feature tied to a major acquisition.
The company agreed to acquire clinical-stage degrader-focused biopharma Cullgen Inc. in an all-stock transaction valuing Cullgen at approximately $300 million. In the merger, Gyre expects to issue 3,697,236 shares of Series B Preferred Stock, which are generally economically equivalent to common stock.
Subject to stockholder approval and individual beneficial ownership limits, each Series B share may convert into five common shares, so up to 18,486,180 shares of common stock are issuable upon conversion. Gyre had 96,994,001 common shares outstanding as of April 16, 2026. The board also highlights its controlled-company status under Nasdaq rules and outlines its governance structure, executive compensation program and board committee responsibilities.
Gyre Therapeutics, Inc. filed an amended report to correct how its planned all-stock acquisition of Cullgen Inc. is described. The deal values Cullgen at approximately $300 million.
Under the revised terms, designated Cullgen common holders receive Series B Convertible Preferred Stock, with each Cullgen common share converted into Company preferred shares equal to 0.4753 (the Exchange Ratio) divided by five. Other Cullgen stockholders receive Gyre common stock based on the full Exchange Ratio.
Each share of Company preferred stock is convertible into five common shares, tied to stockholder approval of a Conversion Proposal. Gyre states it will not issue more than 19.99% of its outstanding common stock or voting power before that approval, preserving a cap on pre-approval dilution.
Gyre Therapeutics filed a preliminary Proxy Statement for its 2026 Annual Meeting to be held virtually on June 10, 2026 (Record Date: April 16, 2026). The Board asks stockholders to vote on four proposals: election of two Class II directors, a non-binding say-on-pay advisory vote, ratification of Grant Thornton as auditor, and approval to permit conversion of Series B Preferred Stock.
The company disclosed a proposed all-stock merger to acquire Cullgen, valuing Cullgen at approximately $300 million. In the Merger the company expects to issue 3,697,236 shares of Series B Preferred Stock, which would convert into 18,486,180 shares of common stock (each Series B convertible into five common shares), subject to holder-set beneficial ownership conversion limits (initially up to 19.99%) and stockholder approval of Proposal 4. The company expects to appoint Ying Luo, Ph.D. as CEO upon closing.
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.