ADDED
As of March 2, 2026, the number of outstanding shares of the registrant s common stock, par value $0.001 per share, was 96,963,611 , which includes 5,649,604 shares of common stock issued in the name of the registrant to a stock plan administrator of the registrant (see Note 8 Stockholders Equity).
Overview We are a commercial-stage biopharmaceutical company focused on the development and commercialization of small-molecule therapies for the treatment of organ fibrosis and inflammatory diseases.
We operate through our majority indirectly owned subsidiary, Gyre Pharmaceuticals, in the PRC, and through our U.S.
In the PRC, we have established a strong commercial and operational foundation in fibrotic diseases through the successful development and commercialization of ETUARY (pirfenidone), which has generated consistent revenue and positioned us as a leading participant in the treatment of pulmonary fibrosis.
Fibrotic diseases affect large patient populations worldwide and involve complex, multi-stage biological processes driven by multiple molecular pathways.
Given this complexity, therapies that modulate key profibrotic signaling pathways may offer meaningful clinical benefit; however, effective treatment may require targeting mechanisms across different stages of disease progression.
Building on our commercialization experience and infrastructure in the PRC, we have expanded our presence into the United States to advance the clinical development of our innovative pipeline, including F351 (Hydronidone), our lead product candidate for liver fibrosis.
Our strategy is to leverage our established commercial portfolio to support and de-risk the advancement of late-stage product candidates, expand approved products into additional indications, and build a diversified pipeline targeting significant unmet medical needs in fibrosis and related inflammatory diseases.
On March 2, 2026, we entered into an Agreement and Plan of Merger and Reorganization (the Merger Agreement ) with Cullgen Inc., a Delaware corporation ( Cullgen ), and Helix Merger Sub Corp., a Delaware corporation and wholly owned subsidiary of Gyre ( Merger Sub ), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Cullgen, with Cullgen continuing as a wholly owned subsidiary of Gyre and the surviving corporation of the merger (the Merger ).
The consummation of the Merger is subject to certain closing conditions, including, among other things, (1) approval by the requisite Cullgen stockholders of the adoption and approval of the Merger Agreement and the transactions contemplated thereby, and (2) a filing under the HSR Act.
REMOVED
As of March 7, 2025, the number of outstanding shares of the registrant s common stock, par value $0.001 per share, was 93,612,442 , which includes 7,280,230 shares of common stock issued in the name of the registrant to a stock plan administrator of the registrant (see Note 8 Stockholders Equity).
Overview We are a commercial-stage pharmaceutical company with a proven track record of financial success developing and commercializing small-molecule anti-inflammatory and anti-fibrotic drugs targeting organ diseases, focusing specifically on organ fibrosis.
Fibrotic diseases represent a large patient population with significant unmet medical needs and involve complex, multi-stage processes with multiple pathways.
While there are numerous potential targets for anti-fibrotic therapy, both established and emerging, addressing a single molecular pathway may not be sufficient to prevent, halt, or reverse fibrosis.
Our strategy is to build on our success in the development and commercialization of ETUARY (pirfenidone) to expand into new indications and advance our pipeline of innovative drug candidates.
By leveraging clinically validated compounds, our goal is to drive a de-risked pipeline through late-stage clinical development and commercialization to provide effective treatments for patients in the United States and globally.
ETUARY (pirfenidone) Pirfenidone, the first anti-fibrotic drug approved for idiopathic pulmonary fibrosis ( IPF ) in Japan, the European Union ( EU ), the United States, and the PRC, is a small molecule drug that inhibits the synthesis of Tumor Growth Transforming ( TGF )- 1, Tumor Necrosis Factor ( TNF )- , and other fibrosis and inflammation modulators.
We successfully advanced pirfenidone from research and development ( R D ) to commercialization in the PRC for the treatment of IPF.
In addition to IPF, pirfenidone is undergoing one additional Phase 3 trial in the PRC for the treatment of pneumoconiosis ( PD ) and was undergoing two Phase 3 trials in the PRC for the treatment of dermatomyositis-related interstitial lung disease ("DM-ILD") and sclerosis-related interstitial lung disease ("SSc-ILD") to broaden its indications and market.
We are prioritizing the development of our product candidates for other targeted indications and, as a result, have paused our two Phase 3 trials in the PRC for the treatment of DM-ILD and SSc-ILD.