We operate through our majority indirectly owned subsidiary, Gyre Pharmaceuticals, in the PRC, and through our U.S. operations headquartered in San Diego, California. 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.
Phase 3 · ActiveModality: small molecule (structurally modified pirfenidone derivative)
Aliases hydronidone
Target TGF-beta1 signaling pathway
Partnerships GNI Japan / GNI Group: Hydronidone IP rights for mainland China (right of first offer for global); RMB 8.3M on NDA inspection pass + RMB 49.6M on NMPA approval; 12 annual royalties (8-16% of sales)
Indications
Chronic hepatitis B (CHB)-associated liver fibrosis (PRC)(Phase 3)
MASH-associated liver fibrosis (U.S.)(Phase 1)
Status note Lead candidate. Pivotal Phase 3 in CHB liver fibrosis met primary and key secondary endpoints (May 2025); NMPA granted priority review (Mar 2026), NDA submitted Mar 22, 2026 and accepted May 12, 2026 (conditional approval sought); Phase 3C confirmatory trial underway. U.S. MASH program: Phase 1 in healthy volunteers completed, IND discussions with FDA ongoing for Phase 2.
ETUARY
Approved · ActiveModality: small molecule
Aliases pirfenidone
Target TGF-β1; TNF-α
Indications
Idiopathic pulmonary fibrosis (IPF)(Approved)
Pneumoconiosis (PRC)(Phase 3)
Radiation-induced lung injury (RILI)(Phase 2/3)
Status note First-in-class PRC approval 2011; National Reimbursement Drug List 2017; leading PRC market position. Pneumoconiosis 52-week Phase 3 enrolled 272 patients (2025). RILI adaptive Phase 2/3 initiated April 2026.
Etorel
Approved · ActiveModality: small molecule
Aliases nintedanib ethanesulfonate soft capsules
Partnerships Jiangsu Wangao Pharmaceuticals: drug registration certificate and marketing authorization holder transfer (May 2024)
Status note Designed to inhibit multiple inflammatory cytokines; IND to NMPA anticipated in 2026.
Per-asset detail extracted from the 10-Q filed 2026-08-07. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
No lead program on file for this company.
No active ClinicalTrials.gov trials matched to this company as sponsor or collaborator.
Specialist fund holders
Tracked specialist funds: ADAR1 Capital Management, Aisling Capital, Ally Bridge Group, Avoro Capital Advisors, BVF Partners, Baker Bros. Advisors, Boxer Capital, Braidwell LP, Casdin Capital, Cormorant Asset Management, DAFNA Capital, Deerfield Management, EcoR1 Capital, Frazier Life Sciences, Great Point Partners, Ikarian Capital, Logos Global Management, OrbiMed Advisors, Perceptive Advisors, RA Capital Management, RTW Investments, Sphera Biotech, Stonepine Capital, Tang Capital Partners, Vivo Capital.
None of the tracked specialist funds reported a position in the latest 13F snapshot.
Latest news
Loading headlines…
Headlines from the Fully Diluted live wire: IR newsrooms, newswires, SEC filings, and halt notices, refreshed every 15 minutes.
Get the weekly biotech catalyst rundown. Cash runways, financings, and trial readouts for all 721 stocks.