Gyre Therapeutics

What Gyre Therapeutics does

Gyre Therapeutics is a publicly-traded (NASDAQ: GYRE) commercial-stage biopharmaceutical company headquartered in San Diego, California, with operations in both the United States and China through its majority-owned subsidiary Gyre Pharmaceuticals. The company focuses on organ fibrosis and inflammatory diseases, with a portfolio centered on small-molecule anti-fibrotic therapeutics. Its flagship approved product, ETUARY (pirfenidone capsule), was the first treatment approved for idiopathic pulmonary fibrosis (IPF) in China in 2011 and generated $116.6 million in FY2025 revenue, representing 10% year-over-year growth. The company distributes ETUARY and pipeline products in China through Gyre Pharmaceuticals, primarily reaching hospitals and specialty pharmacies via direct enterprise sales.

Gyre's lead development candidate is F351 (hydronidone), a structurally modified derivative of pirfenidone targeting the TGF-β1 signaling pathway, being developed for chronic hepatitis B (CHB)-induced liver fibrosis in China and MASH-associated liver fibrosis in the United States. The China NMPA granted priority review status in March 2026 and accepted the New Drug Application in May 2026, with potential first-in-class approval positioning. Additional pipeline assets include F528 (a non-antibacterial macrolide immunomodulator for COPD), CG923308 (a CDK2-cyclin E dual degrader for cancer), and CG620953 (a TYK2-JAK1 dual degrader for autoimmune diseases). The May 2026 acquisition of Cullgen Inc. for approximately $300 million in an all-stock transaction added Targeted Protein Degradation (TPD) and Degrader-Antibody Conjugate (DAC) platforms, enabling pursuit of traditionally undruggable targets.

The company's revenue model is anchored in pharmaceutical product sales of ETUARY in China. Its go-to-market is enterprise field sales through the China subsidiary to hospitals and specialty pharmacies. Future revenue is expected to come from approved indications of pipeline products (F351, F528) and additional indications like pneumoconiosis, where a Phase 3 trial completed enrollment in 2025 with 272 patients across 18 centers. Pricing details are not publicly disclosed; standard pharmaceutical pricing applies through regulatory and market channels. The company raised approximately $19.8 million via a post-IPO secondary offering in May 2025 and is profitable at the quarterly level, with Q3 2025 net income of $5.9 million on $30.6 million in revenue.

Name

Gyre Therapeutics

Legal name

Gyre Therapeutics, Inc.

Website

https://gyretx.com

Company type

Public

Founded year

1997

Operating status

Operating

Headcount range

51–100 employees

Short description

Gyre Therapeutics is a commercial-stage biopharmaceutical company developing anti-fibrotic and inflammatory disease therapeutics, with the approved product ETUARY (pirfenidone) for IPF in China and a pipeline including F351 for liver fibrosis, supported by protein degradation platforms acquired from Cullgen.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

akta.pro secondary industries

Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF), Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE)

Keywords

• Biopharmaceutical therapeutics
• Organ fibrosis treatments
• Anti-fibrotic drugs
• Targeted protein degradation
• Inflammatory disease therapies

Headquarters

HQ city

South San Francisco

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Product Sales (Pharmaceuticals): Gyre generates revenue through the sale of approved pharmaceutical products, primarily ETUARY (pirfenidone capsule) which was the first approved treatment for idiopathic pulmonary fibrosis in China in 2011. Revenue grew 10% to $116.6 million in FY 2025.
2. Pipeline Development: The company is advancing clinical-stage pipeline candidates including F351 (Hydronidone) for liver fibrosis, with NDA accepted by China's NMPA. Future revenue potential from new drug approvals.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Gyre Therapeutics is a commercial-stage biopharmaceutical company developing and commercializing small-molecule therapeutics for organ fibrosis, inflammatory diseases, and cancer. Its flagship approved product, ETUARY (pirfenidone capsule), was the first treatment approved for idiopathic pulmonary fibrosis in China (2011). The pipeline includes F351 (Hydronidone) for liver fibrosis, F528 for COPD, and dual protein degraders (CG923308 for oncology, CG620953 for autoimmune diseases) developed via Targeted Protein Degradation and Degrader-Antibody Conjugate platforms acquired through Cullgen.

Product overview

Gyre Therapeutics is a commercial-stage biopharmaceutical company offering a portfolio of small-molecule therapeutics focused on organ fibrosis and inflammatory diseases. The company's core products include ETUARY™ (pirfenidone capsule) as its flagship approved product for IPF in China, and F351 (Hydronidone) as the lead development candidate for liver fibrosis across multiple indications. The pipeline spans F528 for COPD, CDK2-Cyclin E dual degrader (CG923308) for cancers, and TYK2-JAK1 dual degrader (CG620953) for autoimmune diseases. The May 2024 acquisition of Cullgen expanded capabilities with targeted protein degradation (TPD) and degrader-antibody conjugate (DAC) technology platforms.

Differentiator

Problem solved

Functional benefit

Brands

• ETUARY: Pirfenidone capsule - first approved treatment for idiopathic pulmonary fibrosis (IPF) in the People's Republic of China, approved in 2011
• F351 (Hydronidone)
• F528

Products and services

• ETUARY (pirfenidone capsule) The first approved treatment for idiopathic pulmonary fibrosis (IPF) in the People's Republic of China, approved in 2011. Sold to hospitals and specialty pharmacies in China through the majority-owned subsidiary Gyre Pharmaceuticals for the treatment of IPF patients.
• F351 (Hydronidone) A structurally modified derivative of pirfenidone targeting the TGF-β1 signaling pathway for treatment of liver fibrosis. Lead development candidate for chronic hepatitis B (CHB)-associated liver fibrosis in China and MASH-associated liver fibrosis in the United States. NDA accepted by China's NMPA in May 2026.
• F528 A novel non-antibacterial macrolide discovered through rational design strategy to eliminate antibacterial activity while preserving immunomodulatory properties for treatment of chronic obstructive pulmonary disease (COPD). Designed to address airway inflammation without antibiotic resistance risk.
• CG923308 (CDK2-Cyclin E Dual Degrader) A highly potent and selective dual degrader of CDK2 and cyclin E developed through targeted protein degradation technology. Targets cyclin E amplification and CDK4/6 inhibitor resistance in ovarian, endometrial, gastroesophageal, breast, and lung cancers.
• CG620953 (TYK2-JAK1 Dual Degrader) A highly potent and selective dual degrader of TYK2 and JAK1 targeting inflammatory pathways in systemic lupus erythematosus, rheumatoid arthritis, and inflammatory bowel disease.

Quantifiable outcome

• Statistically significant fibrosis regression after 52 weeks of F351 treatment in CHB patients
• +3 more outcomes

Segments7 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Cullgen Inc.coreStrategic or Co-development Partner · 3 March 2026Gyre Therapeutics agreed to acquire Cullgen Inc., a privately-held clinical-stage biopharmaceutical company focused on targeted protein degrader and degrader-antibody conjugate (DAC) therapies for inflammatory diseases and cancer, in an all-stock transaction valued at approximately $300 million. Cullgen became a wholly-owned subsidiary of Gyre, creating a fully integrated biopharma company with U.S.- and China-based capabilities spanning discovery through commercialization. The acquisition was completed on May 4, 2026.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Madrigal Pharmaceuticals: Madrigal commercializes Rezdiffra, the first FDA-approved treatment for MASH — directly competing with Gyre's F351 in the MASH-associated liver fibrosis indication that Gyre plans to pursue in the US.
• FibroGen: Clinical-stage biopharma focused on fibrosis (previously developed pamrevlumab for IPF and other fibrotic conditions) with comparable therapeutic focus on organ fibrosis and pipeline-stage assets targeting similar indications to Gyre's F351 and ETUARY.
• Pliant Therapeutics: Clinical-stage biopharma developing integrin-targeted therapies for fibrosis (IPF and other fibrotic diseases), with similar therapeutic focus on fibrogenesis pathways to Gyre's TGF-β1-targeted approach.
• Arvinas: Pioneer in targeted protein degradation (PROTAC technology) with clinical-stage oncology and neuroscience assets — directly comparable to Gyre's Cullgen-acquired TPD platform, though Arvinas is more advanced in clinical development.
• Kymera Therapeutics: Clinical-stage biotech developing heterobifunctional protein degraders across immunology and oncology — overlapping modality and target space with Cullgen's TYK2-JAK1 and CDK2-cyclin E degrader programs now under Gyre.
• Intercept Pharmaceuticals: Focused on liver diseases including MASH/NASH with obeticholic acid development — comparable focus on chronic liver fibrosis indications where Gyre's F351 (Hydronidone) is positioned.

Broad incumbents

• United Therapeutics: Established biopharma with commercial franchise in pulmonary hypertension and IPF (Tyvaso, Orenitram) — overlapping pulmonology indication with Gyre's ETUARY and F528, though United Therapeutics is a much larger, multi-product commercial-stage company.
• Boehringer Ingelheim (Ofev): Markets Ofev (nintedanib), the global standard-of-care for IPF alongside Roche's Esbriet (pirfenidone) — directly competitive with Gyre's ETUARY (pirfenidone) globally, though Boehringer operates as a much larger diversified pharma.

Emerging players

• Nurix Therapeutics: Clinical-stage biotech leveraging targeted protein degradation with partnered programs (including with Sanofi) — comparable TPD modality to Cullgen's platform though with different target focus and deeper pharma partnerships.

Regional players

• GENFIT: France-based biopharma focused on MASH and liver diseases — comparable therapeutic focus on MASH-driven fibrosis though operating primarily in European markets, providing regional competition if Gyre's F351 seeks global development.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/catalystbio
• Facebookfacebook.com/catalystbio
• LinkedInlinkedin.com/company/catalyst-biosciences

Revenue estimate

Valuation estimate

Number of profiles

Profiles19 records

Subsidiaries2 records

Funding overview

Funding rounds15 records

Investors24 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Gyre Therapeutics