Gyre Therapeutics (GYRE) Corporate presentation summary

Strategic focus and operational overview

• Fully integrated biopharmaceutical company with a focus on fibrosis, inflammatory diseases, and cancer.

• Pipeline spans from discovery to marketed products, leveraging China operations for accelerated drug development.

• Approximately 740 employees worldwide, with significant R&D, manufacturing, and commercial presence in China and the US.

• Cost-efficient China operations enable rapid discovery, validation, and clinical development.

Key marketed and late-stage products

• ETUARY™ (pirfenidone) is the market leader for organ fibrosis, with strong revenue growth and upcoming line extensions.

• ETUARY™ demonstrated efficacy in preclinical and clinical studies for pneumoconiosis and radiation-induced lung injury.

• F351 (hydronidone) is a next-generation antifibrotic with enhanced potency and safety, targeting liver fibrosis from CHB and MASH.

• F351 met primary and secondary endpoints in Phase 3 for CHB-associated liver fibrosis, with NDA accepted in China and US IND filed for MASH.

Pipeline innovation and clinical development

• Robust pipeline includes targeted protein degraders (TPDs) and degrader-antibody conjugates (DACs) for cancer and inflammatory diseases.

• CDK2-Cyclin E degrader (CG923308) targets solid tumors with CCNE1 amplification and breast cancer resistant to CDK4/6 inhibitors; IND anticipated Q1 2027.

• TYK2-JAK1 dual degrader (CG620953) shows superior efficacy in preclinical lupus and RA models.

• TRK degrader (CG001419) is a first-in-class, non-opioid analgesic for pain and cancer-induced bone pain, with Phase 1 completed and Phase 2 planned.

• GSPT1 degrader (CG009301) in Phase 1 for relapsed/refractory hematologic malignancies, with expansion to MYC-driven solid tumors.