GYRE biotech catalysts & pipeline

GYRE THERAPEUTICS INC · Data as of 2026-09-08

Upcoming catalysts

F528 — IND submission

2026

F528 is our preclinical-stage product candidate for the treatment of chronic obstructive pulmonary disease in the PRC. F528 is an anti-inflammatory small-molecule compound designed to inhibit multiple inflammatory cytokines and potentially modify disease progression. F528 expands our pulmonary-focused development efforts beyond fibrosis and vascular disease into chronic inflammatory respiratory conditions, supporting our broader strategy of addressing organ diseases driven by inflammatory and fibrotic pathways. We anticipate submitting an IND application to the NMPA for F528 in 2026.

Source filing

CG923308 — IND submission

Q1'27

Global Development Programs and Upcoming Catalysts Program and Description Indication Pre-IND Studies Phase 1 Phase 2 Phase 3 NDA Submitted Catalyst DAC Platform / Next-Gen Degrader Technologies Oncology / Inflammatory Disease Discovery Platform Lead DAC selection / IND-enabling advancement CDK2 / Cyclin E DegraderCG923308 CDK4/6i-resistant Breast Cancer and Other Solid Tumors Q1'27 IND-application submission in U.S. and/or China; Phase 1 start in 2027 TYK2 / JAK 1 Degrader CG620953 Systemic Lupus Erythematosus (SLE) & Rheumatoid Arthritis (RA) Q1'27 IND-application submission in U.S. and/or China; Phase 1 start in 2027 GSPT1 Degrader CG009301 R/R AML, HR-MDS, R/R ALL; Solid Tumor Cancers Phase 1 data in patients with high-risk hematologic malignancies expected at trial completion TRK Degrader CG001419 Cancer-induced Bone Pain (CIBP) Planning Phase 2 initiation in U.S. or China Hydronidone F351 Chronic Hepatitis B (CHB)-induced Liver Fibrosis NDA-filing accepted by China NMPA in May 2026; Potential launch post-NMPA decision in early 2027 Inflammation / Fibrosis Cancer Degrader DAC China R&D incubator provides new promising clinical assets for global development in cancer, immunology & inflammatory (I&I) diseases, and pain 5 Discovery & lead selection in China IND-enabling development in China; Phase 1 in U.S. and/or China IND-enabling development in China; Phase 1 in U.S. and/or China Phase 1 dose escalation ongoing in China Phase 1 in healthy volunteers completed in Australia; Phase 2 in U.S. or China

Source filing

CG620953 — IND submission

Q1'27

Global Development Programs and Upcoming Catalysts Program and Description Indication Pre-IND Studies Phase 1 Phase 2 Phase 3 NDA Submitted Catalyst DAC Platform / Next-Gen Degrader Technologies Oncology / Inflammatory Disease Discovery Platform Lead DAC selection / IND-enabling advancement CDK2 / Cyclin E DegraderCG923308 CDK4/6i-resistant Breast Cancer and Other Solid Tumors Q1'27 IND-application submission in U.S. and/or China; Phase 1 start in 2027 TYK2 / JAK 1 Degrader CG620953 Systemic Lupus Erythematosus (SLE) & Rheumatoid Arthritis (RA) Q1'27 IND-application submission in U.S. and/or China; Phase 1 start in 2027 GSPT1 Degrader CG009301 R/R AML, HR-MDS, R/R ALL; Solid Tumor Cancers Phase 1 data in patients with high-risk hematologic malignancies expected at trial completion TRK Degrader CG001419 Cancer-induced Bone Pain (CIBP) Planning Phase 2 initiation in U.S. or China Hydronidone F351 Chronic Hepatitis B (CHB)-induced Liver Fibrosis NDA-filing accepted by China NMPA in May 2026; Potential launch post-NMPA decision in early 2027 Inflammation / Fibrosis Cancer Degrader DAC China R&D incubator provides new promising clinical assets for global development in cancer, immunology & inflammatory (I&I) diseases, and pain 5 Discovery & lead selection in China IND-enabling development in China; Phase 1 in U.S. and/or China IND-enabling development in China; Phase 1 in U.S. and/or China Phase 1 dose escalation ongoing in China Phase 1 in healthy volunteers completed in Australia; Phase 2 in U.S. or China

Source filing

F351 — IND submission

Late 2026

In the United States, Gyre has completed a Phase 1 clinical trial in healthy volunteers evaluating F351's safety, tolerability, and PK. Gyre plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026, and, if the IND becomes effective, to initiate a Phase 2 clinical trial.

Source filing

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