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Gyre Therapeutics Inc. (GYRE+2.66%) has submitted its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing details Gyre's focus on developing and commercializing small-molecule anti-inflammatory and anti-fibrotic drugs targeting organ diseases, with a particular emphasis on organ fibrosis.
Gyre's flagship product, ETUARY, a treatment for idiopathic pulmonary fibrosis (IPF), achieved annual sales of $105 million in 2024. The company is conducting additional Phase 3 trials in China for pneumoconiosis and has paused trials for other indications.
F351, Gyre's lead development candidate for liver fibrosis, is undergoing a Phase 3 trial in China, with results expected in Q2 2025. The company plans to submit an IND in the U.S. and initiate a Phase 2 trial for MASH-associated liver fibrosis in 2025.
Gyre plans to launch two commercial-ready drugs, nintedanib and avatrombopag, in China in 2025. Nintedanib is approved for IPF and other fibrosing lung diseases, while avatrombopag is approved for thrombocytopenia associated with chronic liver disease and chronic idiopathic thrombocytopenia.
Gyre's pipeline includes F573 for acute liver failure, F230 for pulmonary arterial hypertension, and F528 for chronic obstructive pulmonary disease, with varying stages of clinical development.
The company reported a gross margin of 96.3% for 2024, with ETUARY accounting for 99.3% of total revenue. Gyre relies heavily on its distribution network in China and faces competition from other IPF treatments.
Gyre's operations are subject to extensive regulation in the U.S. and China, with ongoing compliance required for manufacturing, marketing, and distribution.
The company acknowledges risks related to intellectual property, regulatory approvals, and market acceptance of its products. Gyre also highlights its dependence on key personnel and potential impacts from geopolitical tensions.
Gyre plans to continue investing in research and development to expand its pipeline and address unmet medical needs in organ fibrosis and other inflammatory diseases.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Gyre Therapeutics Inc. annual 10-K report dated March 17, 2025. To report an error, please email earnings@qz.com.