Gyre Therapeutics, Inc. (NASDAQ: GYRE) announced that its majority‑owned subsidiary, Gyre Pharmaceuticals Co., Ltd., completed a Pre‑New Drug Application (Pre‑NDA) communication with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The meeting confirmed that the Phase 3 data for Hydronidone, a first‑in‑class anti‑fibrotic therapy, are generally supportive of a conditional approval NDA for chronic hepatitis B‑associated liver fibrosis, including early cirrhosis.
The Phase 3 trial showed that 52.85% of patients treated with Hydronidone achieved at least one‑stage fibrosis regression at week 52, compared with 29.84% for placebo (p = 0.0002). These results meet the CDE’s criteria for conditional approval and demonstrate a clinically meaningful benefit in a patient population that currently has no approved anti‑fibrotic options.
The CDE also indicated that Hydronidone qualifies for China’s Priority Review and Approval Program for Innovative Drugs. Gyre plans to file a conditional NDA in the first half of 2026 and will conduct a confirmatory Phase 3c trial to support conversion to regular approval. The conditional pathway is expected to shorten the time to market and provide early revenue while the confirmatory study is underway.
China’s hepatitis B‑related liver fibrosis market is estimated to include 60–70 million infected individuals, with a sizable subset progressing to compensated fibrosis or early cirrhosis. Hydronidone’s approval would open a large addressable market and leverage Gyre’s China‑centric commercial platform, which includes established distribution networks and regulatory expertise. The company’s cash‑rich balance sheet—$30.6 million in revenue for the quarter ended September 30, 2025, up from $25.5 million a year earlier—provides the liquidity needed to fund its U.S. pipeline and support the China launch.
Beyond Hydronidone, Gyre is advancing therapies for metabolic‑associated steatohepatitis, Parkinson’s disease, radiation‑induced lung injury, COPD, and pulmonary arterial hypertension. The company’s diversified pipeline, combined with the expected revenue from Hydronidone, positions Gyre to sustain growth and maintain its cash‑positive trajectory.
Ping Zhang, interim CEO, said, “Hydronidone addresses a significant unmet medical need in patients with CHB‑associated liver fibrosis, for whom there are currently no approved anti‑fibrotic therapies.”
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