TOKYO, Mar 24 (Pulse News Wire) – GNI Group Ltd. (2160.T) announced that its subsidiary, Gyre Therapeutics, submitted a New Drug Application (NDA) to China's National Medical Products Administration (NMPA) on March 24, 2026.
The application targets F351, a drug candidate for liver fibrosis caused by chronic B-type hepatitis. This submission marks a significant step towards commercializing F351, which could potentially revolutionize the treatment landscape for liver fibrosis in China. Current treatments are limited, with many patients relying on traditional Chinese medicines due to their lower costs and fewer side effects. However, F351 has shown strong efficacy in clinical trials, positioning it as a preferred option among Western medical practitioners who prioritize rigorous evidence-based treatments.
Following initial formal checks, Gyre expects to receive an acceptance number from the Center for Drug Evaluation (CDE). Subsequently, the drug will undergo a thorough technical review focusing on safety and effectiveness. Approval would enable F351 to enter the market as an out-of-pocket medication initially, followed by potential inclusion in public health insurance coverage. Successful listing in official treatment guidelines could solidify its position as a top choice for treating liver fibrosis across thousands of hospitals nationwide.
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