TOKYO, May 13 (Pulse News Wire) – GNI Group Ltd. (2160.T) announced that its subsidiary, Gyre Pharmaceuticals Co., Ltd., received formal acceptance notification from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) for the new drug application (NDA) of F351, a treatment for liver fibrosis derived from chronic hepatitis B.
F351 was submitted through Gyre Pharmaceuticals on March 22, 2026. Following a review of the application documents' completeness and formality, the CDE issued a formal acceptance number, initiating the substantive review process for approval. Additionally, F351 was designated for priority review by the CDE on March 18, 2026, which typically results in a shortened review timeline due to its high clinical value. GNI Group views the development and potential approval of F351 as a significant social responsibility.
With no currently approved treatments available to directly inhibit and improve liver fibrosis caused by chronic hepatitis B, F351 offers hope to patients suffering from this condition. Chronic hepatitis B is a severe public health issue across Asia, posing risks such as cirrhosis and liver cancer if left untreated. The impact on GNI Group's consolidated performance for the fiscal year ending December 2026 remains under evaluation, contingent upon the progress and timing of regulatory approvals. However, the company anticipates substantial long-term benefits for both enterprise and societal value.
Any further developments related to the review process will be promptly disclosed.
🟢 Confidence: High AI-translated content.