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GNI Group ( (JP:2160) ) just unveiled an update.
GNI Group announced that its subsidiary Gyre Therapeutics has completed a Pre-New Drug Application meeting with China’s Center for Drug Evaluation regarding F351, confirming that an NDA submission via the conditional approval pathway is acceptable and that the drug may qualify for Priority Review. F351, already designated a Breakthrough Therapy by Chinese regulators, is now positioned for an NDA filing in the first half of 2026, with Gyre preparing a confirmatory clinical trial to support the potential transition from conditional to full approval, a step that could accelerate time to market and strengthen the company’s position in the hepatology drug space in China.
The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2311.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.
More about GNI Group
GNI Group Ltd., listed on the TSE Growth market, operates in the biopharmaceutical sector through subsidiaries such as Gyre Therapeutics, Inc., focusing on the development of innovative therapies. Its pipeline includes F351 (hydronidone), a drug candidate targeting serious liver-related conditions in the Chinese market, where it works closely with China’s regulatory authorities to advance late-stage clinical and regulatory programs.
Average Trading Volume: 1,159,150
Technical Sentiment Signal: Hold
Current Market Cap: Yen134.1B
See more data about 2160 stock on TipRanks’ Stock Analysis page.