GNI Group's Gyre Therapeutics Advances F351 Drug Toward Conditional Approval in China

MT Newswires Live

Jan 06

GNI Group's (TYO:2160) subsidiary, Gyre Therapeutics, has completed a key regulatory meeting with China's CDE following positive Phase 3 trial results for F351, according to its Tokyo bourse filing on Tuesday.

The company confirmed its plan to pursue a New Drug Application via China's conditional approval pathway in the first half of 2026, with eligibility for Priority Review.

Gyre will also prepare a confirmatory trial to support converting the potential conditional approval to regular approval.

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