Wednesday, March 18, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Gyre Receives Priority Review. Hydronidone has been awarded Priority Review Status by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This is consistent with our expectations for an accelerated NDA review and late FY2026 approval for Hydronidone.
Meeting With The CMPA Was Positive. In early January, Gyre Pharmaceuticals (China) held a Pre-New Drug Application meeting with the CDE. At that time, the CDE agreed that data from the Hydronidone Phase 3 trial for treating chronic hepatitis B (CHB)-associated liver-fibrosis supported an application for conditional approval. It also met the criteria for Priority Review.
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