Tuesday, January 06, 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.
Positive Guidance Received From CDE. Gyre announced that its majority-owned subsidiary in China, Gyre Pharmaceuticals Ltd, has completed pre-NDA discussions with the Chinese Center for Drug Evaluation (CDE). The CDE indicated that the Phase 3 data meets the requirements for approval in chronic hepatitis B-associated liver fibrosis, as expected. An NDA submission is planned for 1H26, meeting our expected milestones for the product and the company.
Approval Would Allow Full Commercialization. Under the CDE regulations, the Phase 3 supports Conditional Approval for Hydronidone, allowing full commercialization. As part of the approval, company agrees to conduct a Phase 3c study after commercialization to confirm the effects seen in Phase 3. This is similar to a Phase 4 study in the US. The study design has not be finalized, although we expect similar endpoints for confirmation of the Phase 3 data.
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