Gyre Therapeutics (NASDAQ:GYRE) reached a critical regulatory milestone as the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted Priority Review status to the New Drug Application (NDA) for Hydronidone (F351).
This designation is reserved for innovative drugs with significant clinical value and allows for an expedited assessment process, potentially shortening the timeline for market entry.
The decision follows a constructive pre-NDA meeting held in January 2026, where the CDE reached consensus that Gyre's existing Phase 3 data is sufficient for a conditional approval filing.
The regulatory momentum is underpinned by robust Phase 3 clinical results, which demonstrated that Hydronidone achieved its primary endpoint with high statistical significance.
In a 52-week study of 248 patients, 52.85% of those treated with Hydronidone in combination with entecavir achieved a reduction of at least one stage in liver fibrosis, compared to just 29.84% in the placebo group (P=0.0002).
The drug, a structural analogue of pirfenidone, works by suppressing TGF-β1-induced signal transduction, effectively inhibiting the activation of hepatic stellate cells that drive the progression of scar tissue in the liver.
Financially, Gyre has leveraged its majority-owned subsidiary, Gyre Pharmaceuticals, to maintain a strong operational foundation.
The company reported full-year 2025 revenues of $116.6 million, largely driven by sales of its established idiopathic pulmonary fibrosis (IPF) treatment, Etuary.
While the company reported a net loss for the fiscal year as it accelerated R&D for the Hydronidone pipeline, its gross profit margin remains exceptional at approximately 95%.
This high-margin revenue stream provides the necessary capital to fund the upcoming confirmatory "Phase 3c" clinical trial required to convert a potential conditional approval into full regulatory clearance in China.
Looking forward, Gyre is preparing to submit the formal NDA for conditional approval in the first half of 2026.