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SAN DIEGO - Gyre Therapeutics (NASDAQ: GYRE), currently valued at approximately $988 million, announced that its leading drug candidate, Hydronidone, has achieved its primary endpoint in a pivotal Phase 3 trial for the treatment of liver fibrosis in patients with chronic hepatitis B (CHB) in China. The trial’s results showed a significant regression in liver fibrosis among patients treated with Hydronidone compared to those receiving a placebo. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 3.6, suggesting robust financial flexibility to support its drug development programs.
The double-blind study, conducted over 52 weeks across 39 hospitals in China, enrolled 248 patients with CHB fibrosis. Participants were given Hydronidone (270 mg/day) or a placebo in addition to standard antiviral therapy. The primary endpoint was met, with 52.85% of patients in the Hydronidone group experiencing a ≥1-stage fibrosis regression, significantly higher than the 29.84% observed in the placebo group (P=0.0002). With an impressive gross profit margin of 96.2% in the last twelve months, InvestingPro analysis reveals the company’s efficient operational structure. Subscribers can access 8 additional ProTips and comprehensive financial metrics to better evaluate GYRE’s investment potential.
Hydronidone also demonstrated a favorable safety profile, with serious adverse events reported in 4.88% of patients, compared to 6.45% in the placebo group. There were no discontinuations due to adverse events.
Based on these findings, Gyre plans to submit a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) in Q3 2025, seeking accelerated approval for Hydronidone in CHB-associated liver fibrosis. The company also intends to initiate a U.S. Phase 2 trial for Hydronidone in MASH-associated liver fibrosis in the second half of 2025.
Hydronidone, a structural analogue of Pirfenidone, is designed to inhibit key drivers of liver fibrosis and has shown efficacy in multiple preclinical models. The drug’s development has been supported by a Breakthrough Therapy Designation granted by the NMPA in 2021.
Approximately 75 million people in China are chronically infected with hepatitis B virus, with a significant subset developing CHB with progressive fibrosis. Gyre estimates that around 2.6 million patients in China have compensated F2-F4 CHB fibrosis, highlighting the potential market for Hydronidone. The company reported revenue of $100.6 million in the last twelve months, with InvestingPro data showing an overall Financial Health score of "FAIR," suggesting stable positioning for market expansion. Analysts maintain a strong buy consensus with a significant upside potential from current trading levels.
The company plans to publish the primary results in a peer-reviewed journal and present the full trial data at a future medical congress. This press release statement serves as the basis for the information provided in this article.
In other recent news, Gyre Therapeutics reported fourth-quarter revenue of $27.87 million and provided a 2025 revenue guidance that did not meet analyst expectations. The company anticipates 2025 revenue between $118 million and $128 million, which, although representing growth over 2024, falls short of the $135.7 million analysts projected. Gyre’s guidance factors in the launch of new products, nintedanib and avatrombopag, in China this year. Additionally, the company has initiated a public offering of its common stock, with plans to use the proceeds for its Phase 2 clinical trial of F351 for liver fibrosis and other corporate purposes.
Gyre Therapeutics is also advancing its clinical trials, having recently published the protocol for its Phase 3 trial on hydronidone for liver fibrosis, with patient enrollment completed in October 2024. Meanwhile, the company has received approval from China’s National Medical Products Administration to begin a clinical trial for pirfenidone, targeting radiation-induced lung injury and checkpoint inhibitor pneumonitis. This trial aims to explore the drug’s potential in treating lung injuries in cancer patients.
Analysts from Jefferies LLC and H.C. Wainwright & Co. are involved in Gyre’s public stock offering, with Jefferies leading as the book-running manager. The company ended 2024 with $51.2 million in cash and investments, highlighting its financial position as it moves forward with both commercial and clinical endeavors.
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