Gyre's Hydronidone on Fast Track to Treat Liver Fibrosis in China

By Sam Lidman

SAN DIEGO, CA – January 05, 2026 – Gyre Therapeutics announced a significant breakthrough in its efforts to combat liver disease in China, securing alignment with the country's top drug regulator on an expedited path to market for its novel anti-fibrotic therapy, Hydronidone. The agreement with China's Center for Drug Evaluation (CDE) paves the way for a conditional approval filing based on existing robust Phase 3 data, potentially making Hydronidone the first approved therapy for millions of patients suffering from liver fibrosis associated with chronic hepatitis B (CHB).

Following a successful Pre–New Drug Application (Pre-NDA) meeting, the CDE agreed that Gyre's data for Hydronidone are supportive of a submission for conditional approval. The agency also indicated that the drug meets the criteria for its Priority Review program, a designation designed to accelerate the evaluation of innovative therapies that address significant unmet medical needs. This dual regulatory advantage positions Gyre to file its NDA in the first half of 2026 and could substantially shorten the review timeline from the standard 200 working days to just 130.

“We are encouraged by the positive and constructive Pre-NDA dialogue with the CDE and the alignment achieved on a clear regulatory pathway,” said Ping Zhang, Interim Chief Executive Officer of Gyre. “This milestone reflects the strength of our Phase 3 clinical data and supports our plans to advance Hydronidone toward conditional approval in China.”

The news sent Gyre's stock (Nasdaq: GYRE) surging over 15% in trading, as investors reacted enthusiastically to the de-risking of the drug's path to a major market. Analysts quickly followed suit, with firms like H.C. Wainwright reiterating a "Buy" rating and an $18 price target, citing the accelerated revenue potential in a large, underserved patient population.

A Landmark Regulatory Milestone

Securing a consensus with the CDE on a conditional approval pathway is a critical strategic victory for Gyre. This expedited route, which the NMPA has increasingly used to bring vital medicines to patients faster, is reserved for drugs targeting serious conditions with no effective treatments. Hydronidone's journey was previously bolstered by a Breakthrough Therapy Designation from the NMPA in March 2021, which recognized its potential early on.

China's expedited pathways have become a cornerstone of its pharmaceutical regulatory reform. In 2023, over a third of all new drugs approved in the country utilized at least one fast-track program. While conditional approvals are most common for cancer drugs, Hydronidone's progression signals the CDE's commitment to addressing other urgent public health crises.

Conditional approval, however, is not the final step. To convert it into a full, regular approval, Gyre must conduct an additional confirmatory clinical trial, which the company refers to as a Phase 3c study. This trial will be designed to evaluate long-term, liver-related clinical outcomes, providing the definitive evidence of the drug's benefit. While this process can take several years—historical data shows a median of five years for conversion—it provides a clear framework for market access while further data is collected.

Addressing a Vast Unmet Need in China

The potential impact of Hydronidone in China cannot be overstated. The country bears a significant portion of the global burden of chronic hepatitis B, with an estimated 60 to 70 million people infected. Of those, approximately 2.6 million are believed to have clinically significant liver fibrosis or early-stage cirrhosis, the direct target population for Hydronidone. For these individuals, the progression of liver scarring is a silent threat that can lead to liver failure, cancer, and death.

Currently, there are no approved anti-fibrotic therapies specifically for CHB-associated liver fibrosis in China. The standard of care relies on antiviral medications like entecavir and tenofovir, which suppress the hepatitis B virus but do not directly target the underlying fibrotic damage to the liver. While some Traditional Chinese Medicines (TCM) are used to treat liver fibrosis, Hydronidone represents a modern, targeted pharmacological intervention.

The Phase 3 trial data underscores the drug's potential to fill this therapeutic void. When added to standard antiviral therapy, Hydronidone demonstrated a statistically significant reversal of liver scarring. This direct anti-fibrotic action is precisely what physicians and patients have been waiting for to halt or even reverse the relentless progression of the disease.

The Science and Strategy Behind Hydronidone

Hydronidone is a novel, orally administered small molecule that is a structural analogue of pirfenidone. Gyre's majority-owned subsidiary in China, Gyre Pharmaceuticals, already successfully markets pirfenidone (as ETUARY®) for a fibrotic lung disease, giving the company deep experience in the anti-fibrotic space. Hydronidone, however, boasts a unique metabolic profile that may contribute to an improved liver safety profile.

Its mechanism of action targets the core biological process of fibrosis. The drug works by attenuating the activation of hepatic stellate cells—the primary cells responsible for producing scar tissue in the liver. It achieves this by disrupting a key signaling pathway known as TGF-β/Smad, effectively turning down the genetic instructions that drive fibrogenesis.

The strength of this approach was validated in Gyre's pivotal 52-week Phase 3 study conducted across 39 hospitals in China. The trial's topline results, announced in May 2025, were compelling: 52.85% of patients treated with Hydronidone achieved at least a one-stage regression in liver fibrosis, as measured by histologic assessment, compared to just 29.84% in the placebo group. The results were highly statistically significant (p=0.0002) and were achieved with a favorable safety profile, with no patients discontinuing the trial due to adverse events.

To further bolster the drug's scientific credibility, Gyre is scheduled to present these detailed findings at The Liver Meeting® 2025, the prestigious annual conference of the American Association for the Study of Liver Diseases (AASLD), where the abstract has already been selected as a “Poster of Distinction.”

Gyre's China-First Approach and Global Ambitions

This regulatory milestone is a capstone on Gyre's well-defined, China-focused strategy. By leveraging its established commercial infrastructure and R&D capabilities through Gyre Pharmaceuticals, the San Diego-based company has positioned itself to capture a commanding lead in a multi-billion-dollar market. The subsidiary is already a commercial-stage entity, with its existing product ETUARY® generating over $105 million in net sales in 2024.

The potential revenue from Hydronidone in China is expected to be a significant growth driver and will help fund Gyre's broader "fibrosis-first" pipeline. This includes advancing Hydronidone for other indications and markets, most notably for metabolic dysfunction-associated steatohepatitis (MASH) in the United States. The company plans to initiate a Phase 2 trial for MASH in the second half of 2025, where it envisions Hydronidone as a complementary therapy to the metabolic drugs currently dominating that space.

For now, all eyes are on the upcoming NDA submission in China. The alignment with the CDE not only provides a clear path forward for Hydronidone but also validates Gyre's strategic decision to invest heavily in a market with both immense need and an increasingly sophisticated regulatory environment. The successful launch of Hydronidone could transform the treatment paradigm for chronic liver disease in China and cement Gyre's position as a global leader in fibrosis therapy.