Gyre Therapeutics Announces First Dosing in Phase 1 Trial of F230 for Pulmonary Arterial Hypertension in China

Rhea-AI Summary

Gyre Therapeutics (NASDAQ: GYRE) has initiated dosing in a Phase 1 clinical trial for F230, a novel endothelin A receptor antagonist, targeting pulmonary arterial hypertension (PAH) in China. F230, licensed from Eisai Co. through GNI Group Ltd., is designed to reduce pulmonary vascular remodeling and lower pulmonary pressure. The Phase 1 trial will assess safety, tolerability, and pharmacokinetics in healthy volunteers. This expansion aligns with Gyre's fibrosis-first strategy and targets China's PAH market, valued at $370 million in 2023 with projected growth to $480 million by 2031. The company is also advancing Hydronidone (F351), which succeeded in a Phase 3 trial for CHB-fibrosis, with an NDA submission planned for Q3 2025 in China and preparations for a Phase 2 MASH fibrosis trial in the US.

Positive

• Entry into the growing PAH market in China, valued at $370M with projected growth to $480M by 2031
• Successful completion of Phase 3 trial for lead candidate Hydronidone in CHB-fibrosis
• Strategic expansion of pipeline with multiple drug candidates including F230, F573, F528
• Planned NDA submission for Hydronidone in Q3 2025 shows progress toward commercialization

Negative

• Early-stage development of F230 (Phase 1) indicates long pathway to potential commercialization
• Significant competition and regulatory hurdles in both US and China markets
• Multiple ongoing clinical programs may strain company resources

Insights

Biotechnology and Clinical Development Expert

Gyre's first PAH trial dosing expands pipeline beyond liver fibrosis, following positive Phase 3 data for lead asset.

The initiation of Gyre's Phase 1 trial for F230 represents a strategic expansion of their fibrosis-focused pipeline beyond their core liver disease programs. This first-in-human study evaluating their novel endothelin A receptor antagonist marks Gyre's entry into the pulmonary arterial hypertension (PAH) space, a rare cardiovascular condition with high mortality rates and limited treatment options.

F230's mechanism is scientifically sound - by selectively blocking the ETA receptor, it aims to reduce pulmonary vascular remodeling and lower pulmonary pressure, two critical factors in PAH progression. The compound was originally discovered by Eisai and licensed from GNI Group, suggesting external validation of its potential.

This development comes as Gyre's lead asset, Hydronidone (F351), has recently met its primary endpoint in a pivotal Phase 3 trial for CHB-fibrosis, with an NDA submission to China's regulatory authority planned for Q3 2025. The company is also planning a pre-IND meeting with the FDA for a Phase 2 MASH fibrosis trial, indicating parallel advancement in both Chinese and US markets.

While early-stage trials carry inherent risks, Gyre's strategic expansion into PAH, which has a $370 million market in China projected to grow to $480 million by 2031, demonstrates a thoughtful approach to building a diverse anti-fibrotic portfolio addressing multiple organ systems. The successful completion of Phase 3 for their lead asset provides some risk mitigation as they advance this secondary program.

SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A (“ETA”) receptor antagonist, for the treatment of pulmonary arterial hypertension (“PAH”).

This milestone marks Gyre’s entry into the PAH field, a rare, progressive, and high-mortality cardiovascular condition with limited treatment options. PAH is recognized in China’s National Rare Disease Catalog, underscoring its significance in public health. According to Frost & Sullivan, China’s PAH market was valued at $370 million in 2023 and is projected to grow to $480 million by 2031.

F230, originally discovered by Eisai Co., Ltd. and exclusively licensed by GNI Group Ltd. to Gyre, is a fully synthetic small molecule designed to selectively block the ETA receptor. By targeting this pathway, F230 is designed to reduce pulmonary vascular remodeling and lower pulmonary pressure, key contributors to PAH progression.

The Phase 1 trial is designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. The trial represents the latest expansion of Gyre’s fibrosis-first strategy beyond the liver, leveraging a robust clinical development platform and commercial infrastructure in China.

F230 joins Gyre’s pipeline alongside lead candidate Hydronidone (F351), which met the primary endpoint in a pivotal Phase 3 trial for CHB-fibrosis. A New Drug Application (“NDA”) submission to China’s National Medical Products Administration (“NMPA”) is planned for the third quarter of 2025, and a pre-IND meeting with the U.S. Food and Drug Administration is being planned for an expected Phase 2 trial in metabolic dysfunction-associated steatohepatitis (“MASH”) fibrosis.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning the expectations regarding Gyre’s research and development efforts and timing of expected clinical trials, including an NDA submission to the NMPA for F351, the expected clinical benefits of F230 and expectations regarding interactions with regulators. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:
David Zhang
Gyre Therapeutics
david.zhang@gyretx.com

FAQ

What is the market potential for GYRE's F230 drug in China's PAH market?

China's PAH market was valued at $370 million in 2023 and is projected to grow to $480 million by 2031, according to Frost & Sullivan.

When does Gyre Therapeutics plan to submit the NDA for Hydronidone in China?

Gyre plans to submit the New Drug Application (NDA) to China's National Medical Products Administration (NMPA) in the third quarter of 2025.

What is the mechanism of action for GYRE's F230 drug?

F230 is a fully synthetic small molecule designed to selectively block the endothelin A (ETA) receptor, reducing pulmonary vascular remodeling and lowering pulmonary pressure.

What stage is GYRE's F230 clinical trial currently in?

F230 has just begun Phase 1 clinical trials, with the first volunteer being successfully dosed to evaluate safety, tolerability, and pharmacokinetics.

What are the main therapeutic areas for Gyre Therapeutics (GYRE)?

Gyre focuses on fibrosis-first therapies across organ systems, including liver fibrosis (MASH and CHB-fibrosis) and pulmonary arterial hypertension (PAH).