Gyre Therapeutics Announces Publication of Protocol for Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis in Journal of Clinical and Translational Hepatology
Gyre Therapeutics (GYRE) has published the protocol for its Phase 3 trial of hydronidone (F351) in the Journal of Clinical and Translational Hepatology. The trial evaluates the treatment of liver fibrosis in patients with chronic hepatitis B (CHB).
The randomized, double-blind, placebo-controlled multicenter study has completed enrollment of 248 patients across 44 clinical research hospitals in China. Patients were divided equally between F351 and placebo groups, with both receiving entecavir antiviral basic therapy for CHB. The primary endpoint measures the decrease in liver fibrosis by at least one stage after 52 weeks using the Ishak Scoring System.
The drug received 'Breakthrough Therapy' designation from China's NMPA in 2021. Topline results are expected in Q2 2025.
Gyre Therapeutics (GYRE) ha pubblicato il protocollo per il suo studio di Fase 3 su hydronidone (F351) nel Journal of Clinical and Translational Hepatology. Lo studio valuta il trattamento della fibrosi epatica in pazienti con epatite B cronica (CHB).
Lo studio multicentrico, randomizzato, in doppio cieco e controllato con placebo ha completato l'arruolamento di 248 pazienti in 44 ospedali di ricerca clinica in Cina. I pazienti sono stati divisi equamente tra i gruppi F351 e placebo, con entrambi che ricevevano terapia antivirale di base con entecavir per la CHB. L'endpoint primario misura la diminuzione della fibrosi epatica di almeno un grado dopo 52 settimane utilizzando il Sistema di Punteggio Ishak.
Il farmaco ha ricevuto la designazione di 'Breakthrough Therapy' dall'NMPA cinese nel 2021. I risultati preliminari sono attesi nel secondo trimestre del 2025.
Gyre Therapeutics (GYRE) ha publicado el protocolo para su ensayo de Fase 3 de hydronidona (F351) en el Journal of Clinical and Translational Hepatology. El ensayo evalúa el tratamiento de la fibrosis hepática en pacientes con hepatitis B crónica (CHB).
El estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo ha completado la inscripción de 248 pacientes en 44 hospitales de investigación clínica en China. Los pacientes se dividieron equitativamente entre los grupos de F351 y placebo, recibiendo ambos terapia antiviral básica con entecavir para la CHB. El objetivo primario mide la disminución de la fibrosis hepática en al menos un grado después de 52 semanas utilizando el Sistema de Puntuación Ishak.
El fármaco recibió la designación de 'Breakthrough Therapy' de la NMPA de China en 2021. Se esperan resultados preliminares en el segundo trimestre de 2025.
Gyre Therapeutics (GYRE)는 Journal of Clinical and Translational Hepatology에 hydronidone (F351)의 3상 시험 프로토콜을 발표했습니다. 이 시험은 만성 B형 간염(CHB) 환자에서 간 섬유증 치료를 평가합니다.
무작위 이중 맹검 위약 대조 다기관 연구는 중국의 44개 임상 연구 병원에서 248명의 환자 등록을 완료했습니다. 환자들은 F351 그룹과 위약 그룹으로 균등하게 나뉘었으며, 두 그룹 모두 CHB에 대한 기본 항바이러스 치료로 엔테카비르를 받았습니다. 주요 평가 지표는 Ishak 점수 시스템을 사용하여 52주 후에 간 섬유증이 최소한 한 단계 감소하는지를 측정합니다.
이 약물은 2021년 중국 NMPA로부터 'Breakthrough Therapy' 지정을 받았습니다. 상위 결과는 2025년 2분기에 예상됩니다.
Gyre Therapeutics (GYRE) a publié le protocole de son essai de Phase 3 sur l'hydronidone (F351) dans le Journal of Clinical and Translational Hepatology. L'essai évalue le traitement de la fibrose hépatique chez des patients atteints d'hépatite B chronique (CHB).
L'étude multicentrique, randomisée, en double aveugle et contrôlée par placebo a complété l'inscription de 248 patients dans 44 hôpitaux de recherche clinique en Chine. Les patients ont été répartis également entre les groupes F351 et placebo, les deux recevant une thérapie antivirale de base avec de l'entécavir pour la CHB. Le critère principal mesure la diminution de la fibrose hépatique d'au moins un stade après 52 semaines en utilisant le Système de Notation Ishak.
Le médicament a reçu la dénomination de 'Breakthrough Therapy' de l'NMPA chinois en 2021. Les résultats préliminaires sont attendus au deuxième trimestre 2025.
Gyre Therapeutics (GYRE) hat das Protokoll für seine Phase-3-Studie zu Hydronidon (F351) im Journal of Clinical and Translational Hepatology veröffentlicht. Die Studie bewertet die Behandlung von Leberfibrose bei Patienten mit chronischer Hepatitis B (CHB).
Die randomisierte, doppelblinde, placebokontrollierte multizentrische Studie hat die Rekrutierung von 248 Patienten in 44 klinischen Forschungszentren in China abgeschlossen. Die Patienten wurden gleichmäßig zwischen den Gruppen F351 und Placebo aufgeteilt, wobei beide die antivirale Basistherapie mit Entecavir für CHB erhielten. Der primäre Endpunkt misst die Verringerung der Leberfibrose um mindestens eine Stufe nach 52 Wochen unter Verwendung des Ishak-Bewertungssystems.
Das Medikament erhielt 2021 die 'Breakthrough Therapy'-Einstufung von der NMPA Chinas. Die vorläufigen Ergebnisse werden im 2. Quartal 2025 erwartet.
- Phase 3 trial successfully completed enrollment of 248 patients
- Drug has 'Breakthrough Therapy' designation in China
- Topline results expected in near-term (Q2 2025)
- Results to Chinese market only
- Efficacy data not yet available
SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled “Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial” in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B (“CHB”). The published protocol outlines patient inclusion criteria, randomization and blinding processes, key assessments, and the statistical analysis plan.
The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial (NCT05115942) completed the enrollment of 248 patients across 44 clinical research hospitals in the People’s Republic of China (“PRC”) in October 2024. Patients were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB. The primary endpoint is a decrease in liver fibrosis (as measured by the Ishak Scoring System) by at least one stage after 52 weeks of treatment relative to baseline.
The PRC’s National Medical Products Administration (“NMPA”) designated F351 as a “Breakthrough Therapy” in 2021. Gyre expects to report topline results from this Phase 3 trial in the second quarter of 2025.
About Hydronidone (F351)
F351 is a next-generation anti-fibrotic compound and a structural analogue of Pirfenidone, the first approved treatment for idiopathic pulmonary fibrosis (“IPF”) in Japan, the European Union, the United States and the PRC. F351's dual mechanism has been shown to inhibit in vitro p38γ kinase activity and TGF-β1-driven collagen overproduction—both key drivers of liver fibrosis. F351 specifically targets hepatic stellate cells (“HSCs”), which are central to the progression of fibrosis. In preclinical studies, it has shown strong anti-proliferative and anti-fibrotic effects on HSCs. These effects have been validated across multiple in vivo models of liver fibrosis, including CCl4-induced liver fibrosis in mice, DMN- and HSA-induced liver fibrosis in rats, and a mouse model of MASH fibrosis (a form of MASH with fibrosis) induced by CCl4 plus a Western high-fat diet. Together, these results highlight F351’s potential as a differentiated treatment for liver fibrosis, with a unique mechanism and strong preclinical and clinical evidence supporting its advancement into later-stage development.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company's experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, 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 readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC. 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 the Company may make with the Securities and Exchange Commission.
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.
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FAQ
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