Gyre Therapeutics Announces NMPA Approval for Clinical Trial Evaluating Pirfenidone Capsules in Oncology-Related Pulmonary Complications
Gyre Therapeutics (GYRE) has received NMPA approval in China for a clinical trial evaluating pirfenidone capsules in treating oncology-related pulmonary complications. The study will focus on radiation-induced lung injury (RILI) and checkpoint inhibitor pneumonitis (CIP).
The company plans to conduct an adaptive Phase 2/3 trial to assess pirfenidone's effectiveness beyond its current use in idiopathic pulmonary fibrosis. This expansion targets significant unmet needs, as 5-25% of radiation therapy patients experience lung damage, while 13-19% of patients on immune checkpoint inhibitors develop CIP, accounting for 35% of immune-related adverse event deaths.
The trial is scheduled to begin in the second half of 2025 at leading academic and oncology centers across China. This initiative aims to provide an alternative to corticosteroids, the current standard treatment which has significant long-term side effects.
Gyre Therapeutics (GYRE) ha ricevuto l'approvazione dalla NMPA in Cina per uno studio clinico che valuta l'efficacia delle capsule di pirfenidone nel trattamento delle complicazioni polmonari legate all'oncologia. Lo studio si concentrerà su lesioni polmonari indotte da radiazioni (RILI) e pneumonite da inibitori dei checkpoint (CIP).
L'azienda prevede di condurre uno studio adattivo di Fase 2/3 per valutare l'efficacia del pirfenidone oltre il suo attuale utilizzo nella fibrosi polmonare idiopatica. Questa espansione mira a soddisfare bisogni significativi non soddisfatti, poiché il 5-25% dei pazienti sottoposti a radioterapia sperimenta danni polmonari, mentre il 13-19% dei pazienti in trattamento con inibitori dei checkpoint immunitari sviluppa CIP, rappresentando il 35% delle morti per eventi avversi correlati all'immunità.
Lo studio è programmato per iniziare nella seconda metà del 2025 presso importanti centri accademici e oncologici in tutta la Cina. Questa iniziativa mira a fornire un'alternativa ai corticosteroidi, attuale trattamento standard che presenta significativi effetti collaterali a lungo termine.
Gyre Therapeutics (GYRE) ha recibido la aprobación de la NMPA en China para un ensayo clínico que evalúa las cápsulas de pirfenidona en el tratamiento de complicaciones pulmonares relacionadas con la oncología. El estudio se centrará en lesiones pulmonares inducidas por radiación (RILI) y neumonitis por inhibidores de puntos de control (CIP).
La empresa planea llevar a cabo un ensayo adaptativo de Fase 2/3 para evaluar la efectividad de la pirfenidona más allá de su uso actual en la fibrosis pulmonar idiopática. Esta expansión tiene como objetivo satisfacer necesidades significativas no cubiertas, ya que entre el 5% y el 25% de los pacientes que reciben radioterapia experimentan daño pulmonar, mientras que entre el 13% y el 19% de los pacientes que reciben inhibidores de puntos de control inmunitarios desarrollan CIP, lo que representa el 35% de las muertes por eventos adversos relacionados con la inmunidad.
El ensayo está programado para comenzar en la segunda mitad de 2025 en importantes centros académicos y oncológicos en toda China. Esta iniciativa tiene como objetivo proporcionar una alternativa a los corticosteroides, el tratamiento estándar actual que presenta efectos secundarios significativos a largo plazo.
Gyre Therapeutics (GYRE)는 중국에서 종양 관련 폐 합병증 치료를 위한 피르페니돈 캡슐의 임상 시험에 대해 NMPA 승인을 받았습니다. 이 연구는 방사선 유도 폐 손상 (RILI) 및 체크포인트 억제제 폐렴 (CIP)에 초점을 맞출 것입니다.
회사는 특발성 폐 섬유증에서의 현재 사용을 넘어 피르페니돈의 효과를 평가하기 위해 적응형 2/3상 시험을 실시할 계획입니다. 이 확장은 방사선 치료를 받는 환자의 5-25%가 폐 손상을 경험하고, 면역 체크포인트 억제제를 사용하는 환자의 13-19%가 CIP를 발전시키는 등, 상당한 unmet needs를 해결하는 것을 목표로 합니다. 이는 면역 관련 부작용 사망자의 35%를 차지합니다.
시험은 2025년 하반기에 중국 전역의 주요 학술 및 종양학 센터에서 시작될 예정입니다. 이 이니셔티브는 장기적인 부작용이 큰 현재 표준 치료인 코르티코스테로이드에 대한 대안을 제공하는 것을 목표로 합니다.
Gyre Therapeutics (GYRE) a reçu l'approbation de la NMPA en Chine pour un essai clinique évaluant des capsules de pirfenidone dans le traitement des complications pulmonaires liées à l'oncologie. L'étude se concentrera sur les lésions pulmonaires induites par les radiations (RILI) et la pneumonite causée par des inhibiteurs de points de contrôle (CIP).
L'entreprise prévoit de mener un essai adaptatif de Phase 2/3 pour évaluer l'efficacité du pirfenidone au-delà de son utilisation actuelle dans la fibrose pulmonaire idiopathique. Cette expansion vise à répondre à des besoins non satisfaits significatifs, car 5 à 25 % des patients recevant une radiothérapie subissent des dommages pulmonaires, tandis que 13 à 19 % des patients sous inhibiteurs de points de contrôle immunitaires développent une CIP, représentant 35 % des décès dus à des événements indésirables liés à l'immunité.
L'essai devrait commencer dans la seconde moitié de 2025 dans des centres académiques et oncologiques de premier plan à travers la Chine. Cette initiative vise à fournir une alternative aux corticostéroïdes, le traitement standard actuel qui entraîne des effets secondaires à long terme significatifs.
Gyre Therapeutics (GYRE) hat in China die Genehmigung der NMPA für eine klinische Studie erhalten, die die Wirksamkeit von Pirfenidon-Kapseln bei der Behandlung von onkologisch bedingten Lungenkomplikationen bewertet. Die Studie wird sich auf strahlungsinduzierte Lungenschäden (RILI) und Checkpoint-Inhibitor-Pneumonitis (CIP) konzentrieren.
Das Unternehmen plant, eine adaptive Phase-2/3-Studie durchzuführen, um die Wirksamkeit von Pirfenidon über die derzeitige Anwendung bei idiopathischer Lungenfibrose hinaus zu bewerten. Diese Erweiterung zielt darauf ab, erhebliche unerfüllte Bedürfnisse zu adressieren, da 5-25% der Patienten, die sich einer Strahlentherapie unterziehen, Lungenverletzungen erleiden, während 13-19% der Patienten, die mit Immun-Checkpoint-Inhibitoren behandelt werden, CIP entwickeln, was 35% der Todesfälle durch immunbedingte Nebenwirkungen ausmacht.
Die Studie ist für die zweite Hälfte des Jahres 2025 an führenden akademischen und onkologischen Zentren in ganz China geplant. Diese Initiative zielt darauf ab, eine Alternative zu Kortikosteroiden zu bieten, die gegenwärtig die Standardbehandlung sind und erhebliche langfristige Nebenwirkungen haben.
- NMPA approval received for clinical trial expansion into oncology
- Large potential market: 5-25% of radiation therapy patients and 13-19% of immunotherapy patients
- Addresses unmet medical need with no current targeted therapies
- Potential to replace corticosteroids as standard of care
- Trial results not expected until late 2025 or beyond
- Success in new indication not guaranteed
- to Chinese market initially
Insights
The NMPA approval for Gyre's clinical trial marks a strategic expansion of pirfenidone into oncology supportive care – addressing significant unmet needs in cancer treatment complications. This represents a clever leverage of their existing asset beyond its established role in idiopathic pulmonary fibrosis.
The target conditions present substantial clinical challenges:
The adaptive Phase 2/3 design is particularly notable as it combines dose exploration with efficacy confirmation, potentially accelerating development timelines compared to traditional sequential studies. This approach demonstrates regulatory savvy and development efficiency.
If successful, pirfenidone would become a first-in-class targeted therapy for these conditions, potentially establishing it as a standard component in oncology protocols. The scientific rationale appears sound, as pirfenidone's anti-fibrotic mechanism directly addresses the pathophysiology of these pulmonary complications rather than just managing symptoms.
While this approval only enables clinical testing with no guaranteed success, it represents meaningful pipeline expansion with relatively low development risk given the drug's established safety profile in other fibrotic conditions.
The NMPA approval for pirfenidone's clinical trial in oncology-related pulmonary complications demonstrates Gyre's strategic approach to maximizing asset value through indication expansion. This represents a textbook case of efficient capital allocation, leveraging an existing commercial product into adjacent markets without the considerable expense of developing a novel compound.
The targeted conditions present a compelling market opportunity given the widespread use of radiation therapy and immunotherapy in cancer treatment. With no targeted therapies currently available for these pulmonary complications, pirfenidone could potentially capture significant market share if approved.
The immediate financial impact is minimal since trials won't begin until H2 2025, placing potential revenue contribution several years away. However, this development expands Gyre's long-term growth prospects with relatively additional R&D investment.
The China-focused approach may indicate Gyre's strategic prioritization of the rapidly growing Chinese pharmaceutical market, which has seen accelerating approvals and expanding reimbursement coverage. It remains unclear whether similar development paths are planned for other major markets.
The adaptive trial design suggests operational efficiency that could accelerate time-to-market while optimizing development resources. Investors should view this as a positive indicator of management's focus on pipeline value creation and their ability to navigate complex regulatory pathways across different markets.
SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that the National Medical Products Administration (NMPA) of the People’s Republic of China (“PRC”) has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will evaluate pirfenidone capsules for the treatment of radiation-induced lung injury (RILI), with or without immune-related pneumonitis (CIP).
This regulatory milestone marks the expansion of pirfenidone beyond its established role in idiopathic pulmonary fibrosis (IPF) into the oncology supportive care space, offering a novel lung-protective strategy for cancer patients undergoing radiation therapy or immunotherapy.
In accordance with the NMPA approval, Gyre intends to pursue an adaptive Phase 2/3 clinical trial design, combining dose exploration with efficacy confirmation, to efficiently evaluate pirfenidone's potential in this new indication.
Radiation-Induced Lung Injury (RILI): Radiation therapy is a cornerstone of lung cancer treatment. However,
Checkpoint Inhibitor Pneumonitis (CIP): Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, but
Currently, no targeted therapies exist for lung injuries caused by radiation or immunotherapy. Distinguishing between RILI and CIP is challenging, particularly when both occur concurrently. Corticosteroids remain the standard of care despite significant long-term side effects. By targeting and inhibiting fibrotic pathways, pirfenidone may address the root cause of lung injury progression, offering a new treatment option for patients receiving radiation or immunotherapy.
Gyre anticipates initiating the trial in the second half of 2025 at leading academic and oncology centers across the PRC.
About Pirfenidone
Pirfenidone is an orally administered small molecule approved for the treatment of IPF. It works by inhibiting TGF-β signaling and fibroblast proliferation. The drug has demonstrated clinical benefit in slowing lung function decline in IPF and is now being evaluated for oncology-related pulmonary complications. Gyre has held first-in-class status for pirfenidone in the PRC since its original approval in 2011, underscoring its pioneering role in treating fibrotic lung diseases.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of F351 (Hydronidone) for MASH-associated fibrosis 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 PRC, 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 timing of a clinical trial initiation in the second half of 2025. 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.
For Investors:
Stephen Jasper
stephen@gilmartinir.com
FAQ
What is the potential market impact of GYRE's new pirfenidone trial for cancer-related lung complications?
When will GYRE begin its Phase 2/3 trial for pirfenidone in China?
What advantages does GYRE's pirfenidone offer over current treatments for RILI and CIP?
What percentage of patients could benefit from GYRE's pirfenidone treatment in oncology?
