Nerandomilast

The approval marks the first new treatment option for people living with progressive pulmonary fibrosis (PPF) in more than five years. PPF is a rare lung condition, more life-threatening than many forms of cancer, causing a continuous decline in lung function.1,2,3 PPF is the second approved indication in China for nerandomilast, following recent approvals in the U.S. and China for the treatment of idiopathic pulmonary fibrosis (IPF).4,5 China’s National Medical Products Administration (NMPA) has approved JASCAYD® (nerandomilast) as the first new treatment for adults with progressive pulmonary fibrosis (PPF) in more than five years, marking a breakthrough for millions affected by the life-threatening lung condition.4 The approval, based on the largest clinical trial program in PPF to date, offers new hope for patients facing limited options and declining lung function. Nerandomilast is the only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory, vascular, and antifibrotic effects to be approved in this indication.6,7 “PPF may lead to a continuous decline in lung function, posing a serious threat to patients' lives,” said Professor Xu Zuojun, Chief Physician of the Department of Respiratory and Critical Care Medicine of Peking Union Medical College Hospital. “Current treatment options for PPF are very limited, and there is an urgent need to improve both the survival time and quality of life for these patients. We are pleased to see that nerandomilast has demonstrated highly encouraging results in Phase III clinical trials, significantly slowing the decline in lung function while showing good safety and tolerability. This will help improve adherence to long-term treatment and brings new hope for patients.” Affecting up to 5.6 million people worldwide, PPF may develop in people with underlying conditions, such as rheumatoid arthritis or systemic sclerosis. It can also be caused by environmental exposure to asbestos, silica or other toxins.1,8,9 As PPF progresses, everyday activities become increasingly difficult and the risk of death increases.2,8,10 Unfortunately, people with PPF often delay or discontinue treatment, leaving them vulnerable to worsening symptoms and reduced quality of life as the disease progresses.11,12 “For the first time, people living with PPF will have access to a new treatment option for this progressive and life-threatening condition – a major advancement in a field where innovation has been scarce,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “While this initial approval in China represents a pivotal milestone for the PPF community, we are working tirelessly to ensure patients around the world can benefit from JASCAYD as quickly as possible.” The approval is based on results from the pivotal Phase III clinical trial FIBRONEERTM-ILD. Results showed that nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity (FVC) [mL] at week 52 versus placebo.7 FVC is a key measure of lung function, and the findings indicate that the drug effectively slows the decline of lung function in PPF patients.7 Furthermore, nerandomilast demonstrated favorable safety and tolerability, with low discontinuation rates and no requirement for liver monitoring.7 In the FIBRONEER™-ILD trial, nerandomilast also improved survival shown by a nominally significant reduced risk of death.4 "I deeply understand the immense challenges that patients with PPF face in their daily lives. We have long been awaiting advancements that can address some of the challenges related to existing treatment options,” said Alison Zheng, Founder of the Chinese Organization for Scleroderma, China’s first scleroderma patient organization. “The approval of nerandomilast for the treatment of PPF brings new hope and reflects the urgent need to address longstanding challenges facing people living with the condition.” The approval of nerandomilast in PPF in China comes just seven weeks after its approval by the NMPA in IPF. Progressive pulmonary fibrosis (PPF) affects up to 5.6 million people worldwide.8 It is progressive and ultimately fatal, associated with irreversible scarring in the lungs that worsens over time.8 The lung scarring may be linked to an underlying disease such as rheumatoid arthritis or systemic sclerosis, or result from exposure to inhaled substances.1,8,9 Chronic scarring of lung tissue in these diseases is often the key driver of early mortality.8 Approximately half of people with PPF lose their life within five years of diagnosis.2 On average, diagnosis is delayed by up to two years and up to half of those diagnosed remain untreated.13,14 Nerandomilast is an oral, preferential PDE4B inhibitor approved in China for the treatment of adult patients with IPF and PPF. It was also approved by the U.S. Food and Drug Administration (FDA) for IPF after securing Priority Review and Breakthrough Therapy Designation and is under priority review by the FDA for the treatment of adults with PPF. Regulatory submissions for nerandomilast in IPF and PPF are also under review in the European Union, the UK, Japan and other countries with additional approvals anticipated in 2026. Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com. References 1Kondoh Y, Inoue Y. Progressive Pulmonary Fibrosis: Current Status in Terminology and Future Directions. Adv Ther. 2025;42(7):2988–3001 2Cen Z, et al. Outcomes and predictors of progression in progressive pulmonary fibrosis. Ann Med. 2024;56(1):2406439. 3Siegel RL, et al. Cancer statistics, 2024. CA: A Cancer Journal for Clinicians. 2024;74(1):12–49. 4JASCAYD® (nerandomilast). Package Insert of Nerandomilast Tablets. China. (Last updated: Dec 2025) 5JASCAYD® (nerandomilast). Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 202. (Last updated: Oct 2025). 6Ofev SmPC — Boehringer Ingelheim, 2025. 7Maher T, et al. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2193-2202. 8Cottin V, et al. The Burden of Progressive-Fibrosing Interstitial Lung Diseases. Front Med (Lausanne). 2022;9:799912. 9Wang J, et al. Pathogenesis and therapeutic targets in pulmonary fibrosis. MedComm. 2024;5:e744. 10Nasser M, Larrieu S, Boussel L, et al. Estimates of epidemiology, mortality and disease burden associated with progressive fibrosing interstitial lung disease in France (the PROGRESS study). Respir Res 2021. 22 :162 11Torrisi S, et al. HRCT and histology in the evaluation of fibrotic lung diseases: A correlation study. Eur Respir Rev. 2017;26(145). 12Levra S et al. Long-term safety of antifibrotic drugs in IPF: a real-world experience. Biomedicines. 2022;10(12):3229. 13Chaudhuri et al. Respiratory Research 2024; 25:364 14Wijsenbeek M et al. Current Medical Research and Opinion 2019; 35 (11): 2015-2024 The content above comes from the network. if any infringement, please contact us to modify.

GRI Bio\'s CEO said new data put the biotech in a good position to move into the next stage of development.\n Barreling toward the end of its cash runway, GRI Bio has shared phase 2a data in idiopathic pulmonary fibrosis (IPF) and made the case for further development of its potentially disease-modifying therapy.The phase 2a study randomized 35 people with IPF to receive GRI-0621 or placebo. GRI-0621 is an oral drug candidate that is designed to inhibit invariant natural killer T-cell activity. Because the cells play a role in inflammatory and fibrotic indications, GRI believes the mechanism could represent a new option for IPF patients whose choices are currently limited to three medicines.After 12 weeks of once-daily oral dosing, GRI found no safety or tolerability concerns, hitting the trial’s primary endpoint. Four-fifths of patients were taking Esbriet, which Legacy Pharma recently bought from Roche, or Boehringer Ingelheim’s Ofev. GRI sees safety as one area in which GRI-0621 may have an edge over the incumbent treatments.Secondary endpoints looked at biomarkers and, in an exploratory analysis, lung function. GRI presented data on biomarkers of collagen synthesis and degradation as evidence that GRI-0621 induced resolution of fibrosis.  Existing IPF treatments, including Boehringer’s recently approved Jascayd, slow disease progress rather than halt or reverse fibrosis and its effect on lung function. A drug that resolves fibrosis would represent a leap forward, but GRI is still some way off from showing GRI-0621 can achieve that goal. The biotech included FVC, a measure of lung function, as an exploratory endpoint in the phase 2a trial. At Week 12, GRI saw increases in FVC in 39% of patients on GRI-0621. Conversely, FVC decreased in 80% of patients on placebo. Adjusted for placebo, FVC increased by 99 mL in patients on GRI-0621 and 139 mL in participants who received GRI’s drug candidate with the standard of care. The biotech also shared the findings of a post hoc analysis that excluded patients with the biggest FVC gains and losses in both arms. In that analysis, the placebo-adjusted gains were 54 mL on GRI-0621 and 81 mL in people who also took standard of care.GRI CEO Marc Hertz, Ph.D., said in a statement that the data put the biotech in a good position to move into the next stage of development. The company told investors in November that it could fund operations into the first quarter of 2026. GRI subsequently offered stock and warrants to raise money. The biotech has a market cap of $4 million and saw its stock slip slightly in premarket trading after the data drop.