China Approves JASCAYD® (nerandomilast) for Idiopathic Pulmonary Fibrosis (IPF) Treatment

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Ingelheim, Germany

  • The approval stems from the robust outcomes of the Phase III FIBRONEER™-IPF trial, which demonstrated statistically significant enhancements in the absolute change from baseline in Forced Vital Capacity (FVC) at 52 weeks among adults with idiopathic pulmonary fibrosis (IPF) treated with nerandomilast (both 18 mg and 9 mg doses) compared to placebo1,2.
  • Having received priority review status from the Centre for Drug Evaluation (CDE) of the NMPA in January, nerandomilast recently also secured FDA approval in the United States.

China’s National Medical Products Administration (NMPA) has granted approval for Boehringer Ingelheim’s JASCAYD® (nerandomilast) as an oral treatment for adult patients suffering from idiopathic pulmonary fibrosis (IPF). This marks the first such approval for IPF in over a decade, arriving just two weeks after its endorsement by the U.S. Food and Drug Administration (FDA).

“IPF has long been a difficult disease to diagnose and manage, marked by a progressive decline in lung function and a profound impact on patients’ daily lives,” stated Professor Xu Zuojun, chief physician of the Department of Respiratory and Critical Care Medicine at Peking Union Medical College Hospital. “As the first innovative therapy in over a decade to achieve the primary endpoint in a Phase III clinical trial, nerandomilast not only demonstrates significant clinical efficacy but also offers favorable tolerability. We look forward to seeing this innovative therapy benefit more patients soon, providing a novel solution in the fight against this disease.”

This Chinese approval is underpinned by the pivotal Phase III FIBRONEERTM-IPF clinical trial, recognized as the most extensive Phase III study in IPF treatment to date. The trial results confirmed that nerandomilast successfully achieved its primary endpoint: the absolute change from baseline in Forced Vital Capacity [mL] at week 52, when compared to placebo.1,2 Forced Vital Capacity (FVC) serves as a crucial indicator of lung function3, and these findings underscore the drug’s effectiveness in decelerating the progression of lung function decline in IPF patients.1,2 Moreover, when administered as monotherapy, nerandomilast showcased a favorable tolerability and safety profile, with discontinuation rates on par with those observed in the placebo group.2,4

Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, commented, “Today’s approval of nerandomilast in China is a breakthrough for people living with idiopathic pulmonary fibrosis—a disease defined by relentless loss of lung function and a heavy burden on patients and families. This milestone reflects our commitment to pioneering innovation for those who need it most.”

Separately, a regulatory submission for nerandomilast targeting progressive pulmonary fibrosis (PPF) is currently undergoing review by China’s National Medical Products Administration (NMPA).

About nerandomilast

Nerandomilast is an oral, selective PDE4B inhibitor indicated for the treatment of IPF in adult patients. In the U.S., it received approval from the Food and Drug Administration (FDA) following Priority Review and Breakthrough Therapy Designation, and is also undergoing priority review by the FDA for treating adults with PPF.

Further regulatory applications for nerandomilast in IPF are pending review in Japan and the European Union, with submissions in additional regions anticipated.

About IPF

Idiopathic Pulmonary Fibrosis (IPF) stands as one of the more prevalent progressive fibrosing interstitial lung diseases.5 This condition significantly diminishes patients’ quality of life, with approximately half of those diagnosed succumbing to the disease within five years.6 The underlying cause of pulmonary fibrosis in IPF remains unknown.5 Common symptoms and signs of IPF encompass a dry, persistent cough, breathlessness, fatigue, and finger clubbing (characterized by the widening and rounding of the fingertips).7 Globally, IPF has the potential to impact up to 3.6 million individuals.8 It predominantly affects individuals over 50 years of age, with a higher incidence in men than in women.9

About Boehringer Ingelheim

Boehringer Ingelheim operates as a biopharmaceutical firm engaged in both human and animal health sectors. Recognized as a leading industry investor in research and development, the company is dedicated to creating innovative therapies designed to enhance and prolong lives in areas with significant unmet medical needs. Established in 1885 and remaining independent, Boehringer adopts a long-term vision, integrating sustainability across its entire value chain. With approximately 54,500 employees, the company serves over 130 markets, striving to foster a healthier and more sustainable future. For additional information, visit .

References

  1. JASCAYD (nerandomilast) Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2025.
  2. Richeldi, Luca, Azuma, Arata, Cottin, Vincent, et al. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. NEJM. 2025; 392:2193-2202. doi: 10.1056/NEJMoa2414108.
  3. Twisk JWR et al. (1998). Tracking of lung function parameters and the longitudinal relationship with lifestyle. European Respiratory Journal. 12(3):627–634.
  4. Oldham J, et al. (2025) Efficacy, safety and tolerability of nerandomilast in patients with pulmonary fibrosis: pooled data from the FIBRONEER-IPF and FIBRONEER-ILD trials. Poster, ERS 2025.
  5. Sauleda J, Núñez B, Sala E, Soriano JB. Idiopathic Pulmonary Fibrosis: Epidemiology, Natural History, Phenotypes. Med Sci (Basel). 2018;6(4):110. doi:10.3390/medsci6040110.
  6. Zheng Q, Cox IA, Campbell JA, et al. Mortality and survival in idiopathic pulmonary fibrosis: a systematic review and meta-analysis. ERJ Open Res. 2022 Mar 14;8(1):00591-2021. doi: 10.1183/23120541.00591-2021. PMID: 35295232; PMCID: PMC8918939.
  7. Alsomali H, Palmer E, Aujayeb A, Funston W. Early Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis: A Narrative Review. Pulm Ther. 2023 Jun;9(2):177-193. doi: 10.1007/s41030-023-00216-0. Epub 2023 Feb 11. Erratum in: Pulm Ther. 2023 Sep;9(3):459. doi: 10.1007/s41030-023-00235-x. PMID: 36773130; PMCID: PMC10203082.
  8. Podolanczuk A, et al. Update in interstitial lung disease 2023. Eur Respir J. 2023;61(4).
  9. John, J., Clark, A.R., Kumar, H. et al. Pulmonary vessel volume in idiopathic pulmonary fibrosis compared with healthy controls aged > 50 years. Sci Rep 13, 4422 (2023). .