Ingelheim, Germany

• Approval is based on results from Phase III FIBRONEER™-IPF trial, which showed statistically significant improvements in the absolute change from baseline in Forced Vital Capacity at 52 weeks with nerandomilast 18 mg and 9 mg versus placebo in adults with idiopathic pulmonary fibrosis (IPF)^1,2
• Nerandomilast was included in the priority review by the Centre for Drug Evaluation (CDE) of the NMPA in January this year, and was recently granted FDA approval in the United States.

Boehringer Ingelheim’s JASCAYD® (nerandomilast) has been approved by China’s National Medical Products Administration (NMPA) as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients. This is the first approval in IPF in over a decade and comes only two weeks after being approved by the Food and Drug Administration (FDA) in the United States.

“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,” said Professor Xu Zuojun, chief physician of the Department of Respiratory and Critical Care Medicine of 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.”

The approval in China is based on the pivotal Phase III clinical trial, FIBRONEERTM-IPF, the largest Phase III study conducted to date in the field of IPF treatment. Results showed that nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] at week 52 versus placebo.^1,2 FVC is a key measure of lung function³, and the findings indicate that the drug effectively slows the decline in lung function in IPF patients.^1,2 Furthermore, as monotherapy, nerandomilast demonstrated a favorable tolerability and safety profile with discontinuation rates comparable to placebo.^2,4

“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,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “This milestone reflects our commitment to pioneering innovation for those who need it most.”

A regulatory submission for nerandomilast in progressive pulmonary fibrosis (PPF) is also under review with the National Medical Products Administration (NMPA) of China.

About nerandomilast

Nerandomilast is an oral, preferential inhibitor of PDE4B approved for the treatment of IPF in adult patients. Nerandomilast was approved by the U.S. Food and Drug Administration (FDA) 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 are also under review in Japan and the EU, with filings in other geographies to follow.

About IPF

IPF is one of the more common progressive fibrosing interstitial lung diseases.⁵ IPF substantially impacts quality of life and half of patients succumb to the disease within five years of diagnosis.⁶ In IPF, the root cause of pulmonary fibrosis is not known.⁵ Symptoms and signs of IPF include a dry and persistent cough, shortness of breath, fatigue and finger clubbing (widening and rounding of the topics of the fingers).⁷ IPF may affect up to 3.6 million people worldwide.⁸ The disease primarily affects people over the age of 50 and affects more men than women.⁹

About Boehringer Ingelheim

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

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). https://doi.org/10.1038/s41598-023-31470-6.