China NMPA Approves JASCAYD Nerandomilast As First New Therapy In Over Five Years For Adults With Progressive Pulmonary Fibrosis

China’s National Medical Products Administration (NMPA) has approved JASCAYD® (nerandomilast) as a new treatment for adults with progressive pulmonary fibrosis (PPF), marking the first new therapy for this condition in more than five years. The approval is based on the largest clinical trial program in PPF to date and offers new treatment options for patients facing limited therapies and declining lung function. Nerandomilast is the only preferential phosphodiesterase 4B (PDE4B) inhibitor approved for this indication, with immunomodulatory, vascular, and antifibrotic effects.

Professor Xu Zuojun, Chief Physician at the Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, emphasized that PPF leads to continuous lung function decline, posing serious risks to patients. He noted that current treatment options are very limited, and the encouraging Phase III results for nerandomilast demonstrate a significant slowing of lung function decline while maintaining good safety and tolerability. These outcomes are expected to improve patient adherence to long-term treatment and provide new hope for those affected.

Progressive pulmonary fibrosis affects up to 5.6 million people worldwide and can arise from underlying conditions such as rheumatoid arthritis or systemic sclerosis, as well as environmental exposures to asbestos, silica, or other toxins. As PPF advances, daily activities become increasingly difficult, and the risk of mortality rises. Patients often delay or discontinue treatment, which can worsen symptoms and reduce quality of life over time.

Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, stated that the approval provides a new treatment option for people living with this progressive and life-threatening condition, representing a major advancement in a field with limited innovation. He added that while this initial approval in China is a pivotal milestone, efforts are ongoing to make JASCAYD accessible to patients globally as quickly as possible.

The approval is supported by data from the Phase III FIBRONEER™-ILD trial, which showed that nerandomilast met its primary endpoint of absolute change from baseline in Forced Vital Capacity (FVC) at week 52 versus placebo. FVC is a key measure of lung function, and the results indicate that nerandomilast effectively slows lung function decline in PPF patients. The trial also demonstrated favorable safety and tolerability, with low discontinuation rates and no requirement for liver monitoring. Additionally, nerandomilast showed a nominally significant reduction in the risk of death in the trial.

Alison Zheng, Founder of the Chinese Organization for Scleroderma, highlighted the challenges faced by PPF patients and expressed that the approval of nerandomilast brings new hope, addressing the urgent need for effective treatment options. The approval in PPF follows closely after nerandomilast’s NMPA approval for idiopathic pulmonary fibrosis (IPF) just seven weeks earlier.