Boehringer Ingelheim has announced that its innovative oral therapy JASCAYD® (nerandomilast) has been approved by China’s National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients. This marks the first approval of a new IPF treatment in more than ten years and follows closely on the heels of the drug’s recent U.S. FDA approval, granted just two weeks earlier.
“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 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.”
The NMPA’s approval is based on findings from the pivotal FIBRONEER™-IPF Phase III clinical trial, the largest Phase III study conducted to date in the field of IPF treatment. The trial demonstrated that nerandomilast achieved its primary endpoint—the absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared with placebo. FVC is a critical measure of lung function, and the results confirm that the therapy significantly slows lung function decline in patients with IPF. Moreover, as a monotherapy, nerandomilast exhibited a favorable tolerability and safety profile, with discontinuation rates similar to those seen with placebo.
“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.”
In addition to its approval for IPF, a regulatory submission for nerandomilast in progressive pulmonary fibrosis (PPF) is currently under review by the NMPA, signaling Boehringer Ingelheim’s continued focus on advancing respiratory care and expanding therapeutic options for patients affected by chronic lung diseases.
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