Jascayd (nerandomilast) approved in China for the treatment of idiopathic pulmonary fibrosis – Boehringer Ingelheim

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 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. FVC is a key measure of lung function, and the findings indicate that the drug effectively slows the decline in lung function in IPF patients. Furthermore, as monotherapy, nerandomilast demonstrated a favorable tolerability and safety profile with discontinuation rates comparable to 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.”

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