Boehringer Ingelheim Jascayd gets nod in China for idiopathic pulmonary fibrosis

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.

“The 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.