Boehringer Ingelheim (BI) has secured China National Medical Products Administration (NMPA) approval for PDE4B inhibitor nerandomilast as the first new idiopathic pulmonary fibrosis (IPF) treatment in a decade, following the successful Phase III FIBRONEER trial meeting its primary endpoint of forced vital capacity (FVC) improvement at 52 weeks. The oral small molecule selectively targets a PDE4B isoform highly expressed in lung tissue, demonstrating anti-fibrotic and anti-inflammatory effects in progressive respiratory disease with median survival of 3 years post-diagnosis. Full data will be presented later this year, confirming clinical benefit in the largest IPF Phase III study conducted to date.

IPF affects approximately 50,000 patients in China with increasing incidence rates, and was included in China's first rare disease catalogue in 2018. Current treatment options remain limited, with high unmet need for disease-modifying therapies addressing relentless lung function decline and quality of life impairment. Nerandomilast's novel mechanism inhibits the cAMP degradation pathway involved in fibroblast proliferation and collagen deposition characteristic of progressive fibrotic lung remodelling, offering a new therapeutic approach beyond anti-fibrotic agents targeting tyrosine kinase pathways.

According to PharmCube's NextBiopharm® database, nerandomilast is under development in five other lung diseases. Click here to request a free trial for NextBiopharm®.