勃林格殷格翰IPF新药获批，打破十年市场垄断，百亿级呼吸赛道迎来重估

Core Insights - Boehringer Ingelheim's oral PDE4B inhibitor Nerandomilast has received priority review approval for the treatment of idiopathic pulmonary fibrosis (IPF), marking the first new drug approval in this area in over a decade [1][6] - This approval signifies a breakthrough in IPF treatment, as it is the first drug to meet primary endpoints in a Phase III clinical trial in ten years [1][6] Drug Information - Nerandomilast, also known as Jascayd, is a novel PDE4B inhibitor developed by Boehringer Ingelheim, targeting the PDE4B enzyme which is highly expressed in the lungs and associated with fibrosis and inflammation [3][6] - The drug has shown dual effects of anti-fibrosis and anti-inflammation, potentially benefiting IPF patients clinically [3] Market Dynamics - The IPF market is currently dominated by Boehringer Ingelheim's Nintedanib and Roche's Pirfenidone, with Nerandomilast's entry creating a "three-horse race" in IPF treatment [7] - Nintedanib's patent expiration is set for 2029, and Pirfenidone faces generic competition, indicating a shift in market dynamics with the introduction of Nerandomilast [7] Clinical Development - Nerandomilast received breakthrough therapy designation from the FDA in 2022, highlighting its potential in IPF treatment [6] - The drug's approval in China was based on positive results from the pivotal Phase III clinical trial FIBRONEER™-IPF, which was the first to achieve primary endpoints in a decade [6][10] Future Prospects - Following its approval, Nerandomilast is expected to bring new hope to patients with rare pulmonary fibrosis conditions [10] - The company has submitted an application for Nerandomilast for the indication of progressive pulmonary fibrosis, which could further expand its treatment scope [10]