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]

Company Overview - Gyre Therapeutics is pioneering fibrosis treatment with a track record of success, evidenced by the approval of pirfenidone in China in 2011[7] - The company has treated over 150,000 IPF patients with pirfenidone[7] - Gyre has maintained an approximately 50% IPF market share in China, with over 90% share in pirfenidone in 2024[7] - Gyre's revenue grew at approximately 32% CAGR since 2017, with 2023 revenue at $113.5 million and 2024 revenue at $105.8 million[7] Hydronidone Clinical Trial Results and Regulatory Pathway - In a Phase 3 trial for CHB-associated liver fibrosis, Hydronidone showed a statistically significant ≥1-stage fibrosis regression at Week 52: 52.85% vs Placebo: 29.84% (P = 0.0002)[14] - Hydronidone also achieved a key secondary endpoint with ≥1-grade inflammation improvement without fibrosis progression at Week 52: 49.57% vs Placebo: 34.82% (P = 0.0246)[14] - Serious Adverse Events in the Hydronidone group were 4.88% (6/123) compared to 6.45% (8/124) in the Placebo group[16] - The company expects to file a New Drug Application (NDA) to NMPA in Q3 2025 for Hydronidone, seeking accelerated approval[16] Market Opportunity and Expansion - In China, the total HBV infected population is estimated at 60-70 million, with 2.6 million diagnosed compensated F2-F4 fibrosis patients as the initial target for Hydronidone[21] - The MASH fibrosis market in the U S is approximately 7 2 times larger than the CHB fibrosis market[25]