10月22日，勃林格殷格翰宣布，其口服磷酸二酯酶4B（PDE4B）抑制剂那米司特（Nerandomilast）通过优先审评审批程序获批上市，用于治疗成人特发 性肺纤维化（IPF），这是十年来首个在III期临床试验中达到主要终点并成功获批的IPF治疗药物，打破了该领域十余年无新药获批的僵局，标志着IPF治 疗领域的突破性进展。 | 1 那米司特 | | 全球药物研发>详情 | | --- | --- | --- | | 4 下载报告 | | | | 基本信息 | | | | | 那米司特 研发代码: BI-1015550 | 重要上市事件 全部上市事件 | | 药品名称 | 商品名: Jascayd | ● 展示药品在各个国家/地区首次批准的适应症、上市时间及研发企业 | | | 别名:nerandomilast | | | 创新类型 | 创新药 | 国家/地区 V 适应座 | | 药物类型 | 化学药 | ○ 仅看中国、美国、欧盟、日本首次上市信息 | | 全球最高研发阶段 | 批准上市 | 2025 @ 10-07 ● ■ 美国 美国首次上市 | | | (特发性肺纤维化) | | | | | · 特发性肺 ...

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]