Boehringer Ingelheim has received approval from China’s National Medical Products Administration (NMPA) for JASCAYD® (nerandomilast), marking the first new treatment for adults with progressive pulmonary fibrosis (PPF) in more than five years.

勃林格殷格翰已获得中国国家药品监督管理局（NMPA）批准的JASCAYD®（奈兰多司他）上市许可，这标志着五年多来首个用于治疗成人进展性肺纤维化（PPF）的新疗法问世。

PPF is a progressive and ultimately fatal condition marked by irreversible scarring of lung tissue. It can develop as a result of autoimmune diseases or exposure to inhaled irritants. Around half of those diagnosed are expected to die within five years. Diagnosis is often delayed by up to two years, and a significant proportion of patients remain untreated..

PPF 是一种进行性的、最终致命的疾病，其特征是肺组织不可逆的瘢痕化。它可能由于自身免疫性疾病或吸入刺激物暴露而引发。大约一半的患者在确诊后预计五年内死亡。诊断通常会延迟长达两年，且很大比例的患者仍未接受治疗。

PPF affects an estimated 5.6 million people worldwide and is often linked to underlying autoimmune conditions such as rheumatoid arthritis or systemic sclerosis. It may also arise from long-term exposure to harmful substances, including asbestos and silica. As the disease advances, lung function continues to decline, everyday activities become more difficult, and the risk of death increases.

PPF 影响全球约 560 万人，常与潜在的自身免疫疾病（如类风湿性关节炎或系统性硬化症）相关。它也可能源于长期接触有害物质，包括石棉和二氧化硅。随着疾病进展，肺功能持续下降，日常活动变得更加困难，死亡风险也逐步增加。

Many patients experience delays in diagnosis or discontinue treatment, further affecting outcomes..

许多患者在诊断上经历延误或中断治疗，进一步影响了结果。

Nerandomilast is an oral preferential PDE4B inhibitor approved in China for the treatment of IPF and PPF. It has also been approved by the U.S. Food and Drug Administration for IPF and is currently under priority review for PPF. Regulatory submissions are under way in the European Union, the UK, Japan and other regions, with additional approvals expected in 2026..

Nerandomilast是一种口服的优先PDE4B抑制剂，在中国获批用于治疗IPF和PPF。它还获得了美国食品药品监督管理局对IPF的批准，目前PPF正在优先审查中。欧盟、英国、日本及其他地区的监管提交正在进行中，预计将在2026年获得更多批准。

Nerandomilast is the only preferential phosphodiesterase 4B (PDE4B) inhibitor authorised for this indication. It offers immunomodulatory, vascular and antifibrotic effects, addressing several key disease pathways.

Nerandomilast 是唯一获准用于此适应症的优先磷酸二酯酶 4B (PDE4B) 抑制剂。它提供免疫调节、血管和抗纤维化作用，针对多个关键疾病通路。

The approval is based on the largest clinical trial programme conducted in PPF to date and represents a major advance for patients who have had limited therapeutic options for this life-threatening condition.

该批准基于迄今为止在PPF中进行的最大规模临床试验项目，代表着对这一危及生命的疾病治疗选择有限的患者的重大进展。

The NMPA’s approval is based on results from the Phase III FIBRONEER™-ILD trial. The study met its primary endpoint, showing that nerandomilast slowed the decline in Forced Vital Capacity (FVC) over 52 weeks compared with placebo. FVC is a key measure of lung function, and the findings indicate meaningful benefit for patients.

中国国家药品监督管理局的批准是基于III期FIBRONEER™-ILD试验的结果。该研究达到了主要终点，显示与安慰剂相比，nerandomilast在52周内减缓了用力肺活量（FVC）的下降。FVC是肺功能的关键指标，研究结果表明其对患者有显著益处。

The treatment also showed favourable safety and tolerability, with low discontinuation rates and no need for liver monitoring. The trial results also indicated an improvement in survival, with a reduced risk of death during the study period..

该治疗方案还显示出良好的安全性和耐受性，停药率较低且无需进行肝脏监测。试验结果还表明生存率有所提高，在研究期间死亡风险降低。

The approval responds to long-standing challenges faced by people with PPF, who have had limited treatment choices for many years. The availability of nerandomilast in China is regarded as an important milestone for the PPF community. The company is also working to expand access globally.

批准回应了PPF患者长期以来面临的挑战，这些患者多年来治疗选择有限。内拉多米拉斯特在中国的上市被视为PPF社区的一个重要里程碑。该公司还致力于在全球范围内扩大药物的可及性。

This decision follows nerandomilast’s recent approval in China for idiopathic pulmonary fibrosis (IPF).

这一决定是在尼达尼布近期获得中国批准用于治疗特发性肺纤维化（IPF）之后做出的。

Source: boehringer-ingelheim.com

来源：boehringer-ingelheim.com