China Approves First New Progressive Pulmonary Fibrosis Drug in 5 Years

China’s National Medical Products Administration (NMPA) has approved JASCAYD® (nerandomilast), marking the first new treatment for adults with progressive pulmonary fibrosis (PPF) in more than five years. The decision represents a major breakthrough for patients suffering from this life-threatening lung disease and follows the largest clinical trial program ever conducted in PPF. Nerandomilast becomes the first preferential phosphodiesterase 4B (PDE4B) inhibitor approved for PPF, offering immunomodulatory, vascular, and antifibrotic benefits supported by robust late-stage clinical evidence.

PPF is a debilitating condition affecting up to 5.6 million people worldwide. It can arise from autoimmune diseases such as rheumatoid arthritis or systemic sclerosis, or from long-term exposure to harmful substances including asbestos, silica, and various industrial toxins. As the disease progresses, patients experience worsening breathlessness, reduced lung capacity, and increasing difficulty performing routine activities. Without effective intervention, PPF can lead to rapid decline and heightened risk of death. Despite this, treatment adherence remains low, often due to limited therapeutic options and concerns about side effects or tolerability.

Professor Xu Zuojun, Chief Physician at Peking Union Medical College Hospital, emphasized the urgency of expanding treatment choices. “PPF may lead to a continuous decline in lung function, posing a serious threat to patients’ lives,” he said. Xu highlighted that current options have been scarce, noting that nerandomilast’s Phase III results demonstrate a significant slowing in lung-function decline alongside strong safety and tolerability outcomes. “This will help improve adherence to long-term treatment and brings new hope for patients,” he added.

The approval is grounded in data from the pivotal Phase III FIBRONEER™-ILD clinical trial. The study met its primary endpoint, showing that nerandomilast significantly reduced the decline in Forced Vital Capacity (FVC) over 52 weeks compared with placebo. FVC is a critical measure of lung performance, and preservation of FVC is directly linked to improved prognosis in PPF. Trial results also indicated a favorable safety profile, with low discontinuation rates and no need for liver monitoring—an important advantage over some existing therapies. Notably, the data showed a nominally significant reduction in the risk of death, signaling potential survival benefits for patients.

Patient advocacy groups also welcomed the milestone. Alison Zheng, Founder of the Chinese Organization for Scleroderma, said many patients have been waiting years for advancements that could address unmet needs and improve daily life. “The approval of nerandomilast for the treatment of PPF brings new hope and reflects the urgent need to address longstanding challenges facing people living with the condition,” she said.

Boehringer Ingelheim, the company behind JASCAYD, described the approval as a pivotal step for patients in China and globally. Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, said this marks the first time patients with PPF have access to a new therapeutic option after years without innovation. “We are working tirelessly to ensure patients around the world can benefit from JASCAYD as quickly as possible,” he noted.

The approval comes just seven weeks after nerandomilast received authorization in China for idiopathic pulmonary fibrosis (IPF), another severe fibrotic lung disease. With this latest decision, China solidifies its role as one of the earliest countries to make this new therapy available, offering renewed hope to millions impacted by progressive and degenerative lung conditions.