- The approval marks the first new treatment option for people living with progressive pulmonary fibrosis (PPF) in more than five years.
- PPF is a rare lung condition, more life-threatening than many forms of cancer, causing a continuous decline in lung function.1,2,3
- PPF is the second approved indication in China for nerandomilast, following recent approvals in the U.S. and China for the treatment of idiopathic pulmonary fibrosis (IPF).4,5
China’s National Medical Products Administration (NMPA) has approved JASCAYD® (nerandomilast) as the first new treatment for adults with progressive pulmonary fibrosis (PPF) in more than five years, marking a breakthrough for millions affected by the life-threatening lung condition.4 The approval, based on the largest clinical trial program in PPF to date, offers new hope for patients facing limited options and declining lung function. Nerandomilast is the only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory, vascular, and antifibrotic effects to be approved in this indication.6,7
“PPF may lead to a continuous decline in lung function, posing a serious threat to patients' lives,” said Professor Xu Zuojun, Chief Physician of the Department of Respiratory and Critical Care Medicine of Peking Union Medical College Hospital. “Current treatment options for PPF are very limited, and there is an urgent need to improve both the survival time and quality of life for these patients. We are pleased to see that nerandomilast has demonstrated highly encouraging results in Phase III clinical trials, significantly slowing the decline in lung function while showing good safety and tolerability. This will help improve adherence to long-term treatment and brings new hope for patients.”
Affecting up to 5.6 million people worldwide, PPF may develop in people with underlying conditions, such as rheumatoid arthritis or systemic sclerosis. It can also be caused by environmental exposure to asbestos, silica or other toxins.1,8,9 As PPF progresses, everyday activities become increasingly difficult and the risk of death increases.2,8,10 Unfortunately, people with PPF often delay or discontinue treatment, leaving them vulnerable to worsening symptoms and reduced quality of life as the disease progresses.11,12
“For the first time, people living with PPF will have access to a new treatment option for this progressive and life-threatening condition – a major advancement in a field where innovation has been scarce,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “While this initial approval in China represents a pivotal milestone for the PPF community, we are working tirelessly to ensure patients around the world can benefit from JASCAYD as quickly as possible.”
The approval is based on results from the pivotal Phase III clinical trial FIBRONEERTM-ILD. Results showed that nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity (FVC) [mL] at week 52 versus placebo.7 FVC is a key measure of lung function, and the findings indicate that the drug effectively slows the decline of lung function in PPF patients.7 Furthermore, nerandomilast demonstrated favorable safety and tolerability, with low discontinuation rates and no requirement for liver monitoring.7 In the FIBRONEER™-ILD trial, nerandomilast also improved survival shown by a nominally significant reduced risk of death.4
"I deeply understand the immense challenges that patients with PPF face in their daily lives. We have long been awaiting advancements that can address some of the challenges related to existing treatment options,” said Alison Zheng, Founder of the Chinese Organization for Scleroderma, China’s first scleroderma patient organization. “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.”
The approval of nerandomilast in PPF in China comes just seven weeks after its approval by the NMPA in IPF.
About PPF
Progressive pulmonary fibrosis (PPF) affects up to 5.6 million people worldwide.8 It is progressive and ultimately fatal, associated with irreversible scarring in the lungs that worsens over time.8 The lung scarring may be linked to an underlying disease such as rheumatoid arthritis or systemic sclerosis, or result from exposure to inhaled substances.1,8,9 Chronic scarring of lung tissue in these diseases is often the key driver of early mortality.8 Approximately half of people with PPF lose their life within five years of diagnosis.2 On average, diagnosis is delayed by up to two years and up to half of those diagnosed remain untreated.13,14
About nerandomilast
Nerandomilast is an oral, preferential PDE4B inhibitor approved in China for the treatment of adult patients with IPF and PPF. It was also approved by the U.S. Food and Drug Administration (FDA) for IPF after securing Priority Review and Breakthrough Therapy Designation and is under priority review by the FDA for the treatment of adults with PPF.
Regulatory submissions for nerandomilast in IPF and PPF are also under review in the European Union, the UK, Japan and other countries with additional approvals anticipated in 2026.
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.
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