China’s National Medical Products Administration (NMPA) has granted approval for Boehringer Ingelheim’s Jascayd (nerandomilast) to treat progressive pulmonary fibrosis (PPF).
The approval marks the first new treatment for the adult population with PPF in more than five years, offering a new alternative for those with this life-threatening lung condition.
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The therapy is the sole preferential phosphodiesterase 4B (PDE4B) inhibitor with vascular, immunomodulatory and antifibrotic properties to be approved for this condition.
The approval is supported by outcomes from the pivotal Phase III FIBRONEER-ILD trial, which demonstrated that nerandomilast met its main goal: the absolute change from baseline in forced vital capacity (FVC) [mL] at week 52 compared to placebo.
FVC is a critical measure of the function of the lungs, and findings from the trial indicate that nerandomilast slows the lung function decline in patients with PPF.
The therapy also showed favourable safety and tolerability, with low rates of discontinuation eliminating the need for monitoring of the liver.
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By GlobalDataThe FIBRONEER-ILD study showed that the therapy improved survival, with a significant decrease in mortality risk.
Boehringer Ingelheim human pharma head and managing directors’ board chairman Shashank Deshpande stated: “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.
“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 PPF approval in China comes weeks after its approval by the Chinese regulator for idiopathic pulmonary fibrosis (IPF).
The US Food and Drug Administration has also approved nerandomilast for IPF after granting it priority review and breakthrough therapy statuses.
It is currently conducting a priority review for the therapy’s use in adults with PPF.
Regulatory submissions for the therapy in PPF and IPF are being reviewed in the European Union, Japan, the UK and other nations, with further clearances expected in 2026.
In November 2025, Boehringer and CDR-Life announced a global licensing agreement for the development of CDR111, an antibody-based molecule targeting autoimmune conditions.
