Beijing, China – March 25, 2026. Pulmongene Ltd., a clinical-stage biotechnology company dedicated to pulmonary, fibrotic, and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PMG1015 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The designation supports the ongoing development of PMG1015, which will be evaluated in a 52-week Phase 2b clinical study.
Fast Track is a process designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and fill an unmet medical need. This designation allows for more frequent communication with the FDA, eligibility for Priority Review if relevant criteria are met, and the potential for a Rolling Review of the Biologics License Application (BLA).
“Receiving Fast Track designation is a pivotal moment for our IPF program,” said Nan Tang, Executive Chairman of Pulmongene. “It underscores the urgent need for more effective treatment options for patients living with IPF. This designation enables us to work more closely with the FDA to bring this potentially transformative therapy to patients as efficiently as possible.”
About the Phase 2b Trial
The Phase 2b trial is a 52-week, randomized, double-blind, placebo-controlled global Multi-Regional Clinical Trial (MRCT). The study is designed to evaluate the long-term safety and efficacy of PMG1015.
About PMG1015
PMG1015 is a first-in-class monoclonal antibody targeting Amphiregulin (AREG), a critical upstream driver for fibrosis. By neutralizing AREG, PMG1015 intervenes early in the pathogenic cascade, offering the potential for meaningful disease modification. As a biologic, PMG1015 is designed to minimize the off-target toxicities common in small molecule therapies.
PMG1015 was granted FDA Orphan Drug Designation (ODD) for IPF in 2023. In the completed Phase Ib/IIa trial (2025), PMG1015 demonstrated a favorable safety profile and encouraging preliminary efficacy, characterized by the stabilization of forced vital capacity (FVC) and improvements in AI-Based Quantitative HRCT imaging biomarkers.
About Pulmongene
Pulmongene is a clinical-stage biotechnology company focused on pulmonary, fibrotic, and autoimmune diseases, dedicated to discovering and developing novel medicines. The company has built multiple pipelines of first-in-class candidates across clinical and preclinical stages, leveraging cutting-edge science to translate research into meaningful therapies for patients worldwide.