[Beijing, China] – January 19th, 2026. Pulmongene Ltd., a clinical-stage biotechnology company dedicated to pulmonary, fibrotic, and autoimmune diseases, today announced a significant milestone: the U.S. Food and Drug Administration (FDA) has cleared the IND application to initiate a Phase IIb clinical trial for PMG1015 on Jan 10, 2026.
This approval greenlights a 52-week, randomized, double-blind, placebo-controlled global Multi-Regional Clinical Trial (MRCT). The study is designed to robustly evaluate the long-term safety and efficacy of PMG1015, positioning Pulmongene at the forefront of biological innovation in a field historically dominated by small molecules.
The FDA’s authorization of a 52-week treatment duration for a Phase IIb study is a strong validation of PMG1015’s safety profile and its novel mechanism of action (MoA). While many mid-stage trials rely on 12 or 24-week endpoints, the 52-week duration is the gold standard for assessing the durability of efficacy in halting lung function decline. This clearance underscores the Agency’s confidence in Pulmongene’s preclinical and early clinical data, reinforcing PMG1015’s potential to address the urgent unmet needs of the global IPF community.
“Receiving FDA clearance for this pivotal 52-week study is a transformative milestone for Pulmongene.” said Dr. Nan Tang, Executive Chairman of Pulmongene. “Current standards of care are often limited by tolerability issues and daily dosing burdens. By directly targeting a 52-week endpoint, we are aiming high: to demonstrate that PMG1015 can offer a disease-modifying effect with a superior safety profile and a more patient-friendly dosing regimen. We are poised to redefine the treatment landscape in IPF.”
About PMG1015
PMG1015 is a first-in-class monoclonal antibody targeting Amphiregulin (AREG), a critical driver in the dysregulated repair processes that lead to fibrosis. By neutralizing AREG, PMG1015 intervenes at an upstream point in the pathogenic cascade, offering a unique potential for disease modification. As a biologic, PMG1015 is designed to minimize the off-target toxicities common in small molecule therapies. The drug 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 key lung function metrics (FVC) and improvements in AI-Based Quantitative HRCT imaging biomarkers.
About Pulmongene
Pulmongene is a clinical-stage biotech 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.