— First-in-Human Study: Completion of dosing was achieved in PMG1016-1031 Phase 1a Study in Healthy Volunteers —
Beijing, China, September 24, 2026 — Pulmongene Ltd. (“Pulmongene” or “the Company”), a clinical-stage biotechnology company dedicated to pulmonary, fibrotic, and autoimmune diseases, today announced the completion of dosing in its PMG1016-1031 Phase 1a clinical trial.
“Completing dosing for PMG1016 represents a critical step in validating our differentiated approach to fibrosis,” said Nan Tang, Executive Chairman of Pulmongene. “By engaging two key nodes of the fibrotic cascade at once, PMG1016 addresses disease biology in a way that single-target agents cannot. We believe this strategy has the potential to meaningfully alter disease progression across multiple fibrotic indications, beginning with chronic kidney disease (CKD).”
About the PMG1016-1031 Clinical Trial
The PMG1016-1031 study is a Phase 1a, randomized, double-blind, placebo-controlled, single ascending dose (SAD) clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PMG1016 in healthy volunteers. Data from this study are expected to inform the design of subsequent patient studies in CKD and other fibrotic indications.
“Completion of dosing in this Phase 1 study marks an important clinical milestone for our differentiated and specific dual target approach to address significant unmet needs in CKD and fibrotic diseases.” said Hunter Gillies, MBChB, Chief Medical Officer of Pulmongene. “Establishing a clean safety and pharmacokinetic profile in healthy volunteers is a critical foundation before initiating patient studies. The dual-pathway targeting approach of PMG1016 is informed by robust preclinical data demonstrating meaningful anti-fibrotic activity across renal and other fibrosis models. We look forward to advancing toward patient evaluation in CKD and other fibrotic indications.”
About PMG1016
PMG1016 is a first-in-class bispecific therapeutic designed to simultaneously engage two distinct pro-fibrotic signaling pathways that drive pathological tissue fibrosis across multiple organ systems. This dual-node mechanism is intended to deliver superior anti-fibrotic efficacy relative to single-target agents, with the potential to address the underlying disease biology of CKD, and other severe fibrotic conditions.
About Chronic Kidney Disease and Fibrosis
CKD affects approximately 850 million people worldwide and is one of the leading causes of morbidity and mortality globally. Renal fibrosis is the final common pathway in nearly all forms of progressive CKD, characterized by excessive accumulation of extracellular matrix that destroys normal kidney architecture and drives irreversible loss of renal function. Currently approved therapies slow CKD progression but do not directly target the fibrotic process itself, leaving a significant need for treatments that can halt or potentially reverse fibrosis in the kidney and other organs.
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.
Pulmongene is incorporated in the Cayman Islands with U.S. operations supporting its global clinical development programs. For more information, please visit www.pulmongene.com.
