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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.

[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.

Beijing, China – September 2, 2025 – Pulmongene Ltd., a leading clinical-stage biotechnology company focused on discovering and developing innovative therapies for respiratory disorders and fibrotic diseases, today announced that its Phase 1b clinical trial data for PMG1015 have been selected for a presentation as a Late-Breaking-Abstract at the European Respiratory Society (ERS) International Congress 2025 in Amsterdam, Netherlands. The conference will be held from September 27 to October 1, 2025. The presentation, titled “PMG1015 Demonstrates Well-Tolerated Safety and Favorable FVC Changes After 12 Weeks of Treatment in IPF Patients”, will be presented in the poster presentation session on September 30th, 2025, by Dr. Toby Maher. Late-breaking abstracts are reserved by ERS for studies deemed to have significant clinical or scientific impact, underscoring the novelty and potential of PMG1015 in addressing critical unmet needs in pulmonary fibrosis treatment. “We are honored that ERS has recognized the importance of our PMG1015 Phase 1b data as late-breaking science,” said Nan Tang, Founder of Pulmongene Ltd. “These results represent a critical step forward in validating PMG1015’s potential to transform treatment for IPF. We look forward to sharing our findings with the global respiratory community and advancing PMG1015 into later-stage clinical development.”

On July 5, 2023, Pulmongene Ltd. announced that its investigational drug PMG1015 has completed the first administration in a patient with idiopathic pulmonary fibrosis (IPF) at the China-Japan Friendship Hospital. This study is a multicenter, randomized, double-blind, placebo-controlled Phase Ib clinical trial aimed at evaluating the safety, tolerability, and pharmacokinetics of multiple doses of PMG1015 in IPF patients. The study is led by the China-Japan Friendship Hospital and plans to recruit 30 patients with IPF across six research centers nationwide. This marks a significant advancement for Pulmongene in the development of new drugs, with the hope of providing new treatment options for IPF patients. “We are pleased to have completed the enrollment and administration of the first IPF patient at the China-Japan Friendship Hospital, marking an important step forward in the clinical development of PMG1015,” said Dr. Nan Tang, the founder of Pulmongene. “We hope that PMG1015 can fundamentally delay the progression of IPF in patients and greatly improve their survival time and quality of life. Pulmongene remains committed to a patient-centered approach and will fully promote the clinical development plan for PMG1015 in the future, aiming to quickly bring safe and effective new treatment options to IPF patients worldwide.”

On February 17th, 2023 , Pulmongene Ltd. announced that the company’s investigational drug PMG1015 has been granted Orphan Drug Designation (ODD) for the indication of Idiopathic Pulmonary Fibrosis (IPF). The FDA’s orphan drug designation supports the development of medicines intended to treat rare diseases that affect fewer than 200,000 people in the United States. Products that receive this designation are eligible for various incentives in the U.S., including tax credits and seven years of market exclusivity after approval. Additionally, the FDA provides regulatory guidance and support to expedite drug development and review processes. “We are pleased that PMG1015 has been granted Orphan Drug Designation by the FDA. This represents the FDA’s full recognition of Pulmongene’s first-in-class drug candidate and its novel mechanism for treating IPF,” said Dr. Nan Tang, the founder of the Pulmongene. “The ODD designation for PMG1015 will also help accelerate its clinical development in the United States and provide a new therapeutic option for IPF patients worldwide who currently need effective treatment options.” IPF is a progressive lung fibrotic disease and the most common type of interstitial lung disease. The median survival time after diagnosis is 2-4 years, with 80% of patients dying within 5 years of diagnosis. It has an insidious onset and progressively worsens. Symptoms include progressive deterioration of lung function, breathing difficulties, and decreased exercise tolerance, severely impacting patients’ quality of life. The incidence of IPF is continuously rising globally. According to IPF Foundation, the incidence rate has doubled over the past decade. It is estimated that approximately 50,000 people die from IPF annually in the United States, exceeding the death toll of most cancers, including breast cancer. To date, the FDA has only approved two drugs for treating IPF: Pirfenidone and Nintedanib. While these two drugs can slow down the decline in lung function, they have severe side effects, often leading to reduction in dosage or discontinuation of treatment altogether. About Pulmongene Pulmongene Ltd. is dedicated to developing innovative first-in-class drugs for the treatment of lung diseases and organ fibrosis. The company currently has multiple first-in-class pipeline products in both clinical and preclinical stages. With its top-tier scientific research capabilities, Pulmongene strives to translate solid scientific discoveries into effective novel therapeutic solutions.