SHANGHAI, China, March 13, 2026 – Shanghai Novamab Biopharmaceuticals Co., Ltd. (Novamab), a biotechnology company dedicated to the research and development of innovative VHH antibody drugs, today announced that its lead inhaled product, LQ036 (an anti-IL-4Rα VHH antibody), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase Ⅱ clinical trial for a new indication: chronic obstructive pulmonary disease (COPD). This marks a significant breakthrough in the treatment of respiratory diseases, following positive progress made with LQ036 in asthma, and promises to offer a novel treatment option for the vast population of COPD patients.

This newly approved clinical trial aims to evaluate the efficacy, safety, pharmacokinetic profile, and immunogenicity of LQ036 in patients with moderate-to-severe COPD, laying the groundwork for subsequent clinical research. Novamab will rapidly advance this study to further explore the substantial potential of LQ036 in the COPD therapeutic area.

About LQ036

LQ036 is a proprietary inhaled VHH antibody drug candidate targeting IL-4Rα, discovered and developed by Novamab with fully independent intellectual property rights, for the treatment of asthma and chronic obstructive pulmonary disease (COPD). VHH (Variable domain of Heavy chain of Heavy-chain antibody) represents the smallest functional antigen-binding fragment derived from heavy chain-only antibody, offering unique advantages such as small size, high stability, and ease of inhalation delivery. LQ036 effectively inhibits the binding of IL-4Rα to IL-4 and IL-13, blocking the signaling pathway and modulating immune function, thereby alleviating respiratory symptoms driven by Th2-type inflammation. In clinical development for asthma, LQ036 has demonstrated excellent potential. Previously completed Phase Ⅰ studies in Australia and China, along with a Phase Ⅱa study in China, have indicated that LQ036 features rapid onset of action, significant and sustained anti-inflammatory effects, and a favorable safety profile.

About Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a common chronic airway disease characterized by persistent respiratory symptoms and airflow limitation. COPD is the third most common chronic disease in China, affecting nearly 100 million people [1], placing a heavy economic burden on patients' families and society. The pathogenesis of COPD is complex. Notably, approximately 10% to 40% of patients exhibit features of Th2-type inflammation [2]. These patients often respond poorly to traditional triple inhaled therapy, representing a significant area of unmet clinical need.

In recent years, major breakthroughs have been achieved with targeted therapies. Clinical research has confirmed that the use of biologics targeting IL-4Rα in patients with moderate-to-severe COPD accompanied by Th2-type inflammation can significantly improve lung function and reduce the rate of severe acute exacerbations [3]. Currently approved biologics are all administered via subcutaneous injection. In contrast, LQ036, a first-in-class inhaled anti-IL-4Rα VHH antibody independently developed by Novamab, is delivered directly to the lungs via nebulization. This approach is expected to offer therapeutic advantages including faster onset of action, lower dosage requirements, and reduced systemic side effects, providing patients with a more convenient and safer treatment option.

Company Introduction

Shanghai Novamab Biopharmaceuticals Co., Ltd. (Novamab), located in the Shanghai International Medical Zone (Pudong New Area), is a clinical-stage innovative biopharmaceutical company focused on developing VHH antibody drugs, targeting the multi-billion dollar respiratory and inflammatory disease markets. Our mission is to provide patients with life-changing therapies through the discovery and development of innovative VHH drugs, while committing to enhancing drug efficacy and ease of use.

Leveraging its advanced proprietary NanoVibe™ VHH platform, the company capitalizes on the unique advantages of VHH antibodies to build a portfolio of highly differentiated antibody platforms, including the inhaled antibody platform (Aerobody), the oral antibody platform (Orabody), and the bispecific/multispecific antibody platform (Pluribody). Its product pipeline features a first-in-class (FIC) inhaled anti-IL-4Rα VHH antibody in Phase II clinical trials, an inhaled anti-TSLP VHH antibody in Phase I, and several TL1A-targeting bispecific/multispecific antibodies and oral programs, with indications spanning asthma, chronic obstructive pulmonary disease (COPD), and inflammatory bowel disease (IBD).

Novamab is dedicated to providing more effective, safer, and more convenient treatment options for patients worldwide through innovative VHH antibody drugs.

Reference:

[1] Wang C, Xu J, Yang L, et al. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018;391(10131):1706-1717. doi:10.1016/S0140-6736(18)30841-9

[2] Singh D, Kolsum U, Brightling CE, et al. Eosinophilic inflammation in COPD: prevalence and clinical characteristics. Eur Respir J. 2014;44(6):1697-1700. doi:10.1183/09031936.00162414

[3] Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab reduces exacerbations and improves lung function in patients with chronic obstructive pulmonary disease and emphysema: Phase 3 randomized trial (BOREAS). Respir Med. 2025;236:107846. doi:10.1016/j.rmed.2024.107846