Shanghai, China, March 25, 2025 – Novamab, a biotechnology company dedicated to the development of innovative VHH therapeutics, announced today that its core inhaled product, LQ036 (a VHH targeting IL-4Rα), has successfully completed a Phase IIa proof of concept (POC) clinical trial in patients with moderate to severe asthma. The study results indicate that LQ036 exhibits rapid, significant and sustained anti-inflammatory effects, as well as a favorable safety and tolerability profile. These encouraging findings lay a solid foundation for upcoming Phase IIb trials and further development. The clinical study report has now been finalized.

About the LQ036 Phase IIa Clinical Trial

This Phase IIa trial was a 4-week, multicenter, randomized, double blind, placebo controlled, parallel group study designed to evaluate the pharmacodynamic effects, safety, immunogenicity, and preliminary clinical efficacy of LQ036 in patients with moderate to severe asthma. Led by Professor Su Nan at China-Japan Friendship Hospital, the trial enrolled 19 adult patients across 14 clinical centers nationwide, who were randomized to receive inhaled LQ036 or placebo once daily for 4-weeks.

Key Study Results

Data from the trial demonstrate that LQ036 delivers rapid, significant and sustained anti inflammatory effects. On the second day of inhaled treatment, the key pharmacodynamic marker—fractional exhaled nitric oxide (FeNO)—began to decline. By Day 14, FeNO levels in the LQ036 group had decreased by 40%, achieving statistical significance compared to the placebo group (p = 0.007). This inhibitory effect persisted throughout the 4-week treatment period and gradually reversed following treatment cessation, suggesting that LQ036 may offer a more rapid onset of action compared to existing injectable biologics.

Furthermore, LQ036 demonstrated promising improvements in lung function parameters (FEV1, FVC, and PEF) and asthma symptom scores, thereby providing robust support for subsequent Phase IIb trials. The study further confirmed the excellent safety profile of LQ036, with all participants exhibiting favorable tolerability and no detectable immunogenicity—findings that are consistent with prior Phase I data in healthy subjects.

Professor Su Nan, the principal investigator from the Pulmonary and Critical Care Medicine Department at China-Japan Friendship Hospital (PCCM), stated, “The primary objective of this Phase IIa study was to validate the pharmacodynamic efficacy of LQ036 in asthma patients. The results are truly encouraging, as they not only demonstrate robust anti-inflammatory effects but also reveal favorable trends in clinical outcome measures. Coupled with the inhaled delivery method, we believe that, if successfully commercialized, LQ036 has the potential to transform current treatment paradigms by shifting biologic therapy to an earlier stage in asthma, thereby preventing or delaying disease progression and reducing patients’ corticosteroid use as well as their clinical, economic, and societal burdens.” 

Dr. Wan Yakun, Founder, Chairman, and CEO of Novamab, commented, “As the world’s first inhaled VHH therapeutic targeting IL4Rα, LQ036 has the potential to overcome the limitations of current injectable biologics for respiratory diseases and fill a critical gap in the field. The success of this Phase IIa proof of concept trial further validates the significant clinical potential and consistent safety profile of LQ036, reinforcing our determination to expedite the initiation of Phase IIb trials. We look forward to continued breakthroughs in upcoming clinical studies and to delivering an improved therapeutic option for asthma patients worldwide as soon as possible.”

About LQ036

LQ036 is a proprietary inhaled VHH therapeutic developed by Novamab, holding independent intellectual property rights, and is intended for the treatment of asthma and COPD. LQ036 effectively inhibits the binding of IL-4 and IL-13 to IL-4Rα, thereby blocking downstream signaling pathways and modulating immune responses—including the inhibition of Th2 cell differentiation, reduction of airway allergic reactions, and suppression of IgE synthesis—to ameliorate asthma symptoms. Previous Phase I clinical studies conducted in Australia and China have demonstrated that LQ036 possesses an excellent safety and tolerability profile.

About Asthma

Asthma remains a globally recognized medical challenge and is listed by the World Health Organization as one of the four major refractory diseases. It is the second leading cause of death and disability worldwide, affecting approximately 350 million people. Among these patients, 5–10% do not achieve adequate symptom control with small-molecule inhaled therapies, representing a significant unmet clinical need. According to GINA guidelines, antibody-based therapeutics are recommended as add-on controllers for severe patients, necessitating long-term administration^[1]. However, due to the large molecular weight (approximately 150 kDa) and instability of monoclonal antibodies, current technologies do not support the inhalation delivery of such large molecules, which typically require administration via intravenous or subcutaneous routes.

Compared to systemic administration via intravenous or subcutaneous injection, inhaled delivery offers superior patient compliance, rapid onset of action, lower dosing requirements, reduced systemic exposure, and potentially fewer adverse events, making it suitable for a broader range of asthma patients^[2]. To date, no inhaled large-molecule asthma therapeutics have been approved.

About Novamab

Shanghai Novamab Biomedical Technology Co., Ltd. is an innovative biopharmaceutical company dedicated to the research, development, and commercialization of VHH therapeutics. Founded in October 2017 and located in the Shanghai International Medical Park, the company has established a comprehensive platform covering R&D, CMC, and pilot-scale manufacturing, and operates China’s first 500-L Pichia pastoris VHH GMP pilot production facility. Novamab is currently the only company in China with full-process development capabilities for VHHs.

As of March 2025, Novamab has filed over 80 domestic and international invention patents, with 31 patents granted. Its product pipeline spans respiratory, autoimmune, ophthalmologic, and oncology indications, and it has secured four clinical trial authorizations. Notably, both LQ036 and LQ043H—targeting the same pathway—represent the world’s first inhaled VHH therapeutics and have the potential to revolutionize the treatment of respiratory diseases.

References

[1] O’Byrne PM, Panettieri RA Jr, Taube C, Brindicci C, et al. Development of an inhaled anti-TSLP therapy for asthma. Pulm Pharmacol Ther.2023 Feb;78:102184.
[2] Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2023. Updated May 2023. (Available from: www.ginasthma.org).