Luqi Bio's Inhaled TSLP-Targeting Nanobody LQ043H Nebulizer Solution Receives IND Approval in China for Moderate-to-Severe Asthma

Tengjing Ang announced on its official media

On January 6, 2023, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Shanghai Novamab Biopharmaceuticals Co., Ltd.'s IND Application for LQ043H Single-Domain Antibody Nebulizer Solution, a Core Drug for Moderate to Severe Asthma Treatment, Officially Approved (Approval No.: 2023LP00043).This is another nanobody drug for respiratory diseases developed by Novamab, following the LQ036 in 2022, which has received Phase I clinical trial approval in China.

LQ043H Nebulizer Solution, Independently Developed by Novamab, is an Inhaled Nanobody Drug Targeting TSLP for the Treatment of Broad-Spectrum Moderate to Severe Asthma. Inhibiting Thymic Stromal Lymphopoietin (TSLP) Has Been Proven in Recent Clinical Studies to Be an Effective Treatment for Both Non-Eosinophilic and Eosinophilic Asthma. TSLP, Secreted by Airway Epithelial Cells, Is Considered an "Upstream" Cytokine That Activates DCs and Releases Chemokines, Thereby Recruiting and Activating Th2 Cells; TSLP May Also Be Involved in Airway Wall Remodeling by Acting on Pulmonary Fibroblasts.

Currently, most of the drugs targeting TSLP in clinical research are monoclonal antibodies, with the drug formulation being subcutaneous injections. The commercial competition is intense, and there is an urgent need for differentiated second-generation products. Among the ongoing global research projects targeting TSLP, three drugs are administered via inhalation: Ecleralimab (Phase II clinical trials) by Novartis/MorphoSys, AMG 104 (Phase I clinical trials) by AZ/Amgen, and LQ043H (Phase I clinical trials) by Novamab.

Novamab's LQ043H has numerous product advantages,Expected to become the world's first nebulized nanobody solution for the treatment of broad-spectrum asthma, benefiting a wider range of asthma patients:

• High activity:This TSLP-neutralizing nanobody has a significant activity advantage compared to commercially available antibody drugs targeting the same pathway.

• Good stability:This product has good storage stability and can be stored stably at room temperature for 2 years. It can be used with various portable nebulizers, maintaining good quality stability and activity before and after nebulization.

• Nebulized drug delivery directly targets the lesion, with minimal toxic side effects:This product uses nebulized administration to deliver the drug directly to the lungs for rapid onset of action. Moreover, only a minimal amount of the drug enters the systemic circulation, resulting in low systemic toxicity.

• Produced by Pichia pastoris, with stable production processes and low cost:This product is produced through Pichia pastoris expression, with a stable production process; the expression yield is as high as 20g/L, and the production cost is relatively low, laying a solid foundation for its commercial promotion in the later stages.

About Nanobody Drugs

Currently, the nanobody industry is in the early development stage, and the market is active. Many large and medium-sized pharmaceutical companies are actively laying out pipelines related to nanobodies. To date, four nanobody drugs have been approved for marketing:

Sanofi's Cablivi (Caplacizumab), for the treatment of adult acquired thrombotic thrombocytopenic purpura;

Alphamab Oncology's Envada®, the world's first subcutaneously injectable PD-L1 inhibitor;

Janssen and Legend Biotech's BCMA CAR-T product, Ciltacabtagene Autoleucel (trade name Carvykti), has been approved by the U.S. FDA for marketing to treat adult patients with relapsed/refractory multiple myeloma.

Ozoralizumab Injection from Taisho Pharmaceutical Co., Ltd. was approved by Japan's PMDA for marketing on September 26, 2022, for the treatment of rheumatoid arthritis. Ozoralizumab, originally developed by Ablynx, is a humanized TNFα nanobody.

About Novamab's "Inhaled Large Molecule Drug Development Platform"

Novamab has independently developed five core technology platforms based on nanobodies: the Nanobody Rapid Screening Platform, the Pichia CMC Process Development Platform, the Inhalable Macromolecule Drug Research and Development Platform, the Nanobody Long-acting Platform, and the Nanobody Bispecific Platform. Each platform possesses unique industry advantages.

Among them, Novamab's inhaled large molecule drug development platform covers various respiratory diseases such as asthma, COPD, COVID-19, and pulmonary fibrosis, including popular targets like IL-4R, TSLP, and the S protein of the coronavirus. The drugs reach the lesion directly, with high utilization, minimal toxic side effects, and good portability when paired with a small nebulizer, maintaining stable quality before and after nebulization. Currently, the first drug from the inhaled large molecule drug development platform, LQ036, is undergoing Phase I clinical trials in Australia and China, demonstrating good safety and tolerability.

Editor: Dada Xiwa

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