Luoqi Biotech LQ043H single-domain antibody nebulizer was approved for clinical trials

Luoqi Biotech announced in its official media that on January 6, 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that the clinical trial application (IND) of LQ043H single-domain antibody nebulizing solution, a core drug for the treatment of moderate to severe asthma by Shanghai Luoqi Biomedical Technology Co., Ltd., was officially approved (notification number: 2023LP00043). This is also another nanobody drug for respiratory diseases after LQ036 in 2022, which has been approved by the first phase of clinical trials in China.

LQ043H nebulized liquid independently developed by Luoqi Biotech is an inhaled nanobody drug targeting TSLP for the treatment of broad-spectrum moderate to severe asthma. Inhibition of human thymic stromal lymphopoietin (TSLP) has been shown in recent clinical studies to be an effective treatment for non-eosinophilic and eosinophilic asthma. TSLP is secreted by airway epithelial cells and is considered an "upstream" cytokine that activates DC and releases chemokines, thereby recruiting and activating Th2 cells; TSLP may also be involved in airway wall remodeling by acting on lung fibroblasts.

At present, most of the clinical drugs under clinical development of TSLP targets are monoclonal antibodies, and the dosage form of drugs is subcutaneous injection, and the commercial competition is fierce, and differentiated second-generation products need to be launched urgently. At present, in the research projects of TSLP targets around the world, three drugs are administered by inhalation, namely Ecleralimab (Phase II) of Novartis/MorphoSys, AMG 104 (Phase I) of AZ/Amgen and LQ043H (Phase I) of Luoqi Biologics.

LQ043H has many product advantages and is expected to become the world's first nanobody nebulizer that can treat broad-spectrum asthma, benefiting a wider range of asthma patients:

• Strong activity: Compared with commercially available anti-TSLP nanobodies, this product has better activity advantages than commercially available antibody drugs of the same target.

• Good stability: This product has good storage stability and can be stably stored at room temperature for 2 years. This product can be used with a variety of portable nebulizers, which has good quality stability and activity before and after atomization.

• Aerosolized administration directly reaches the lesion, with small toxic side effects: this product adopts atomized administration to deliver the drug directly to the lungs and quickly takes effect; And only a very small amount of the drug enters the blood circulation system, and the systemic toxicity is small.

• Pichia yeast production, stable process and low cost: this product is obtained by Pichia saccharomyces expression production, and the process is stable; The expression yield is as high as 20g/L, and the production cost is low, which lays a good foundation for its commercial promotion in the later stage.

About nanobody drugs

At present, the nanobody industry is in the early stage of development and the market is active. Many large and medium-sized pharmaceutical companies are actively deploying nanobody-related pipelines. Up to now, four nanobody drugs have been approved for marketing:

Sanofi Cablivi (Caplacizumab), for the treatment of acquired thrombotic platelet purple in adults;

Corning Jerry's Envida ®, the world's first commercially available subcutaneous PD-L1 inhibitor;

The BCMA CAR-T product Cedarchicel (trade name Carvykti), jointly developed by Janssen and Legend Biologics, has been approved by the US FDA for the treatment of adult patients with relapsed/refractory multiple myeloma;

Ozoralizumab injection from Taisho Pharmaceutical Company was approved for marketing by the Japanese PMDA on September 26, 2022, and is suitable for rheumatoid arthritis. The single antigen research company of the Oli group is Ablynx, which is a human TNFα nanobody.

About Luoqi Biotech "Inhaled Macromolecule Drug R&D Platform"

Luoqi Biotech has independently created five core technology platforms based on nanobodies: nanobody rapid screening platform, Pichia CMC process development platform, inhaled macromolecular drug research and development platform, nanobody long-acting platform and nanobody dual antibody platform, each platform has very unique industry advantages.

Among them, the inhaled macromolecule drug R&D platform of Luoqi Biotech covers a variety of respiratory diseases such as asthma, COPD, new crown, pulmonary fibrosis, etc., including IL-4R, TSLP, new coronavirus S protein and other popular targets; The drug directly reaches the lesion, with high utilization rate and few toxic side effects; With small atomizer, it has good portability and stable quality before and after atomization. At present, LQ036, the first drug of the inhaled macromolecule drug development platform, is undergoing phase I clinical studies in Australia and China, showing good safety and tolerability.