With people’s in-depth understanding of the inflammatory pathways of psoriasis, biologics continue to develop. From tumor necrosis factor alpha (TNF-α), to IL-17 inhibitors, and then to IL-23 inhibitors, biologics have brought new light to the treatment of psoriasis again. In recent years, the exploration of IL-23 by new drug developers has never stopped.
IL-23 is mainly produced by activated dendritic cells, macrophages and monocytes. It is a new member of the IL-12 heterodimeric cytokine family. It is mainly composed of two subunits: IL-23p19 and IL-12/IL-23p40, among which IL-12/IL-23p40 is the subunit that it contains with IL-12. When the two subunits of IL-23p19 and IL-12/IL-23p40 exist alone, they have no biological function. However, when the two subunits connected to form a homodimer, they will then play a biological function.[1].
IL-23 mainly interacts with its receptor to activate downstream signaling pathways to perform biological functions. IL-23 receptor includes two subunits of IL-12 receptor β1 and IL-23 receptor [2]. IL-23 mainly acts on Th17 cells, plays an important role in the proliferation and stabilization of Th17 cells, and can promote Th17 cells to produce IL-17A, IL-17F, IL-22 and other cytokines. These inflammatory factors act on keratinocytes, leading to activation and excessive proliferation of keratinocytes. Activated keratinocytes recruit and activate immune cells such as T cells through the production of a large number of cytokines, chemokines, and antimicrobial peptides, forming a cascade of immune responses and causing psoriasis damage [3].
In the field of IL-23 monoclonal antibody drug research and development, Medicilon’s Pharmacodynamics Department has been deeply involved for many years, has an excellent evaluation ability of animal efficacy evaluation models, and strictly complies with the GLP specifications of NMPA, OECD and FDA. Medicilon provided the pharmacodynamic research services for the experimental new drug of the fully human antibody drug NBL-012 independently developed by NovaRock Biotherapeutics Limited, and assisted them to achieve the dual approval for both China and the United States. Furthermore, Medicilon also provided the pharmacodynamic research services for QX001S injection (usnumumab biosimilar) and QX004N injection of Qyuns Therapeutics, and successfully assisted the project to obtain clinical approval. At this moment, QX001S injection has successfully entered to phase III clinical trials and QX004N injection has entered to phase I clinical trials.
It is worth mentioning that the pre-clinical efficacy department of Medicilon has been deeply involved in the field of inflammation and immune system diseases for many years. It has provides a variety of targets and pathways for the evaluation of the efficacy of drugs for inflammatory and immune diseases. Medicilon also provide animal drug efficacy evaluation model with good evaluation ability.
Currently, the “Inflammation and Immune System Evaluation System” of Medicilon’s Pharmacodynamics Department includes models and evaluation methods for immune arthritis, psoriasis, atopic dermatitis, ulcerative colitis, and various acute and chronic inflammatory diseases. Especially for the recent research and development of new drugs focusing on some specific immune targets in the inflammatory pathway (JAK/STAT pathway or IL-23 pathway, etc.), they all have mature and stable evaluation methods. The system has also effectively evaluated the innovative drugs for other pharmaceutical companies and research institutes and received high praise.
Medicilon is honored to participate in the development of IL-23 monoclonal antibody drugs. Medicilon will continue to explore and accumulate relevant technical service experience, improve R&D capabilities, in order to provide clients with high-quality and efficient services, and promote new innovations in IL-23 monoclonal antibody drugs.
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