JYB1904 is a new anti-IgE recombinant humanized monoclonal antibody targeted therapy drug. IgE is the main immunoglobulin that mediates type I hypersensitivity diseases. When the body is exposed to allergens, the allergens can combine with IgE bound to FcεRI on the surface of effector cells and cross-link each other to form cross-linked products, causing inflammatory mediators release, leading to various allergic symptoms. Jemincare’s researchers found that JYB1904 can specifically bind to free IgE, thereby blocking the binding of IgE to its receptor FcεRI, thereby preventing it from being activated by allergens, which is expected to rapidly and effectively relieve the symptoms of patients clinically.
In the preclinical study of head-to-head comparison with omalizumab, JYB1904 showed better biological activity, druggability and stability, quick onset and good efficacy in animal asthma models, and good safety in animals. The drug has a long serum half-life. These research results show that JYB1904 injection has excellent clinical therapeutic potential and can provide a potential new solution for the clinical treatment of allergic diseases such as moderate to severe asthma.
The concentration of pre-stored targets is high, the analysis methods are many and complex, and factors such as IgE, free drugs, IgE-drug complexes and even ADA-drug complexes cause various biological analysis interferences...Facing a series of challenges, Medicilon toxicology and biological The experts of the analysis team fully researched and judged and comprehensively tackled key problems: firstly, the individual subjects were screened based on the concentration level of the target before the animals were enrolled; secondly, in terms of analysis methods, it not only involved the development, verification and corresponding analysis of multiple biological analysis methods. For sample analysis, consider the distinction between Total drug and Free drug, and also involve Total IgE and Free IgE. In addition, in response to the methodological problems caused by IgE and the problems of ADA method development, the Medicilon bioanalysis team used years of rich project experience to constantly change their thinking and method design strategies many times, and finally formed a mature drug that can tolerate high concentrations. The ADA analysis method for drugs that are resistant to high-concentration target interference; finally, to overcome various interference problems, analysts need to continuously optimize the technical effect of Troubleshooting, such as for the PK/TK analysis method of drugs. For the selectivity of drug and total drug, it is also necessary to consider how to overcome the double interference of high-concentration IgE and potential ADA on the detection of drug molecules; for the detection of IgE targets, it is necessary to consider how to adopt an appropriate Assay Format in terms of technical strategy To design and realize the selectivity of the methodology itself for Free IgE and Total IgE, it is also necessary to consider establishing a special pretreatment method to overcome the interference of high-concentration circulating drugs on IgE detection.
The successful support of the JYB1904 project is not only a strong combination of Medicilon’s rich industry accumulation in the field of preclinical biomedical research and development and Jemincare’s technical advantages in the field of innovative drug research and development, but also once again verified Medicilon’s profound research and development strength. Medicilon congratulates Jemincare JYB1904 Injection for its successful clinical approval and looks forward to the early approval of JYB1904 Injection for marketing.
Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.
Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.
Medicilon provides antibody drugs discovery, CMC research (API + formulation), pharmacodynamics research, PK study, safety evaluation and other services. As of the end of June 2023, Medicilon has successfully assisted in the clinical approval of 31 antibody drugs (8 approved by FDA and NMPA, 1 approved by NMPA and TGA, 1 approved by FDA, NMPA, and TGA) and has multiple antibody projects under development.
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