Biocytogen (HKEX: 02315), an international biotechnology company that drives new drug development with innovative technologies,  announced that its preclinical business segment has been fully upgraded, covering target humanized mice, immune system humanized mice, transgenic mice, immunodeficient mice and other model animal products, and providing integrated preclinical products and services covering pharmacodynamics, PK/PD, biomarkers, and non-GLP toxicology evaluation, providing more accurate and efficient solutions for global drug development. At the same time, the company's new official website https://biocytogen.com.cn was launched simultaneously, providing professional and efficient online service support for global customers with a clearer architecture, richer product content and more convenient user experience.

Model animal resources have been comprehensively upgraded, and more than 1,000 species of targeted humanized mice have been developed

Biocytogen has built more than 1,100 targeted humanized mouse strains so far, accurately replacing mouse genes with human sequences through in situ replacement technology, and more realistically simulating the human physiological and pathological environment without affecting endogenous expression regulation, which is the "gold standard" for the evaluation of the efficacy and safety of antibody drugs, cell therapy, bispecific antibodies/multiple antibodies, ADCs, small ribonucleic acids and other therapies Model.

Focusing on key disease directions such as tumors, autoimmunity, metabolic, and neurological diseases, Biocytogen has deployed a number of high-value target models, including CD3 (tumor TCE), HER2 (TAA), TL1A (inflammatory bowel disease IBD), TSLP (atopic dermatitis AD), GLP1R (muscle building and fat loss), TFR1 (brain delivery BBB), etc., which are widely used in drug target validation, functional mechanism research and preclinical evaluation. These models can also be applied to drug safety evaluation, and 15 drugs have been approved by China's NMPA IND based on the safety evaluation data of targeted humanized mice, and 5 have obtained the U.S. FDA IND approval, of which 4 have been declared to China and the United States at the same time. In addition to targeted humanized mice, the company also provides immune system humanized mice (such as huPBMC-B-NDG mice, huHSC-B-NDG mice and upgraded huHSC-B-NDG hIL15 mice, huPBMC-B-NDG MHC I/II DKO mice plus), transgenic mice and immunodeficient mice to meet the evaluation needs of cutting-edge therapies such as tumor immunotherapy, T or NK cell therapy, and immune agonists. Create a multi-level and full-type model animal product matrix.

A global animal supply network ensures the efficient advancement of preclinical trials

Biocytogen has three animal production and service centers in Haimen, Jiangsu Province, Daxing, Beijing, and Boston, USA, with a total area of 55,000 square meters and an annual supply capacity of more than 800,000 laboratory rats. With a rigorous quality control system and microbiological standards, Biocytogen has established an international transportation system covering Asia, Europe, and North America, and its products have been successfully exported to more than 20 countries and regions around the world, providing reliable model guarantee for global new drug research and development.

Integrated preclinical service system to assist in IND application and clinical translation of new drugs

With a powerful animal model platform, Biocytogen provides one-stop non-GLP preclinical products and services, covering in vivo pharmacodynamic assessment, PK/PD analysis, biomarker detection, and early toxicology studies. The company has a rich library of CDX and PDX tumor models, and provides customized solutions, covering more than 20 types of diseases such as parenchymal tumors, hematomas, autoimmunity, metabolic, neurodegenerative diseases, etc., supporting the evaluation of antibody drugs, small molecules, ADCs, bispecific antibodies, cell therapy, small ribonucleic acid drugs, vaccines and other drug forms. Up to now, Biocytogen has completed more than 5,300 drug evaluation projects for nearly 900 pharmaceutical companies and scientific research institutions around the world.

More than one million fully human antibody molecules to assist in the development of antibody drugs

In addition to preclinical services, Biocytogen also carries out fully human antibody/TCR development business with its self-developed RenMice antibody discovery platform (including RenMab fully human antibody, RenLite full human co-light chain antibody, RenNano fully human nano antibody, RenTCR full human TCR, and RenTC Ramimic whole human TCR antibody). The company has built a molecular resource library of more than one million fully human antibodies around more than 1,000 potential drug targets, with differentiated antibody structure and functional characteristics. As of December 31, 2024, Biocytogen has signed approximately 200 drug cooperative development/authorization/transfer agreements, and has reached more than 50 targeted project RenMice platform licensing and development cooperation with a number of MNC companies, and multiple clinical-stage antibody molecules have also reached external licensing cooperation. With strong antibody development, screening and engineering capabilities, Biocytogen is accelerating the transformation process from target validation to drug candidate molecules, empowering global innovative drug research and development.