BEIJING -- Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, announced a comprehensive upgrade to its preclinical business division. The upgrade features an expanded portfolio of genetically engineered animal models—including target-humanized, immune-humanized, transgenic, and immunodeficient mice—alongside a full suite of preclinical services such as efficacy studies, PK/PD analysis, biomarker evaluation, and non-GLP toxicology testing. In parallel, the company also launched its new official website (https://biocytogen.com), featuring an intuitive structure, enriched content, and an optimized multilingual user experience to serve global clients and partners better.

Extensive Model Portfolio with Over 1,100 Target-Humanized Mouse Models

In 2021, Biocytogen launched the “BioMice” sub-brand to advance its portfolio of genetically engineered mouse models. Leveraging its proprietary gene-editing platform, the company has developed more than 1,100 target-humanized mice. These models are generated using precise in situ gene replacement technology, which substitutes mouse genes with human sequences while preserving endogenous gene regulation. This approach enables a more accurate simulation of human physiological and pathological conditions, establishing BioMice as the gold-standard platform for evaluating the efficacy and safety of various therapeutic modalities, including antibody drugs, cell therapies, bispecific/multispecific antibodies, ADCs, and oligonucleotide-based treatments.

The company has established high-value disease models for oncology, autoimmune, metabolic, and neurological disorders, including CD3 (TCEs), HER2 (TAAs), TL1A (IBD), TSLP (AD), GLP1R (muscle gain/weight loss), and TFR1 (BBB delivery). These models are widely used for target validation, mechanistic studies, and preclinical evaluations. To date, safety data generated from these models have supported 15 IND approvals by China’s NMPA and 5 IND approvals by the U.S. FDA (including 4 dual submissions). Biocytogen also offers immune-humanized mouse models (e.g., huPBMC-B-NDG, huHSC-B-NDG, huHSC-B-NDG hIL15, and huPBMC-B-NDG MHC I/II DKO plus), transgenic mice, and immunodeficient strains to support evaluations of immuno-oncology agents, T/NK cell therapies, and immunostimulatory drugs, building a comprehensive and multi-dimensional model portfolio.

Global Animal Supply Network Supporting Efficient Preclinical Research

Biocytogen operates three AAALAC-accredited animal facilities in Haimen (Jiangsu), Daxing (Beijing), and Boston (USA), covering a total area of 55,000 m² and offering an annual supply capacity of over 800,000 laboratory animals. With a robust quality control system and standardized microbial monitoring, Biocytogen has established an international distribution network spanning Asia, Europe, and North America. The company’s mouse models have been successfully delivered to clients in over 20 countries and regions, providing reliable model support for global drug development efforts.

Integrated Preclinical Services to Accelerate IND Filing and Clinical Translation

Leveraging its proprietary animal models, Biocytogen provides one-stop, non-GLP preclinical products and services, including in vivo efficacy testing, PK/PD analysis, biomarker assessment, and early toxicology studies. With a vast collection of CDX and PDX tumor models and customizable study designs, Biocytogen serves over 20 therapeutic areas—including solid tumors, hematologic malignancies, autoimmune diseases, metabolic disorders, and neurodegenerative diseases—and supports a variety of drug modalities such as antibodies, small molecules, ADCs, bispecifics, cell therapies, nucleic acids, and vaccines. As of now, Biocytogen has completed more than 5,300 drug evaluation studies for nearly 900 pharmaceutical and academic institutions worldwide.

Over One Million Fully Human Antibodies Empowering Antibody Drug Discovery

Beyond preclinical services, Biocytogen also leads in antibody discovery through its proprietary RenMice® platforms—including RenMab™ (fully human antibody), RenLite® (common light chain), RenNano® (VHH antibody), RenTCR™ (fully human TCR), and RenTCR-mimic™ (fully human TCR-mimic antibody). The company has built a library of over one million fully human antibody sequences against more than 1,000 potential therapeutic targets, with diverse structures and functional profiles. As of December 31, 2024, Biocytogen has signed approximately 200 drug co-development, licensing, or transfer agreements, including over 50 target-based RenMice® platform collaborations with multinational pharmaceutical companies. Multiple clinical-stage antibody candidates have also been successfully out-licensed to global partners. Biocytogen’s integrated capabilities in antibody discovery, screening, and engineering are accelerating the transition from target validation to clinical candidate selection, empowering global biopharmaceutical innovation.

New Official Website Launched to Serve Global Clients

To enhance global service capabilities, Biocytogen has officially launched its new website: https://biocytogen.com. Designed for a clean and intuitive user experience, the new site features streamlined architecture, upgraded content organization, improved search functionality, and multilingual support in Chinese, English, Japanese, and Korean. Structured around its two main business divisions—BioMice® for preclinical products and services and RenBiologics™ for antibody discovery and collaboration—the site offers a comprehensive overview of Biocytogen’s model products, antibody assets, project portfolios, and service capabilities. It provides an efficient and direct information portal for global partners and supports the company’s ongoing internationalization strategy.