Biocytogen and Nanjing Chia Tai Tianqing Announce IND Approval in China for Co-Developed Anti-IGF-1R Antibody NTB003 (BCG009)

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) and Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. (“NJCTTQ”) announced that NTB003 (formerly BCG009), a co-developed injectable drug candidate, has received the Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA). The approved indication is Thyroid Eye Disease (TED).

About NTB003 Injection

NTB003 is a second-generation fully human anti-IGF-1R monoclonal antibody co-developed by Biocytogen and Nanjing Chia Tai Tianqing. Antibody discovery and optimization were completed by Biocytogen using its proprietary RenMab™ fully human antibody discovery platform, while Nanjing Chia Tai Tianqing was responsible for CMC process development, GLP-compliant toxicology studies, and IND application. Compared with first-generation approved anti-IGF-1R therapeutics, NTB003 demonstrates enhanced molecular affinity, improved druggability, and an extended half-life. In vitro studies have shown that NTB003 exerts potent signal-blocking activity and effectively inhibits the release of hyaluronic acid (HA), indicating strong potential for further clinical development.

Clinical studies of teprotumumab and other investigational anti-IGF-1R biologics have demonstrated that targeting IGF-1R can deliver significant clinical benefits. These agents have shown rapid onset of therapeutic response and favorable outcomes in reducing proptosis and diplopia, improving quality of life, and lowering clinical activity scores in patients with TED.

Nanjing Chia Tai Tianqing will lead the clinical development and commercialization of NTB003 in China, aiming to provide an improved therapeutic option for Chinese TED patients. Biocytogen will be responsible for the global out-licensing of the product outside China.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice^® (RenMab^™/ RenLite^®/ RenNano^®/ RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of December 31, 2024, approximately 200 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn.

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