Biocytogen Pharmaceuticals and Nanjing Chia Tai Tianqing Pharmaceutical have received Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA) for NTB003, a co-developed injectable drug candidate targeting Thyroid Eye Disease (TED). The approval marks a significant milestone for the second-generation fully human anti-IGF-1R monoclonal antibody, formerly known as BCG009.
Enhanced Second-Generation Anti-IGF-1R Therapy
NTB003 represents an advancement over first-generation approved anti-IGF-1R therapeutics, demonstrating enhanced molecular affinity, improved druggability, and an extended half-life. The antibody was discovered and optimized by Biocytogen using its proprietary RenMab™ fully human antibody discovery platform, while Nanjing Chia Tai Tianqing handled CMC process development, GLP-compliant toxicology studies, and the IND application.
In vitro studies have demonstrated that NTB003 exerts potent signal-blocking activity and effectively inhibits the release of hyaluronic acid (HA), indicating strong potential for further clinical development. These characteristics position NTB003 as a potentially improved therapeutic option for TED patients.
Clinical Validation of IGF-1R Targeting
Clinical studies of teprotumumab and other investigational anti-IGF-1R biologics have demonstrated that targeting IGF-1R can deliver significant clinical benefits in TED patients. 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.
The established clinical validation of the IGF-1R pathway provides a strong foundation for NTB003's development, with the potential for enhanced efficacy given its improved molecular characteristics.
Development and Commercialization Strategy
Under the partnership agreement, 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, leveraging its established network of international partnerships.
Biocytogen has established approximately 200 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements globally as of December 31, 2024, including several partnerships with multinational pharmaceutical companies. This extensive partnership network positions the company well for the global development of NTB003.
