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Biocytogen and Nanjing Chia Tai Tianqing Secure Approval for NTB003 Antibody in China

Biocytogen Pharmaceuticals and Nanjing Chia Tai Tianqing Pharmaceutical have jointly secured regulatory approval in China for their co-developed anti-IGF-1R antibody, NTB003, aimed at treating Thyroid Eye Disease (TED). This milestone achievement was marked by the Investigational New Drug (IND) approval granted by the National Medical Products Administration (NMPA) in China. The drug, previously known as BCG009, has shown promising results in preclinical studies.

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NTB003 is a second-generation fully human monoclonal antibody developed through a collaboration between Biocytogen and Nanjing Chia Tai Tianqing. Biocytogen utilized its proprietary RenMab™ platform for antibody discovery and optimization, while Nanjing Chia Tai Tianqing focused on process development, toxicology studies, and securing regulatory approval. Compared to existing therapies, NTB003 boasts improved molecular affinity, enhanced druggability, and an extended half-life, offering potential advantages in clinical efficacy.

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Research on teprotumumab and other anti-IGF-1R biologics has demonstrated the therapeutic benefits of targeting IGF-1R in treating TED. These studies have highlighted the rapid onset of action and positive outcomes in reducing symptoms and improving the quality of life for patients with this condition. The approval of NTB003 marks a significant step towards providing an advanced treatment option for TED patients, particularly in China.

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Nanjing Chia Tai Tianqing will spearhead the clinical development and commercialization efforts for NTB003 within China, with a focus on addressing the unmet medical needs of TED patients in the region. Biocytogen, on the other hand, will oversee the global licensing and distribution of the product outside of China, aiming to expand its reach to a wider patient population worldwide.

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Biocytogen, a leading biotechnology company, has been at the forefront of developing novel antibody-based therapeutics using cutting-edge technologies. Leveraging its gene editing expertise and proprietary platforms, Biocytogen has established itself as a key player in the field of monoclonal antibody discovery. The company’s commitment to innovation and collaboration has led to numerous successful partnerships and research initiatives globally.

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As the pharmaceutical industry continues to evolve, collaborations between companies like Biocytogen and Nanjing Chia Tai Tianqing underscore the importance of cross-border partnerships in advancing healthcare innovation. The approval of NTB003 reflects the growing trend towards personalized and targeted therapies, offering new hope for patients with challenging medical conditions.

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With the IND approval paving the way for further clinical development and commercialization, NTB003 represents a significant advancement in the treatment landscape for Thyroid Eye Disease. The combined expertise of Biocytogen and Nanjing Chia Tai Tianqing has culminated in the development of a promising therapeutic option that holds great potential for improving patient outcomes and quality of life.

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