Jiangsu Chia Tai Tianqing’s TQB2102m Gains NMPA Clinical Approval

Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd’s (CTTQ) Category 1 biologic product TQB2102m, an HER2 targeted antibody drug conjugate (ADC), has obtained clinical approval from the National Medical Products Administration (NMPA). The targeted indication is advanced malignant tumors, with no similar product currently approved for marketing anywhere in the world.

Mechanism of Action and Development
After intravenous injection, the antibody part of TQB2102m binds to ECD2 and ECD4 on the surface of HER2 positive tumor cells. The ADC complex is then internalized and transferred to lysosomes within the cells, where the linker releases small molecule drugs after enzyme digestion, leading to DNA damage and cell death. This innovative mechanism positions TQB2102m as a promising candidate for the treatment of advanced malignant tumors.

Future Prospects and Strategic Implications
The clinical approval from the NMPA marks a significant milestone for CTTQ in advancing its HER2 targeted ADC. By leveraging innovative drug development capabilities, CTTQ aims to address significant unmet medical needs in oncology, improving patient outcomes and contributing to the global fight against cancer.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry