China's IND Approved! BioTroy Therapeutics' Globally Pioneering Anti-Tumor Drug Receives NMPA Approval to Enter Clinical Phase

Shanghai BioTroy Therapeutics officially announced that its self-developed new target anti-tumor drug, BT02 monoclonal antibody injection, has recently passed the review of the National Medical Products Administration's Drug Evaluation Center, and has been approved to conduct clinical trials in China for advanced solid tumors.

       The BT02 IND application has been approved by the CDE (approval number CXSL2300740), marking another important milestone following its clinical approval by the U.S. FDA in September 2023. This approval demonstrates that the preclinical research work of the BT02 product has received high recognition from the drug regulatory authorities of both China and the United States, representing the innovation, high standards, and global perspective of the BT02 research and development efforts.

BT02 is a First-in-class anti-cancer drug developed by BioTroy Therapeutics, based on an original target discovery. It exemplifies the "from 0 to 1" model of original research and development, and has established a global patent layout in terms of antibodies, epitopes, and targets for intellectual property protection. In preclinical studies, the drug not only demonstrated good safety through detailed data but also showed outstanding preclinical efficacy against various hard-to-treat advanced solid tumors, highlighting BT02's enormous potential in treating multiple solid tumors. The approval of its clinical trial in China marks another breakthrough and milestone in the company's pipeline development.

Dr. Xu , founder of BioTroy Therapeutics  and a leading talent in national science and technology innovation, stated: "Target discovery is a key step in drug development, but breakthroughs at the target level have been rare in China. BioTroy Therapeutics' original new drug, which was approved for clinical research in both China and the United States on its first attempt, represents an endorsement of the company's high-quality preclinical research. I am grateful for the tireless efforts of our colleagues, the strong support from our investors, and the solid advancement in the transformation of innovative achievements by high-level domestic universities.”

BioTroy Therapeutics is a company engaged in the research and development of new tumor treatment targets and drugs. Established in Shanghai in 2020, it has completed financing of over 150 million RMB. BioTroy Therapeutics has established multiple research platforms including BioTroy Engine for tumor multi-omics analysis, receptor-ligand discovery, target signal transduction pathway research, antibody discovery and engineering, in vivo pharmacodynamics and translational medicine in large animals, biomarkers, and precision medicine. The company is committed to 'from 0 to 1' original target discovery and global intellectual property layout. It advances 'first in class' new drug development based on solid scientific research data and cutting-edge translational medicine concepts. The company's main pipeline focuses on tumors that are unresponsive to PD-1/PD-L1 inhibitors, and has achieved encouraging results.