BioTroy Therapeutics' globally pioneering anti-tumor drug receives approval for clinical research in the United States

Shanghai BioTroy Therapeutics has officially announced that its self-developed novel anti-tumor drug BT02 has recently received Investigational New Drug Clinical Trial (IND) approval from the U.S. Food and Drug Administration (FDA) and has officially entered the clinical development stage  

The advancement of cancer immunotherapy checkpoint inhibitors has revolutionized clinical practices with their profound therapeutic efficacy. Identifying novel, efficacious targets is pivotal in augmenting response rates and achieving clinical benefits. Historically, significant advancements at the target level have predominantly been achieved by international entities, including Medarex, Inc. (focusing on PD-1 and LAG-3 targets), Forty Seven, Inc. (specializing in CD47 target), and Jounce Therapeutics, Inc. (concentrating on ICOS target), all of which are leading biotechnology firms listed on NASDAQ. However, with the continuous enhancement of China's foundational scientific research capabilities and the maturation of the innovative incubation investment landscape, a shift in this trend is anticipated. BioTroy Therapeutics has pioneered in advancing new target antibody drugs into clinical trials, concurrently contributing to the biological research of these targets. This initiative epitomizes the 'from 0 to 1' paradigm in original drug research and development, establishing a comprehensive global patent framework encompassing antibodies, epitopes, and targets for robust intellectual property protection. The investigational drug has demonstrated remarkable preclinical efficacy against a range of intractable late-stage solid tumors. The successful authorization of this clinical trial signifies a landmark progression in the development of its pipeline.

Dr. Jie Xu, founder of BioTroy Therapeutics and a distinguished figure in national scientific and technological innovation, remarked: 'The discovery of therapeutic targets represents a crucial phase in drug development. Despite the scarcity of breakthroughs at the target level within the domestic realm, the clinical trial approval of BioTroy Therapeutics’ 'from 0 to 1' innovative drug harbors the potential to infuse newfound hope and vigor into the oncological therapeutic arena.'

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.

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