BioTroy Therapeutics Announces FDA IND Approval for BT02, a First-in-Class Anti-Cancer Drug Targeting Novel Immune Checkpoint

Shanghai BioTroy Biotechnology Co., Ltd. (BioTroy, BioTroy Therapeutics) officially announced that its self-developed novel-target anti-tumor drug BT02 has recently received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), formally entering the clinical development stage.

Tumor immune checkpoint inhibitors have driven transformative changes in clinical practice due to their remarkable efficacy, and the discovery of new effective targets is a key pathway to improving response rates and clinical benefits. Historically, target-level breakthroughs have largely been achieved by foreign companies, such as Nasdaq-listed leading biotechnology firms including Medarex, Inc. (PD-1 and LAG-3 targets), Forty Seven, Inc. (CD47 target), and Jounce Therapeutics, Inc. (ICOS target). With the enhancement of China’s basic scientific research capabilities and the maturation of its innovation incubation and investment ecosystem, this landscape is poised to shift. Baiquan Biopharma has taken the lead in advancing an antibody drug targeting a novel candidate into clinical trials, while also serving as a co-contributor to the biological research of this target. This exemplifies an original “zero-to-one” R&D model and has established a global patent portfolio covering antibodies, epitopes, and targets for intellectual property protection. The drug has demonstrated outstanding preclinical efficacy against various refractory advanced solid tumors, and the successful approval of this clinical trial marks a milestone progress in the development of its pipeline.

Dr. Xu Jie, Founder of Baiquan Biology and National Leading Talent in Technological InnovationIt stated: “Target discovery is a critical step in drug development, yet breakthroughs at the target level have been rare in China. Boquan Biopharma’s innovative ‘from 0 to 1’ original new drug has been approved for clinical trials, holding promise to bring new hope and strength to the fight against cancer.”

About Baiquan Bio

BioTroy Therapeutics is a biopharmaceutical company dedicated to the discovery of novel oncology targets and drug development. Founded in Shanghai in 2020, the company has secured over RMB 150 million in financing. BioTroy has established multiple research platforms, including the BioTroy Engine for multi-omics tumor analysis, receptor-ligand discovery, target signal transduction pathway research, antibody discovery and engineering, in vivo efficacy and large-animal translational medicine, as well as biomarkers and precision medicine. Committed to original target discovery “from 0 to 1” and global intellectual property layout, the company advances the development of first-in-class new drugs based on robust scientific data and cutting-edge translational medicine concepts. Its primary pipeline focuses on tumors refractory to PD-1/PD-L1 inhibitor therapy, having already achieved promising results.

Figure: Antibody Epitopes and Preclinical Study Results of Boquan Biologics’ Pipeline