By Fineline Cube Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biotech firm, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for BAT8008, its antibody-drug conjugate (ADC) targeting solid tumors. This marks the fourth product from Bio-Thera’s pipeline to advance into clinical trials.
Drug Profile
BAT8008 combines a recombinant humanized anti-Trop2 antibody with a topoisomerase I inhibitor payload, linked via a cleavable linker. The ADC demonstrates potent anti-tumor activity and a strong bystander effect, enabling it to overcome tumor heterogeneity. Preclinical data show BAT8008 has excellent stability and safety, with minimal off-target toxicity due to low plasma release of the small molecule toxin.
Strategic Outlook
The initiation of clinical trials for BAT8008 expands Bio-Thera’s oncology portfolio, following three previously approved products. The company aims to leverage its ADC platform to address unmet needs in solid tumor treatments.-Fineline Info & Tech