Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for three of its drug candidates. These include BAT8010 in combination with BAT1006 for the treatment of locally advanced or metastatic solid tumors, as well as BAT7205 as a monotherapy for the same patient population.
BAT8010 is an antibody-drug conjugate (ADC) consisting of a recombinant humanized anti-HER2 antibody linked to a topoisomerase I inhibitor, a toxic small-molecule payload, through the company’s independently developed cleavable linkers. This ADC is designed to deliver efficient anti-tumor activity, with the cytotoxic payload possessing strong cell membrane permeability. Its mechanism allows for a bystander effect, where the ADC molecule, after killing a cancer cell, releases the payload to kill nearby cancer cells, effectively addressing tumor cell heterogeneity. BAT8010 also demonstrates good stability and safety, with minimal release of cytotoxic molecules into the plasma, thus reducing the risk of off-target toxicity.
BAT1006 is a monoclonal antibody (mAb) that targets HER2, binding to the HER2 extracellular domain II and blocking the heterodimerization of HER2 with other HER family receptors. This action inhibits tumor cell proliferation and survival mediated by the HER2 receptor. As an ADCC-enhanced mAb, BAT1006 has an enhanced ability to recruit NK cells and other cytotoxic cells, exerting a potent killing effect on tumor cells.
BAT7205 is composed of a recombinant humanized anti-PD-L1 antibody and an IL-15/IL-15R α sushi fusion protein. It functions to block the PD-1/PD-L1 immunosuppressive pathway and activate immune cells through IL-15, achieving a synergistic effect of relieving immunosuppression and activating immune anti-tumor activity. The PD-L1 antibodies can target IL-15 to the PD-L1+ tumor microenvironment, selectively activating tumor-infiltrating CD8+ T cells and NK cells, while reducing the systemic side effects of IL-15. The fusion with the PD-L1 antibody significantly extends the half-life of IL-15 in vivo.- Flcube.com
