BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as "BIO-THERA" or the "Company". The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People's Republic of China ("SDA"), which approves the application for a clinical trial of the investigational drug BAT8010 for injection in combination with BAT1006 for injection for the treatment of locally advanced or metastatic solid tumors.

BAT8010 consists of recombinant humanized anti-HER2 antibody and toxin small molecule topoisomerase I inhibitor, connected by self-developed shearable linker.BAT8010 has highly efficient anti-tumor activity, the toxin small molecule has strong cell membrane permeability, and it can be released and kill nearby cancer cells after ADC kills the cancer cells, generating the bystander effect, effectively overcoming the tumor cells' heterogeneity of tumor cells. Meanwhile, BAT8010 has excellent stability and safety, and the release of toxin small molecules in plasma is extremely low, reducing the risk of off-target toxicity.

BAT1006 is a monoclonal antibody targeting HER2, which binds to HER2 extracellular structural domain II, blocks the heterodimerization of HER2 with other HER family receptors (EGFR/HER3/HER4), and inhibits HER2 receptor-mediated proliferation and survival of tumor cells.BAT1006 is an ADCC-enhanced monoclonal antibody, which recruits killer cells such as NK ability and has a stronger killing effect on tumor cells.

The use of BAT8010 for injection combined with BAT1006 for injection in the treatment of patients with locally advanced or metastatic solid tumors is expected to further improve the therapeutic effect and provide new therapeutic options for patients.

https://mp.weixin.qq.com/s/-EY1i_AcAP8tDro_nt7a7w