BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), 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, which approves the clinical trial application of the Company's investigational drug BAT1308 in combination with BAT8006 for the treatment of advanced solid tumors.

BAT1308 injection is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA. Its active ingredient is an antibody targeting human programmed cell death protein 1 (PD-1) expressed by Chinese hamster ovary cells, which belongs to the immunoglobulin IgG4κ subtype, and is capable of binding specifically to human PD-1 with high affinity, thus blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2. BAT1308 is able to bind to PD-1 on the surface of T-cells and release the inhibitory effect of the PD-1 pathway on T-cells, thus restoring and improving the immunocidal function of T-cells and inhibiting tumor growth.

BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located on cell membranes and is overexpressed in a variety of solid tumors, such as ovarian, lung, endometrial, and breast cancers, and is expressed at a lower level in normal human tissues. The difference in expression levels between tumor and normal tissues makes FRα an attractive target for development as an antitumor drug.BAT8006 consists of a recombinant humanized anti-FRα antibody linked to a toxic small-molecule topoisomerase I inhibitor by a company-developed shearable linker. Preclinical studies have shown that BAT8006 has highly potent anti-tumor activity. The toxin small molecule has strong cell membrane permeability and can release and kill nearby cancer cells after ADC kills the cancer cells, generating a bystander effect, which is expected to be effective in overcoming the heterogeneity of tumor cells.

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