BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company located in Guangzhou, China, is 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 approved the application for Phase IB-II clinical trial of BAT8008 for injection in combination with BAT1308 for the treatment of advanced solid tumors.

BAT8008 is an antibody-drug coupling (ADC) developed by BIO-THERA to target Trop2, a tumor-associated calcium signal transducer (TACSTHERA), to be developed for the treatment of solid tumors. Trop-2 (Trophoblast cell-surface antigens 2, Trop2), a member of the tumor-associated calcium signal transducer (TACSTD) family of genes, is involved in the regulation of intracellular calcium concentration.Trop2 is not expressed or is lowly expressed in normal human tissues, but is highly expressed in a variety of human tumor tissues, especially in epithelioid tumors, including breast, cervical, colorectal, esophageal, gastric, lung, squamous cell carcinomas of the mouth, ovarian, prostate, pancreatic, and pancreatic cancers, and is also expressed in many other tumors. BAT8008 is composed of recombinant humanized anti-Trop2 monoclonal antibody and topoisomerase I inhibitor linked by a self-developed shearable linker.BAT8008 has highly efficient anti-tumor activity, strong paracrine effect, stable in the plasma, and is highly stable in the plasma. effect, more stable in plasma, very low shedding rate, and also showed better safety in non-clinical evaluation, it is a new generation of ADC drugs.

BAT1308 Injection is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA, whose 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 able to bind specifically to human PD-1 with high affinity, thus blocking the interaction between PD-1 and its ligands PD-L1 and PD -L2.BAT1308 can 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.

The use of BAT8008 for injection combined with BAT1308 injection in the treatment of patients with advanced solid tumors is expected to further improve the therapeutic effect and provide new treatment options for patients.

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