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 BAT7104 injection in combination with BAT4706 injection for the treatment of advanced malignant tumors.

BAT7104 is a bispecific antibody against PD-L1 and CD47 developed by BIO-THERA and is intended to be developed for the treatment of tumors.BAT7104 activates macrophages to phagocytose tumor cells by blocking the CD47/SIRPα pathway; BAT7104 relieves tumor cells from inhibiting T-cells through the PD-L1/PD-1 pathway by blocking the PD-L1/PD-1 pathway, achieving adaptive immunity and solid immunity. inhibition, realizing the combined anti-tumor effect of adaptive and intrinsic immune systems. Through affinity differentiation design, the target CD47 arm of BAT7104 has moderate affinity, which reduces the potential for toxic side effects; meanwhile, its target PD-L1 arm has high affinity, which improves the tumor cell selectivity of the antibody and enhances the targeted tumor cytotoxicity.

BAT4706 Injection is a fully human monoclonal antibody candidate in the IgG1 class optimized for the treatment of advanced solid tumors by BIO-THERA without fucoidan glycosylation, targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), an immune checkpoint expressed on regulatory T cells (Tregs) and activated CD4+ and CD8+ T cells. BAT4706 specifically binds to CTLA-4 molecules and restores T-cell activation, while its enhanced antibody-dependent cytotoxicity (ADCC) leads to apoptosis of Tregs in the tumor microenvironment, thereby enhancing the body's immune response to cancer. Studies have demonstrated that CTLA-4 monoclonal antibody alone or in combination has a favorable anti-tumor effect in the treatment of a variety of solid tumors.

BAT7104 injection combined with BAT4706 injection for the treatment of patients with advanced malignant tumors is expected to further improve the therapeutic effect and provide new treatment options for patients.

https://mp.weixin.qq.com/s/A0UFLavtKT7GH4sro4XL_g