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[Medicilon Assist] Bio-Thera's Bispecific Antibody BAT7104 has been Approved for Clinical Trials

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Recently, Bio-Thera’s PD-L1/CD47 bispecific antibody BAT7104 injection has been granted implicit permission for clinical trials, and the approved indication is advanced malignant tumors. It is reported that BAT7104 has started overseas clinical research.

This is Bio-Thera's first bispecific antibody new drug application, and it is also one of bispecific antibody drugs assisted by Shanghai Medicilon. The research and development also marks another achievement of Medicilon in the IND approval of macromolecular drugs.

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BAT7104 is a bispecific antibody drug targeting PD-L1/CD47, designed to inhibit PD-1/PD-L1 and CD47/SIRP-α pathways. In preclinical studies, BAT7104 can effectively block the combination of the two pathways, mediate T cell activation and trigger phagocytosis of macrophages. As a next-generation anti-PD-L1/CD47 bispecific antibody, BAT7104 does not bind to CD47 on red blood cells, and preferentially binds to PD-L1-positive tumor cells, thereby reducing the possibility of toxic effects of some anti-CD47 antibodies in clinical trials, because CD47 is expressed in many normal tissues.

Medicilon provides antibody drugs discovery, CMC research (API + formulation), pharmacodynamics research, PK study, safety evaluation and other services. As of the end of June 2023, Medicilon has successfully assisted in the clinical approval of 31 antibody drugs (8 approved by FDA and NMPA, 1 approved by NMPA and TGA, 1 approved by FDA, NMPA, and TGA) and has multiple antibody projects under development.

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As a long-term partner of Bio-Thera, Medicilon was honored to cooperate with Bio-Thera in the research and development of BAT7104 injection. Under the GLP laboratory environment and operating specifications, the BAT7104 injection (including pharmacokinetics and safety The comprehensive preclinical research service including clinical evaluation provides a professional guarantee for the efficient and high-quality clinical approval of BAT7104 injection.

While achieving the approval of many new protein/antibody drugs, Medicilon also built a protein/antibody pharmacokinetics research platform, biotechnology drug non-human primate safety evaluation professional technical service platform with complete functions and complete facilities, flexible use of ELISA, ECL, TRFIA, CLIA, IF, IP, CoIP, qPCR, FACS, ELISpot, enzymology, etc. This method supports the preclinical research and evaluation of various protein and antibody drugs, and improves the research technical support of domestic antibodies and antibody drug conjugates and other biotechnology drugs.

Medicilon congratulates Bio-Thera BAT7104 injection for clinical approval, and looks forward to the early launch of BAT7104 to benefit the majority of patients with advanced malignant tumors. At the same time, after the IND approval of macromolecular drugs has been achieved, Medicilon will maintain high R&D investment, continue to make breakthroughs in key core technologies, and look forward to achieving a grand slam in the field of cell gene therapy.

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