Medicilon Helps Hangzhou Dac Biotechnology Muc1-ADC Get Clinical Approval

Recently, a recombinant humanized anti-MUC1 monoclonal antibody-Tub201 coupling agent (hereinafter referred to as "Muc1") for the treatment of advanced solid tumor class 1 ADC drug injection from Dac Biotechnology was approved for clinical use. This is the first clinically approved Muc1-ADC drug in China.

Shanghai Medicilon has provided a full set of preclinical research services including pharmacology, pharmacokinetics and safety evaluation in the research and development of new Muc1 drugs, helping the project to be successfully approved for clinical trials.

ADC drugs have the characteristics of heterogeneity, complex metabolic pathways in vivo, and diverse metabolic active substances. The research and development involves antibodies, cytotoxins, and chemical coupling technologies. Therefore, the technical barriers to R&D of ADCs are much higher than other drugs, and they face many difficulties and challenges.

Aiming at the dilemma of Muc1 "there is no relevant animal species, and it is almost impossible to study alternative molecules and select transgenic animals, how to analyze test data and evaluate human safety?", Medicilon and Dac Biotechnology’s personnel learned the lessons of early ADC drug development and safety evaluation and the new requirements of domestic and foreign regulatory agencies for ADC drug safety evaluation in recent years, combined with years of practical experience and technology in ADC drug safety evaluation, and finally overcome the difficulties. In addition, Medicilon has also innovatively designed a variety of original small molecule/linker and original antibody toxicity experiments to provide customers with more choices and fully guarantee the strict, orderly, high-quality, and efficient testing of MUC1-ADC drugs. Research and development has been highly recognized by Dac Biotechnology.

As a strategic partner, Medicilon's antibody-drug conjugate (ADC) preclinical R&D platform provides customized one-stop preclinical research services for Dac Biotechnology, strictly ensuring the safety and quality of new drugs, and has successfully assisted Dac Biotechnology 5 sets of ADC projects to be under pre-clinical research and development, and several ADC projects to be under development.

Medicilon congratulates Dac Biotechnology MUC1 on its phased success, and hopes that MUC1 will be launched as soon as possible to bring good news to patients with advanced solid tumors.