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The national drug evaluation center officially accepted the clinical application of TAA013, an antibody-coupled drug from TOT


TOT BIOPHARM announced that the national drug evaluation center officially accepted the new drug clinical application of TAA013 (acceptance number: CXSL1800045), and entered the review process. This is the seventh drug and the fourth biological medicine clinical application submitted by TOT BIOPHARM up to now. Among them, the first three biological drugs have been approved by the clinical department in the early days, and two applications have been issued with no compensation.

Antibody conjugated drug (ADC) is a highly active toxic drug conjugated by monoclonal antibody and highly active toxic drugs. It is a kind of powerful anticancer drug that specifically targets cancer cells. Due to the accurate identification of targets and the non-cancer cells are not affected, the product has the advantages of good selectivity, high efficacy and low side effects, and has a broad market prospect. However, the threshold for the development of ADC drugs is relatively high. First, the threshold for the research and development of the drug itself is relatively high, and it is difficult for antibodies to be coupled with small-molecule drugs. Second, large molecule and small molecule are involved in the production process, and the safety and stability of ADC products should be ensured to avoid cross-contamination of the environment and the industrialization process is complex. Currently, the number of domestic enterprises capable of producing ADC drugs is limited.

At present, the production technology and industrialization capacity of adc-coupled drugs in TOT BIOPHARM are at the forefront in China. TAA013 as the HER2 target antibody conjugated drug is independently developed and produced by TOT BIOPHARM. The company is equipped with oel-5 level isolators, and plans to have an industrialization level ADC workshop in the future, so as to meet the market supply of ADC products of TOT BIOPHARM.

The successful submission of the clinical application for the antigen-coupled drug TAA013 will further enrich the anti-tumor product portfolio of TOT BIOPHARM, which is another milestone in the industrialization of the advanced manufacturing technology of TOT BIOPHARM.