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TAA013, an antibody coupled drug of TOT BIOPHARM has been approved clinically


Recently, TAA013 (CXSL1800045), a self-developed anti-her2-targeting antibody conjugate drug for injection, was approved by the national drug administration for the treatment of breast cancer. TAA013 for injection is the seventh product approved by TOT BIOPHARM to enter the clinical stage.

Antibodies (ADC) by coupling drugs targeted monoclonal antibodies and highly active cytotoxic chemical drugs based on the combination of links sub-tab coupling, with the help of antibody drugs targeting the characteristics of strong sex, make direct effects on tumor cell cytotoxic drugs, give full play to the two drugs antitumor advantage, has the advantages of good selectivity, high efficacy and low side effect, wide prospect of market. Kadcyla (ado-trastuzumab emtansine) is one of the most successful antibody-coupled drugs, with global sales of $914 million in 2017. According to Research & Markets, the ADC drug market will reach $10 billion by 2024.

Domestic research and development of ADC drugs are not uncommon, but most are still in the early stage. The threshold for industrial amplification production of ADC drugs is relatively high, and the production process involves two types of drug molecules, namely large molecule and small molecule. Meanwhile, the safety and stability of ADC products should be ensured to avoid cross-contamination of the environment and the industrialization process is complex. TOT BIOPHARM is equipped with oel-5 level of antibody coupled drugs pilot production workshop, and the industrialization level of antibody coupled drugs (ADC) production workshop is about to be built, is currently one of the few domestic enterprises with antibody coupled drugs research and development and industrial production capacity.

TOT BIOPHARM is specialized in the research and development, production and sales of tumor drugs. Its product line covers different product categories including chemical drugs, monoclonal antibodies, antibody-coupled drugs and oncolytic viruses. The approval of the antigen-coupled drug TAA013 into the clinic 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.