Has gosatuzumab been included in China’s medical insurance coverage?

Sacituzumab govitecan (Sacituzumab govitecan), an antibody-drug conjugate targeting Trop-2, has attracted widespread attention in the global pharmaceutical field. Trop-2, as a cell surface antigen ubiquitous in various tumors such as breast cancer, bladder cancer, and lung cancer, has become the main target of gosatuzumab. The unique design of this drug is connected to the topoisomerase I inhibitor SN-38 through a proprietary hydrolyzable linker. It not only targets Trop-2 expressing cells, but also has an effect on the tumor microenvironment through the bystander effect.

To date, gosatuzumab has been approved for use in nearly50 countries around the world, and is undergoing more regulatory reviews. It has demonstrated significant efficacy in the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), particularly those who have undergone two or more systemic therapies. In addition, it also plays an important role in the treatment of pretreated HR+/HER2 metastatic breast cancer and second-line or advanced metastatic urothelial carcinoma.

However, for Chinese patients, although gosatuzumab has been marketed in China, unfortunately, it has not been included in China's medical insurance directory. Although the drug has proven its efficacy against a variety of cancers in clinical trials around the world, it still needs to pass a series of strict evaluations and approvals before entering China's medical insurance system. Drugs in the medical insurance catalog must meet specific efficacy and safety standards, and their prices must be within the country’s medical insurance affordability. As an innovative drug, gosatuzumab’s R&D and production costs are relatively high, so its price may also become a problem in entering the medical insurance catalog.