Is Datopotamab already on the market in China?

As of2025 July , datopotomab deruxtecan (Datopotamab deruxtecan, trade name: Datroway) has not been officially launched in mainland China. However, in March 2024, Daiichi Sankyo and AstraZeneca jointly developed this antibody-drug conjugate targeting TROP2 (A DC) has submitted a marketing application to the National Medical Products Administration of China (NMPA), and it was officially accepted on March 16th of the same year. This drug is mainly used to treat HRpositive, HER2negative (IHC 0, IHC 1+ or IHC) who have received endocrine therapy and at least one systemic therapy. 2+/ISH-) in adults with unresectable or metastatic breast cancer. The marketing application submitted this time is based on the research data of the pivotal Phase III clinical study of TROPION-Breast01.

In the international market, dabrotuzumab has been approved and marketed. For example, in Japan, the drug was first approved for marketing in December 2024 for the treatment of adult patients with HR-positive, HER2-negative unresectable or recurrent breast cancer. Subsequently, in January 2025, the drug was approved in the United States. In addition, in April 2025, the European Medicines Agency (EMA) approved its marketing.

Although dedabrotuzumab has not yet been launched in mainland China, its clinical research results in the treatment of breast cancer have attracted widespread attention. According to the results of the TROPION-Breast01 study, dabrotuzumab showed significant efficacy in patients with HR-positive, HER2-negative unresectable or metastatic breast cancer who had previously received endocrine therapy and at least one systemic therapy. The study results showed that the median progression-free survival (PFS) of dabrotuzumab was 6.9 months, significantly reducing the risk of disease progression or death by 37%.

As China's drug approval process advances, dedabrotuzumab is expected to obtain approval from the China National Medical Products Administration and officially enter the Chinese market in the future. While patients are waiting, they can obtain the drug by participating in clinical trials. It is recommended that patients understand the latest drug information and treatment options under the guidance of professional doctors in order to make the best treatment decisions.

Reference materials:https://www.drugs.com/