Is Datopotamab currently available for purchase and use in China?

As of2025 year7 months, datopotamab (Datopotamab deruxtecan (trade name: Datroway) has not been approved for marketing by the National Medical Products Administration (NMPA) in China, so it cannot be purchased and used through formal channels in China.

This drug is manufactured by Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) is jointly developed with AstraZeneca (AstraZeneca) and is mainly used to treat advanced or metastatic triple-negative breast cancer (TNBC) and EGFR mutation-positive non-small cell lung cancer (NSCLC). In2025year1month,Datopotamab Deruxtecanobtained accelerated approval from the FDA in the United States for the treatment of patients with hormone receptor-positive, HER2-negative breast cancer; in April of the same year, it received similar approval in the European Union. In June 2025, the FDA expanded its indications and approved it for the treatment of patients with EGFR mutation-positive advanced or metastatic non-small cell lung cancer.

Although the drug is approved internationally, it has not been approved by the NMPA in China. Currently, if patients want to use dabrotuzumab, they may need to participate in international clinical trials or purchase drugs through overseas channels. However, these routes involve certain legal and regulatory risks and may result in high costs. In addition, patients need to pay special attention to the side effects of the drug during use, such as interstitial lung disease, stomatitis, fatigue, etc., and should consult a professional doctor before use.

Wikipedia

In general, dabrotuzumab has not yet been approved for marketing in China, and patients in the country cannot purchase and use the drug through formal channels. If you are considering using this medication, it is recommended that you discuss it in detail with a medical professional to assess its indications, potential risks and possible access.

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