Estimated launch time of Datopotamab in China

Datopotamab (Datopotamab), domestically known as Datopotamab/Datroway, is a Trop-2 targeting antibody-drug conjugate developed by Daiichi Sankyo. With the rapid development of ADC treatment in the field of breast cancer and lung cancer, the launch of this variety has attracted much attention from domestic patients and medical institutions. According to public information,In August 2025, the State Food and Drug Administration has officially approved dabrotuzumab for marketing in China, bringing a new back-line option to patients with hormone receptor-positive, HER2-negative breast cancer who have undergone multiple lines of treatment.

The approved indications are mainly for adult patients with HR-positive, HER2-negative breast cancer who have received endocrine therapy and have experienced disease progression despite having received at least first-line chemotherapy in the advanced stage. This group of people has high clinical needs in China. Traditional treatments include endocrine drugs and chemotherapy. However, when the disease develops into advanced stages, options are often limited. The introduction of Trop-2 ADC is considered an important supplement after HER2 ADC, bringing more hope to breast cancer patients with no target available and treatment resistance.

The research and development of dabrotuzumab overseas is progressing rapidly, and multiple clinical trials have shown its good potential in breast cancer and lung cancer, thus gaining attention in the review of regulatory agencies. Its approval in China was earlier, indicating that the domestic regulatory system has introduced international innovative drugs more quickly and shortened the time gap between patients and new treatments.

Most patients are concerned about accessibility after launch, including whether it will be included in medical insurance and whether there will be a price difference with other ADCs At present, although dabrotomab has been officially launched in China, its medical insurance negotiations require follow-up processes, and self-pay may still be the mainstay in the short term. As more and more ADC drugs enter the Chinese market, the industry generally believes that future prices will become more rational amid competition.

Reference materials:https://dailymed.nlm.nih.gov/