On June 29, 2021 Remegen reported that National Medical Products Administration (NMPA), China’s first novel antibody-drug conjugate (ADC)- Disitamab vedotin, which was just approved to market has been officially included in the breakthrough treatment category for HER2-positive late-stage breast cancer patients with liver metastasis who have received Trastuzumab and taxane therapy in the past (Press release, RemeGen, JUN 29, 2021, View Source [SID1234594765]). The indication is currently in phase Ⅲ clinical trials in China.

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This is the third time that Disitamab vedotin has been granted breakthrough therapy. In September and December 2020, Disitamab vedotin was granted breakthrough designation by the Food and Drug Administration (FDA) and National Medical Products Administration (NMPA) respectively for the treatment of urothelial cancer, becoming the first ADC drug to be dual recognized by both the US and China as breakthrough therapy and Disitamab vedotin is so far the only ADC from China that recieved breakthrough designation from US FDA .

The criteria for breakthrough designation are significantly higher than the other accelerated review pathways of FDA, such as Fast Track, Accelerated Approval, and Priority Review. However, since breakthrough designation emphasizes on significant improvement over currently available treatment, the application drugs must have clinical data with clear advantages, and approvals in the United States are extremely hard, making it very rare for a single drug to be granted both in the United States and China.