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Disitamab Vedotin has been granted breakthrough designations in the United States and China, new drug application (NDA) of urothelial carcinoma was accepted

15

2021.07
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On July 14th, National Medical Products Administration (NMPA) has accepted the new drug application (NDA) for disitamab vedotin, the anti-HER2 antibody-drug conjugate (ADC) independently developed by Remegen, for the treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma. This is another big news after it successfully received conditional marketing approval by the NMPA for the first indication last month.


Before this, the first ADC drug created and developed by a China biopharma was granted breakthrough designation by the Food and Drug Administration (FDA) and National Medical Products Administration (NMPA), becoming the first ADC drug to be dual recognized by both the US and China as breakthrough therapy, and the indication was urothelial carcinoma.


Disitamab vedotin was the first antibody-drug conjugate (ADC) for the treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma to submit new drug application (NDA) in China with great potential to achieve a breakthrough for urothelial carcinoma first-line treatment. This is the second NDA in China for Disitamab vedotin after it successfully received conditional marketing approval by the NMPA for the treatment of locally advanced or metastatic gastric cancer (including gastro esophageal junction (GEJ) carcinoma) in China on June 9th, 2021.


The approval of Disitamab vedotin has broken through the current empty space of domestic novel ADC drugs, and filled the gap in the global post-line treatment of patients with HER2 over-expression of gastric cancer. It is a milestone in the history of independent innovation of biological medicine in China.


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