On June 9th, 2021, National Medical Products Administration(NMPA) announced that China's first independently developed antibody-drug conjugate (ADC)- Disitamab vedotin (trade name: Aidexi®, research code: RC48) was approved to market for the treatment of locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) with HER2 over-expression in patients who have received at least two types of systemic chemotherapy.
The approval of Disitamab vedotin has broken the situation that there is no original domestic new drug in the field of 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.
Prior to this, the world's first dual-target treatment for systemic lupus erythematosus (SLE) biological medicine Telitacicept was approved by the NMPA on March 9. In less than 6 months, two world-class novel drugs have been approved, RemeGen shows its strength in research and development, and aims to become a leader in the China bio-pharmaceutical industry.