CeluPro's medium supports listing of Chinese first self-developed ADC new drug

On June 9, 2021, Chinese National Medical Products Administration (NMPA) announced that Chinese first self-developed antibody-drug conjugate (ADC) new drug, Disitamab Vedotin (brand name: Aidexi®, research code: RC48) was listed. It is applicable to the treatment of locally advanced or metastatic gastric cancer (including adenocarcinoma of esophagogastric junction, AEG) patients with HER2 overexpression after at least two kinds of systemic chemotherapy. The approval of Disitamab Vedotin marks the Chinese first self-developed ADC new drug, filling gaps in the late-line treatment of gastric cancer patients with HER2 overexpression worldwide. It is a milestone in the history of Chinese self-developed biological drugs.

Aidexi is RemeGen’s self-developed original ADC new drug, a conjugate of monoclonal antibodies, linkers and small molecule cytotoxic drugs, which precisely targets cancer cells like missiles. Different from foreign similar drugs, the antibody of Disitamab Vedotin is a brand new drug with differentiated biological characteristics. Thus, by targeting HER2 protein on tumor surfaces, Disitamab Vedotin accurately identify cancer cells and kill them with small molecule cytotoxic drugs after penetrating cell membranes, which shows better targeting, curative effect and resistance.

Based on clinical data, Disitamab Vedotin is a global leading ADC drug in the clinical trials on treatment of gastric cancer and urothelial carcinoma with HER2 expression. Moreover, several studies on breast cancer have been carried out, filling gaps at home and abroad. In August 2020, RemeGen received prioritized approval of listing application submitted to NMPA for gastric cancer indications. Globally, urothelial carcinoma indications of Disitamab Vedotin have been certified as breakthrough therapy by NMPA and FDA.

The approval of Aidexi marks CelluPro as the first domestic medium brand that supports listing of domestic ADC new drug. As the long-term cooperation medium supplier of RemeGen, CelluPro would like to express sincere congratulations on the good news.