Mabwell Announces the CDE Approval of Novel Nectin-4 Targeting ADC to Initiate Phase III Clinical Trial for the Treatment of Cervical Cancer

SHANGHAI, Aug. 23, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the "A Randomized, Open-label, Phase III Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects with Recurrent or Metastatic Cervical Cancer Who Progressed on or after Platinum-based Chemotherapy" has been approved. The company will initiate the Phase III clinical study to assess the efficacy and safety of 9MW2821 in patients with recurrent or metastatic cervical cancer (CC) that has progressed on or after platinum-based chemotherapy.

9MW2821, a novel Nectin-4 targeting ADC developed by Mabwell, is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. It's also the first Nectin-4-targeting ADC to enter phase III clinical study for the treatment of CC worldwide. Multiple clinical studies have been conducted for urothelium carcinoma, cervical cancer, esophageal cancer, and breast cancer, and more than 400 subjects have been enrolled. The results of the existing clinical studies have demonstrated outstanding therapeutic efficacy and safety.