Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its pipeline candidate, the antibody-drug conjugate (ADC) 9MW2821. This designation is for the drug’s potential in treating esophageal cancer. Previously, the FDA had granted fast-track status to 9MW2821 for the treatment of advanced recurrent or metastatic esophageal squamous cell carcinoma.
9MW2821 is currently under evaluation in multiple clinical trials in China. This includes a Phase III study focused on patients with locally advanced or metastatic urothelial carcinoma who have been previously treated with chemotherapy and PD-(L)1 inhibitors. Additionally, a Phase I/II study combining 9MW2821 with a PD-1 inhibitor has shown promising early results in the treatment of cervical cancer as of March this year.- Flcube.com
