9MW2821 is a novel Nectin-4 targeting ADC developed independently by Mabwell, marking the first of its kind among the products developed in China with the same target to enter clinical trials. As of December 5, 2023, more than 250 subjects were enrolled. In the Phase II clinical trial of 9MW2821, at a dose of 1.25 mg/kg, the monotherapy resulted in an objective response rate (ORR) of 62.2% (95% CI: 44.8%–77.5%) and a disease control rate (DCR) of 91.9% (95% CI: 78.1%–98.3%) in patients with advanced urothelial carcinoma. The median progression-free survival (PFS) was 6.7 months (95% CI: 3.8–NR), while the median overall survival (OS) has not been reached yet.

Currently, multiple clinical trials are being conducted simultaneously for this project. Clinical trials on combination therapy with other treatments, in addition to monotherapy, are also advancing. Promising antitumor activity coupled with favorable safety profiles has been observed across various cancer types.