Mabwell receives approval for Phase III trial of urothelial carcinoma drug in China
Mabwell Therapeutics received NMPA approval for a Phase III trial of 9MW2821 plus Toripalimab vs. chemotherapy for urothelial carcinoma. The trial is currently enrolling patients previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy. 9MW2821, a Nectin-4-targeting ADC, is the first of its kind in China, with over 400 subjects enrolled across multiple indications. It has received FDA Fast Track, Orphan Drug, and Breakthrough Therapy designations for various indications.
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Mabwell's novel Nectin-4 targeting ADC, 9MW2821, receives CDE approval for Phase III trial in cervical cancer. The ADC, first in its class globally, has shown promising efficacy and safety in over 400 subjects across various cancers. The trial aims to compare 9MW2821 with standard chemotherapy in recurrent or metastatic cervical cancer patients who have failed platinum-based therapy.
Mabwell Therapeutics received NMPA approval for a Phase III trial of 9MW2821 plus Toripalimab vs. chemotherapy for urothelial carcinoma. The trial is currently enrolling patients previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy. 9MW2821, a Nectin-4-targeting ADC, is the first of its kind in China, with over 400 subjects enrolled across multiple indications. It has received FDA Fast Track, Orphan Drug, and Breakthrough Therapy designations for various indications.