Mabwell receives approval for Phase III trial of urothelial carcinoma drug in China

CAR-T Digest - August 2020

27 Aug 2024: Mabwell receives approval for Phase III trial of urothelial carcinoma drug in China

Mabwell Therapeutics has received approval from NMPA to begin a Phase III clinical trial of 9MW2821 plus Toripalimab for treating urothelial carcinoma
To date, 9MW2821 has been approved for three clinical trials and the drug is a Nectin-4-targeting ADC that has been independently developed by Mabwell and is the first drug of its kind to enter trials in China targeting the same molecule
Clinical studies have shown that 9MW2821 has a promising therapeutic efficacy and safety profile
The US-FDA recently granted Fast Track Designation for 9MW2821 for the treatment of various indications
9MW2821 has also received Orphan Drug Designation from the FDA for the treatment of oesophagal cancer, as well as Breakthrough Therapy Designation from the NMPA for locally advanced or metastatic urothelial carcinoma after previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy has failed