Mabwell's Nectin-4 ADC Gains Breakthrough Status for Urothelial Carcinoma

Mabwell, a forward-thinking biopharmaceutical company with a complete industry chain, revealed that its new Nectin-4 targeting ADC has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for treating locally advanced or metastatic urothelial carcinoma that didn't respond to prior platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

Being labeled as a breakthrough therapy is intended to speed up the development of potential drugs for severe illnesses, with these drugs showing notable effectiveness or safety benefits over current treatments in clinical trials.

CDE will focus on assisting drug candidates in the breakthrough therapy list by allocating resources to improve communication and offer guidance, ultimately benefiting the progression of clinical development and speeding up market review and approval. This will speed up the progress of developing 9MW2821 and address the medical needs of Chinese patients that have not been met.

9MW2821 is the initial Nectin-4 targeting ADC novel specifically designed for a particular site by Mabwell through the ADC platform. It is the primary drug candidate from Chinese companies focusing on Nectin-4 to undergo clinical trials and the first global therapeutic candidate to demonstrate clinical effectiveness against cervical cancer (CC), esophageal cancer (EC), and breast cancer.