Mabwell's 9MW2821 ADC Targeting Nectin-4 Receives Breakthrough Therapy Designation from NMPA
Mabwell has announced that its novel Nectin-4-targeting antibody-drug conjugate (ADC), designated as 9MW2821, has received Breakthrough Therapy Designation (BTD) from the Centre for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).
This designation is for treating locally advanced or metastatic urothelial carcinoma that has not responded to previous platinum-based chemotherapy and PD-(L) 1 inhibitor therapies.
The Breakthrough Therapy Designation is intended to accelerate the development of promising drug candidates for serious illnesses, especially those showing significant efficacy or safety advantages over existing treatments in early clinical trials.
With this designation, the CDE will prioritise resources to facilitate communication and provide guidance, thereby supporting drug development. This approach aims to advance the clinical progress and speed up the review and approval process for 9MW2821, addressing the unmet medical needs of patients.
9MW2821 is the first site-specific conjugated Nectin-4-targeting ADC. It is the first therapeutic candidate targeting Nectin-4 globally to demonstrate clinical efficacy in cervical cancer, esophageal cancer, and breast cancer.
9MW2821 received Fast Track Designation from the FDA for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma, recurrent or metastatic cervical cancer after prior platinum-based chemotherapy, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer. Additionally, it has been granted an Orphan Drug Designation by the FDA for treating esophageal cancer, along with Breakthrough Therapy Designation from the NMPA.
Utilising proprietary conjugation technology, 9MW2821 achieves site-specific modification of antibodies through an optimised ADC conjugation process. Following administration, 9MW2821 specifically binds to Nectin-4 on the surface of tumour cells, facilitating internalisation and the release of a cytotoxic drug, ultimately inducing apoptosis in the cancer cells.
