Mabwell's ADC 9MW2821 Granted Breakthrough Therapy from CDE, NMPA
Tuesday, August 13, 2024
Mabwell has announced that its novel Nectin-4 targeting ADC, known as 9MW2821, has received Breakthrough Therapy Designation (BTD) from the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
9MW2821 is the first site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using its ADC platform. It is also the first Nectin-4 targeting ADC developed by a Chinese company to enter clinical trials and the first in the world to demonstrate clinical efficacy in treating cervical cancer, oesophageal cancer, and breast cancer.
Additionally, it received Orphan Drug Designation from the FDA for oesophageal cancer and Breakthrough Therapy Designation from the CDE of the NMPA.
The 9MW2821 ADC uses a proprietary conjugation technology that allows site-specific modification of the antibody, optimising the drug’s effectiveness. Once administered, 9MW2821 binds specifically to Nectin-4 on the cell membrane, is internalised, and releases a cytotoxic drug, leading to the apoptosis of tumour cells.
This designation is for the treatment of locally advanced or metastatic urothelial carcinoma in patients who have not responded to previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.
In 2024, the FDA granted 9MW2821 Fast Track Designation for advanced, recurrent, or metastatic oesophageal squamous cell carcinoma, recurrent or metastatic cervical cancer that has progressed following prior platinum-based chemotherapy, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer.
The Breakthrough Therapy Designation is intended to accelerate the development of promising drug candidates for serious conditions. It is awarded to drugs that have shown significant improvements in efficacy or safety in early clinical trials compared to existing treatments.
For drugs granted this designation, the CDE will allocate additional resources to enhance communication and provide guidance, thereby accelerating the development, review, and approval processes. This prioritisation is expected to hasten the development of 9MW2821, addressing the unmet clinical needs of patients in China.
Source:mabwell.com
