Mabwell Receives China NMPA Nod To begin Phase II Trial

Mabwell, a cutting-edge biopharmaceutical company with full industry integration, revealed that its new Nectin-4 focused ADC (R&D code: 9MW2821) has been given the green light by the NMPA to move into phase II clinical testing as a standalone treatment or in conjunction with a PD-1 inhibitor for addressing triple-negative breast cancer (TNBC).

The recently approved phase II clinical trial is designed to assess how effective and safe 9MW2821 is as a standalone treatment or when used with a PD-1 inhibitor in patients with locally advanced or metastatic TNBC.

The research will involve two groups: Group A will consist of patients with advanced TNBC who have been treated with certain drugs in the past and will be given 9MW2821 alone; Group B will consist of patients with advanced TNBC who have not received any treatment before and will be given a combination of 9MW2821 and a PD-1 inhibitor.

9MW2821 attains site-specific alteration of antibodies using exclusive conjugate technology linkers and an improved ADC conjugation procedure. Upon injection, 9MW2821 is capable of binding directly to Nectin-4 located on the surface of the cell membrane. Subsequently, it can enter the cell and release a toxic drug, leading to the programmed cell death of tumor cells.

Mabwell, a biopharmaceutical company driven by innovation, possesses the full industry chain of research and development, production, and marketing. The company pledged to offer improved therapy and innovative medicines to meet worldwide medical demands more efficiently and easily.