Mabwell Achieves Breakthrough Designation for Nectin-4 ADC Therapy with High Response Rates

Mabwell's Achievement in Biopharmaceuticals

Mabwell, a renowned biopharmaceutical firm based in Shanghai, has reached a remarkable milestone with its innovative Nectin-4 targeted antibody-drug conjugate (ADC), known as 9MW2821. On January 8, 2025, this groundbreaking treatment received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA). This designation is a crucial step aimed at accelerating the development of medicines that address serious illnesses, providing clear evidence of the treatment's significant benefits.

The 9MW2821 ADC is used in conjunction with toripalimab, an anti-PD-1 monoclonal antibody, specifically for patients with treatment-naïve, unresectable, locally advanced, or metastatic urothelial carcinoma. The clinical results have been impressive, demonstrating an overall response rate (ORR) of 87.5% among the 40 patients who participated in the therapy. Notably, the confirmed ORR was 80%, while the disease control rate (DCR) reached 92.5%, underscoring the therapy's effectiveness.

Currently, a pivotal Phase III trial is underway to further assess the efficacy of 9MW2821 combined with PD-1 therapy, exploring its advantages over other similar ADC and PD-1 combinations available in the market. Previous studies have shown that this particular ADC outperforms others in terms of response rates, emphasizing the potential it holds for changing treatment paradigms in urothelial carcinoma.

The recognition of the BTD is especially significant as it is awarded to therapies that exhibit noteworthy advantages in efficacy or safety over existing treatments during early-stage clinical trials. For drugs on this list, the CDE intensively prioritizes resources, streamlining communication efforts and offering guidance that facilitates rapid clinical development as well as expedited market reviews and approvals.

About Mabwell

Mabwell is committed to innovation, encapsulating the complete value chain of the pharmaceutical industry. Since its inception in 2017, the company has developed a robust research and development (R&D) system that spans target discovery to drug development and manufacturing. With 16 products in its developmental pipeline, which includes 12 novel candidates and 4 biosimilars, Mabwell is actively engaged in various therapeutic areas including oncology, immunology, and infectious diseases.

Three of its products have already received market approval, showcasing its capability in delivering effective therapies to meet global health needs. The company's facilities comply with international GMP standards, and its manufacturing plants in Taizhou and Shanghai are equipped for large-scale production.

Mabwell's mission,