Mabwell's ADC 9MW2821 Combo Gets 87.5% ORR and CDE Breakthrough Status

SHANGHAI, January 9, 2025 - Mabwell (688062.SH), a pioneering biopharmaceutical enterprise with a comprehensive industry chain, has announced a significant development involving its proprietary Nectin-4 targeted Antibody-Drug Conjugate (ADC), known as 9MW2821. On January 8, 2025, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) awarded Breakthrough Therapy Designation (BTD) to 9MW2821. This medication, used alongside toripalimab (an anti-PD-1 monoclonal antibody), is intended for patients with previously untreated, unresectable, locally advanced, or metastatic urothelial carcinoma (la/mUC).

To date, 40 patients with la/mUC, who had not undergone prior treatment, have been enrolled in a study and received the combination therapy. The interim results reveal a notable objective response rate (ORR) of 87.5%, with a confirmed ORR of 80%, and a disease control rate (DCR) of 92.5%. Notably, the study has not yet reached median progression-free survival (PFS) and duration of response (DoR), indicating promising outcomes.

A crucial Phase III clinical trial is currently underway to further evaluate the efficacy of 9MW2821 in combination with PD-1 therapy. The investigational drug has already shown a marked improvement in ORR when compared to other ADC and PD-1 treatment combinations. Previously, 9MW2821 had received BTD status as a standalone therapy for advanced or metastatic urothelial carcinoma that had not responded to platinum-based chemotherapy and PD-(L)1 inhibitor treatment.

The Breakthrough Therapy Designation is aimed at accelerating the development of promising new therapies for severe conditions. It is awarded to treatments that demonstrate significant efficacy or safety benefits over existing options in early clinical trials. For those drugs granted BTD, the CDE prioritizes resource allocation to support communication and provide guidance, thus accelerating clinical development and hastening the market review and approval processes.

Mabwell is dedicated to innovation within the biopharmaceutical landscape, boasting an entire value chain from R&D to manufacturing. The company was established in 2017 and has since developed a sophisticated research and development system encompassing target discovery, early-stage discovery, druggability assessments, preclinical and clinical research, and manufacturing transformation. Mabwell currently has 16 pipeline products at various stages of development. This includes 12 novel drug candidates and 4 biosimilars, focusing on therapeutic areas such as oncology, immunology, bone disorders, ophthalmology, hematology, and infectious diseases.

Of Mabwell's pipeline products, three have been approved and commercialized, one has been submitted for marketing authorization, and three are undergoing pivotal trials. The company is also involved in a national scientific project for "Significant New Drugs Development," along with two National Key R&D Programmes and several provincial and municipal science and technology innovation projects.

Mabwell's manufacturing capabilities are robust, with its Taizhou factory adhering to international Good Manufacturing Practice (GMP) standards, as regulated by the NMPA, FDA, and EMA. This facility has successfully passed the EU Qualified Person (QP) Audit. Additionally, large-scale manufacturing facilities in Shanghai and a commercialized ADC manufacturing base in Taizhou are currently under construction.

Mabwell's mission is "Explore Life, Benefit Health," reflecting its commitment to transforming innovative ideas into tangible realities. The company's vision emphasizes the importance of innovation in making significant strides in the biopharmaceutical field, addressing global medical needs with more effective and accessible therapies.