Mabwell's 9MW2821 Gets CDE Phase III Trial Nod for Urothelial Carcinoma with PD-1 Inhibitor

SHANGHAI, Aug. 26, 2024 -- Mabwell (688062.SH), a pioneering biopharmaceutical enterprise with a complete industry chain, has announced the approval of its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for a significant Phase III clinical trial. This trial, titled "a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer," has been initiated and is currently in the patient enrollment phase. Notably, 9MW2821 has been approved for three pivotal clinical trials to date.

9MW2821 is an innovative Nectin-4-targeting ADC (antibody-drug conjugate) created by Mabwell. It is the first of its kind in China to begin clinical trials targeting the same molecule. Over 400 participants have been enrolled in clinical studies for multiple uses of 9MW2821, which has shown remarkable therapeutic effectiveness and safety in existing clinical trials. The ongoing pivotal Phase III clinical study, an open-label, randomized trial comparing 9MW2821 to the investigator's choice of chemotherapy in patients with locally advanced or metastatic urothelial cancer who have previously received PD-(L)1 inhibitor and platinum-based chemotherapy, is currently in the enrollment stage.

Bladder cancer, a subtype of urothelial carcinoma, holds significant public health importance due to its prevalence. According to the American Society of Clinical Oncology, bladder cancer is the ninth most common malignant tumor and ranks thirteenth in mortality among all cancers. The Global Cancer Statistics released by the International Agency for Research on Cancer (IARC) in 2022 reported around 614,000 new cases and 220,000 deaths from bladder cancer worldwide. The National Cancer Center in China, in its 2022 report on The Disease Burden of Malignant Tumors in China, recorded 92,900 new cases and 41,400 deaths from bladder cancer, placing it eleventh and thirteenth globally in new incidences and mortality, respectively. Urothelial carcinoma in China is marked by its high metastatic potential, frequent recurrence, and short survival period in advanced stages, posing a major health burden.

9MW2821 is a site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell, and it is the first drug candidate among Nectin-4-targeting ADCs developed by Chinese companies to enter clinical trials. It is the world’s first therapeutic drug candidate targeting Nectin-4 to show clinical efficacy data in cervical cancer, esophageal cancer, and breast cancer. In 2024, the FDA granted Fast Track Designation to 9MW2821 for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic cervical cancer that has progressed following platinum-based chemotherapy, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC). Additionally, it has received Orphan Drug Designation from the FDA for treating esophageal cancer and Breakthrough Therapy Designation from the CDE of NMPA for treating locally advanced or metastatic urothelial carcinoma that has not responded to previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

The unique properties of 9MW2821 include site-specific modification of the antibody through proprietary conjugation technology linkers and an optimized ADC conjugation process. Upon injection, 9MW2821 specifically binds to Nectin-4 on cell membranes, is internalized, and releases a cytotoxic drug, inducing apoptosis in tumor cells.

Mabwell (688062.SH) is a biopharmaceutical company driven by innovation and encompassing the entire pharmaceutical value chain. The company aims to provide more effective and accessible therapies and innovative drugs to meet global medical needs. Since 2017, Mabwell has established an advanced R&D system that spans target discovery, early discovery, druggability, preclinical and clinical research, and manufacturing. The company’s pipeline includes 14 products at various stages, consisting of 10 novel drug candidates and 4 biosimilars. Their focus areas include oncology, autoimmune diseases, metabolic disorders, ophthalmologic diseases, and infectious diseases. Three of these products have been approved and commercialized, one product has been filed for marketing approval, and three are in pivotal trials. Mabwell also participates in national and provincial scientific and technological innovation projects. Their manufacturing capabilities comply with international GMP standards and have passed the EU QP Audit. Facilities in Shanghai and Taizhou are under construction to further boost manufacturing capabilities. Their mission is "Explore Life, Benefit Health," and their vision is "Innovation, from ideas to reality."

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