Shanghai – Mabwell (688062.SH) announced that its novel Nectin-4 targeting ADC, 9MW2821, has received approval from China's National Medical Products Administration (NMPA) for two new clinical trials. These trials aim to broaden the therapeutic application of 9MW2821 in urothelial carcinoma and advanced solid tumors.
The first clinical trial will assess the efficacy and safety of 9MW2821 in combination with a PD-1 monoclonal antibody for the treatment of perioperative urothelial carcinoma. The second trial will explore the potential of 9MW2821 in combination with other antitumor agents for patients with advanced solid tumors.
9MW2821: A Novel Nectin-4 Targeting ADC
9MW2821 is a novel ADC developed by Mabwell, targeting Nectin-4, a protein overexpressed in various cancers. It is the first clinical-stage drug candidate targeting Nectin-4 among Chinese companies. The drug is currently being evaluated in multiple clinical trials across a range of tumor indications.
Ongoing Clinical Trials
9MW2821 is currently in Phase III clinical trials for urothelial carcinoma (UC) as a monotherapy and in combination with a PD-1 inhibitor. The monotherapy arm has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) in China. For cervical cancer (CC), 9MW2821 is also in Phase III trials and has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA).
In addition, 9MW2821 is in Phase II clinical trials for triple-negative breast cancer (TNBC) and esophageal cancer (EC), both as a monotherapy and in combination with a PD-1 inhibitor. The FDA has granted Fast Track Designation (FTD) for esophageal squamous cell carcinoma (ESCC) and Orphan Drug Designation (ODD) for esophageal cancer.
Mabwell's Pipeline and Manufacturing Capabilities
Mabwell is an innovation-driven biopharmaceutical company with a fully integrated pharmaceutical value chain. The company has 15 pipeline products in various stages of development, including 11 novel drug candidates and 4 biosimilars. Mabwell's focus areas include oncology, immunology, bone disorders, ophthalmology, hematology, and infectious diseases. The company's Taizhou factory is compliant with international GMP standards and has passed the EU QP Audit. Large-scale manufacturing bases are under construction in Shanghai and Taizhou.
