Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). This randomized, controlled, open, multi-center trial received clearance from the National Medical Products Administration (NMPA) in China.
9MW2821 is an antibody-drug conjugate (ADC) that targets Nectin-4 and is currently under investigation in multiple clinical studies for various cancers, including esophageal cancer and urothelial carcinoma. The drug has been granted fast-track designations (FTDs) by the US FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma, previously treated recurrent or metastatic cervical cancer, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer. Additionally, 9MW2821 has received an orphan drug designation (ODD) for esophageal cancer in the US. This month, the drug earned a breakthrough therapy designation in China for the treatment of locally advanced or metastatic UC in patients who have failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.
Loqtorzi (toripalimab), a programmed death-1 (PD-1) inhibitor developed by Shanghai Junshi Biosciences Co., Ltd (HKEX: 1877; SSE: 688180), marked a significant milestone as China’s first domestically approved PD-1 inhibitor for the second-line treatment of melanoma in December 2018. Since then, the drug has received a total of ten indication approvals in China. Loqtorzi has six indications included in the National Reimbursement Drug List (NRDL), after successfully passing NRDL negotiations in December 2020.- Flcube.com
