China’s Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has received approval from the National Medical Products Administration (NMPA) to launch a clinical trial for its CD20 monoclonal antibody (mAb) in primary membranous nephropathy, a chronic kidney disorder with limited treatment options.
Study Details
The drug, developed by Shanghai Jiaolian Drug R&D Co., Ltd—a wholly owned subsidiary of Shanghai Pharmaceuticals—is currently in Phase I trials for CD20-positive B-cell non-Hodgkin lymphoma in China. The new indication in primary membranous nephropathy marks a strategic expansion into nephrology, with the NMPA greenlight enabling the company to explore the therapy’s efficacy in a high-need patient population.
Market Context
CD20-targeting therapies, such as Roche’s rituximab, obinutuzumab, and ocrelizumab, and Novartis’ ofatumumab, generated USD 9.89 billion in global sales in 2021, per Cortellis data. Shanghai Pharmaceuticals’ entry into this market underscores its ambition to challenge incumbents with its in-house pipeline, leveraging the NMPA’s support to accelerate development.-Fineline Info & Tech
