On July 23, 2024, RemeGen Co., Ltd. (“RemeGen”) (688331.SH/09995.HK) announced that IND of Telitacicept Injection for the treatment of adult patients with primary membranous nephropathy (PMN) had been cleared by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

PMN is an autoimmune disease characterized by abnormal thickening and dysfunction of the glomerular basement membrane. Around 80% of patients with membranous nephropathy (MN) are diagnosed with PMN. PMN is the most common cause of nephrotic syndrome (NS) which is defined by massive proteinuria (generally > 3.5g/24h) with resulting hypoalbuminemia, hyperlipidemia and edema. Other common symptoms among NS patients include fatigue, dyspnea, nausea, and anorexia. The natural course of PMN is relatively long and characterized by alternating remissions and relapses. About 30% of untreated patients undergo spontaneous remission. About 50% of patients continue to have NS and 30% progress to end-stage renal disease within 10 years. The long-term disease state can increase the risk of hypertension, cardiovascular and cerebrovascular accidents, abnormal blood coagulation and infection, posing a great threat to the life of patients.

MN is a disease affecting individuals worldwide with an annual incidence of about 1 per 100,000 people globally. According to data from Sullivan, the number of patients with PMN in China was 10.7 million in 2020.

In August 2023, an article published in the World Journal of Clinical Cases (IF: 1.1) reported a case of a patient with MN and HIV infection who was successfully treated with Telitacicept. In October of the same year, another article published in Frontiers in Immunology (IF: 7.3) detailed a patient with refractory MN who achieved complete proteinuria remission following treatment with Telitacicept. The patient had progressed on various treatments before, including glucocorticoids, tacrolimus, mycophenolate mofetil, cyclophosphamide and rituximab. Both articles demonstrated the efficacy of Telitacicept in treatment of MN. Given the pathogenesis of the disease and the mechanism of action of Telitacicept, it can be expected that this therapy may provide new options for treating MN.