Recently, Hengrui Pharmaceuticals' subsidiary Guangdong Hengrui Pharmaceuticals Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, approving SHR-2173 Injection, a Class 1 new drug, to carry out clinical trials for IgA nephropathy. At present, there is no similar drug to SHR-2173 on the market or in the clinical development stage at home and abroad.

IgA nephropathy is a group of autoimmune glomerulonephritis characterized by IgA deposition in the glomerular mesangial area. Typical clinical manifestations can be seen in microscopic hematuria, and patients have a history of mucosal (e.g., upper respiratory tract, gastrointestinal tract) infections, which is the most common primary glomerulopathies worldwide, and also a major cause of chronic kidney disease (CKD) and renal failure.

In China, IgA nephropathy accounts for 45% of primary glomerular diseases in China. There are geographical differences in the incidence of the disease, and the peak age of onset is mainly concentrated in 20-40 years old. It is worth noting that 20-40% of patients can progress to end-stage renal disease (ESRD) within 20 years of the onset of the disease, and ESRD requires renal replacement therapy (dialysis or kidney transplantation), which seriously affects the quality of life and life expectancy of patients, and imposes a heavy economic burden on the family and the society. The main treatment for IgA nephropathy is supportive therapy aiming at slowing down the rate of progression of the disease, including blood pressure control, RAS, and other therapies. IgA nephropathy is currently treated with supportive therapy aimed at slowing down the rate of disease progression, including blood pressure control, RAS blocker application, lifestyle changes, etc. There is no recognized specific therapy based on immunosuppressive mechanism.

SHR-2173 injection is a therapeutic biologic product independently developed by Hengrui Pharmaceuticals, which is able to target abnormally activated immune cells, exerting anti-inflammatory and immunosuppressive biological effects, and is expected to reduce autoantibody levels and improve the disease activity status of patients with IgA nephropathy, thus bringing a new therapeutic option for patients.

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