CCHT(SZ:000661) Shang Hai Zheng Quan Bao·2026-02-09 19:00Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial application of the injectable GenSci136 drug, which is intended for the treatment of Immunoglobulin A Nephropathy (IgAN) [1][2]. Group 1: Drug Information - The product name is injectable GenSci136, and it is a Class 1 biological product developed by Jinsai Pharmaceutical for the treatment of IgAN [1]. - The clinical trial application was approved under acceptance number CXSL2600033, allowing the drug to proceed with clinical trials [1]. Group 2: Disease Context - IgAN is the most common primary glomerulonephritis globally and accounts for 39.73% of primary glomerulonephritis cases in China, primarily affecting individuals aged 30 to 40 [2]. - The disease progresses slowly but has a poor prognosis, with 20%-50% of patients eventually progressing to renal failure, posing a significant burden on families and the healthcare system [2]. - There is a substantial unmet clinical need for effective treatments for IgAN, as existing therapies have limitations in efficacy and safety [2]. Group 3: Drug Mechanism and Potential - Injectable GenSci136 is designed as a B-cell maturation antigen (BCMA) trimeric fusion protein, which enhances the blocking activity against endogenous ligands, potentially impacting the survival and differentiation of B lymphocytes and plasma cells [3]. - The drug aims to provide a new, safe, and effective first-line targeted treatment option for IgAN patients, with the potential for long-term application without the need for preventive anti-infection treatment [3].