Sichuan Provincial People's Hospital Licenses PLA2R Antibody Patent for Membranous Nephropathy Diagnostics to Chengdu Diao Pharmaceutical Group for RMB 2.1 Million

Recently,Sichuan Provincial People's Hospital has announced the transfer of the scientific and technological achievement "An Anti-Human PLA2R Antibody, Its Antigen-Binding Fragment, and Applications Thereof" (Patent No. ZL202311204566.1) to Chengdu Di'ao Pharmaceutical Group Co., Ltd. at a proposed transaction price of RMB 2.1 million (payable in installments).

It is understood that the core of this patent lies in the high affinity of its antibody and antigen-binding fragments for the phospholipase A2 receptor (PLA2R), enabling specific binding to the PLA2R protein. Notably, these antibodies and fragments can precisely target PLA2R segments containing three key domains: CysR, FnII, and CTLD1. This characteristic grants the innovation broad application potential across various biomedical testing and screening fields.

As a nephrotic syndrome triggered by excessive deposition of immune complexes in the glomerular capillary walls, membranous nephropathy (membranous glomerulonephritis) is one of the most common pathological types of nephrotic syndrome in adults. Patients often present clinically with massive proteinuria, hypoalbuminemia, edema, and hyperlipidemia, symptoms that significantly impair their quality of life.

In the diagnostic landscape of membranous nephropathy (MN), PLA2R-Ab serves as a highly specific biomarker and plays a pivotal role. According to in-depth research by Professor Lian Mingjian from Xiamen University, serum PLA2R-Ab testing demonstrates an overall sensitivity of 69% and an overall specificity of 97% in the diagnosis of primary membranous nephropathy, underscoring its significant clinical value. Notably, PLA2R is composed of multiple domains, among which CysR, FnII, and CTLD1 are the key domains responsible for inducing the production of PLA2R-Ab.

Therefore, monoclonal antibodies targeting these three domains demonstrate significant potential value in the development of cellular and animal models for PLA2R-associated membranous nephropathy, elucidation of pathogenesis, clinical diagnosis, and novel drug discovery. However, there is currently a lack of commercially available mouse monoclonal antibodies capable of targeting these three domains.

In the face of this challenge,After rigorous screening, Professor Li Guisen’s team from the Department of Nephrology at Sichuan Provincial People’s Hospital successfully identified an antibody, along with its antigen-binding fragments, featuring specific heavy-chain and light-chain complementarity-determining regions.This antibody exhibits extremely high affinity for PLA2R, enabling it to specifically bind to the PLA2R protein and precisely target PLA2R fragments containing the three key domains: CysR, FnII, and CTLD1.

According to the patent specification for “An Anti-Human PLA2R Antibody and Its Antigen-Binding Fragment and Applications Thereof,” this innovative anti-human PLA2R monoclonal antibody can be used not only to develop products for the detection, diagnosis, prognosis, efficacy assessment, or recurrence monitoring of membranous nephropathy.

To this end, LiProfessor Gui Sen’s team has also introduced a series of innovative methods for developing detection products based on anti-human PLA2R antibodies, including but not limited to reagents, assay kits, and chips. These products incorporate the antibody or its antigen-binding fragments, labeled with detectable markers (such as fluorescent dyes, enzymes, radioisotopes, chemiluminescent reagents, etc.), ensuring high sensitivity and accuracy in detection.。

In the design of the test kit, the team employed various advanced carrier technologies, such as nanoparticles, magnetic beads, agarose gel microspheres, silica microspheres, latex microspheres, and porous materials (e.g., ELISA plates), to optimize the interaction between antibodies and samples, thereby enhancing detection efficiency. Among these, magnetic bead technology has emerged as a standout due to its unique magnetic properties and ease of handling. Furthermore, this invention encompasses multiple types of magnetic beads, including carboxyl-modified and amino-modified magnetic beads, to meet diverse detection requirements.

Furthermore, the kit covered by this patent is equipped with a complete set of ancillary reagents, such as buffers, positive controls, and wash solutions, providing significant convenience for the detection process. The launch of these innovative products not only simplifies the testing workflow for membranous nephropathy but also enhances the accuracy and reliability of the assay, thereby offering a robust basis for physicians to formulate personalized treatment plans.