Sansure Biotech’s Gene Polymorphism Detection Kits Receive NMPA Class III IVD Certification

Sansure Biotech's Gene Polymorphism Detection Kits Receive NMPA Class III IVD Certification

China-based Sansure Biotech Inc. (SHA: 688289) announced on July 28, 2025, that it has received Class III In Vitro Diagnostic (IVD) Medical Device Registration Certificates from China’s National Medical Products Administration (NMPA) for two of its gene polymorphism detection kits. The certificates are valid until July 23, 2030. The approved products are the Human ADRB1 Gene Polymorphism Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method) and the Human AGTR1 and CYP2C9 Gene Polymorphism Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method).

Product Applications
Both kits are designed to detect polymorphisms in key gene loci—ADRB1, AGTR1, and CYP2C9*3—which are associated with hypertension. These tests provide a genetic basis for personalized treatment of patients using medications such as β-blockers and angiotensin II receptor antagonists.

Company Expansion
Over the past year, Sansure Biotech has launched eight related products, establishing a comprehensive pharmacogenomics testing portfolio that covers anticoagulation, hypertension, and hyperlipidemia. The company stated it will continue to expand its presence in this field.-Fineline Info & Tech