Ningbo MedicalSystem Biotechnology Co Ltd

MedicalSystem Biotechnology Co., Ltd., stock code 300439 on the Shenzhen Stock Exchange, announced on September 10 that it recently obtained two Medical Device Registration Certificates for in vitro diagnostic reagents issued by the Zhejiang Medical Products Administration. The Immunoglobulin G4 Assay Kit, using latex immunoturbidimetry, has registration certificate number Zhejiang Medical Device Registration Approval 20262400468, valid from September 7, 2026 to September 6, 2031, and is used for the quantitative in vitro determination of immunoglobulin G4 concentration in human serum. The Ammonia Assay Kit, using the glutamate dehydrogenase method, has registration certificate number Zhejiang Medical Device Registration Approval 20262400475, valid from September 9, 2026 to September 8, 2031, and is used for the quantitative in vitro determination of ammonia concentration in human plasma. The company stated that obtaining these registration certificates enriches its product line in the in vitro diagnostic biochemistry segment, helps enhance its core competitiveness and market expansion capabilities, and will have a positive impact on future operations. The company also cautioned that actual sales will depend on market promotion results, and the specific impact on performance cannot yet be predicted.

Meikang Bio released its 2026 interim report. First-half operating revenue was 828 million yuan, up 12.5% year on year. Net profit attributable to the parent was 61.95 million yuan, up 9.0% year on year. Non-GAAP net profit attributable to the parent was 44.24 million yuan, up 47.3% year on year. In the second quarter, operating revenue was 452 million yuan, up 24.8% year on year, and non-GAAP net profit attributable to the parent was 21.09 million yuan, up 125.0% year on year. As of the end of the second quarter, total assets were 3.709 billion yuan, up 1.5% from the end of the previous year, and net assets attributable to the parent were 3.003 billion yuan, up 1.7% from the end of the previous year. The company continues to focus on the research, development, production and sales of in vitro diagnostic products, and has obtained 523 registration certificates for in vitro diagnostic reagent products and 55 registration certificates for in vitro diagnostic instruments.

MedicalSystem has obtained a medical device registration certificate from the Zhejiang Medical Products Administration for its Alpha-1 Antitrypsin Test Kit, which uses an immunoturbidimetric method. The certificate is valid from July 17, 2026, to July 16, 2031. The product is intended for the in vitro quantitative determination of alpha-1 antitrypsin in human serum. In the first quarter of 2026, MedicalSystem achieved revenue of 376 million yuan and a net profit attributable to the parent company of 33.77 million yuan.