Kehua Bio obtains registration certificate for new product

Shanghai Kehua Bio-Engineering (SZSE:002022) announced that its wholly-owned subsidiary, Kehua (Xi'an) Biological Engineering Co., Ltd., has received a medical device registration certificate from the Shaanxi Provincial Drug Administration for its automated chemiluminescence immunoassay analyzer. The registration is valid from April 14, 2025, to April 13, 2030. This product utilizes direct chemiluminescence based on acridine esters and is intended for in vitro diagnostic use, specifically for qualitative and quantitative detection of analytes in human serum and plasma samples. The company anticipates that the registration will positively impact its business development by enriching its product portfolio. However, the company notes that it cannot currently predict the impact of this product on future revenues and advises investors to be aware of investment risks.