Kehua Bio-Engineering subsidiaries secure three new medical device registrations

Shanghai Kehua Bio-Engineering Co., Ltd. (Kehua Bio-Engineering), through its subsidiaries Xi'an Tianlong Technology Co., Ltd. and Kehua (Xi'an) Bio-Engineering Co., Ltd., has obtained three new medical device registration certificates for in-vitro diagnostic reagents. These approvals, issued by the National Medical Products Administration and Shaanxi Provincial Medical Products Administration, are expected to positively impact the company's business development by enriching its product line.

The newly registered products include a "Human CYP3A5 Gene Polymorphism Detection Kit (Fluorescent PCR method)" from Xi'an Tianlong, valid until December 11, 2030, for qualitative detection of CYP3A5 gene polymorphism in whole blood samples. Kehua (Xi'an) secured registrations for a "25-Hydroxyvitamin D Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)" and a "Cyclosporine, Tacrolimus, and Sirolimus Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)," both valid until December 14, 2030. These kits are designed for quantitative detection of 25-hydroxyvitamin D in human serum and therapeutic drug monitoring of immunosuppressants in whole blood, respectively.

While these new registrations are a positive step for Kehua Bio-Engineering, the company states that it is currently unable to predict the impact of these products on its future operating revenue. Investors are advised to pay attention to and be aware of potential investment risks.