DIAGENS-B (02526) announced that on May 20, 2026, its core product AI AutoVision® has obtained a Class III Medical Device Registration Certificate issued by China's National Medical Products Administration (NMPA). The approved indications for this certificate cover (i) chromosomal karyotype analysis for prenatal diagnosis of birth defects using amniotic fluid samples; and (ii) chromosomal karyotype analysis for assisted reproduction using peripheral blood samples. AI AutoVision® is an intelligent chromosomal karyotype analysis product developed based on the Group's iMedImage® medical imaging large model. It assists in completing chromosome segmentation, counting, and arrangement, and provides anomaly recognition prompts to aid clinicians in clinical diagnosis. To the knowledge of the Board and based on information currently available to the Company, this registration certificate is the world's first Class III medical device registration certificate for chromosomal karyotype analysis with anomaly recognition capability reaching L3 level; it is also the first medical device registration certificate obtained based on large model technology. The Board believes that obtaining this certificate reflects the regulatory authority's recognition of the safety, efficacy, and clinical application value of the iMedImage® medical imaging large model technology in medical devices. The acquisition of this registration certificate is a significant regulatory milestone for AI AutoVision®, laying the foundation for the commercialization of this core product within the scope of its approved indications. The Group believes that this approval will further consolidate its leading position in the fields of AI medical imaging and intelligent chromosomal analysis, and will support the Group in accelerating market access, hospital deployment, and clinical applications in compliance with applicable laws and regulations.