Core Insights - The company, Beikang Medical-B (02170), announced that its Gems embryo culture medium series (VitBase embryo processing fluid) received a Class III medical device registration certificate from the National Medical Products Administration (NMPA) on August 25, 2025 [1] - This approval highlights the support from the government for the innovative transformation of medical products acquired overseas, positioning the company as one of the few globally to hold CE, FDA, and TGA certifications for assisted reproductive fluids [1] - The VitBase embryo processing fluid is the first of 11 products in the GEMS embryo culture medium series to receive medical device approval, marking a significant step towards the localization of high-quality embryo culture technology in China [2] Company Overview - The Gems embryo culture medium series is developed by Genea Biomedx Pty Ltd., a wholly-owned subsidiary of BMX Holdco Pte. Ltd., which is fully owned by the company [1] - The approval of VitBase embryo processing fluid is based on over 30 years of clinical experience from Genea Biomedx, ensuring high product quality while enhancing accessibility and supply chain security [1] Industry Context - Historically, core culture media used in IVF laboratories in China have relied heavily on overseas brands, making the safety, stability, and long-term clinical validation of these products critical for both doctors and patients [1] - The successful registration of the VitBase embryo processing fluid lays the groundwork for the subsequent localization of the entire product line in China [2]

长期以来，中国IVF实验室使用的核心培养液主要依赖海外品牌。培养液作为影响试管婴儿成功率的关 键因素之一，其安全性、稳定性和长期临床验证资料对医生和患者而言至关重要。公司此次获批的 VitBase胚胎处理液，源自Genea Biomedx 30余年的临床经验积累，结合本土化生产和监管要求，既延续 了国际高水准的产品品质，又显著提升了可及性和供应链保障。 VitBase胚胎处理液是GEMS胚胎培养液系列11款培养液中的首个获得医疗器液的获批不仅意味着国际一 流的培养液技术逐步实现国产化落地，同时也将为行业带来械注册证的产品，这为后续全品系培养液在 中国的国产化奠定了基础。 格隆汇8月26日丨贝康医疗(02170.HK)发布公告，公司的Gems胚胎培养液系列（VitBase胚胎处理液）于 2025年8月25日获得国家药品监督管理局颁发的三类医疗器械注册证（注册证号：国械注进 20253180356）。 公司的Gems胚胎培养液系列（VitBase胚胎处理液）隶属于公司全资拥有的BMX Holdco Pte. Ltd.的全资 子公司Genea Biomedx Pty Ltd.开发的GEMS培养液系列。此次获批不仅体 ...