贝康医疗Gems培养液获注册证,开启国产化新篇章

格隆汇
6 hours ago

近日,贝康医疗宣布其胚胎处理液VitBase正式获得批准,拿下该公司GEMS胚胎培养液全品系中的首张国产化注册证。此次获证标志着贝康医疗在辅助生殖上游耗材领域开启国产化新篇章,为后续GEMS全品系培养液国产化奠定基础。 据了解,GEMS胚胎培养液源自拥有30年研发历史的新加坡BMX公司,是全球知名辅助生殖用液产品,此前GEMS初代配方曾授权Cook Medical使用,是中国胚胎师青睐的培养液之一,至今已有30年历史。目前11款获欧盟CE认证,8款通过美国FDA批准,11款符合澳大利亚TGA标准,可覆盖辅助生殖全流程。 临床层面,胚胎处理液VitBase与贝康医疗此前获批的Geri无干扰时差培养箱协同使用,能显著提升囊胚形成率、临床妊娠率及首次移植活产率,为辅助生殖技术成功率提供有力支撑。

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