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习近平同老挝人革党中央总书记举行会谈

李在宪1个月前39511浏览0评论

炒股就看,权威,专业,及时,全面,助您挖掘潜力主题机会!

来源:长江商报

(002932.SZ)发布上半年业绩预增公告,预计实现净利润为24亿元—27.5亿元,净利润同比增长314.11%—374.5%。

对此,明德生物表示,公司凭借灵敏度高、操作便捷的产品和优质的客户服务,新冠核酸检测试剂市占率持续走高,新冠抗原检测试剂在疫情发生地区成为重要抗疫物资,海外抗原检测试剂出口也取得同比大幅增长。

此前明德生物还公告称,参与投资基金北京君联昕远壹号创业投资合伙企业(有限合伙),公司作为资金有限合伙人出资人民币4500万元,持股比例27.2727%。

发力拓展海外市场

2022年3月,明德生物4款A类产品首次通过欧盟IVDR注册。仅3个月后,明德生物自主研发了实时荧光PCR分析仪等五款仪器。

6月底,明德生物研制的血气分析仪和猴痘病毒核酸检测试剂盒获得欧盟CE认证。

对于A类产品来说,通过IVDR注册是进入欧盟市场的必要条件。2017年4月5日欧盟正式签发新版体外诊断医疗器械法规IVDR(EU 2017/746),相对于旧指令,新法规无论从上市前申请或上市后监督都进行了大规模的修订,内容更全面系统。

随着UDI的实施和 EUDAMED数据库的建立,新IVDR法规下上市的产品将实现全球多方全生命周期的监管,实现产品动态实时追踪的可能。这也标志着欧盟当局对医疗设备领域监管的进一步重视,同时也预示着在欧盟各成员国内医疗器械监管的尺度将得到进一步的统一。

明德生物自主研发的血气分析仪PT1000采用便携式设计,内置锂电池,具有检测快速、仪器免维护、稳定性高等优点,且试剂包采用一体化设计,用完即弃,可室温保存,无需冷藏。该款产品在床旁、推车等场景均可使用。明德生物介绍,该产品主要应用于不同等级医院的急诊室、麻醉科、ICU、NICU、CCU、心内科、手术室、呼吸科等临床科室以及透析病房、救护车、野外医院等应用场景。

该款血气分析仪已于2019年6月取得国内医疗器械许可证,荣获“创之星”杯2019年度中国体外诊断优秀创新产品金奖,第七批优秀国产医疗设备等奖项。

同时获得欧盟CE认证的猴痘病毒核酸检测试剂盒(荧光PCR法)通过实时荧光PCR法检测猴痘病毒的特异性基因片段,适用于猴痘病毒感染的辅助诊断,为猴痘病毒感染提供分子诊断依据。明德生物表示,本次欧盟CE证书的取得,可在欧盟和认可欧盟CE证书的国家和地区销售, 有利于公司拓展海外市场,将对公司业绩产生正面影响。

拟出资4500万参投基金

明德生物成立于2008年,坐落于武汉光谷生物城。是一家专业提供体外诊断试剂及配套仪器(POCT/分子诊断/化学发光/血气分析等)产品以及急危重症救治一体化(胸痛中心/卒中中心/创伤中心)、PCR实验室、智能化发热门诊建设等医疗服务的国家高新技术企业。

为重点投资以分子生物学为基础的创新诊断及治疗技术等领域的项目,明德生物与北京君远企业管理咨询合伙企业(简称“北京君远”)、北京君联和泰创业投资合伙企业(简称“君联和泰”)、海南省康哲创业投资有限公司(简称“康哲创业”)共同签署《北京君联昕远壹号创业投资合伙企业(有限合伙)有限合伙协议》,参与投资基金北京君联昕远壹号创业投资合伙企业(有限合伙)。

基金的规模为1.65亿元,其中,北京君远作为普通合伙人出资人民币2000万元,持股比例12.1212%;明德生物作为资金有限合伙人出资人民币4500万元,持股比例27.2727%;君联和泰作为特殊有限合伙人,以自有资金出资人民币4000万元,持股比例24.2424%;康哲创业作为资金有限合伙人出资人民币6000万元,持股比例36.3636%。

公告显示,基金项目包括但不限于基因检测、单细胞、细胞基因治疗、mRNA和小核酸药物、基因编辑、新分子机制、AI与合成生物学等。

明德生物称,公司本次与专业投资机构合作设立股权投资基金,可借助专业投资机构的管理团队、行业经验、项目资源和平台优势,整合各方资源,共同寻找以分子生物学为基础的创新诊断及治疗技术等领域的项目,有利于公司持续保持对前沿技术开发、应用和商业机会的把握,不断提升公司的盈利能力和综合竞争实力。

此外,本次对外投资的资金全部来源于明德生物自有资金,该公司表示,设立投资基金符合公司的战略规划,不会对公司财务及经营状况产生不利影响,不存在损害公司及股东利益的情形。

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