Industry | 制造业 | ||||||||||||||||||||||||
Company Introduction | 发行人前身奥泰有限,原名培乐生物,成立于2009年4月17日,设立时注册资本为人民币10万元,由自然人股东杨美云以货币出资8万元,由自然人股东姚海峰以货币出资2万元。2009年4月15日,杭州联信会计师事务所有限公司对前述出资进行审验并出具了《验资报告》(杭联会验字(2009)132号),确认该等注册资本已经全部缴足。 2009年4月17日,培乐生物取得杭州市工商行政管理局西湖分局核发的《企业法人营业执照》(注册号:330106000082569)。 发行人系由奥泰有限整体变更设立的股份公司。2017年10月19日,奥泰有限召开股东会,全体股东一致同意作为发起人,以2017年7月31日为改制基准日,以有限公司经中汇会计师事务所(特殊普通合伙)审计的账面净资产值122,411,449.07元(中汇会审[2017]4842号《审计报告》),按照3.13956:1的比例折合为股本3,899万股(每股面值人民币1元),整体变更为股份公司,注册资本为3,899万元,净资产扣除股本后的余额83,421,449.07元计入资本公积。2017年11月29日,奥泰生物取得杭州市市场监督管理局核发的《营业执照》(统一社会信用代码:91330101685842840Y)。 公司专注于体外诊断行业中的POCT细分领域,主营业务为体外诊断试剂的研发、生产和销售,主要产品为快速诊断试剂,包括毒品及药物滥用检测、传染病检测、妇女健康检测、肿瘤检测以及心脏标志物检测等五大系列,产品种类、形态多样,覆盖面广,目前已上市产品多达700余种,广泛应用于临床检测、现场检测及个人健康管理等领域,能满足客户的多元化需求。特别是在一些新型毒品(蓝精灵、浴盐、卡西酮等)检测、新型冠状病毒检测、热带传染病(基孔肯亚热、查克斯病、钩端螺旋体病等)检测、呼吸道多合一(流感、合胞病毒、腺病毒、肺支)联检、小儿腹泻多合一(轮状病毒、腺病毒、诺如病毒、星状病毒)联检以及大便隐血多合一(转铁蛋白/血红蛋白+结合珠蛋白/血红蛋白复合物)联检等领域,公司产品具有较强的市场竞争力。 公司十分重视海外市场发展战略,截至2020年8月31日公司产品已取得8项美国FDA(510K)注册、531项欧盟CE认证(其中20项公告机构类认证,511项自我声明类认证)、40项加拿大MDL认证,4项澳大利亚TGA注册。同时,公司已通过了ISO9001:2015、ISO13485:2016等国际质量体系认证,以零缺陷通过了美国FDA质量管理体系现场审核,并取得了包括美国、加拿大、巴西、日本、澳大利亚等在内多个国家认可的MDSAP医疗器械单一审核程序认证,成为国内较早通过该项认证的企业之一。公司产品远销欧洲、亚洲、非洲、北美洲、南美洲和大洋洲,客户遍布全球100多个国家和地区,其中优势产品多项联检毒品检测试剂被用于俄罗斯各大国家实验室,传染病检测试剂被用于东南亚等地区的大型政府、海军医院,心肌肌钙蛋白I、A族链球菌等检测试剂销往世界500强企业雅培旗下公司,公司客户在体外诊断领域具有一定的影响力。 公司是浙江省科学技术厅认定的高新技术企业,具有较强的技术研发和创新能力,在POCT快速诊断试剂领域实现了多项技术创新和突破,在胶体金、乳胶等标记技术,单克隆抗体、多克隆抗体、基因重组抗原、合成抗原等生物原料技术以及免疫层析技术等生物领域的研究方面具备雄厚的技术实力,并依托上述技术建立起POCT试剂研发平台。 | ||||||||||||||||||||||||
Main Business | 为体外诊断试剂的研发、生产和销售 | ||||||||||||||||||||||||
Legal Representative | 高飞 | ||||||||||||||||||||||||
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Company Secretary | 傅燕萍 | ||||||||||||||||||||||||
Solicitors | 北京市通商律师事务所 | ||||||||||||||||||||||||
Auditors | 致同会计师事务所(特殊普通合伙) | ||||||||||||||||||||||||
Tel No | 0571-56207860 | ||||||||||||||||||||||||
Fax No | 0571-56267856 | ||||||||||||||||||||||||
Website | www.alltests.com.cn | ||||||||||||||||||||||||
info@alltests.com.cn | |||||||||||||||||||||||||
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Listing Date | 25/03/2021 | ||||||||||||||||||||||||
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EPS(RMB)* | ¥ 2.280 | ||||||||||||||||||||||||
DPS(RMB)* | ¥ 1.500 | ||||||||||||||||||||||||
NBV Per Share(RMB)* | ¥ 48.275 | ||||||||||||||||||||||||
Market Capitalization(RMB) | 5.489B |
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* | Unadjusted Data |
Information provided by: etnet | ||
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