江苏(su)默乐(le)生(sheng)(sheng)(sheng)物(wu)科(ke)技股份有限公司(si)成立于2008 年5 月,坐落(luo)在中(zhong)国唯(wei)一(yi)的医药国家(jia)级(ji)高(gao)(gao)新技术(shu)产(chan)业(ye)(ye)园(yuan)区——泰州国家(jia)医药高(gao)(gao)新技术(shu)产(chan)业(ye)(ye)开(kai)发(fa)区,是一(yi)家(jia)以浙江大学(xue)为依托,专注于分子生(sheng)(sheng)(sheng)物(wu)体外诊断(duan)试(shi)剂(ji)的研发(fa)与(yu)生(sheng)(sheng)(sheng)产(chan),集科(ke)学(xue)研究、技术(shu)开(kai)发(fa)、技术(shu)服(fu)务、产(chan)品生(sheng)(sheng)(sheng)产(chan)与(yu)销售为一(yi)体的高(gao)(gao)新技术(shu)企业(ye)(ye)。
公(gong)司(si)坚(jian)持“质量(liang)第(di)一(yi)、诚信(xin)经(jing)营(ying)、预防为主(zhu)、风险控制、使(shi)用(yong)方便、不断(duan)(duan)创(chuang)新”的质量(liang)方针,拥有(you)可(ke)用(yong)于(yu)规模化(hua)(hua)(hua)生(sheng)产的万级、十(shi)万级净化(hua)(hua)(hua)车间一(yi)千(qian)余(yu)平方米,建(jian)有(you)通(tong)(tong)过医(yi)(yi)疗器械质量(liang)管(guan)理体(ti)系(xi)(YYT0287/ISO13485)认证的诊断(duan)(duan)试剂生(sheng)产体(ti)系(xi)。研(yan)发(fa)平台(tai)(tai)和(he)生(sheng)产车间配有(you)国(guo)(guo)(guo)内外先进(jin)的仪器设备,可(ke)以满足研(yan)发(fa)、生(sheng)产和(he)质检(jian)的需要(yao)。公(gong)司(si)于(yu)2009 年(nian)2 月(yue)与浙江大学合作建(jian)立(li)(li)(li)“浙江大学中(zhong)(zhong)(zhong)(zhong)国(guo)(guo)(guo)医(yi)(yi)药城研(yan)发(fa)中(zhong)(zhong)(zhong)(zhong)心(xin)”,于(yu)2010年(nian)获(huo)江苏(su)(su)(su)省科技(ji)厅立(li)(li)(li)项,挂牌(pai)成(cheng)立(li)(li)(li)“江苏(su)(su)(su)省分(fen)子诊断(duan)(duan)工(gong)程技(ji)术研(yan)究中(zhong)(zhong)(zhong)(zhong)心(xin)”,于(yu)2016 年(nian)经(jing)江苏(su)(su)(su)省发(fa)改委立(li)(li)(li)项建(jian)立(li)(li)(li)“江苏(su)(su)(su)省高(gao)(gao)通(tong)(tong)量(liang)分(fen)子诊断(duan)(duan)工(gong)程中(zhong)(zhong)(zhong)(zhong)心(xin)”。公(gong)司(si)重(zhong)视知识产权(quan)管(guan)理和(he)自主(zhu)创(chuang)新,目前(qian)拥有(you)多重(zhong)荧光(guang)定量(liang)PCR 技(ji)术及产业化(hua)(hua)(hua)平台(tai)(tai)、高(gao)(gao)通(tong)(tong)量(liang)测(ce)序技(ji)术及产业化(hua)(hua)(hua)平台(tai)(tai)、抗(kang)原抗(kang)体(ti)检(jian)测(ce)技(ji)术及产业化(hua)(hua)(hua)平台(tai)(tai),已获(huo)得国(guo)(guo)(guo)家授权(quan)发(fa)明专(zhuan)(zhuan)利9项(其中(zhong)(zhong)(zhong)(zhong)“肠道病(bing)毒EV71 检(jian)测(ce)特(te)异性引物和(he)探针”获(huo)中(zhong)(zhong)(zhong)(zhong)国(guo)(guo)(guo)国(guo)(guo)(guo)际专(zhuan)(zhuan)利与名牌(pai)博(bo)览会金奖)。公(gong)司(si)在第(di)五(wu)(wu)届全国(guo)(guo)(guo)创(chuang)业创(chuang)新大赛生(sheng)物医(yi)(yi)药总(zong)决(jue)赛上(shang)获(huo)“优秀企业”称号,进(jin)入全国(guo)(guo)(guo)“十(shi)二强”,名列第(di)八(ba)。公(gong)司(si)先后承担(dan)国(guo)(guo)(guo)家“十(shi)一(yi)五(wu)(wu)”科技(ji)重(zhong)大专(zhuan)(zhuan)项、“十(shi)二五(wu)(wu)”科技(ji)重(zhong)大专(zhuan)(zhuan)项,国(guo)(guo)(guo)家高(gao)(gao)技(ji)术研(yan)究发(fa)展计划(hua)(“863 计划(hua)”)等国(guo)(guo)(guo)家、省市(shi)项目30 余(yu)项。
公(gong)(gong)司的体(ti)外诊(zhen)(zhen)(zhen)断(duan)试剂产(chan)品(pin)主要应用于感染类(lei)疾(ji)病(bing)、肿瘤个(ge)体(ti)化用药(yao)和(he)遗传性疾(ji)病(bing)的检(jian)测,产(chan)品(pin)涵盖了呼(hu)吸系(xi)(xi)统(tong)、消化系(xi)(xi)统(tong)、血液系(xi)(xi)统(tong)、内分泌系(xi)(xi)统(tong)、神经系(xi)(xi)统(tong)和(he)生(sheng)殖泌尿系(xi)(xi)统(tong)的感染性疾(ji)病(bing)、传染性疾(ji)病(bing)以及(ji)恶性肿瘤等全(quan)身各个(ge)系(xi)(xi)统(tong)的诊(zhen)(zhen)(zhen)断(duan)试剂及(ji)试剂盒。公(gong)(gong)司拥有(you)医(yi)疗器械注(zhu)册证70张,其中(zhong)(zhong)三(san)类(lei)体(ti)外诊(zhen)(zhen)(zhen)断(duan)试剂产(chan)品(pin)注(zhu)册证19张,另有(you)200 多个(ge)体(ti)外诊(zhen)(zhen)(zhen)断(duan)试剂产(chan)品(pin)已开(kai)发成功,公(gong)(gong)司产(chan)品(pin)已在全(quan)国各省、市级重点(dian)医(yi)院、疾(ji)控中(zhong)(zhong)心(xin)和(he)第三(san)方检(jian)测中(zhong)(zhong)心(xin)得到(dao)应用。