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云南生物谷藥業股份有限公司(si)


       生物谷藥業是集燈盞花系列藥品的研究、開發、生產、銷售為一體的高科技制藥企業。公司成立于1999年6月,前身為云南生物谷燈盞花藥業有限公司,于2012年11月完成股份制改造與更名。2015年8月在新三板掛牌,2016年6月進入創新層,2020年7月進入精選層,2021年11月成為北交所首批上市企業。


  

       公(gong)(gong)(gong)司(si)是(shi)云南省(sheng)首批(pi)、國(guo)(guo)家第(di)(di)二(er)批(pi)創新(xin)型試點(dian)企(qi)(qi)業,國(guo)(guo)家知識產(chan)權優勢企(qi)(qi)業。公(gong)(gong)(gong)司(si)擁(yong)有較強的(de)技(ji)術(shu)研(yan)(yan)(yan)發和(he)創新(xin)能力,并一貫重視對(dui)技(ji)術(shu)創新(xin)和(he)研(yan)(yan)(yan)發的(de)投入,到(dao)目(mu)(mu)前為(wei)止公(gong)(gong)(gong)司(si)共擁(yong)有發明專(zhuan)利49件。經(jing)國(guo)(guo)家認定和(he)批(pi)準(zhun),公(gong)(gong)(gong)司(si)設立(li)了企(qi)(qi)業博士(shi)后科研(yan)(yan)(yan)工作站,是(shi)云南省(sheng)特(te)色植(zhi)物(wu)藥工程技(ji)術(shu)研(yan)(yan)(yan)究(jiu)中(zhong)(zhong)心。研(yan)(yan)(yan)究(jiu)中(zhong)(zhong)心擁(yong)有多臺(tai)高(gao)精密檢測設備(bei),如核磁共振譜(pu)儀、液相色譜(pu)/飛行時(shi)間質譜(pu)聯(lian)用儀、制(zhi)備(bei)液相色譜(pu)儀等(deng)(deng),建(jian)成了國(guo)(guo)內一流的(de)“天然產(chan)物(wu)高(gao)效分離和(he)鑒定系統”。公(gong)(gong)(gong)司(si)是(shi)國(guo)(guo)家“863”計(ji)劃、“國(guo)(guo)家十(shi)一五科技(ji)支撐計(ji)劃”、國(guo)(guo)家火炬計(ji)劃項目(mu)(mu)和(he)國(guo)(guo)家重點(dian)研(yan)(yan)(yan)發計(ji)劃“中(zhong)(zhong)醫藥現(xian)代化(hua)研(yan)(yan)(yan)究(jiu)”項目(mu)(mu)等(deng)(deng)國(guo)(guo)家重點(dian)科技(ji)計(ji)劃項目(mu)(mu)承擔(dan)單(dan)位(wei)。公(gong)(gong)(gong)司(si)榮(rong)獲2018年度國(guo)(guo)家科技(ji)進(jin)步二(er)等(deng)(deng)獎,入圍“2018、2019、2020、2021年度中(zhong)(zhong)國(guo)(guo)中(zhong)(zhong)藥企(qi)(qi)業 TOP100 排行榜”、2022年云南省(sheng)省(sheng)級專(zhuan)精特(te)新(xin)“小巨人”企(qi)(qi)業名單(dan),并獲得第(di)(di)九屆云南省(sheng)民營經(jing)濟先(xian)進(jin)單(dan)位(wei)榮(rong)譽稱(cheng)號。公(gong)(gong)(gong)司(si)專(zhuan)利“一種(zhong)具有藥用活性的(de)新(xin)化(hua)合物(wu)燈盞細辛酸乙酯”榮(rong)獲第(di)(di)二(er)十(shi)二(er)屆中(zhong)(zhong)國(guo)(guo)專(zhuan)利優秀獎。


公司目前(qian)已(yi)擁有(you)燈盞(zhan)花系列(lie)品(pin)(pin)種(zhong)7個,已(yi)上市的(de)(de)燈盞(zhan)生(sheng)脈(mo)(mo)膠(jiao)(jiao)囊、燈盞(zhan)細(xi)(xi)辛(xin)注射(she)液(ye)、燈盞(zhan)花滴丸、燈盞(zhan)細(xi)(xi)辛(xin)軟膠(jiao)(jiao)囊4個品(pin)(pin)種(zhong)是(shi)(shi)全國(guo)獨家(jia)品(pin)(pin)種(zhong),公司參(can)(can)與(yu)(yu)(yu)了燈盞(zhan)生(sheng)脈(mo)(mo)膠(jiao)(jiao)囊、燈盞(zhan)細(xi)(xi)辛(xin)注射(she)液(ye)、燈盞(zhan)花滴丸3個藥(yao)品(pin)(pin)的(de)(de)國(guo)家(jia)標準(zhun)制定(ding)工作。公司主導產(chan)品(pin)(pin)燈盞(zhan)生(sheng)脈(mo)(mo)膠(jiao)(jiao)囊為《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)國(guo)藥(yao)典(dian)》2010版(ban)、2015版(ban)、2020版(ban)的(de)(de)收(shou)(shou)錄(lu)(lu)品(pin)(pin)種(zhong),2022版(ban)醫保(bao)目錄(lu)(lu)產(chan)品(pin)(pin)、2018版(ban)基(ji)藥(yao)目錄(lu)(lu)產(chan)品(pin)(pin);2007年(nian)(nian)(nian)(nian)參(can)(can)與(yu)(yu)(yu)了國(guo)家(jia)“863”計(ji)劃(hua)和(he)(he)國(guo)家(jia)“十(shi)一五(wu)”科技支撐(cheng)計(ji)劃(hua)重(zhong)大(da)(da)疾病中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)醫防治研究(jiu)(jiu)課(ke)(ke)題(ti),是(shi)(shi)具有(you)循(xun)證醫學(xue)(xue)(xue)(xue)證據的(de)(de)腦(nao)卒(zu)(zu)(zu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)二級預(yu)防用中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成藥(yao), 并在(zai)產(chan)品(pin)(pin)說明(ming)書中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)記載可(ke)用于預(yu)防腦(nao)卒(zu)(zu)(zu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)復發的(de)(de)口服中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成藥(yao);被收(shou)(shou)錄(lu)(lu)在(zai)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)華中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)學(xue)(xue)(xue)(xue)會2019版(ban)《冠心病穩定(ding)型心絞痛中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)醫診療(liao)(liao)指南(nan)(nan)(nan)(nan)》,和(he)(he)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)華醫學(xue)(xue)(xue)(xue)會外科學(xue)(xue)(xue)(xue)分會發布的(de)(de)《下肢動脈(mo)(mo)硬化(hua)閉塞癥診治指南(nan)(nan)(nan)(nan)(2015版(ban))》以(yi)及中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)華醫學(xue)(xue)(xue)(xue)會《缺(que)(que)血性(xing)卒(zu)(zu)(zu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)基(ji)層診療(liao)(liao)指南(nan)(nan)(nan)(nan)(2021 年(nian)(nian)(nian)(nian))》、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)國(guo)老(lao)(lao)年(nian)(nian)(nian)(nian)學(xue)(xue)(xue)(xue)和(he)(he)老(lao)(lao)年(nian)(nian)(nian)(nian)醫學(xue)(xue)(xue)(xue)學(xue)(xue)(xue)(xue)會《老(lao)(lao)年(nian)(nian)(nian)(nian)缺(que)(que)血性(xing)腦(nao)卒(zu)(zu)(zu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)慢病管(guan)理(li)指南(nan)(nan)(nan)(nan)》、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)華醫學(xue)(xue)(xue)(xue)會神(shen)經病學(xue)(xue)(xue)(xue)分會《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)國(guo)缺(que)(que)血性(xing)卒(zu)(zu)(zu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)和(he)(he)短暫性(xing)腦(nao)缺(que)(que)血發作二級預(yu)防指南(nan)(nan)(nan)(nan)2022》中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)。公司主導產(chan)品(pin)(pin)燈盞(zhan)細(xi)(xi)辛(xin)注射(she)液(ye)為《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)國(guo)藥(yao)典(dian)》2005版(ban)、2010版(ban)、2015版(ban)、2020版(ban)的(de)(de)收(shou)(shou)錄(lu)(lu)品(pin)(pin)種(zhong),是(shi)(shi)全國(guo)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)醫醫院急診必(bi)備(bei)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成藥(yao)、2022版(ban)醫保(bao)目錄(lu)(lu)產(chan)品(pin)(pin);2001年(nian)(nian)(nian)(nian)參(can)(can)與(yu)(yu)(yu)了國(guo)家(jia)火(huo)炬(ju)計(ji)劃(hua)項目,2007年(nian)(nian)(nian)(nian)參(can)(can)與(yu)(yu)(yu)了國(guo)家(jia)“863”計(ji)劃(hua)研究(jiu)(jiu)課(ke)(ke)題(ti),2012年(nian)(nian)(nian)(nian)-2015年(nian)(nian)(nian)(nian)參(can)(can)與(yu)(yu)(yu)了“重(zhong)大(da)(da)新藥(yao)創制”國(guo)家(jia)科技重(zhong)大(da)(da)專(zhuan)項“中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)上市后再評價關(guan)鍵技術研究(jiu)(jiu)”之(zhi)臨床安全性(xing)評價研究(jiu)(jiu)課(ke)(ke)題(ti);被收(shou)(shou)錄(lu)(lu)在(zai)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)華醫學(xue)(xue)(xue)(xue)會《缺(que)(que)血性(xing)卒(zu)(zu)(zu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)基(ji)層診療(liao)(liao)指南(nan)(nan)(nan)(nan)(2021 年(nian)(nian)(nian)(nian))》中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)。


為滿足市(shi)場需求(qiu),保障產(chan)(chan)品(pin)(pin)質(zhi)量(liang),經(jing)過(guo)持(chi)續地(di)經(jing)營(ying)和(he)發(fa)展,公(gong)司已建(jian)成集開發(fa)研究、加工生產(chan)(chan)、市(shi)場營(ying)銷為一體(ti)的(de)燈盞(zhan)花產(chan)(chan)業(ye)鏈平臺,包(bao)括紅河(he)州(zhou)彌勒產(chan)(chan)業(ye)基地(di)及昆明(ming)馬金(jin)鋪生產(chan)(chan)基地(di),并建(jian)構(gou)了從藥材種(zhong)植源頭到(dao)生產(chan)(chan)各個環節直至(zhi)最(zui)(zui)終產(chan)(chan)品(pin)(pin)的(de)全(quan)過(guo)程質(zhi)量(liang)控(kong)制(zhi)體(ti)系。生產(chan)(chan)過(guo)程以物料(liao)管(guan)理為主線(xian)索,嚴格(ge)按照GMP要求(qiu),對原(yuan)輔料(liao)、包(bao)裝材料(liao)、工藝用(yong)水、生產(chan)(chan)環境、產(chan)(chan)品(pin)(pin)中間體(ti)、待(dai)包(bao)品(pin)(pin)直至(zhi)最(zui)(zui)終成品(pin)(pin)建(jian)立完善(shan)的(de)全(quan)過(guo)程、多(duo)項目質(zhi)量(liang)監測網絡。采用(yong)多(duo)指(zhi)標含量(liang)測定(ding)、指(zhi)紋圖譜(pu)、高(gao)精度雜質(zhi)限度測定(ding)等技術手(shou)段,高(gao)效、準(zhun)確地(di)進行質(zhi)量(liang)控(kong)制(zhi)。以完善(shan)的(de)生產(chan)(chan)、質(zhi)量(liang)管(guan)理體(ti)系和(he)科學檢(jian)測手(shou)段為堅實(shi)后盾(dun),實(shi)現藥品(pin)(pin)質(zhi)量(liang)控(kong)制(zhi)全(quan)程、高(gao)效、精準(zhun)控(kong)制(zhi)的(de)規(gui)范(fan)化管(guan)理。

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