山東全面完成國家綜合性新藥研發大平臺“十一五”建設任務
2012-06-26 988 山東省科技廳
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國家綜合性新藥研發技術大平臺——“山東省重大新藥創制中心建設”(簡稱大平臺)項目是國家“重大新藥創制”科技重大專項在全國重點支持的15個國家綜合性新藥研發技術大平臺之一,是全國由省政府牽頭組織實施的三家大平臺之一。經過三年的建設,“大平臺”超額完成了合同內容和任務,全面完成先導化合物發現與優化平臺、藥物篩選平臺、藥效學評價平臺、臨床前藥代動力學平臺、新制劑與新釋藥系統平臺、藥物分析與質量控制平臺和藥物安全性評價平臺、中藥創新藥物研究平臺等8個單元技術平臺硬件條件的完善強化建設,基本建成了條件配套完整、功能齊全完備、技術手段先進、技術鏈較為完整的綜合性新藥研發大平臺,形成了海洋藥物、糖藥物和微生物藥物的研究特色。平臺在實現國家目標的基礎上,突出了“產學研”結合,構筑了“一區、六基地、二十個示范企業、三十個人才團隊”的架構。在平臺建設期間,獲得國家新藥證書50件,其中3.1類以上的新藥證書23個。臨床研究批件90個,其中1.5類2個,3.1類以上的臨床研究批件37個,正在進行臨床研究的1.1類新藥8個。19個候選藥物(一類新藥)正在臨床前的研究與評價中;8個一類新藥SFDA已經受理,待批臨床研究。共申請專利470項,授權發明專利173項,其中授權國際發明專利2項,計算機軟件著作權4項。SCI收錄論文達610篇,其中影響因子2.0以上的達371篇。由管華詩院士領銜完成的項目“海洋特征寡糖的制備技術(糖庫構建)與應用開發”,榮獲了國家技術發明一等獎。
山(shan)(shan)(shan)(shan)東(dong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)委(wei)、省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)政(zheng)(zheng)府(fu)(fu)高度重(zhong)(zhong)視,全方位(wei)、高強(qiang)度、多舉措(cuo)支持新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)研(yan)(yan)發(fa)(fa)大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)。一(yi)是(shi)建(jian)(jian)(jian)(jian)(jian)(jian)立(li)(li)了(le)(le)(le)(le)組(zu)(zu)(zu)織(zhi)保障(zhang)體(ti)(ti)系(xi)(xi)。省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)政(zheng)(zheng)府(fu)(fu)成(cheng)(cheng)立(li)(li)了(le)(le)(le)(le)由(you)14個(ge)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)直相(xiang)關(guan)部門(men)(men)和(he)(he)(he)相(xiang)關(guan)市(shi)負責人(ren)(ren)組(zu)(zu)(zu)成(cheng)(cheng)的(de)(de)“山(shan)(shan)(shan)(shan)東(dong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)重(zhong)(zhong)大(da)(da)(da)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)平(ping)臺(tai)(tai)(tai)(tai)(tai)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)協調小組(zu)(zu)(zu)”,濟(ji)南市(shi)政(zheng)(zheng)府(fu)(fu)成(cheng)(cheng)立(li)(li)了(le)(le)(le)(le)平(ping)臺(tai)(tai)(tai)(tai)(tai)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)領導小組(zu)(zu)(zu),濟(ji)南高新(xin)(xin)(xin)(xin)區設(she)(she)(she)(she)(she)立(li)(li)了(le)(le)(le)(le)“山(shan)(shan)(shan)(shan)東(dong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)重(zhong)(zhong)大(da)(da)(da)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)創制(zhi)平(ping)臺(tai)(tai)(tai)(tai)(tai)服務中(zhong)心(xin)(xin)”。大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)成(cheng)(cheng)立(li)(li)了(le)(le)(le)(le)理事(shi)會(hui)、專(zhuan)(zhuan)(zhuan)(zhuan)家(jia)委(wei)員會(hui)。各共(gong)建(jian)(jian)(jian)(jian)(jian)(jian)單(dan)位(wei)成(cheng)(cheng)立(li)(li)了(le)(le)(le)(le)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)辦公室(shi)。基本(ben)(ben)形成(cheng)(cheng)了(le)(le)(le)(le)政(zheng)(zheng)府(fu)(fu)、主管部門(men)(men)、參建(jian)(jian)(jian)(jian)(jian)(jian)單(dan)位(wei)齊抓共(gong)管的(de)(de)組(zu)(zu)(zu)織(zhi)保障(zhang)體(ti)(ti)系(xi)(xi),為(wei)(wei)(wei)大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)奠定了(le)(le)(le)(le)組(zu)(zu)(zu)織(zhi)基礎。二是(shi)建(jian)(jian)(jian)(jian)(jian)(jian)立(li)(li)了(le)(le)(le)(le)政(zheng)(zheng)策保障(zhang)體(ti)(ti)系(xi)(xi)。為(wei)(wei)(wei)組(zu)(zu)(zu)織(zhi)實(shi)(shi)施(shi)“重(zhong)(zhong)大(da)(da)(da)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)創制(zhi)”科(ke)技(ji)重(zhong)(zhong)大(da)(da)(da)專(zhuan)(zhuan)(zhuan)(zhuan)項,加快大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she),省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)政(zheng)(zheng)府(fu)(fu)連(lian)續(xu)出臺(tai)(tai)(tai)(tai)(tai)了(le)(le)(le)(le)《山(shan)(shan)(shan)(shan)東(dong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)人(ren)(ren)民政(zheng)(zheng)府(fu)(fu)關(guan)于(yu)(yu)加快醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)科(ke)技(ji)創新(xin)(xin)(xin)(xin)體(ti)(ti)系(xi)(xi)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)的(de)(de)意(yi)見》、《山(shan)(shan)(shan)(shan)東(dong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)人(ren)(ren)民政(zheng)(zheng)府(fu)(fu)關(guan)于(yu)(yu)促進(jin)新(xin)(xin)(xin)(xin)醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)產(chan)(chan)(chan)業(ye)(ye)(ye)加快發(fa)(fa)展(zhan)的(de)(de)意(yi)見》等8個(ge)加快醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)科(ke)技(ji)創新(xin)(xin)(xin)(xin)與產(chan)(chan)(chan)業(ye)(ye)(ye)發(fa)(fa)展(zhan)的(de)(de)政(zheng)(zheng)策性文件,提(ti)(ti)出以建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)和(he)(he)(he)國(guo)家(jia)山(shan)(shan)(shan)(shan)東(dong)創新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)物(wu)孵化(hua)基地為(wei)(wei)(wei)突破口,舉全省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)之力(li)(li),以“整合、提(ti)(ti)升(sheng)、拓展(zhan)”為(wei)(wei)(wei)主線,以“一(yi)個(ge)中(zhong)心(xin)(xin)區、六類(lei)研(yan)(yan)發(fa)(fa)孵化(hua)基地、三(san)十(shi)個(ge)創新(xin)(xin)(xin)(xin)團隊(dui)(dui)、五(wu)十(shi)個(ge)示范(fan)企業(ye)(ye)(ye)和(he)(he)(he)三(san)個(ge)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)產(chan)(chan)(chan)業(ye)(ye)(ye)密(mi)集區”為(wei)(wei)(wei)重(zhong)(zhong)點,構(gou)筑全省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)重(zhong)(zhong)大(da)(da)(da)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)創制(zhi)體(ti)(ti)系(xi)(xi)和(he)(he)(he)重(zhong)(zhong)大(da)(da)(da)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)成(cheng)(cheng)果(guo)轉(zhuan)化(hua)體(ti)(ti)系(xi)(xi)。規劃到(dao)2020年,逐步建(jian)(jian)(jian)(jian)(jian)(jian)成(cheng)(cheng)運行機制(zhi)科(ke)學(xue)(xue)(xue)(xue)、技(ji)術鏈與產(chan)(chan)(chan)業(ye)(ye)(ye)化(hua)鏈密(mi)切銜接、區域(yu)相(xiang)對集中(zhong)、服務能力(li)(li)完(wan)善、具(ju)有(you)國(guo)內先進(jin)水平(ping)并能夠支撐醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)產(chan)(chan)(chan)業(ye)(ye)(ye)快速(su)發(fa)(fa)展(zhan)的(de)(de)醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)科(ke)技(ji)創新(xin)(xin)(xin)(xin)體(ti)(ti)系(xi)(xi),形成(cheng)(cheng)魯(lu)中(zhong)、半島、魯(lu)南3個(ge)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)產(chan)(chan)(chan)業(ye)(ye)(ye)密(mi)集區。為(wei)(wei)(wei)大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)和(he)(he)(he)醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)科(ke)技(ji)創新(xin)(xin)(xin)(xin)體(ti)(ti)系(xi)(xi)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)提(ti)(ti)供了(le)(le)(le)(le)政(zheng)(zheng)策保障(zhang)。三(san)是(shi)建(jian)(jian)(jian)(jian)(jian)(jian)立(li)(li)了(le)(le)(le)(le)人(ren)(ren)才(cai)保障(zhang)體(ti)(ti)系(xi)(xi)。為(wei)(wei)(wei)解決本(ben)(ben)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)高端人(ren)(ren)才(cai)缺乏(fa)問(wen)題(ti),經(jing)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)委(wei)、省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)政(zheng)(zheng)府(fu)(fu)同意(yi),山(shan)(shan)(shan)(shan)東(dong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)人(ren)(ren)才(cai)工(gong)(gong)作(zuo)領導小組(zu)(zu)(zu)印發(fa)(fa)了(le)(le)(le)(le)《“泰山(shan)(shan)(shan)(shan)學(xue)(xue)(xue)(xue)者(zhe)(zhe)—藥(yao)(yao)(yao)(yao)學(xue)(xue)(xue)(xue)特(te)聘專(zhuan)(zhuan)(zhuan)(zhuan)家(jia)”專(zhuan)(zhuan)(zhuan)(zhuan)項建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)工(gong)(gong)程(cheng)實(shi)(shi)施(shi)方案(試行)》,利用“泰山(shan)(shan)(shan)(shan)學(xue)(xue)(xue)(xue)者(zhe)(zhe)”人(ren)(ren)才(cai)品牌(pai),為(wei)(wei)(wei)大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)增設(she)(she)(she)(she)(she)30個(ge)“泰山(shan)(shan)(shan)(shan)學(xue)(xue)(xue)(xue)者(zhe)(zhe)—藥(yao)(yao)(yao)(yao)學(xue)(xue)(xue)(xue)特(te)聘專(zhuan)(zhuan)(zhuan)(zhuan)家(jia)”人(ren)(ren)才(cai)崗位(wei),引(yin)進(jin)和(he)(he)(he)培育(yu)30名左右的(de)(de)高端人(ren)(ren)才(cai),組(zu)(zu)(zu)建(jian)(jian)(jian)(jian)(jian)(jian)30個(ge)醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)研(yan)(yan)發(fa)(fa)團隊(dui)(dui),這(zhe)是(shi)全國(guo)第一(yi)個(ge)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)級政(zheng)(zheng)府(fu)(fu)專(zhuan)(zhuan)(zhuan)(zhuan)門(men)(men)為(wei)(wei)(wei)大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)設(she)(she)(she)(she)(she)置的(de)(de)品牌(pai)人(ren)(ren)才(cai)崗位(wei),受到(dao)了(le)(le)(le)(le)國(guo)內外醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)界(jie)的(de)(de)關(guan)注和(he)(he)(he)贊賞。通過專(zhuan)(zhuan)(zhuan)(zhuan)項建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)工(gong)(gong)程(cheng)實(shi)(shi)施(shi),有(you)望大(da)(da)(da)大(da)(da)(da)改變山(shan)(shan)(shan)(shan)東(dong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)研(yan)(yan)發(fa)(fa)人(ren)(ren)才(cai)布局不合理,缺少國(guo)家(jia)隊(dui)(dui)專(zhuan)(zhuan)(zhuan)(zhuan)家(jia)的(de)(de)局面。通過省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)委(wei)組(zu)(zu)(zu)織(zhi)部、省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)科(ke)技(ji)廳(ting)積極努力(li)(li),到(dao)目前為(wei)(wei)(wei)為(wei)(wei)(wei)止,全省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)共(gong)引(yin)進(jin)17位(wei)“泰山(shan)(shan)(shan)(shan)學(xue)(xue)(xue)(xue)者(zhe)(zhe)-藥(yao)(yao)(yao)(yao)學(xue)(xue)(xue)(xue)特(te)聘專(zhuan)(zhuan)(zhuan)(zhuan)家(jia)”,其中(zhong)千人(ren)(ren)計劃7位(wei),長江學(xue)(xue)(xue)(xue)者(zhe)(zhe)2位(wei),90%以上有(you)海外留學(xue)(xue)(xue)(xue)經(jing)歷,配(pei)備(bei)的(de)(de)17個(ge)研(yan)(yan)發(fa)(fa)團隊(dui)(dui)正承(cheng)擔國(guo)家(jia)和(he)(he)(he)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)科(ke)研(yan)(yan)任務,為(wei)(wei)(wei)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)創制(zhi)做出了(le)(le)(le)(le)貢(gong)獻。四是(shi)建(jian)(jian)(jian)(jian)(jian)(jian)立(li)(li)了(le)(le)(le)(le)資金保障(zhang)體(ti)(ti)系(xi)(xi)。以大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)為(wei)(wei)(wei)引(yin)導,激發(fa)(fa)了(le)(le)(le)(le)全省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)科(ke)技(ji)創新(xin)(xin)(xin)(xin)投入(ru),拉動醫(yi)(yi)(yi)藥(yao)(yao)(yao)(yao)研(yan)(yan)發(fa)(fa)和(he)(he)(he)產(chan)(chan)(chan)業(ye)(ye)(ye)化(hua)159億(yi)元(yuan)(yuan)(含大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)基建(jian)(jian)(jian)(jian)(jian)(jian)經(jing)費),國(guo)家(jia)財(cai)政(zheng)(zheng)投入(ru)放大(da)(da)(da)效應達到(dao)40多倍(bei)。其中(zhong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)級財(cai)政(zheng)(zheng)為(wei)(wei)(wei)大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)提(ti)(ti)供專(zhuan)(zhuan)(zhuan)(zhuan)項配(pei)套(tao)經(jing)費近(jin)2億(yi)元(yuan)(yuan),2010年省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)科(ke)技(ji)廳(ting)、財(cai)政(zheng)(zheng)廳(ting)配(pei)套(tao)4200萬元(yuan)(yuan)組(zu)(zu)(zu)織(zhi)實(shi)(shi)施(shi)了(le)(le)(le)(le)“山(shan)(shan)(shan)(shan)東(dong)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)重(zhong)(zhong)大(da)(da)(da)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)產(chan)(chan)(chan)值、利稅雙倍(bei)增科(ke)技(ji)示范(fan)工(gong)(gong)程(cheng)”,2011年省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)財(cai)政(zheng)(zheng)配(pei)套(tao)6000萬元(yuan)(yuan),加上濟(ji)南高新(xin)(xin)(xin)(xin)區配(pei)套(tao)6000萬元(yuan)(yuan),主要(yao)用于(yu)(yu)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)大(da)(da)(da)平(ping)臺(tai)(tai)(tai)(tai)(tai)大(da)(da)(da)型儀器(qi)設(she)(she)(she)(she)(she)備(bei)的(de)(de)購置和(he)(he)(he)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)臨床評價基地建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)。2012年省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)財(cai)政(zheng)(zheng)配(pei)套(tao)6400萬元(yuan)(yuan),用于(yu)(yu)省(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)(sheng)重(zhong)(zhong)大(da)(da)(da)新(xin)(xin)(xin)(xin)藥(yao)(yao)(yao)(yao)創制(zhi)中(zhong)心(xin)(xin)共(gong)建(jian)(jian)(jian)(jian)(jian)(jian)單(dan)位(wei)的(de)(de)科(ke)研(yan)(yan)設(she)(she)(she)(she)(she)備(bei)和(he)(he)(he)能力(li)(li)建(jian)(jian)(jian)(jian)(jian)(jian)設(she)(she)(she)(she)(she)。