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          生物醫藥十三五規劃制定完成,重點發展這些技術!

                 記者日前從權威渠道獨家獲悉,生物醫藥“十三五”規劃已基本制定完成,按照相關工作流程,這一規劃將在今年下半年正式出臺。根據規劃,“十三五”期間我國生物醫藥產業將重點發展重大疾病化學藥物、生物技術藥物、新疫苗、新型細胞治療制劑等多個創新藥物品類,同時發展生物3D打印技術等重大醫療技術。
                  根據規劃,抗腫瘤、抗抑郁、糖尿病、腎病、心腦血管病等藥物將是“十三五”期間重點發展的新藥品類;在臨床中有巨大應用前景的蛋白及多肽藥物、新型細胞制劑等生物醫藥制劑也將得到優先發展;此外,生物3D打印、大分子藥物、干細胞、基因等前沿性生物醫藥技術,在未來五年也將得到長足發展。
                  此外規劃還提出,加快專利到期藥物仿制上市。針對防治重大疾病或突發疫情等用藥需求,仿創結合、系統集成,研制20到30個臨床需求巨大的藥物品類,并切實解決產業化問題,滿足臨床用藥的急迫需求,到2020年國際專利到期的重要藥物90%以上實現仿制生產。
                  值得注意的是,生物醫藥“十三五”規劃除了對“十三五”期間藥物品類的研發和技術發展作出詳細部署外,還對整個生物醫藥產業提出了新的發展目標,即進一步促進整個產業的國際化發展。根據規劃,到2020年,要推動一大批生物醫藥企業實現藥品質量標準和體系與國際接軌,其中至少100家藥品制劑企業取得美、歐、日等發達國家和WHO認證,并實現藥品出口;按照國際藥品標準、研制并推動10到20個化學藥及高端制劑、3到5個新中藥、3到5個新生物技術藥在歐美發達國家完成藥品注冊,并加快其進入國際市場。
                  規劃還提出,到2020年,推動3到5家基礎好的大專院校與制藥企業聯合建立具有高技術水平和研發能力的大型醫藥研發基地,同期建立國家級轉化科學中心和協同創新中心,突破10到20項重大核心關鍵技術,初步建立國家藥物創新體系和創新團隊,并使我國制藥工業體系達到國際先進水平,并促成部分重點醫藥企業在國際市場站穩腳跟,力爭國際銷售收入平均突破百億元水平。
                  國家制造強國建設戰略咨詢委員會向《經濟參考報》記者介紹,發展生物醫藥產業意義重大。一方面,我國生物醫藥市場巨大,目前我國是全球第二大醫藥消費市場,2014年我國藥品市場純銷售額已突破1.5萬億元。當前我國已進入老齡化社會,65歲以上人口超過1.2億,醫療需求快速增長,將對我國生物醫藥產業未來發展提出新的要求;另一方面,雖然我國生物醫藥產業規模龐大,到2014年全產業銷售額接近2.5萬億元,但我國藥物的自主研發仍很薄弱,藥品生產以仿制為主,原創性藥物較少,生物醫藥關鍵技術也和國際水平有較大的差距。因此,培育發展生物醫藥產業,并力促整個產業涉足國際競爭,將成為提升我國生物醫藥產業整體發展水平和競爭力的關鍵。
                   為了能在“十三五”期間達到上述規劃目標,規劃還提出了多項戰略支撐和保障措施。其中包括:遵照國際規范的藥物臨床試驗質量管理規范(GCP)和藥物非臨床研究質量管理規范(GLP),建立或標準化國際前沿的各項新藥臨床前和臨床評價關鍵平臺;優化和完善新藥物優先評審和快速審批政策,強化審批檢驗人員隊伍的擴充;細化落實國務院《關于改革藥品醫療器械審評審批制度的意見》,保障新藥審批。
                  招商證券等券商研報指出,生物醫藥產業作為我國確定的七大戰略新興產業之一,有巨大的現實意義和經濟意義。一方面,加快發展生物醫藥產業,將進一步滿足我國人民不斷增長的衛生健康服務需求;另一方面,作為重要的產業,生物醫藥領域和化工等基礎制造業部門息息相關,提升生物醫藥產業的整體發展水平,對促進上下游產業、帶動化工等傳統行業轉型升級也有著巨大促進作用。(生物谷Bioon.com)
           

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