湖南萊拓福生物科技有限公司于2011年12月創(chuàng)辦，落戶湖南省長沙市寧鄉(xiāng)國家高新技術(shù)產(chǎn)業(yè)園，專注于體外診斷試劑創(chuàng)新產(chǎn)品的開發(fā)及產(chǎn)業(yè)化，是全國科技型中小企業(yè)、湖南省創(chuàng)新型中小企業(yè)。公司總部與營銷中心位于湖南省會長沙。
公司歷時十余年，開發(fā)了一系列基于全新腫瘤標(biāo)志物——醛酮還原酶1B10(AKR1B10)的肝癌診斷試劑盒，屬于境內(nèi)同品種首個產(chǎn)品，在全球范圍內(nèi)亦無同品種產(chǎn)品；獲得多項(xiàng)國家授權(quán)發(fā)明專利和省政府項(xiàng)目資金支持。2023年初，湖南省發(fā)改委批準(zhǔn)萊拓福生物聯(lián)合南華大學(xué)，以AKR1B10為研究核心，共同組建”肝癌早診早治湖南省工程研究中心“。
創(chuàng)新產(chǎn)品《醛酮還原酶1B10測定試劑盒》（?？诵? AKR）已獲得國家III類體外診斷試劑注冊證(國械注準(zhǔn)20223400138)，為同品種產(chǎn)品首個III類注冊證。
目前，公司擁有全球首款、全球唯一創(chuàng)新型國家級三類注冊證一個，三類注冊產(chǎn)品2個，二類注冊產(chǎn)品10余個，一類注冊產(chǎn)品20余個。
Hunan Light of Life Biotechnology Co., Ltd. was founded in December 2011. The company is located in the National High-tech Industrial Park in Ningxiang, with the headquarter and sales center in Changsha, Hunan, focusing on the development and marketing of innovative in vitro diagnostic products.
Over the past ten years, with a total investment of more than 40 million yuan, the company has independently and innovatively developed a series of liver cancer diagnostic kits based on the new tumor marker aldo-keto reductase 1B10 (AKR1B10), which is the first product in China [Review Report of the National Medical Products Administration (NMPA)] and there are no similar competitors in the world. This product has been awarded a number of national invention patents and provincial government project supports.
The innovative product "aldo-keto reductase 1B10 assay kit" has obtained the national class III in vitro diagnostic product registration certificate (GXZZ 20223400138), which is the first certificate of Class III for the same type of products in the world.
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