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博瑞生物 BrightGene
博瑞生物醫(yī)藥（蘇州）股份有限公司位于蘇州工業(yè)園區(qū)風(fēng)景秀麗的獨(dú)墅湖畔，是“國家級高新技術(shù)企業(yè)”、“江蘇省多手性藥物工程技術(shù)中心”和“江蘇省科技創(chuàng)新型企業(yè)”，財(cái)務(wù)評級AAA。公司專注于研發(fā)和生產(chǎn)市場稀缺的高難度原料藥和制劑，以專業(yè)的產(chǎn)品工藝開發(fā)能力和商業(yè)化能力為全球客戶提供高質(zhì)量的產(chǎn)品和技術(shù)服務(wù)。

　　博瑞生物在國家、江蘇省和蘇州工業(yè)園區(qū)各級領(lǐng)導(dǎo)和各界朋友的關(guān)心支持下每年保持100%成長。目前擁有4家全資子公司：在蘇州工業(yè)園區(qū)建成6000㎡研究院、3000㎡中試基地和6000㎡GMP制藥工廠；在重慶建成2000㎡發(fā)酵研發(fā)中心，在泰興建成占地30畝的制藥前端生產(chǎn)基地。垂直整合后的博瑞生物，已成為涵蓋研發(fā)、生產(chǎn)、銷售全產(chǎn)業(yè)鏈的醫(yī)藥集團(tuán)。靚麗的業(yè)績吸引了包括禮來亞洲基金等專業(yè)投資機(jī)構(gòu)的青睞。

　　博瑞生物持續(xù)投入研發(fā)，每年研發(fā)資金不少于銷售收入的30%，全公司500名員工中將近70%是研發(fā)人員。藥物研究院僅高效液相超過100臺，添置了核磁共振、液質(zhì)聯(lián)用、原子吸收等高端設(shè)備，具備良好的硬件設(shè)施，形成了多手性、多糖、發(fā)酵半合成等原料藥技術(shù)平臺以及熱熔擠出、納米靜脈鐵等新型給藥技術(shù)平臺。公司共申請發(fā)明專利106項(xiàng)，授權(quán)27項(xiàng)，其中2項(xiàng)PCT全球?qū)＠?/p>

　　領(lǐng)先的研發(fā)優(yōu)勢和較強(qiáng)的項(xiàng)目管理，使博瑞生物能為客戶提供全方位產(chǎn)品和服務(wù)。博瑞生物曾為正大天晴提供了恩替卡韋非侵權(quán)專利路線和申報(bào)技術(shù)服務(wù)，支持正大天晴成功獲得國內(nèi)首仿。博瑞生物既能為客戶提供首仿解決方案、提供多步驟、多手性中心、新晶型原料藥和高活性細(xì)胞毒性藥物，又能開發(fā)非侵權(quán)的工藝、中間體、工藝優(yōu)化、分析方法開發(fā)、標(biāo)準(zhǔn)品和雜質(zhì)譜建立，還擅長小分子發(fā)酵領(lǐng)域的菌種選育、工藝開發(fā)、放大、分離和純化技術(shù)。公司已向歐盟和美國申報(bào)注冊發(fā)酵半合成產(chǎn)品卡泊芬凈和吡美莫司，標(biāo)志著博瑞生物在發(fā)酵半合成領(lǐng)域處于全球領(lǐng)先水平。

　　博瑞不僅擅長仿制藥研發(fā)，還在創(chuàng)新藥領(lǐng)域積極耕耘。目前有8個(gè)全新化合物和4個(gè)新的制劑釋藥項(xiàng)目在研。新化合物的治療領(lǐng)域涉及肝病、糖尿病和腫瘤。其中最引人關(guān)注的是口服GLP-1降糖產(chǎn)品，進(jìn)展最快的是治療乙肝的一類新藥，目前已經(jīng)進(jìn)入二期臨床。

　　博瑞生物重視藥品注冊體系和cGMP質(zhì)量體系建設(shè)。2013年通過美國FDA現(xiàn)場考核。2014年向USFDA提交4個(gè)DMF申請。2015年順利通過歐盟cGMP檢查。這意味著公司生產(chǎn)和質(zhì)量體系和國際接軌，產(chǎn)品可以進(jìn)軍歐美高端市場。

　　博瑞生物擁有高效率的研發(fā)，質(zhì)量和生產(chǎn)體系符合cGMP要求，精通法規(guī)和知識產(chǎn)權(quán)，掌握市場脈動(dòng)，能夠?yàn)槿蛑扑幙蛻籼峁┫∪钡漠a(chǎn)品和服務(wù)，我們愿以開放的心態(tài)、靈活的商業(yè)模式和客戶合作，實(shí)現(xiàn)共贏。

BrightGene Bio-Medical Technology Co., Ltd. locates next to the beautiful Dushu Lake at Suzhou Industrial Park. As the one awarded with "National High-Tech Company", "Jiangsu Innovative Company", "Jiangsu Provincial Engineering and Technology Research Center of Drug with Multiple Chiral Centers" and "Financial Rating AAA" etc. awards or nominations, BrightGene dedicates itself on research, develop and industrialize of high-end drug substances and products, serves global customers with high-class products and technologies, based on the professional develop ability and excellent business philosophy.

With the support of national, provincial and district government, BrightGene has achieved more than 100% annual growth rate since its foundation to a group incorporating 4 wholly-owned subsidiaries: 6000 m2 – research institute, 3000 m2 – pilot plant, 6000 m2 – GMP facility at Suzhou Industrial Park, 2000 m2 – fermentation R&D center at Chongqing and 20,000 m2 – front-end production base at Taixing. Now the company has become a great pharmaceutical corporation with complete industry chain of research, development, production and marketing. These remarkable achievements attracted many institutional investors like Lilly Asia Fund.

BrightGene invested not less than 30 percent of annual revenue in research and development study, and R&D personnel account for near 70% of total 500 employees. The research institute has acquired more than 100 HPLC, introduced state-of-the-art equipment such as NMR, LC-MS and AAS, and established the research platforms for multi-chiral, polysaccharide, semi-synthetic APIs and novel drug delivery systems such as hot-melt extrusion, nano intravenous iron, etc. The company has files 106 patent applications, 27 of them are authorized and 2 of them are the PCT patents.

On the strength of excellent research and project management capability, our company provides comprehensive services for global market. BrightGene has successfully supported Chia Tai Tianqing Pharmaceutical Group to develop the first generic Entecavir in domestic market, by non-infringed synthetic route and technology transfer. Not only solutions for such first generic drugs, multi-steps, multi-chiral, new crystal form APIs and highly active cytotoxic drugs, BrightGene but also provides independent process, analytical method development, working standard and impurity profiles. Furthermore, our company is skilled in small molecule fermentation area, including strain breeding, process development, scale-up and purification. BrightGene has filed Caspofungin and Pimecrolimus with US and Europe agencies, indicating the leading level in semi-synthetic fermentation area.

BrightGene is also focusing on innovative drugs. Now there are 8 novel chemical compounds and 4 new drug products being studied, for the treatment of hepatopathy, diabetes and tumour. The most attractive one is the oral GLP-1 antidiabetic drug, and the fastest project is the first-type new drug for anti-HBV, which has been into phase II clinical trials.

BrightGene is continuously building cGMP quality system and good registration system. In the year 2013, the facility has been acceptable by US FDA through on-site inspection; in 2014, four DMFs were filed with US agency; in 2015, the cGMP certificate was issued by European authority. Through the progress, BrightGene’s products successfully export to foreign high-end market, with the quality in line with international standard level.

Highly efficient R&D, cGMP-compliant quality system, proficient regulatory knowledge, wise marketing strategy and open-minded business model, all these factors will continue driving BrighGene to provide high-class products and services and realize win-win cooperation with global customers.