公司简介

上海科新生物技术股份有限公司成立于2008年4月，是一家位于上海浦东张江高科技园区，集研发、生产、销售为一体的高新技术企业。公司主要从事生物药物、新型诊断试剂的研发、生产、销售和技术服务，于2012年12月在新三板上市（股票名称：科新生物，股票代码：430175），拥有北京金豪制药股份有限公司、中山瑞福医疗器械科技有限公司和中山瑞福医疗器械研究有限公司三家子公司。2015年，在新三板“最有价值和最具创新力企业”评选中，公司从数千家企业中脱颖而出，被评为最有价值企业排行第12名和制药、生物科技与生命科学行业最具创新力企业第1名。

公司始终秉承“自主创新是企业第一生产力”的发展理念，倡导“坦诚、理解、尊重、信任”的企业文化，拥有一流的人才队伍，公司及子公司现有员工380余人，科研人员的比例高达30％以上。此外，还拥有一支由多位国际著名权威学者组成的专家团队，并与多家国际顶尖科研机构、大学院校和专业化公司建立了广泛、长期的合作。

目前，公司拥有从基因克隆、蛋白表达与制备、抗体制备到细胞培养等一系列专业化实验平台，建有符合国家GMP要求的药品研发中试车间和符合ISO13485标准的诊断试剂生产车间。在诊断试剂研发方面，具备成熟的酶联免疫吸附( ELISA ) 、免疫印迹（ImmunoBlotting）和胶体金（GICA）等工艺平台；在原料制备方面，具备大肠肝菌表达系统技术平台、酵母表达系统技术、大规模发酵及复性纯化技术、CHO细胞表达系统技术、大规模瞬时基因表达技术、杂交瘤技术、大规模动物细胞培养技术。

公司现有十多个产品已获得了药监局的生产注册证并上市销售。自主研发的酶联免疫诊断试剂产品、胶体金诊断试剂产品，被认定为上海市高新技术成果转化项目、上海市自主创新产品。公司还承担了多项国家级重点科研课题和项目 ，其中包括国家新药创制重大专项、国家创新基金、上海重大专项基金等 。公司目前已拥有近40 项发明专利，也因此获得了上海市专利示范企业的殊荣。

强大的科研团队和持续的研发投入为公司建立具有自主知识产权的高新技术产品体系打下了坚实基础。公司自主研发的系统性红斑狼疮、类风湿关节炎、自身免疫性肝炎等新型诊断试剂自投入市场以来，受到广大客户的广泛好评和高度认同，销售收入每年高速递增，并已形成了基本覆盖全国的营销网络，建立了良好的品牌知名度和美誉度，也在国外厂商林立、竞争极为激烈的新型诊断试剂产品市场中为国有自主品牌赢得了一席之地。

“科无界，新无限，永争先”，这不仅是科新的口号，更是科新不变的追求。公司一直恪守“以科技创造价值，以创新引领未来，以品质立信社会，以健康奉献大众”的经营理念，致力于将公司发展成为行业内“成长最快、品质最好、品牌最优”的极具竞争力的生物企业。曾经、现在和未来，科新人将始终保持一颗竭诚服务社会的赤子之心，立志以一流的产品和服务为大众提供最为优质的健康产品，也为人类生命科学的不断发展做出积极贡献!

Established in April 2008 and located in Shanghai Pudong ZhangJiang High Technology Park, Shanghai Kexin Biotech Co. Ltd., is a public hi-tech company specializing in the development, manufacture and marketing of clinical diagnostic and biological products. Our products and services include biological medicines, innovative In Vitro diagnostic kits and Contract R&D. Our company was successfully listed in the National Equities Exchange and Quotations system (the New Third Board Over the Counter System) in December 2012 (Name: Kexin Biotech, Code: 430175). After a few years of rapid growth, we have now acquired three subsidiary companies. They are Beijing Jin Hao Pharmaceutical Co., Ltd, Zhongshan Ruifu Medical Devices Technology Co., Ltd and Zhongshan Ruifu Medical Device Research Co., Ltd. In 2015, during the New Third Board “Most Valuable and Most Innovative Corporations Contest”, from thousands of companies participated, our company was ranked No. 12 in the “Most Valuable Corporation Rank” and Amazing No.1 in the “Most Innovative Corporation Rank” of Pharmaceutics, Bio-tech and Life Science Industry.
Kexin’s continued success is based on the fact, that as a company, “Independent Innovation is our company’s most important competitive advantage.” Our business culture, “Genuineness, Comprehension, Respect and Trust”, has been attracting many talented people, which have become our most valuable assets now. We now have over 380 employees and more than 30% are R&D staff. Besides, we have top level professional teams consists of multinational world-famous scientists and engineers. Therefore, we have been able to cooperate with many world renowned research institutes, universities and companies, building a wide and effective cooperation network.
Kexin’s basic technology platforms include Genetic Engineering, Protein Expression and Purification, Antibodies production and Mammalian Cell Cultivation. We have established a pilot plant, which complies with cGMP, for biological pharmaceutics trial production. We have established a production plant of In Vitro diagnostic (IVD) test kits, which complies with the ISO13485. The IVD kits we manufacture are based on the ELISA, Immunoblotting and GICA techniques. Furthermore, we specialize in the development and production of recombinant and native antigens, using proprietary technologies. The production platforms range from Prokaryotes to Eukaryotes as well as In Vitro production.
Kexin’s IVD kits are approved by China Food and Drug Administration (CFDA). The ELISA kits and GICA kits we developed have been certified as “Shanghai hi-tech achievements transformation project” as well as “Shanghai Self-dependent Innovative products”. We have participated and undertaken a number of National Key Research Projects including National Major New Drugs Innovation and Development, National Innovative Funds, Shanghai Major Special Fund and many others. We now have over 40 patents awarded, and are certified as Shanghai Patent Demonstration Enterprise.
Kexin’s continuous investment in R&D and our top level scientific teams grant us the capacity to manufacture proprietary and cutting edge products. Our innovative IVD kits are widely used in the clinical laboratory and point-of-care segments of the diagnostic market for systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Autoimmune Liver Disease (ALD) and other autoimmune diseases. These kits have gained in high reputation. Sales revenue has been growing rapidly. After years of efforts, our nationwide marketing network has been established. Kexin brand has now been recognized and we have achieved a favorable position in the heavily competitive market place where major players are multinational- corporations.
“Science without boundary, Inovation without limit and Being first as always”, are our slogans, and moreover, our perpetual quest. Kexin is dedicated to the business philosophy that we “create value using science and technology, lead the future trend by innovation, win the trust of society with high quality products and make a commitment to the public with health”. We are devoted to the establishment of a better and more competitive Kexin Biotech, which has “Fastest growth, Best Quality and Best Brand”. Kexin has now established sterling reputation among the clinical community, a reputation built on innovative products, customer service and attention to detail. Driven by the commitment to the society, Kexin will keep on providing best quality health products to the public, contributing greatly to life science research and development, and most important, making a difference to the world.