【杨森生物是哪个国家的品牌?】
武汉杨森生物技术有限公司是一家从事医疗器械研发和代理的企业,成立于2009年4月,公司位于湖北省武汉国家生物产业基地。企业始终坚持以自主创新为主,企业结构和规模得到迅速的发展和壮大。
公司从2009年50万的注册资金,到现在已有注册资产779.22万;拥有1000m2GMP认证的生产厂房,200m2 办公楼;目前已拥有3项发明专利和1项实用新型,3项发明专利和1项PCT专利已受理,公司设置3个职能部门,包括研发部门、管理部门和销售部门;现有员工30余人,其中博士硕士以上学历者占总人数的83%,体现企业自主研发特色。
杨森公司所研制的三层仿生小口径人造血管项目是以人体自身的小动脉的结构作为参照的人造血管。与以前普遍采用纯纤维材料(涤纶织物或蚕丝)或某种高分子材料(ePTFE)单一组成的人造血管相比,本项目创造性地设计出具有三层结构的更接近于人体血管结构和功能的复合人造血管。该人造血管不仅模拟人体小动脉血管的三层解剖结构(单层上皮细胞构成的血管内膜、富含弹力的平滑肌纤维构成的中层和结缔组织构成的外层),而且还模拟每层结构的功能,内层采用聚氨酯与非水溶性丝素粉体相结合模拟内皮及其少量结缔组织,中间层采用纺织材料制成的管状弹性织物来模拟人体血管中的富含弹性的平滑肌纤维层,外层采用聚氨酯与非水溶性丝素粉体来模拟结缔组织;同时沿厚度方向由内向外实现梯度多孔,模拟血管壁的微孔结构。
核心发明专利:一种织物增强的复合人造血管,专利号:200610166568。 该项目已于2014年完成该项目的生产许可认证,2014年底将样品递交至第三方机构进行形式审核,预计2015年完成该第三方检测工作并提交至国家药监局进行临床申报工作,2016年-2018年完成该项目的临床试验,2018年中旬获取该项目的注册批件并在国内进行上市销售。在此期间,力争同时完成欧盟的CE认证与通过FDA510K证书,从而打开产品的国际市场。
公司的人造血管项目已获得专利,目前该人造血管在动物实验中已取得重大突破,正处于投产阶段,这将是较符合人体生理结构的人造血管。一旦产品成功上市,将推动该领域民族工业的发展,对中国生物医用材料的发展也具有重要的经济价值和社会价值。
英文翻译:Wuhan YANGSEN Biotechnology Co., Ltd. is an enterprise engaged in R & D and agency of medical devices, established in April 2009, located in Wuhan National biological industry base, Hubei Province. Enterprises always adhere to the principle of independent innovation, and their structure and scale have been rapidly developed and expanded. The company has registered capital of RMB 500000 in 2009, and now has registered assets of RMB 7792200; it has 1000m2gmp certified production plant and 200m2 office building; at present, it has 3 invention patents and 1 utility model, 3 invention patents and 1 PCT patent have been accepted, and the company has set up 3 functional departments, including R & D department, management department and sales department; it has more than 30 employees, including Bo Bo Scholars with master's degree or above account for 83% of the total number, reflecting the independent R & D characteristics of the enterprise. The three-layer bionic small caliber artificial blood vessel project developed by Janssen company is an artificial blood vessel with reference to the structure of human own small artery. Compared with the artificial blood vessel made of pure fiber material (polyester fabric or silk) or a kind of polymer material (ePTFE), this project creatively designs a composite artificial blood vessel with three-layer structure, which is closer to the structure and function of human blood vessel. The vascular prosthesis not only simulates the three-layer anatomical structure of human arterioles (the vascular intima composed of monolayer epithelial cells, the middle layer composed of elastic smooth muscle fibers and the outer layer composed of connective tissue), but also simulates the function of each layer structure. The inner layer uses polyurethane combined with insoluble silk powder to simulate the endothelium and a small amount of connective tissue, and the middle layer uses spinning The tubular elastic fabric is made of the fabric material to simulate the elastic smooth muscle fiber layer in human blood vessels, and the outer layer is polyurethane and insoluble silk fibroin powder to simulate the connective tissue; at the same time, the gradient porous is realized from the inside to the outside along the thickness direction to simulate the microporous structure of the blood vessel wall. Core invention patent: a fabric reinforced composite artificial blood vessel, patent No.: 200610166568. The project has completed the production license certification of the project in 2014. At the end of 2014, the samples will be submitted to a third-party organization for formal review. It is expected that the third-party testing will be completed in 2015 and submitted to the State Food and Drug Administration for clinical application. The clinical trials of the project will be completed in 2016-2018. In the middle of 2018, the project's registration approval will be obtained and listed in China. During this period, strive to complete the CE certification of EU and pass the fda510k certificate at the same time, so as to open the international market of products. The company's artificial blood vessel project has been patented. At present, the artificial blood vessel has made a major breakthrough in animal experiments and is in the production stage, which will be more in line with human physiological structure. Once the product is successfully listed, it will promote the development of national industry in this field, and also has important economic and social value for the development of biomedical materials in China.
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