2021年10月,金秋时节,yl23455永利(中国)公司官网申报的“中国-德国中药与植物药创新国际合作基地”中标,获得国家中医药管理局国际合作专项资助。
yl23455永利(中国)公司官网60余年来一直致力于药物创新研发,其中自主研发41项中药新药,获得新药证书并全部产业化。yl23455永利(中国)公司官网作为第一完成单位、刘昌孝院士领衔完成的《基于“物质-药代-功效”的中药创新研发理论与关键技术及其应用》项目获得2020年国家科技进步二等奖。
yl23455永利(中国)公司官网历来重视中药的国际化推广和合作,特别是与德国高校及科研机构具有良好的合作基础。其中,自主研发的“三七三醇皂苷”作为第一个中国提取物标准进入《德国药品法典》(2018版),成为我国中药国际化的标志性成果之一;为中药品种复方丹参滴丸(已美国III期临床)、桂枝茯苓胶囊(已美国临床)、康莱特注射液(已获俄罗斯批准上市)等品种的国际注册提供了重要的技术支持。
自2013年起,我院对疏风解毒胶囊持续进行系统的二次开发研究,阐明疏风解毒胶囊复杂体系的药效物质基础和作用机制,发现和提炼疏风解毒胶囊的作用特点和比较优势,挖掘其临床核心价值,指导临床实践,提高临床疗效;疏风解毒胶囊陆续被列为国家卫计委的12项重大疾病的推荐用药、诊疗指南和2017年国家医保目录甲类品种;入选《中药大品种科技竞争力报告(2017版)》,科技影响因子41.096,为全国呼吸系统用药第一名;获得授权发明专利2项,提升后的产品质量标准已被《中国药典》2020年版收载;全面扩大了临床应用,超过5000万患者使用获益,覆盖29个省、市、自治区;产品年销售额由二次开发前5000余万元增长至2019年约6亿元;取得了显著的经济效益和社会效益,研究成果“疏风解毒胶囊的二次开发研究”获得2017年安徽省科技进步获一等奖。
2020年疏风解毒胶囊先后收录于我国《新型冠状病毒肺炎诊疗方案》(试行第四-八版)中;新冠疫情期间,汉堡大学附属埃彭多夫医院之汉莎美安中医中心联合国内科研机构开展了疏风解毒胶囊治疗新冠肺炎的基础和临床研究。研究成果发表在权威顶级期刊《Phytomedicine》。
德国前总理默克尔博士在2019年8月22日的贺信中讲到:“德国第一家销售高质量中药配方颗粒的药房开业,这无疑会推动中医药在施特拉尔松德市的发展。高质量的中药材将在这里根据患者的要求,为患者单独制造和包装,以及所有药房的全体员工,在中医药领域取得圆满成功和喜悦。高质量中药配方颗粒拉茨药店,这是德中两国友好合作的体现,也是高校、产业界以及文化机构合作富有成效的成功典范。……这些迄今的成就感到自豪和喜悦”。2020年,以中药配方颗粒配置的疏风解毒颗粒在德国上市销售。
本次,我院和汉堡大学附属埃彭多夫医院之汉莎美安中医中心联合承担建设“中-德中药与植物药研发国际合作基地”具有明显的优势互补性和重要的社会效益与价值。
1)中国是世界上最大的中药研发、生产和销售国,为世界提供了最为丰富的中药品种资源库和临床数据库;德国是世界上植物药研发、生产和销售最多的国家之一,在国际市场都有很强的竞争力。中-德在传统医药不同领域具有各自独特的优势,又具有很强的互补性。
2)产品市场互补性强。中国是中药和植物药的消费大国,国民认可度很高;德国植物药研发、生产、销售体系比较完善。目前,中药产品(尤其是中药复方)的国际市场占有率还较低,但认可度正不断提升。中-德既具有共同的市场需求,又具有各自的市场体系和特色。
3)科学研究互补性强。本项目承担方具有各自的科研优势,其中yl23455永利(中国)公司官网在中药新药研发及中药二次开发方面科研体系完整,研究成果突出;汉堡大学附属埃彭多夫医院之汉莎美安中医中心在药品临床评价及基础研究方面优势明显,二者联合研发共同探索中药产品在德国注册和德国植物药在中国注册的策略及可行性路径;并开展疏风解毒胶囊(配方颗粒)在新冠肺炎病程干预中的作用特点及机制,具有很好的互补性。
在“中国-德国中药与植物药创新国际合作基地”项目实施过程中,我院将与德国汉堡大学加强合作,共同围绕中药的欧盟(德国)注册路径、德国植物药的国内注册路径、中药治疗新冠肺炎作用特点及机制等领域开展系统研究工作,助推中药的国际化输出与欧洲植物药的国内输入,从而实现传统药物的国际化交流与协同发展。
yl23455永利(中国)公司官网将持之以恒地开展中药的国际化合作研究,并积极推动中药产品的国际市场准入和国际植物药引进工作,从而为公司中药大健康板块的发展开辟新的篇章。
附:德国汉堡大学附属埃彭多夫医院之汉莎美安中医中心简介
Institute and Team Introduction
Institute
The HanseMerkur Center for TCM at the UKE (HMC) is located on the campus of the University Medical Center Hamburg Eppendorf (UKE). The HMC was founded under the umbrella of the Shanghai-Hamburg sister city cooperation.
The shareholders of the research institute are the University Medical Center Hamburg
Eppendorf (UKE) and the Hanse Merkur insurance-group. The center provides a stimulating research environment since it brings together, western medicine – and traditional Chinese medicine medical doctors with natural scientist. This combination ensures that current available treatment options are viewed by different perspectives which could enhance the development of novel improved treatment concepts.
The HMC unites a non-profit limited liability research company and an independent medical clinic with a team of 7 German and Chinese doctors and two therapists. In 2004 the UKE signed a cooperation contract with the Shanghai TCM-University. Since 2018, the HMZ, the academy of the UKE and the Shanghai TCM-University offer a joint postgraduate three-year TCM-Master program.
Research team
The research team consists of 5 medical physicians for clinical research, which are all trained in western and Chinese Medicine. The laboratory head is Prof. Dr. Thomas Friedemann, a biologist with experience in TCM research for 10 years. The UKE provides access to intellectual exchange, collaborations and joint use of equipment via the core facility service (e.g. cell sorter, confocal microscope, HPLC) and via different research groups. Furthermore, the UKE gives access to the Library services (e.g.electronic subscriptions to a large number of scientific journals) and proviedes technical support, discounts on purchases for electronic as well as facility services (electricity, plumbing, maintenance). The researchers supervise 15 TCM Master students or western medicine doctoral students. They were supported by the staff of
the clinic and technical assistants Privat-Dozent Dr. med. Sven Schröder Geschäftsführer HanseMerkur Zentrum für TCM am UKE Lehre:
Projects and cooperation partners.
- Herbal Medicine for infectious diseasese (Cooperation with Anhui TCM-University,
Shanghai Public Health Clinical Center, Fudan University)
- Herbal medicine of neurodegenerative diseases (Cooperation with Anatomy UKE, ZMNH
UKE, Baptist University HongKong, Zhejiang University Hangzhou, Tongji University
Shanghai, Institute of Pharmacy and Biochemistry University of Mainz)
- Herbal medicine for wound healing (Cooperation with Dermatology UKE)
- Acupuncture for peripheral neuropathy (Cooperation with Neurology UKE)
- Mechanisms of acupuncture analgesia (Cooperation with Neurophysiology UKE, Surgery UKE)
Head of Instiute
Privatdozent Dr. med. Sven Schröder (born 1962 in Hamburg) completed his training as a specialist in neurology in Berlin and Hamburg, primarily at the University Medical Center Hamburg-Eppendorf (UKE). He received his TCM training in acupuncture, medicinal herbal therapy and tuina in Germany and China. From 2000 on, he was in charge of one of the largest TCM practices in Hamburg. Schröder chairs the Quality Circle for Acupuncture and TCM of the Hamburg Medical Chamber. He has authorization for postgraduate medical education in acupuncture and neurology from the Hamburg Medical Chamber. In 2010 he became founding medical director of the new HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center Hamburg Eppendorf. Since 2008 he is the chairman of the german committee and delegation in the ISO process for the standardization of Chinese medicine (ISO-TC-249-TCM) and the convener of the working group safety and quality of Chinese herbs. His habilitation thesis with the title “Research of TCM therapy on the nervous system” was accepted by the Hamburg University in 2017. Since 2018 he organizes the Hamburg TCM Master studies, a joint program of the academy of the University Medical Center Hamburg, the Hanse Merkur Center for TCM and the TCM University Shanghai. He was appointed as Professor of Shanghai TCM University International College and is a visiting Professor of Jiangxi TCM University, Nanchang. His own research work focuses on neuroprotective and neuroregenerative effects of TCM, pain management and herbal medicine for infectious diseases.