论全球生物制药业变化为中国带来的发展新契机要点分析.docVIP

摘 要 在过去的二十年中，众多的单克隆抗体、疫苗和融合蛋白等生物药品因其显著的临床疗效和较低的副作用被大量投放市场，并使数以百万的病患受益。这些通过长期临床试验被证实具有极好的安全性的生物药品，很大一部分的专利都将在近几年陆续到期。显而易见，生物仿制药将为全球药品研发注入一针新的强心剂。 中国的生物制药行业曾经遭遇了很多瓶颈，特别是在研发投入和政府监管等方面与发达国家相距甚远。然而随着近年来中国经济的腾飞，伴随法规政策的革新和来自发达国家大型制药公司的巨额投入，生物制药行业已经成为中国最具有前景的领域之一。 本文通过分析全球生物制药行业的变革，揭示了生物技术的日新月异给中国带来的历史性机遇，并给中国生物制药行业的发展提出了一些建议。 关键词：生物制药行业 变革 机遇 生物仿制药 China’s opportunity in the changing global biopharmaceutical industry Jing Wang (International Pharmaceutical Engineering Management) Directed by Dr. Joe X. Zhou Abstract During last 20 years, numerous biological therapeutics including monoclonal antibodies vaccines and Fc-fusion proteins were successfully launched into market for many diseases without noticeable side-effects, benefiting millions of patients. Such a long period of clinical application testifies excellent safety profile for protein therapeutics while their patent expiration is approaching in the next few years. It is clear that biologics including many bio-similar molecules becomes the major driver in current drug development globally in near future. Although drug development in bio-therapeutics in China faced many bottlenecks in the past because of?extreme underdevelopment of governmental regulation and lack of investment in comparison with industrial countries, it is a very meaningful field where this country can catch up with these advanced industrial countries due to recent economic boom in China, new development in?government regulation?and heavy investments from many giant pharmaceutical companies of the industrial countries. In this article, the changes of global biopharmaceutical industry were analyzed and advanced technology in the field that led to great historical opportunity for China was reviewed. In addition, several recommendations were provided. ? Keywords: Biopharmaceutical Industry Change Opportunity Biosimilar 目 录 第1章 序言··············································1 第2章 生物制药行业简介··································2 2.1