The development of chemical drugs comes to the bottleneck. Fewer drugs are approved by FDA. Corresponding to this is the rise of biopharmacy. Biopharmacy gets attention from the world's major biopharmaceutical giants and is expected to completely replace chemical drugs in 2017. As the important part of biopharmaceutical, monoclonal antibody has become the most active and fastest growing area. Since biopharmacy has become the trend, to keep up with the world’s footsteps and walk in the front of world, China also made relevant policy to develop biopharmacy. The major pharmaceutical companies concern about how to transform monoclonal antibody technology into value. Business model play an important part in the technology-value transforming, so it is necessary to research the business model of domestic and foreign monoclonal drugs. In this study, business model theory is used to analysis the operation mode of monoclonal antibody products and learnt about the status and limitations of this technology. In the dimension of business model, we can understand the operation and product characteristics of different enterprises. Combined with current situation and background, the research will give advices to domestic pharmaceutical companies to develop monoclonal antibody industry. Starting from the definition of the business model, we give five dimensions to analysis monoclonal antibodies, the five dimensions are target market, value proposition, key processes, network location and key resources. 7 domestic listed monoclonal products and 10 foreign products listed in China are chosen as case study to analysis the whole current development status of monoclonal antibody in China. We also study the world’s market status and compare it with domestic market. This study found that the development of monoclonal antibodies is not optimistic, current mode of operation need to improve urgently. According to the current development state of Chinese monoclonal antibodies there are three conclusions. First, domestic pharmaceutical companies are on the sidelines for the future prospects of monoclonal antibodies, and it is short of R & D investment. Secondly, cooperation between enterprises and research institutes is not enough, resulting in a mismatch between research and development, increasing costs and tome of R & D. Thirdly, the monoclonal antibody production capacity of Chinese pharmaceutical companies is too poor to realize industrialization, and is far from the international pharmaceutical giants. The business model of monoclonal antibody in China is not reasonable enough, and it is not conducive to the future development of this new technology in the country. Three suggestions are given to improve the development of monoclonal antibody in China. Firstly, improve the strength of R & D, keep up with the world’s pace. Secondly, strengthen cooperation with research institutions, in order to reduce time and investment of R & D. Finally, increase the production level, increase production capacity. At the same time, strengthen communication with government to make monoclonal antibodies into the medical insurance list.

化学药发展进入了瓶颈期，FDA 批准上市的化学药越来越少，与之对应的是 生物制药的兴起。生物制药的发展受到了来自世界各大制药巨头的青睐和关注， 预计在 2017 年，生物药将全面取代化学药。单克隆抗体作为生物制药中最重要 的一部分，已成为当今最活跃和发展最迅速的领域。 同样，中国将单克隆抗体作为重要发展领域，并且制定出相关的鼓励政策， 以期在发展生物制药的潮流下，能够跟紧世界的脚步，走在世界制药业的前列。 但是如何来发展单克隆抗体，使这一技术能够转化为更多的价值，这是各大制药 企业所关心的。技术转化为价值，是商业模式在起作用，因此对于现有国内外单 克隆药品的商业模式进行研究，是十分必要的。本研究通过商业模式理论去分析 单克隆抗体产品，了解当前世界单克隆抗体技术的现状和局限，分析当前世界单 克隆抗体产品的运作模式，运用商业模式的维度进行分析，对不同企业的运作方 式以及产品特色进行充分认识，同时结合国内的现状背景等因素，为中国制药企 业发展单克隆抗体这一新型产业提供建议。 本研究从商业模式的定义出发，提出适合单克隆抗体的五个维度：目标市场、 价值主张、关键流程、网络定位、关键资源。从这五个维度来分析单克隆抗体。 采用案例研究的方法，选取了国内 7 个上市的单克隆产品以及国外 10 个在中国 上市的单克隆产品来分析整个中国单克隆抗体的现状。同时还研究了世界单克隆 抗体市场的现状，并且与国内市场进行了对比性分析。 本研究发现，中国单克隆抗体发展状况不容乐观，急需改善当前的运作模式。 根据中国单克隆抗体目前的发展状况得到以下三个结论：第一，中国医药企业对 于单克隆抗体未来前景持观望态度，企业研发投入远远不够；第二，企业与科研 单位间的合作太少，造成了研发上的脱节，增加了研发成本和时间；第三，中国 制药企业对于单克隆抗体的生产能力无法达到产业化，与国际制药巨头相距甚 远。总结这三点，发现中国对于单克隆抗体的商业模式运用不够合理，这不利于 这一新型技术在国内的未来发展。 最后本研究为中国单克隆抗体的发展给出了三个建议：首先，提高研发实力， 跟紧世界单克隆发展脚步。其次，加强与高校间的合作，以此减少研发时间和费用。最后，加大生产化水平，提高生产能力。同时加强和政府间的沟通，让单克 隆抗体早日进入医保目录。 关键词：单克隆抗体；商业模式；中国