从临床治疗进展与商务开发的角度评价最具市场潜力的抗肿瘤单抗详细分解.docxVIP

关键词：抗肿瘤单抗；临床治疗需求；在研管线；市场潜力 摘 要 生物药已成为全球制药领域争夺市场的制高点，仅单抗药物一类，2011 年全球销售 金额已超过 560 亿美元。目前已上市的单抗类药物的适应症主要集中于抗肿瘤、免疫调 节、类风湿关节炎等疾病领域。抗肿瘤单抗因为临床治疗需求的未满足度高、存在高投 资和高技术壁垒、价格高昂等原因，吸引了全球很多公司的关注，并成为研发最活跃和 关注度最集中的药物类别之一。 本文采用对比、类比、列举、引用、归纳演绎以及 SWOT 分析等论证方法，分别从 临床治疗进展与商务开发的角度，针对全球在研的 740 个抗肿瘤单抗进行筛选分析，初 步得出以下结论：1)，全球抗肿瘤单抗开发的趋势为：已上市产品的新适应症拓展或者 治疗地位的提升；专利即将到期的重磅产品的生物类似物；目的为提高疗效、减少不良 反应的升级换代产品；具有明确靶向蛋白激酶抑制作用的抗肿瘤单抗；与免疫毒素、抗 肿瘤抗生素偶联的抗肿瘤单抗等。2)，重点关注肺癌、乳腺癌、结肠癌、肝癌、胃癌、 食管癌、胰腺癌和血液淋巴系统等八大癌种。最终，遴选评价出未来十年里最具市场潜 力和最值得关注的 14 个产品：1)，依然会保持或将成为市场重磅炸弹的有：Bevacizumab、 Rituximab、Trastuzumab、Cetuximab、Pertuzumab、Trastuzumab emtansine、Ipilimumab 等；2)，有机会成为最具市场潜力和市场价值的有：Brentuximab、Onartuzumab、 Ramucirumab、Nivolumab、Obinutuzumab、Necitumumab、Inotuzumab 等。 Keywords: anti-tumor mAb, clinical requirments, RD pipeline, market potential Evaluation of the most promising anti-tumor mAbs, from the view of clinical application and business development Biologics has already been the most active commanding heights of the world drug market. The market of mAb is worth more than $56 billion in 2011. Currently the indications of mAb are mainly concentrated in the field of anti-tumor, immunomodulatory, rheumatoid arthritis and other diseases. Because of the shortage in effective clinical treatments for patients, and high drug price for market potential, anti-tumor mAbs attract much more attention to drug companies, and become the most active drug development field. From the view of the clinical progress and business development, 740 anti-tumor mAbs in different stage globally were studied in this paper, by methods of contrast, analogy, induction, deduction and SWOT analysis, the conclusions were drawn as follow:1). Global Trend: a, expending new indications with current mAb molecules already in the market; b, mAb biosimilar development with low cost for the blockbust molecules that their patent are expired soon; c, antitumor mAb development for their clear target aiming at different cytokins; d, development of Ant