从临床治疗进展和商务开发的角度评价最具市场潜力的抗肿瘤单抗.doc

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、Trastuzumabemtansine、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。 Evaluationofthemostpromisinganti-tumormAbs,fromtheviewofclinicalapplicationandbusinessdevelopment Biologicshasalreadybeenthemostactivecommandingheightsoftheworlddrugmarket.ThemarketofmAbisworthmore than$56billionin 2011.CurrentlytheindicationsofmAbaremainlyconcentratedinthefieldofanti-tumor,immunomodulatory,rheumatoidarthritisandotherdiseases.Becauseoftheshortageineffectiveclinicaltreatmentsforpatients,andhighdrugpriceformarketpotential,anti-tumormAbsattractmuchmoreattentiontodrugcompanies,andbecomethemostactivedrugdevelopmentfield. Fromtheviewoftheclinicalprogressandbusinessdevelopment,740anti-tumormAbsindifferentstagegloballywerestudiedinthispaper,bymethodsofcontrast,analogy,induction,deductionandSWOTanalysis,theconclusionsweredrawnasfollow:1).Global Trend: a,expendingnewindicationswithcurrentmAbmoleculesalreadyinthemarket;b,mAbbiosimilardevelopmentwithlowcostfortheblockbustmoleculesthattheirpatentareexpiredsoon;c,antitumormAbdevelopmentfortheircleartargetaimingatdifferentcytokins;d,developmentofAntibody-Drug-Conjugatesasantitumordrugs.2).CancersasmAbtreatmenttargetscurrentlyandmainlydiscussedinthisarticle:lungcancer,breastcancer,coloncancer, livercancer,gastriccancer,esophagealcancer,pancreaticcancerandbloodandlymphcancer.Throughdeepanalysys,finallyatotalof14mAbproductswereselelctedas candidateswh