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New Products Development Introduction overview Daxas related clinical study introduction --- ChenxiaojunAsthma - ongoing and upcoming studiesStudyTypeObjectiveTarget populationLeading PIStatusSymbicort as neededPhase IIIIMCT327/3750Well controlled asthma weeksBudesonide/formoterol as needed superior to terbutaline ‘as needed’ and non-inferior to budesonide bid plus terbutaline ‘as needed’Mild asthmaticsZhong NanshanActively recruiting2016Q2 LPIObservational cohort study525/725Severe asthma registry in ChineseUncontrolled severe asthmaticsZhong NanshanActively recruitingBenralizumabanti-IL-5RαPhase IIIRMCTReduce asthma exacerbation when add on to mId to high dose ICS/LABAUncontrolled severe asthmatics with higher level of blood eosinophils2016Q3 CTP-Approval2017Q1 FSITralokinumabanti-IL-13Phase IIIRMCTReduce asthma exacerbation when add on to mId to high dose ICS/LABAUncontrolled severe asthmatics with positive Th2 biomarkers2016Q2 CTP-Submission研究设计研究终点和观察变量 25预期研究结果深入了解具有不同发病机制和临床特征的重度哮喘表型获得用于疾病表型分类和预测的信号包括生物标志物促进研发直接针对特定疾病特征的个体化精准治疗方案IL-5可促进嗜酸性粒细胞的生长、成熟、迁移，并抑制嗜酸性粒细胞凋亡benralizumab是一种单克隆抗体，能够与白细胞介素5受体的α亚基（IL-5Rα）结合，消耗嗜酸性粒细胞其他抗IL-5药物：GSK 美泊利单抗 (mepolizumab)， FDA于2015.11批准 Teva 制药 Cinquil(reslizumab)， FDA于2016.3批准通过阻断IL-5结合至嗜酸性表面上表达的IL-5受体复合物的α链抑制IL-5生物活性，减低嗜酸性的生产和生存Benralizumab是我们公司呼吸领域的第一个生物制剂两个关键的III期临床试验（SIROCCO和CALIMA研究）在减少重度未控制哮喘患者的急性加重方面获得了显著的结果将在今年下半年向美国和欧洲提交 Benralizumab的注册申请/apex/Main?sname=Intranetname=heartbeat_may2016_Benralizumabr=truer=true#//apex/Main?sname=Intranetname=heartbeat_may2016_Benralizumabr=truer=true/apex/Main?sname=Intranetname=heartbeat_may2016_Benralizumabr=truer=true#/#/Aug 2016Aug 2016Aug 2016Primary endpoint: Annual asthma exacerbation rateStudy drug: 30mg/mL solution for injection in accessorized pre-filled syringe Patient population: Severe asthma uncontrolled on medium-to-high dose ICS/LABA with ≥2 exacerbations in the previous year required use of systemic corticosteroid.Tralokinumab: mechanism and indicationTralokinumab is a fu