医学交流课件：New Products Development Introduction overview.pptxVIP

New Products Development Introduction overview Daxas related clinical study introduction --- ChenxiaojunNew Products Development IntroductionDaxas related clinical study introduction --- ChenxiaojunPromising late-stage respiratory pipeline for Chinese patientsAcuteMild to Moderate to SevereSevere to Very SevereFrequent ExacerbatorsAdd-onCOPDAdult ≧ 40 yearsPatients Diagnosed with ExacerbationsClosed TriplePT010 – Y2021 Project Laser (IL-5Rα)(2)Y2022 LAMA (for LABA-Intolerant Open Triple): (3)Patients Diagnosed with SymptomsY2020-2021(1)TBDLABA / LAMAY2020-2021(1)Y2019AcuteMild to Moderate to Severe(4)Severe UncontrolledAdd-on(5)AsthmaPatients ＜6 yrsProject Laser (IL-5Rα)Y2022 Pulmicort Home NebTralokinumab (IL-13 )Y2023Adolescent SMART Y2018Patients≧6 yrsMEDI9929 (Anti-TSLP)TBDAs Needed (Mild) Y2021Forecast approval depending on timing of China Duaklir study startSevere COPD patients eligible based on Personalized Health Care after standard therapy has failed to offer sufficient benefitSevere COPD patients on maintenance treatment with inhaled drugs who have symptoms of chronic cough and sputum and/or a history of frequent exacerbationsGINA Step 2 to 5. (5) GINA Step 4 to 5. |最新产品及相关信息介绍PT010 – 2021Y：三联 pMDI Budesonide/Formoterol/Glycopyrronium Glycopyrronium：是一种每日一次的吸入性长效毒蕈碱受体拮抗剂，用于缓解慢性阻塞性肺病患者的症状。相关产品信息： 2012年诺华的格隆溴按干粉吸入性胶囊（商品名Seebri）在日本获得批准，同年10月获得欧盟批准。 2014年5月21日诺华公布了新药glycopyrronium/indacaterol，格隆/马来酸茚达特罗，50mcg/110mcg （商品名Ultibro Breezhaler）治疗COPD的III期QUANTIFY研究的新数据。Ultibro被认为是一种具有双重作用模式的支气管扩张剂，结合了诺华2种药物的疗效和安全性；Eklira:Aclidinium、Duaklir GenuairAclidinium/ Formoterol 2020-2021 Aclidinium 阿地溴安 2012年FDA批准上市，剂型为干粉吸入剂，用于慢性阻塞性肺病引起的支气管痉挛（肺气道变窄），包括慢性支气管炎和肺气肿的长期维持治疗。阿地溴铵是一种长效抗胆碱药，能帮助肺部大气道周围的肌肉放松，从而改善通气。该药物是2015年AZ从阿特维斯进行的收购，分别收购了Eklira(Aclidinium TUDORZA PRESSAIR 吸入性粉剂)、LAS40464(Duaklir Genuair Aclidinium/ Formoterol )两种药物。最新产品介绍Bevespi Aerosphere:Formoterol fumarate/Glycopyrronium 4.8mcg/9mcg 2019Y 该产品在2016年4月25日被美国FDA批准作为长效的LABA和LAMA用于长期维持治疗COPD包括慢性支气管炎和肺