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【沙利文】2024中国生物医药出海现状与趋势蓝皮书VIP免费

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www.frostchina.com©202420242024“1992FDA20172019FDA2022CAR-TCarvyktiCAR-T2023Abstract•--------------------------------7•--------------------------------8•--------------------------------12•--------------------------------13•--------------------------------15•--------------------------------16•——--------------------------------18•——--------------------------------19•——--------------------------------20•——--------------------------------21•——--------------------------------22•——--------------------------------2320242024•--------------------------------25•--------------------------------26•--------------------------------27•--------------------------------28•--------------------------------29——CXO——————•--------------------------------33•--------------------------------36•--------------------------------39•--------------------------------41•--------------------------------42——————20242024•--------------------------------50•--------------------------------54•--------------------------------55————License-outADC——•--------------------------------65•--------------------------------71•--------------------------------74•--------------------------------75•--------------------------------77•--------------------------------78•--------------------------------80•--------------------------------82◆--------------------------------82◆--------------------------------8320242024202401◼◼“9.5%4.28%1,0004727896414.8%DRG/DIP2019-2030E◼2019202313,24514,7232026203017,66720,69420232,315202620302,9113,732405.5458.3569.8652.3236.3231.5291.1373.2163.3184.5215.0247.2519.3597.9690.8796.720191,324.520232026E2030E1,472.31,766.72,069.4EU52018-2023◼——◼20171315060%2017-2023◼50%60%202590%5002021202220232017-2023*202167**2022&202344.0%56.7%60.7%54.3%61.7%60.1%61.7%20172018201920202021*2022**2023**52.0%59.0%53.0%53.0%52.0%56.0%48.0%48.0%56.0%58.0%36179711994121121153432326228201720182019202020212022202344181501621171471436254516253255616039414+70121304150617281931253356456216614142◼——◼2024““2024.032023.072022.08“2021.122021—20252021.1230301050“2021.1292021.102021.103.5%3.3%5.0%3.5%2.6%3.0%4.6%4.9%16.2%53.4%◼——◼20152018-20202019-2023◼2018-20202,75860%2021-20235,216ADC1.8%4.9%◼NMPA2019-20232021-20231.5%5.7%2.4%2.6%2.9%2.1%1.5%1.8%19.0%60.3%ADC2,758ADC5,216514883494020192020202120222023◼——◼01ICH20176ICH2019ICHE172023Q4BQ6B2025ICHICHICHPIS/CGMPPICGMPPIC/SGMPPIC/SGMPGMPPIC/SGMP20219NMPAPIC/SPIC/SPIC/S7820239NMPAPIC/S11PIC/SPIC/SPIC/SGMPGMPPIS/C02WHOPQWHOExpressionofInterestforProductEvaluationWHOPQPQWHOPQ202471WHO11PQHPV6WHOPQWHOPQ03◼◼FDAEMAFDA2018-20233022018-2023FDAEMAPMDA◼201320247215465%202318.6189.920225948535037554245395441392018201920202021202220232023TOP1038.231.923.321.220.018.915.715.214.514.1NMEs)NAS◼202312SystimmuneBL-B01D1EGFR/HER3BL-B01D1Systimmune857184License-out109.26131.1120.00%01020304202311FDATKI5mg*2125,2008,456.0/5mg*72,513.7359.1/2420231,5102023112024Q11016,5002023H15,630HLX02®501002023®162.3%65MCLCLL/SLLCLL/SLLBTK2511%25%3.7%5%ORR93%85%PFS202384.6%202402◼◼20192,116.920214,752.620233,371.520222019-20232023——2023——◼202373.1%11.3%8.8%6.5%60%28.6%16.2%8.5%36.8%5.7%4.2%73.1%11.3%8.8%6.5%0.4%2,116.93,019.54,752.64,037.83,371.520192020202120222023◼•FDAFDA•FDA•01•ICH\\•CAR-TCAR-TCarvyk...

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