2024中国生物医药出海现状与趋势蓝皮书

www.frostchina.com©2024 Abstract 2024 “ 1992FDA20172019FDA2022CAR-TCarvyktiCAR-T2023 •--------------------------------7•--------------------------------8•--------------------------------12•--------------------------------13 •--------------------------------15•--------------------------------16 •——--------------------------------18•——--------------------------------19•——--------------------------------20•——--------------------------------21•——--------------------------------22•——--------------------------------23 • •--------------------------------26•--------------------------------27•--------------------------------28•--------------------------------29 ——CXO—————— •--------------------------------33•--------------------------------36•--------------------------------39•--------------------------------41•--------------------------------42 —————— •--------------------------------50•--------------------------------54•--------------------------------55 ————License-outADC—— ••••••◆◆ --------------------------------74--------------------------------75--------------------------------77--------------------------------78--------------------------------80--------------------------------82--------------------------------84--------------------------------85 01 ◼ “9.5%4.28%1,0004727896414.8% DRG/DIP ◼ 201920232.7%13,24514,7232026203017,66720,69420234,58331.1%EU520231,84512.5% —— ◼ 20171315060% ◼ 50%60%202590%500 —— ◼ 2024““ —— 2015 2018-20202,75860%2021-20235,216ADC1.8%4.9% ◼ NMPA2019-20231140202340191647.5%40.0% —— ◼ ICH 01 ICH20176ICH2019ICHE172023Q4BQ6B2025ICHICH PIC/S02 PIC/SGMPPICGMPPIC/SGMPPIC/SGMPGMPPIC/SGMP20219NMPAPIC/SPIC/SPIC/S7820239NMPAPIC/S11PIC/SPIC/SPIC/SGMPGMP WHOPQWHOExpressionofInterestforProductEvaluationWHOPQPQWHOPQ20247 1WHO11PQHPV6 ◼ FDAEMAFDA2018-2023302 ◼ 201320247 215465%202318.6189.92022 202312SystimmuneBL-B01D1 EGFR/HER3BL-B01D1Systimmune857184License-out109.26131.1120.00% HLX02®501002023®162.3% 202311FDATKI20231,5102024H12024H11.3056,100 MCLCLL/SLLCLL/SLLBTK2511%25%3.7%5%ORR93%85%PFS202384.6% 02 ◼ 20192,116.920214,752.620233,371.52022 ◼ 202373.1%11.3%8.8%6.5%60% ◼ 1992FDA20060120172022CarvyktiFDACAR-T FDA •FDAFDA • •Biotech • •ICH\\ •FDAICHE17ICHE17 •CAR-TCAR-TCarvyktiFDACAR-T •License-out58License-inFDAPD-1FDAPD-1 •CAR-T4CarvyktiFDABCMACAR-T2024License-out2024H1license-out34 03 —— ◼ WorldBank2023GDP27.4GDP2.5%GDP8.22.0%20233.40.5%20224.54.1%1.4GDP17.3%NationalHealth ExpenditureProjections,2023–32GDP2032GDP19.7%202217.3% ◼ MedicareMedicaidMedicare65MedicaidEmployer-ProvidedInsurance202265.6%6%/ ◼ FDAFDACDERCBERORACDERIQACDERCBERORAFederalFood,Drug,andCosmeticActFD&CActFDACurrentGoodManufacturingPracticeCGMP 01 2018 02 03 2020 —— ◼ WorldBank2023274.490.5%GDP18.4GDP4.1GDP0.5%652024AgingReporting202221%24%207030%20211,591.93,562GDP10.9% ◼ NHSSHIPHINHSSHIPHISHI5NHSSHINHSSHIPHISHI ◼ EMACPDCPMRPINPEMACPHMADCPMRPINPCPCP20045 20210 01 02 MNC 03 EMA —— ◼ WorldBank20231.250.5%2023GDP4.21GDP1.9%GDP3.42023653,62429.0%20704175WHO20215,417.3GDP11%4,347Statista20225,250.620.8% ◼ ◼ MHLWPMDAMHLW2002PMDA2004 4 1PMDECOPSR/KIKOJAAMEMHLWPMDA 01 PMDA80% 02 03MAH MAHMAHMAH —— ◼ WorldBank2023116.8GDP3.8GDP1.422.4GDP8.50.1GDP5.5%5.4% CBCGroup20302,7008%200 ◼ 2021GHS52412615420013012306Medisave76.5%MedishieldMedifund ◼ 1999PPWGICHPIC/SJACPPCPPCPP 01 02 03 —— GDP ◼ WorldBank20232.20.5%2023GDP2.2GDP2.9%GDP1.02021GDP9.9%1,625.6IBGE2022≥6510.9%1419.8% ◼ IBGESUS72%100%41%25%59% ◼ ANVISAPIC/SANVISAANVISAANVISAAPI 01 02 AFEAFE —— ◼ WorldBank20235.01.5%GDP 4.38,561.920231.18,917.28GDP20233,959.3GDP3.8%3,512.6GDP8.752021GDP10.1%20211,459.3GDP20216.0%20252,200 ◼ 2025 ◼ DOH2023EDEMOHAPJFDA 01 02 6 03 ESG 04 ◼ API ◼ 192090209020089.3%202230.0% ◼ 1992FDA1/32013236.02022517.92020-2022TOP1 20231,248.95.4%409.320.6% 2002023TOP325.2%15.2%10.5%40.424.5% ◼ 2023TOP337.932.727.520222023 27.517.7% 37.912.4% 2023820.7514.53%2CEPASMFCEPEDQMCEPASMFEDMFEMA// 20247EDQM6,590 CEPCEP1,18618.0%20231/4 FDA201912%88%TOP10083%JAMA20149%40%30%ClarivateCortellis Generics Intelligence20202021API42/5651,379APIDMF2024Q1DMF3,539DMF13.4%2023529TOP361.9% 90%201920236.5%202343.020238%TOP31,047.7989.2900.360% 2023101.568.8%2020DoP EDQMFDA Teva2025TAPI TevaAPITAPI3502023Teva1587%2024Teva4211%TevaAPI5% 202311TevaR.AnanthTAPIAnanthAPITAPIAPI Teva2023APITAPI2025 MerckKGaAAPI MerckKGaA APIMilliporeSigmaAPIHPAPIsMilliporeSigma20211972025250Merck6,500HPAPIs7MilliporeSigmaAPI20225MilliporeSigma4.4 20224MerckKGaALSSCDMOCTOLSSHPAPIsmRNA AurobindoPharmaAPI AurobindoPharmaAPI200APIAurobindoFDAEMAAPICDMO 2023AurobindoPharmaAPIApitoriaPharmaPrivateLimited3,303.17UnitI Unit VIII Unit IX Unit XIApitoria/ EuroAPIFOCUS-27”CDMO EuroAPI2022200APIEuroAPI80CDMO EuroAPIFOCUS-2741B12API13API 2ElbeufVertolaye460%80% CXO CMOCDMOCXOCDMOAPI+CXOCDMO  CDMOCDMO202379.8769.61%CDMO20.0517.47%27.10%  cGMP2008CDMO+CDMOCMC