20231109_国金证券_医药健康行业研究报告：阿尔茨海默病（AD）诊断与治疗带来医药领域新增长动力_21页.pdf
1 投资逻辑 GLP-1 AD Donanemab 2023 7 8 10 31 FDA NMPA AD 1 AD 60-70%WHO 5500 60%1000 2 AD A Donanemab TRAILBLAZER-ALZ2 47%29%1 CDR-SB Donanemab 35%40%3 AD A Donanemab AD ADC AD AD CT MRI AD 23 11 8 AD,18F AI CSF MCI(2020)(APP PSEN1 PSEN2)AD(1A)2023 7 7 16 AD 投资建议 A Donanemab Ad 1b A 2b QPCT 3 AD AD 风险提示 2 AD.4 AD.4 Donanemab.9.12 AD.14 AD 12.14 AD.15.17.19.19 1.5 2 AD.6 3 AD.7 4 ApoE A AD.8 5 12-.9 6 Aduhelm.9 7 Leqembi AD.10 8 Leqembi.10 9 Leqembi2023 100.11 10 N3pG-A AD.11 11 N3pG-A AD.11 12 Donanemab iADRS 22%.12 13 Donanemab iADRS 35%Tau.12 14 AD 2.13 15.15 16 AD.15 17 AD.16 18(2020).16 19(2020).16 20(2020).17 21 AD.17 1ZAZwPnQpMnMqOnOqNrOoPaQbP6MpNmMsQsReRnMoPiNpOoO8OmMvMxNsOrMxNsPtQ 3 22 AD.17 23(2020).17 24 AD.18 25 AD.18 26 AD.18 4 AD 创新药，撬动医药空间的下一重磅利器 AD Donanemab 2023 7 8 10 31 FDA NMPA 11 6 Marketwatch Daniel Skovronsky Alzheimer Disease AD 60-70%WHO 5500 60%1000 40 AD 65 5.6%AD 60%65 AD 3%4%2020 AD 900 2050 2100 AD AD 5 1 1906(Alois Alzheimer)AD AD AD 2 6 AD A 2 AD NCBI AD 20 70(ChAT)(ACh)ACh AD ACh A ChAT(VAChT)AD-A AChE A AD(M2)Ach(EAA)D-AD 7 3 AD NCBI AD ApoE 19 ApoE(SNP)ApoE2 ApoE3 ApoE4 ApoE 2 ApoE 3 ApoE 4 EOAD LOAD ApoE 4 A(CAA)CAA AD ApoE 4 AD 8 4 ApoE A AD Nature Reviews NMDA AD N-d-(NMDA)AD AD 2021 2023 FDA AD AD Donanemab 2023 AD 1996 11 FDA AD 5 16 2020 Merz 2013 2020 2022 6 2020 2022 39 2016 2016 01 22 4 15 9 1997 3 AchE Sopharma 2001 FDA,5 12-PDB Donanemab AD AD A AD Aduhelm 20 AD 2021 6 FDA Aduhelm(aducanumab)FDA aducanumab 2003 AD AD first therapy that targets the fundamental pathophysiology of the disease 6 Aduhelm The Journal of Prevention of Alzheimers Disease 10 Aduhelm 3 EMERGE Study1 ENGAGE Study2 Aduhelm 1b PRIME Study3 Aduhelm ENGAGE 59%p0.0001 EMERGE 71%p0.0001 EMERGE 61%p0.0001 2021 11 Aduhelm 75 ARIA amyloid-related imaging abnormalities 2022 4 Aduhelm ARIA(MRI)MRI ARIA 2022 Aduhelm 480 Leqembi 2023 1 FDA Leqembi(lecanemab-irmb)2023 6 9 FDA 3 Clarity AD Leqembi Leqembi 2023 7 FDA Leqembi 7 Leqembi AD 8 Leqembi NEJM,NEJM,Leqembi A 1 IgG1 3 ClarityAD Leqembi 18 27%p=0.00005 11 9 Leqembi2023 100 2023 11 7 Leqembi FDA Leqembi 800 10000 2023 4-9 Leqembi 4 265 100 6600 Donanemab Donanemab A N 3 A N3pG-A IgG1 N3pG-A AD 2023 5 TRAILBLAZER-ALZ2 3 Donanemab 10 N3pG-A AD 11 N3pG-A AD nature molecular psychiatry,nature molecular psychiatry,3 Donanemab(iADRS)tau(n=1182)Donanemab iADRS 35%CDR-SB 36%AD(n=1736)Donanemab iADRS 22%CDR-SB 29%Donanemab 18 12 Donanemab 84%1%12 Donanemab iADRS 22%13 Donanemab iADRS 35%Tau Donanemab FDA 10 31 CDE Donanemab NMPA Donanemab AD AD AD A 1b QPCT 2b IND 3 Protollin 1 OAB-14 1 2 HEC30654AcOH 1 3 2 3 2 13 14 AD 2/I II 26/54 III 2015 8 III 2017 1 34 2021 8 III ADAS-cog P0.001 2021 6 29 Vivoryon Therapeutics N.V.N3pE pGlu-Abeta varoglutamstat(PQ912)Vivoryon IIb(QPCT)N3pE PBD-C06 Vivoryon N3pE Vivoryon 14 5.65 Vivoryon QPCT N3pE AD N3pE AD tau QPCT N3pE varoglutamstat Vivoryon N3pE PBD-C06 N3pE ARIAs AD AD 新药破局，将推动诊断赛道快速增长 AD 12 AD AD AD MCI 1 3 1 2 3 4 5 6 2 10 1 2 3 4 5 6 8 12 15 15-AD tau AD IWG 2007 AD amyloid-beta protein A tau tau protein PET AD AD 2023 7 16 tau 42/40 tau pTau-181 pTau-217 AD AD AD CT MRI AD AD AD 16 AD 2016 AD 191.3 2020 217.5 CAGR 3.3%2025 260.2 CAGR 3.7%16 17 AD(2020)AD 18(2020)MTA-MRI MTA-MRI AD AD MCI AD FTD(2B)MRI MRI AD AD(3C)A-PET A-PET AD MCI(2B)FDG-PET FDG-PET AD AD DLB(2B)Tau-PET Tau-PET AD MCI(2B)(2020)(2020)AD CSF MCI CSF MCI 85-90%AD 19(2020)A 42 A 42 AD AD AD(2B)A 42/A 40 A 42/A 40 AD AD AD(2B)Tau P-tau181 Tau P-tau181 AD AD AD P-tau181/T-tau AD(2B)(2020),2018 3%3%3%3%3%4%4%4%4%0501001502002503002016 2017 2018 2019 2020 2021E 2022E 2023E 2024E 2025E/YoY%17 2021 MCI(2020)(APP PSEN1 PSEN2)AD(1A)(APOE4)AD 20(2020)APP PSEN1 PSEN2(APP PSEN1 PSEN2),AD(1A)APOEs4(APOEs4)AD(2B)(2020)MicroRNA 2023 7 7 16 NIA-AA Revised Clinical Guidelines for Alzheimer s 21 AD 22 AD CSF 23(2020)A 42 A 42/A 40 A 42 A 42/A 40 AD MCI A-PET(2B)Tau Tau AD MCI AD MCI(2B)P-tau181 P-tau181 A-PET Tau-PET AD AD AD FTLD AD MCI(2B)P-tau217 P-tau217 Tau-PET AD AD(2B)(2020)23 11 8 AD,18F AI 23 9 15 18F-APN-1607 III mAb005 I 18 AD AD AD 24 AD 18F A 23/9/15 18F-APN-1607 Tau III mAb005 1 AI 23/9/22 NMPA 23/11/8 25 AD PET/MRI/CT PET 1 MRI 1500 CT 300 CSF 10003000 QPCR Nature 26 AD(APOE)rs429358 rs7412 PCR()Tau 4 23.13%AD AD 5 23/11/6 3 A1-42,T-tau,p-181 AD Caris200 Wan200 Wan100 AD 23/11/8 19 投资建议 A Donanemab Ad 1b A 2b QPCT 3 AD AD 风险提示 AD AD AD 20 3 6 15%3 6 5%15%3 6-5%5%3 6 5%21 C3(C3 021-80234211 201204 1088 5 010-85950438 100005 26 8 0755-83831378 0755-83830558 518000 2028 18 1806
