|2023 11 14 6 RSV 证券分析师：陈益凌021-S0980519010002证券分析师：马千里010-S0980521070001证券分析师：张佳博021-S0980523050001 6 RSV 2022 10 RSV GSK/Pfizer/Sanofi RSV/Ph3 RSV Arexvy/Abrysvo/Beyfortus 2023Q3 GSK/Pfizer/Sanofi 7.09/3.75/1.37 RSV 5 HPV GSK Shingrix 2017Q4 10 7.84 2022 29.58+72%2026 40 4 HPV HPV 2017 MSD4/9 GSK2 2019 HPV WHO 2030 HPV HPV/2XVEVwPsPoNnMpRoNtOpQoPaQ8Q9PoMoOsQnOjMrQpOkPpOsP6MnMrRuOrRyQwMqQnP 3 2030+2015 WHO 2030 Vero WHO HDCV HDCV 2 mRNA mRNA mRNA mRNA mRNA mRNA 1 Delta mRNA 10 mRNA 3 RSV 2 40%LRTI 6 2019 5 3300 RSV 360 10.1 2.6 2%6 2019 660 RSV 140 4.6 1.3 2.6%USCDC RSV 17.7 65 1.4 30 RSV/RSV RSV RSV 2023 GSK Arexvy Pfizer Abrysvo Sanofi Beyfortus 2023Q3 7.09/3.75/1.37 Moderna mRNA-1345 BLA Merck Clesrovimab Ph3 RSV/Sanofi Beyfortus 2023 5 NDA Merck Clesrovimab Ph2b/3 2023 7 450 GSK Arexvy GSK RSV ADV110/BARS13 Ph2/GSK RSV GSK/Pfizer/Sanofi RSV/Sanofi/GSK RSV 4 RSV RNA Respiratory Syncytial Virus RSV RNA 1956 RSV 15.2kb 10 11 NS1 NS2 G F M SH N P L M2-1 M2-2 G F RSV 2 G attachmentprotein F fusion protein 5 RSV Nature Review Microbiology doi 10.1038/s41579-019-0149-x RSV US CDC COVID-19 RSV 10 12 4 202021 COVID-19 NPI RSV 202122 RSV 5 7 1 202223 6 11 202122 COVID-19 2017-2023 RSV US CDC US CDC 2 RSV PCR 3%6 RSV 2009-2019 23.1 etiological epidemiological 28.5%RSV 16.8%16.7%RSV-5 RSV 25.7%17.4%15.8%14.2%2009-2019%Nature Communication doi 10.1038/s41467-021-25120-6 A Children 5 School-age children 517 7 RSV-Nature Communication doi 10.1038/s41467-021-25120-6 APC annual percentage change RSV LRTI 2 40%LRTI Lower Respiratory Tract Infection 6 2019 5 3300 RSV 360 10.1 2.6 2%6 2019 660 RSV 140 4.6 1.3 2.6%US CDC RSV Bronchiolitis Pneumonia 5 210 5.88.0 100300 19992018 8076 51 RSV/561/504/1603 28/25/80 2003 ACIP 6 6 4 60%70%RSV RSV 61.9 94.8 5 RSV 21.5 50.0 1998-2018/RSV/The Journal of Infectious Diseases doi 10.1093/infdis/jiac127 8 RSV 2015 150 RSV-ARI 33.6 US CDC RSV 17.7 65 1.4 30 65 28 3 2017-2018 retrospective cohort study RSV/18 51/279 64.1/60.2 RSV/30/60 RSV/RSV(N=51)Influenza A(N=279)(%)32(62.7)242(86.7)(%)34(66.7)225(80.6)(%)32(62.7)192(68.8)(%)2(3.9)15(5.4)(%)5(9.8)53(19.0)(%)8(15.7)71(25.4)/(%)32(62.7)126(45.2)(%)26(51.0)96(34.4)(%)30(58.8)107(38.4)(%)12(23.5)48(17.2)30(%)7(13.7)14(5.0)60(%)9(17.6)21(7.5)Influenza Other Respi Viruses doi 10.1111/irv.12754 9 65 RSV/hMPV/PIV/Infuenza Sanofi Vaccine Day pre-F G F RSV G F F RSV F pre-F post-F pre-F post-F pre-F 6 post-F 4 pre-F pre-F pre-F RSV/Nature Review Microbiology doi 10.1038/s41579-019-0149-x 10 pre-F RSV 2022 8 Lancet doi 10.1016/S1473-3099(22)00291-2 11 RSV RSV 60/RSV RSV RSV 60 Pfizer RSV FI-RSV formalin-inactivated RSV Vero+2/3 0/1 0/1/2 0/1/4 2 10 9 RSV FI-RSV ERD Enhanced respiratorydisease FI-RSV Th2 T FI-RSV ADE 2013(pre-fusion Pre-F)pre-F RSV 2023 GSK Pfizer RSV RSV RSV 1998 FDA MedImmune AstraZeneca Synagis Palivizumab RSV Synagis Pre-F Post-F site II 32 210 mL/L 12 RSV1 15mg/kg/1 5 RSV 55%RSV RSV 2022 11 Sanofi/AstraZeneca Beyfortus Nirsevimab RSV 74.5%RSV-LRI 2023 8 Pfizer RSV Abrysvo FDA 3236 6 RSV LRTD Lower Respiratory Tract Disease LRTD 12 RSV RSV/ABRYSVO Pfizer Pre-F+60 3236 6 Arexvy GSK Pre-F+AS01E 60 5059 Ph3 NCT05590403 2022/08/21BARS13 G 60 Ph2 NCT04681833 2020/12/14VN-0200 Daiichi Sankyo VAGA-9002b+MABH-9002b 60 Ph2 NCT05547087 2022/09/15SynGEM Mucosis BV VLP 1849 Ph1 NCT02958540 2017/01/30DS-Cav1 NIAID Pre-F Ph1 NCT03049488 2017/02/09DPX-RSV(A)IMV SHe 5064 Ph1 NCT02472548 2017/03/14V306 VLP Virometix V-306 SVLP+Pam2Cys 1845 Ph1 NCT04519073 2020/08/15IVX-121 Icosavax pre-F VLP Ph1 2022/12/13 Ad26.RSV.pre-F J&J/Jassen 60 Ph3（NCT04908683 2021/05/271224 RSV Ph1/2 NCT03303625 2017/07/17MVA-BN-RSV Bavarian Nordic MVA F/G/N/M2 60 Ph3 NCT05238025 2022/02/03VXA-RSV-f VAXART 1849 Ph1 NCT02830932 2016/03/23rBCG-N-hRSV Pontificia RSV N 1850 Ph1 NCT03213405 2017/06/27HRSV001 ReiThera Srl 1850 6075 Ph1 mRNA-1345 Moderna pre-F mRNA+LNP 60 BLA50 Ph3 NCT05330975 2022/04/081259 Ph1 NCT04528719 2020/08/27SP0256 Sanofi mRNA RSV Ph1 2023/08/04 MV-012-968 Meissa Vaccines 1845 Ph2 NCT04690335 2020/12/28SP0125 Sanofi RSV Ph2 NCT04491877 2022/02/07RSV NS2/1313/I1314LNIAID 624 Ph1/2 NCT03916185 2019/04/16RSV 6120/NS2/1030s NIAID RSV NS2+L 1030s 624 Ph1/2 NCT03916185 2019/04/16RSV 6120/F1/G2/NS1 NIAID RSV NS1+F/G 624 Ph1 NCT03596801 2018/07/24RSV 6120/NS1 NIAID RSV NS1 624 Ph1 NCT03596801 2018/07/24RSV-MinL4.0 Codagenix L 5075 Ph1 NCT04295070 2020/02/28RSV LID/M2-2/1030s NIAID RSV M2-2+L 1030s 624 Ph1 NCT04520659 2020/08/20 ClinicalTrials 13 RSV RSV ABRYSVO（Pfizer，Arexvy（GSK，mRNA-1345（Moderna，mRNA BLA）Beyfortus（Sanofi/AZ，Synagis（AZ，ABRYSVO（Pfizer，Ph3 MVA-BN-RSV（Bavarian Nordic Clesrovimab（Merck，Ph2BARS13（VN-0200（Daiichi Sankyo，MV-012-968 Meissa Vaccines SP0125（Sanofi，Ad26.RSV.pre-F（J&J，Ph1SynGEM Mucosis BVDS-Cav1 NIAID DPX-RSV IMV IVX-121 Icosavac VXA-RSV-f VAXART rBCG-N-hRSV PontificiaHRSV001 ReiThera Srl RSV-MinL4.0 CodagenixSP0256 Sanofi mRNA mRNA-1345（Moderna，mRNA mRNA-1230mRNA-1045mRNA-1365RSV NS2/1313/I1314L NIAID RSV 6120/NS2/1030sRSV 6120/F1/G2/NS1RSV 6120/NS1RSV LID/M2-2/1030sV306 VLP（Virometix，ClinicalTrials 14 Novavax ResVax Ph3 ResVax Novavax RSV F Pre-fusogenic Alum 60 135g 120g Ph3 60 2016.09 11856 RSV/VE=-7.9%RSV VE=12.6%Ph3 PREPARE 2019.02 4600 90 RSV VE=39.4%RSV VE=44%RSV LRTI VE=48%50%ResVax Pre-fusogenic F BLI Vaccine doi10.1016/j.vaccine.2019.07.089 F Pre-fusion Post-fusion Furin 109 Site I 136 Site II 27aa p27 Pre-fusogenic F1 N p2715 GSK AREXVY 2023Q3 AREXVY GSK RSV 2023 5 60 RSV A/B F RSVPreF3+AS01E AS-01B MPL QS-21 Ph3 AReSVi-006 VE=82.6%RSV-LRTD VE=94.1%VE=94.6%7079 VE=93.8%A VE=84.6%B VE=80.9%RSV 2 RSV RSV-LRTD RSV-LRTD VE=56.1%/64.2%2nd Ph3 5059 RSV A/B GMT 60 0.84/0.82 with comorbiditiesassociated with RSV-LRTD 0.95/0.90 w/o 2023Q4 5059 sBLA 2023Q3 AREXVY CDC/Private Sector 198/280 7.09 8.70 910 Q3 initial channel inventory build 1/3 TRx volumes representing 1/3volumes sold 140 Q3 AREXVY 50%AREXVY 2 RSV RSV-LRTD RSV-LRTD ACIP RSV-LRTD RSV-LRTD 16 Pfizer Abrysvo Abrysvo Pfizer RSV 2023 5 60 RSV 2023 8 32 36 RSV A/B F 120g Ph3 RENOIR 60 3.7 RSV-LRTI VE=66.7%3 RSV-LRTI VE=85.7%Ph3 MATISSE 7400 24-36 Abrysvo 90 180 Abrysvo MA-LRTI Medically Attended Lower Respiratory Tract Illnes VE=81.8%/69.4%MA-LRTI VE=57.1%99.5%CI=14.7%79.8%20%/51.3%24 2023Q3 Abrysvo CDC/Private Sector 220/295 3.75 Abrysvo Ph3 Abrysvo/modFlu mRNA Ph1 Abrysvo 218 Ph1 17 Abrysvo 60 2 3 RSV-LRTI ACIP Moderna mRNA-1345 BLA mRNA-1345 Moderna mRNA RSV prefusion F mRNA+LNP Ph3 ConquerRSV 2 3 RSV-LRTD VE=83.7%/82.4%w/ocomorbidity/1 VE=81.6%/88.4%12 Ph3 GBS Guillain-Barr Syndrome ADEM Acute demyelinatingencephalomyelitis 2023H1 BLA Priority Review Voucher 2024Q2 mRNA-1365 RSV/hMPV mRNA-1230 Flu/RSV/COVID mRNA-1045 RSV/Flu Ph1 mRNA-1345 Ph3 Moderna 18 J&J/Jassen Ad26.RSV.preF Ph3 RSV Ad26.RSV.preF Jassen RSV pre-F GSGSGR p27 furin Fibritin C+Ad26 1x10e11vp Ph2 65 3 1 2 2 2 1 1 3 VE=80%/75%/69.8%Ph3 EVERGREEN 2021 6 60 2.7 LRTD 2023 3 Jassen Ph3 RSV Ad26.RSV.preF Ph2 New England Journal of Medicine doi 10.1056/NEJMoa2207566 19 Sanofi/AstraZeneca Beyfortus RSV Beyfortus Nirsevimab AstraZeneca Sanofi 2023 7 RSV RSV 2 RSV pre-F Fc M252Y/S254T/T256E(YTE)6373d 5 IgG1k 50mg 5kg/100mg 5kg 2 200mg 2x100mg Ph3 MELODY Beyfortus 150 RSV RSV ITT N=786 Beyfortus N=1564 79.5%Synagis Palivizumab RSV 5 TEAE TESAE 20 2023Q3 Beyfortus 9 CDC/Private Sector 395/495 50mg/100mg Q3 1.37 0.92 0.45 2023 8 ACIP Nirsevimab VFC Vaccine for Childrenprogram RSV 8 1/All Infant Protection programs SP0125 RSV Toddler 2 RSV Ph2 2024H1 Ph3 SP0256 Older Adult FIC RSV/hMPV/PIV mRNA Ph1 Nirsevimab Ph3 Sanofi Vaccine Day Merck Clesrovimab/MK-1654 Ph3 Clesrovimab/MK-1654 Merck RSV F Fc YTE Ph1/2 NCT03524118 100/300mg 300/1000/3000mg 610 7085 Ph2b/3 NCT04767373 2021 4 3300 Ph3 NCT04938830 2021 11 1000 21 MK-1654 Ph1 IDSA ADV110/BARS13 Ph2 ADV110/BARS13 RSV G+AE011 A 1 2 1/29 3 1/29/57 10/20g Ph2 2021 4 6080 125 1 10g+29 1/29 20g 1/29/57 20g ADV110 GMC 80%ADV110 10g ADV110 20g ADV110 ADV110/BARS13 22 RSV/Ph3 RSV/AREXVY Abrysvo mRNA-1345 ResVax Ad26.RSV.preF Beyfortus Synagis GSK Pfizer Moderna Novavax J&J/Jassen Sanofi/AZ AZ/Pre-F Pre-F Pre-F Pre-fusogenic Pre-F（Pre-F Pre-F II AS01E/RSV 1 5 15mg/kg 2 RSV-LRTD VE=82.6%3 RSV-LRTD VE=94.1%2 RSV-LRTD VE=66.7%3 RSV-LRTD VE=85.7%2 RSV-LRTD VE=83.7%3 RSV-LRTD VE=82.4%RSV VE=12.6%RSV/LRTD VE=-7.9%2 RSV-LRTD VE=75%3 RSV-LRTD VE=80%Ph2 3236 90/180RSV-LRTD VE=57.1%/51.3%RSV-LRTD VE=81.8%/69.4%90 RSV VE=39.4%RSV VE=44%RSV LRTI VE=48%2935 150 MA RSV-LRTI VE=70.1%35 150 MA RSV-LRTI VE=74.9%6 55%2 45%198/280 220/295 395/495(50/100mg)1927/50mg US CDC 23 1 60yrs+AREXVY Abrysvo CDC 198/220 200/AREXVY Ph3 RSV VE=80%90%2 VE 55%65%3 65yrs+75%RSV 60yrs+20%/25%/30%2 Abrysvo Beyfortus CDC 220/395 300/6 4 70%RSV RSV 70%/80%/90%3 2 Synagis 67 2000/5 67 2%3%Synagis 5%/10%/15%4060 1/2 80120 1 60yrs+HPV RSV 1500/202021 60 4%5%RSV 60yrs+3%/4%/5%2&PCV13 20%30%RSV 20%/30%/40%2 2%/3%/4%150250 RSV 60 83 83 83 20%25%30%/200 200 20060 33.2 41.5 49.8 3.7 3.7 3.7 70%80%90%/300 300 300 7.8 8.9 10.0 2 3.7 3.7 3.7 5%10%15%/300 301 3022 0.6 1.1 1.7 RSV 41.5 51.5 61.5 US CDC24 RSV 60 264 264 264 3%4%5%/1500 1500 150060 118.8 158.4 198.0 8 8 8 20%30%40%/1500 1500 1500 24.0 36.0 48.0 2 8 8 8 2%3%4%/1500 1500 15002 2.4 3.6 4.8 RSV 145.2 198.0 250.8 China CDC RSV 2 40%LRTI 6 2019 5 3300 RSV 360 10.1 2.6 2%6 2019 660 RSV 140 4.6 1.3 2.6%USCDC RSV 17.7 65 1.4 30 RSV/RSV RSV RSV 2023 GSK Arexvy Pfizer Abrysvo Sanofi Beyfortus 2023Q3 7.09/3.75/1.37 Moderna mRNA-1345 BLA Merck Clesrovimab Ph3 RSV/Sanofi Beyfortus 2023 5 NDA Merck Clesrovimab Ph2b/3 2023 7 450 GSK Arexvy GSK RSV ADV110/BARS13 Ph2/GSK RSV GSK/Pfizer/Sanofi RSV/Sanofi/GSK RSV 25 GSK 2023 10 9 GSK GSK GSK RSV GSK 2023 10 8 2026 12 31 2024202634.4/68.8/103.2 200 GSK Shingrix 2022 30+72%Shingrix 2019 2023 20232025 90.98/113.08/141.81 PE 17/13/11x 26 27 23/11/13/PEROE22APEG23E 22A 23E 24E 25E 22A 23E 24E 25E300122.SZ 63.35 1520 75.39 90.98 113.08 141.81 19 17 13 11 31.1 0.7 300601.SZ 30.22 338-1.33 10.02 14.15 18.95-266 34 24 18-1.5 0.9 300142.SZ 23.84 383 7.29 9.16 10.69 12.39 89 42 36 31 8.0 2.6 1093.HK 6.87 818 60.91 62.73 69.78 76.71 16 13 12 11 20.2 1.2 6660.HK 8.82 107-3.20-90-6.4 2197.HK-B 0.71 9-24.52-1/Wind Wind 28 6 12 6 12 A 300 000300.SH 899001.CSI(HSI.HI)500(SPX.GI)IXIC.GI 20%10%-20%10%10%10%10%10%125 36 518046 0755-82130833 1199 1 12 200135 6 9 100032