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20231025_东方证券_医药生物行业证券研究报告:自免药物空间广阔重磅药物及相关布局的优质企业值得关注_34页.pdf

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20231025_东方证券_医药生物行业证券研究报告:自免药物空间广阔重磅药物及相关布局的优质企业值得关注_34页.pdf

|100 5-8%5 4000 1900 600 2022 1323 2030 1767 2020 25 2020-2025 28.1%TNF-JAK IL-17 JAK 璟 IL-12/23 QX001S(688336)(600276)-U(688443)璟-U(688266)/2023 10 25 021-63325888*6111 S0860521080001 2023-10-22 2023-10-15 2023-10-09 2.5 1.1.5 1.2.6 1.3.8 1.3.1 9 1.3.2 11 1.3.3 13.14 2.1 TNF-.14 2.2 JAK.16 2.3.18 2.4 BlyS.21.23 3.1.23 3.2.25 3.3 璟 JAK.26 3.4.28 3.5.30.32.32 WUFUwPqNoNmNtNmPtOrOqR6MaObRnPmMpNtQjMnMoOkPsQtNbRmMxPMYmRuMNZoPnR 3 1.6 2 2022 TOP100.7 3 2022 TOP100.7 4.8 5.11 6 Bimekizumab PASI.13 7 Sonelokemab.14 8 2003-2022.15 9 2022 TNF-.15 10 JAK.16 11.21 12 2016-2022.23 13 2016-2022.23 14.24 15 23.25 16.28 17 2022 top10.28 18 23 10.30 19 23 10.30 20 QX001S-.31 1.5 2 2020.5 3.6 4 2022 TOP10.7 5 2018-2030E.8 6.9 7 2023 9.9 8 TNF 23 9.11 9 23 9.12 10 JAK.17 11 JAK.17 12 JAK 23 8.17 13 IL-17.19 4 14.19 15 IL-17 23 7.19 16 IL-12/23.20 17 IL-12/23 23 8.21 18.22 19.22 20 2023.24 21 IL-17.25 22 IL-17.26 23 GR1603 23 10.26 24 23.27 25.27 26 23.28 27.29 28 QX001S.31 29.32 5 1.1 100 1 5 4000 5-8%2-5%2-3%0.5-1%2021 1900 664 600 1 0.01-0.09%sj gren 0.2-1.0%0.5-1.0%0.2-0.3%0.06-0.25%0.2-0.4%0.30%0.7%0.1-1.4%0.03%0.02%2-3%0.01%2-5%0.02%0.01%0.008-0.2%0.004%0.5-1.0%0.4%0.1%Graves 0.5%0.03%0.1%2 2020 16,725 18,750 3,980 7,500 960 680 48,595 6 1,900 664 600 400 103 13.38 40 3,720 2021 2 4 2-4 3 1ml:150mg 1,188.00/4.04 0.5ml:45mg 4,318.00/2.59 0.8ml:40mg 799.00/2.24 1mL:100mg 28,000.00/22.40 10 20 30mg/60/3,500/4.22 2022 1.2 2022 1323 964 72.9%2030 1767 1450 82.1%2023 2398 big pharma biotech 1 Frost&Sullivan 113.7116.9120.6127.7132.3137.2142.3147.3153159164.8170.5176.70204060801001201401601802002018 2019 2020 2021 2022 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E 7 2022 TOP100 18 TOP100 861.7 18%2022 2 2022 TOP100 3 2022 TOP100 2022 TOP100 212.37 Stelara 97.23 Dupixent 86.81 Ocrevus 63.27 2022 75.7%52.8%57.4%4 2022 TOP10 Humira Stelara Dupixent Ocrevus Skyrizi Entyvio Cosentyx Enbrel Jakafi Xolair 2010 2013 2017 2017 2019 2014 2016 2004 2011 2003/Incyte/2022 212.37 97.23 86.81 63.27 51.65 51.64 47.88 41.17 39.7 36.79 y oy 2.6%6.5%4 0.0%1 7.0%7 5.7%1 2.1%5.0%-2 3.0%6.4%3.3%RA/AS/PS/CD PS/CD AD MS PS UC/CD PS/AS RA/AS TNF-IL-12/23 IL-4R CD20 IL-23 TNF-IL-17A TNF-JAK IgE 051015202530 24%28%18%9%5%3%3%5%3%2%8 RA AS PS CD MS UC AD Insights 1.3 2020-2025 28.1%2020 25 6 23.8%2025 87 48 2020-2025 28.1%4 Frost&Sullivan 2022 17 14 5 2018-2030E 2018 2019 2020 2021 2022 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E 13 13 14 16 17 22 26 32 40 48 55 61 65 yoy 0%8%14%6%29%18%23%25%20%15%11%7%6 7 8 11 14 19 25 33 42 54 68 83 99 yoy 16%7%48%29%33%31%30%30%29%25%23%20%6 7 8 9 11 13 17 21 26 32 39 47 55 yoy 19%9%15%19%26%26%26%25%23%22%20%17%2 2 3 4 4 6 9 12 16 21 26 30 34 yoy 8%16%30%26%36%41%39%36%30%23%18%13%Frost&Sullivan 2 2 3 3 4 5 7 9 11 14 17 21 25 04812162024282018 2019 2020 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E 9 1.3.1 40%TNF-6/(SAID)NSAID 100 7 2023 9 TNF-JAK 10 Rinvoq IL-17 Taltz Bimekizumab Bimzelx Netakimab Efleira IL-23 Stelara Tremfya Ilumyatm Skyrizi IL-6 Sarilumab Kevzara CD20 Ocrevus IL-4 BLyS IFANR-1 Saphnelo 22 19 10.2%Journal of Crohns and Colitis 0.7%0.5%11 2002 15 1.3.2 2020 769 2020 68.6%23.8%2012 50.7%2017 8.3%5 TNF-7,600/2019 7600/3160/60%2019 1,290/59%3.4 8 TNF 23 9 0%10%20%30%40%50%60%70%80%90%2018 2019 2020 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E 12-25mg 316 25mg 2 32864 100mg 2006.8 25mg 2 29,741 49,568 40mg 1290 40mg 2 1 33,540 50mg 324.7 50mg 1 16884-25mg 316 25mg 2 32864-25mg 318 25mg 2 33072 40mg 1090 40mg 2 1 22890 9 23 9 TNF-是 JAK1/JAK2 Incyte/JAK RINVOQ JAK1 IL-17 IL-6 IL-12/23 13 IL-23 BLyS BLyS/APRIL 1.3.3 FDA Arcutis Biotherapeutics PDE4 PDE4 TNF-Bimekizumab IL-17A IL-17F IL-17A 16 Bimekizumab 100%PASI 61.7%48.9%Bimekizumab 8 Bimekizumab 2021 Lzokibep IL-17A Lzokibep 18.6KDa 1/8 IL-17A IL-17A 1000 6 Bimekizumab PASI 14 Kristian Reich,et al.N Engl J Med 2021;385:142-152 CAR-T CAR-T CAR-T CAR-T PV BCMA CAR T/NMOSD CAR-T CAR-T pH MoonLake Sonelokimab IL-17A IL-17F VHH 40KDa 24 48 Sonelokimab 7 Sonelokemab Kristian Reich,Eva Cullen,Mark Weinberg et al.British Journal of Dermatology Volume187,Issue4 October 2022 Pages 591-593 2.1 TNF-15 TNF-TNF-TNF-TNF-2003 20 2000 TNF-2022 212 8 2003-2022 16 TNF-11 99%TNF-50%2018 TNF-23 2023 TNF-130 TNF-9 2022 TNF-3 9 14 20 30 45 55 65 79 93 107 125 140 161 184 199 192 198 207 212-50%0%50%100%150%200%250%050100150200250 yoy 16 2.2 JAK JAK JAK STAT STAT DNA JAK-STAT JAK 10 JAK Azucena Salas et al.Nature Reviews Gastroenterology&Hepatology volume 17,pages323337(2020)JAK FDA JAK JAK1 JAK2 JAK3 JAK JAK1 JAK 2011 JAK FDA JAK JAK 31%27%15%10%5%3%3%2%17 JAK JAK1 JAK3 TYK2 10 JAK JAK1/2 JAK JAK1/2 Incyte/2011 2012 2017 2017 2017 2019 2022 39.70 17.96 8.30 JAK JAK JAK JAK TNF-RA TNF-JAK 11 JAK Smyraf RINVOQ Inrebic Jyseleca Cibinqo Sotyktu Vonjo Peficitinib Fedratinib Filgotinib Deucravacitinib Pacritinib JAK3 JAK1 JAK2/Flt3 JAK1 JAK1 TYK2 JAK2 CTI Bio 2019 2019 2019 2020 2021 2022 2022 2022 2022-2022-2022 0.18 25.22 0.85-0.08-JAK JAK 璟 JAK NDA TYK2 ICP-332 JAK II 12 JAK 23 8 18 NDA JAK1/2/3 璟 JAK1 JAK1 ICP-332 TYK2 ICP-488 2023 2.3 naive Th1 Th2 Th1 Th2,TNF-IL-17 IL-23 IL-6 IL-6 IL-12/23 IL-17A IL-23 2021 IL-17A IL-12/23 TNF-IL-17 2019 3 IL-17 IL-17 19 IL-17 2022 47.88 6.01 UCB Bimekizumab IL-17 A/F 2022 0.35 2021 400 13 IL-17 IL-17 IL-17 IL-17 2015 2016 2017 2019 2019 2020 2022 47.88 24.82-Insights 14 PASI 90 12 PASI 75 12 IGA mod 0/1 12 150mg 42%137/327 67%219/327 51%167/327;2.14%7/327 300mg 54%175/323 77%249/323 63%202/323 1.23%(4/326)21%67/323 44%142/323 27%88/323 0.93%(3/323)2%5/324-1.83%(6/327)clinical trials IL-17 GR1501 3 4 15 IL-17 23 7 GR1501 NDA 20 III II SHR-1314 NDA II III Graves III II II I SSGJ-608 III BAT2306 III III III Biocad/Netakimab III I JS005 II II I II/XKH004 I II II/HB0017 II QX002N III CMAB015 I I IL-12/23 IL-23 22 176 3 16 IL-12/23 Stelara Tremfya Ilumyatm Skyrizi IL12/23 IL-23 IL-23 IL-23/21 2009 2017 2023 2021 2017 2019 2023 NDA 2022 97.23 26.68-51.65 Insights IL-12/23 AK101/NDA 2023 8 NMPA IL-12/IL-23 17 IL-12/23 23 8 QX001S IL-12/IL-23 III BAT2206 IL-12/IL-23 III AK101 IL-12/IL-23 NDA IBI112 IL-23 II NBL-012 IL-23 I QX004N IL-23 I 2.4 BlyS BLyS B T BLyS B B 2019 SLE 2019 7 SLE SLE 2022 SLE 4.5 2030 34.3 11 22 BLyS GlaxoSmithKline III 18 IND I II III NDA/BLA IgA 19 IFNAR1 52 BICLA 62.8%300mg 38.8%BlyS 48 SRI 52.4%160mg 25.8%2.18 2.36 2.75 3.57 4.49 6.08 8.55 11.88 16.13 20.93 25.71 30.29 34.31 05101520253035402018 2019 2020 2021 2022 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E 23 BlyS GSK 52 SRI 53.8%40.1%3.1 2002 2005 TNF-2023 12 2016-2022 13 2016-2022 Wind Wind 2023(TNF-)CD25 HER2 CDMO 2022 65%2022 2023 2020 HER2 863 2020 HER2 1300 2022 138.14%-50%-40%-30%-20%-10%0%10%20%30%40%50%024681012142016 2017 2018 2019 2020 2021 2022%-250%-200%-150%-100%-50%0%50%100%150%200%-3-2-10123452016 2017 2018 2019 2020 2021 2022%24 CD25 CD25 2022 45.43%14 wind NDA 5 4 608 2023 III 611 613 2023 III NDA-100%0%100%200%300%400%024681012142017 2018 2019 2020 2021 2022 YoY YoY YoY 20 2023 2023/301s TNF-/608 IL-17A III III 610 IL-5 II 611 IL-4R II III/IND IND IND 613 IL-1 II II III CDE III 621 IL-33 FDA IND IND 25 608 TNF-IL-17 608 III 608 21 IL-17/608 608 PASI75 100%(160mg)96.43%(300mg)93.55%9.09%PASI90 91.43%(160mg)92.86%(300mg)83.87%0%sPGA 91.43%(160mg)89.29(300mg)83.87%9.09%63.3%(160mg)58.8%(300mg)60.0%(160mg)45.50%3.2 IL-17A IFNAR1 GR1603 15 23 GR1501 NDA IL-17A 26 III I III IL-17A 2024 22 IL-17 PASI 75 PASI 90 12 16 52 12 16 52 87.2%(150mg)97.7%(300mg)3.7%()95.2%(150mg)97.7%(300mg)85.0%(150mg)95.4%(300mg)65.7%(150mg)81.0%(300mg)0.9%()76.2%(150mg)87.0%(300mg)66.7%(150mg)82.1%(300mg)88.2%(80mg)91.2%(80mg)88.2%(80mg)72.8%(80mg)83.1%(80mg)76.5%(80mg)90.7%(200mg)8.6%()98.6%(200mg)96.5%(200mg)/II 16 ASAS20 72.5%-77.5%VS 52.5%III 24Q2 GR1603 IFNAR1 IFNAR I I JAK-STAT GR1603 IFNAR IFN I IFNAR1 IFN/IFNAR GR1603 II BLyS GR1603 23 GR1603 23 10 CTR20210804 GR1603-001 I CTR20213169 GR1603-002 Ib/II Ib/II 3.3 璟 JAK 27 璟 JAK JAK1/2/3 璟/璟 JAK NDA/BLA 24 23 IND I II III NDA/BLA JAK 2017 JAK JAK 25 II III(COMFORT-I COMFORT-II RESPONSE)3/4 24.2%100mg 28.8%200mg 42.5%28 3/4 16.7%100mg 11.5%200mg 11.6%14.3%100mg 5%200mg 29.3%3.4 2011 11 1 2022 48.87 16 17 2022 top10 wind wind 138 IL-17 JAK1 IL-4R ROR MASP2 TSLP 26 23 IND I II III NDA/BLA SHR-1314 IL-17A SHR-4640 URAT1()SHR0302 JAK1-20%0%20%40%60%0102030405060702017 2018 2019 2020 2021 2022%25%25%23%23%22%21%20%19%16%15%11%0%5%10%15%20%25%30%BMS GSK 29 SHR-1703 IL-5 SHR-1819 IL-4R RS1805 ROR RS2102/SHR-1654/SHR-2001/SHR-2106/IL-17 III 75%56.8%65.8%81.6%86.5%5.4%JAK1 3 JAK 璟 JAK 12 27 12 PASI 75 12 PGA0/1 56.8%40mg 65.8%80mg 81.6%160mg 86.5%240mg 45.9%40mg 47.4%80mg 60.5%160mg73.0%240mg 5.4%8.1%30 clinical trials ROR ROR ROR t IL-6 TGF-Th17 IL-17A,IL-17F IL-23R T Th17 ROR t T IL-17 ROR t ROR IL-17 ROR ROR RS1805 3.5 2015 18 III 9 IFNAR1 TSLP c-kit 18 23 10 IL-17 IL-23/IL-12/23 IFNAR1 19 23 10 31 QX001S BLA QX001S 12 PASI-75 QX001S 2024 BLA 28 QX001S QX001S 12 PASI-75 70.4%CTCAE3 2.4%12 PASI-75 64.3%CTCAE3 3.1%20 QX001S-QX001S QX002N QX004N QX006N 32 29 QX001S IL-12/23 1 2 IL-17 TNF-PK 3 4 QX002N IL-17A 1 IL-17 TNF-2 IL-17 3 4 LN QX004N IL-23 1 IL-23 QX001S 2 QX001S IL-23 QX001S TNF-QX006N IFNAR1 1 SLE BLyS APRIL 2 3 IFNAR1 4 IL-17 JAK 璟 IL-12/23 QX001S(688336)(600276)-U(688443)璟-U(688266)33 Tabl e_Disclai mer 12 A 300 500 15%5%15%-5%+5%-5%5%-5%+5%-5%HeadertTabl e_Discl ai mer HeadertTabl e_Address 318 26 021-63325888 021-63326786 Tabl e_Disclai mer

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