[沙利文]：2024中国生物医药出海现状与趋势蓝皮书 -尊龙凯时人生就博

2024 www.frostchina.com ©2024 abstract 2024 “ 1992fda 20172019 fda2022 car-tcarvykticar-t2023 •--------------------------------7 •--------------------------------8 •--------------------------------12 •--------------------------------13 •--------------------------------15 •--------------------------------16 •—— -------------------------------- 18 •—— -------------------------------- 19 •—— -------------------------------- 20 •—— -------------------------------- 21 •—— -------------------------------- 22 •—— -------------------------------- 23 •--------------------------------25 • -------------------------------- 26 • -------------------------------- 27 • -------------------------------- 28 •———————— cxo -------------------------------- 29 • -------------------------------- 33 • -------------------------------- 36 • -------------------------------- 39 • -------------------------------- 41 •—————— -------------------------------- 42 • -------------------------------- 50 • -------------------------------- 54 • -------------------------------- 55 ————license-out adc ——• -------------------------------- 65 • -------------------------------- 71 •--------------------------------74 •--------------------------------75 •--------------------------------77 •--------------------------------78 •--------------------------------80 •--------------------------------82 --------------------------------84 --------------------------------85 01  “ 9.5% 4.2 8% 1,00047278964 14.8% drg/dip  20192023 2.7% 13,245 14,723 20262030 17,667 20,694 2023 4,583 2023 31.1% eu5 1,845 12.5% 2019-2030e eu5 eu5 2019-2023 2023-2030e 2.7% 5.0% 3.6% 4.2% 3.1% 4.3% -0.5% 7.1% 1,766.7 1,472.3 796.7 1,324.5 690.8 597.9 215.0 291.1 247.2 373.2 569.8 652.3 519.3163.3 184.5 236.3 231.5 405.5 458.3 2019 2023 2,069.4 2026e2030e eu5 2017 13 150 60%  2017-2023 2017-2023 56.7% 54.3% 44.0% 162 150 147 143 117 44 18 1 17 36 8 94 97 23 119 53 43 60.7% 61.7`.1a.7% 121 26 121 22 2017201820192020202120222023 2021 2022 2023  20172018201920202021*2022**2023** *202167 **2022&2023 50% 60% 2025 90p0 2018-2023 52.0% 59.0% 53.0s.0r.0% 56 56.0% 62 48.0h.0% 61 56.0% 58.0% 3133 25 25 2532 45 5561 4516 16 4142 39 60 41 601 10 10 121 4 7 2 3 4 5 6 7 8 9  2024 “ “ 2024.032023.072022.08 “ 2021.12 30 3010 2021.12 50 2021—2025 “ 2021.12 9 2021.102021.10  2015  2018-2020 2,758 60% adc 2021-2023 5,216 1.8% 4.9% 2018-20202021-2023 1.5% 2.4% 2.6% 5.7%2.9% 2.1% 1.5% 2,758 1.8% adc 60.3% 19.0% 3.5% 3.3% 5,216 53.4% 3.0% 4.6% 4.9% adc 16.2% 2.6% 3.5% 5.0%  nmpa2019-2023 40 1140 47.5@.0% 2023 1916 1 2019-2023 47 40 20 21 12 20192020202120222023  01 ich ich ich 2019 20176 iche17 2023q4bq6b 2025ich ich 02 pic/s pic/s gmp gmp pic gmp gmp pic/s pic/s gmp 20219 nmpa78 pic/s 20239 pic/spic/s nmpa gmp gmp pic/s 11pic/s pic/s pic/s pic/s gmp 03 whopq whopq who expressionofinterestforproductevaluation whopq pq whopq 202471 6 who 11 pq hpv fdaema  fda ema fda 2018-2023 302 2018-2023 59 54 55 48 53 50 42 45 39 37 41 39 nmes) nas 201820192020202120222023  2013 202472 65% 154 2023 18.6 189.9 2022 2023 top10 31.9 23.3 21.2 20.0 18.9 15.7 15.2 14.5 14.1 38.2 2023 12 systimmune bl-b01d1egfr/her3 bl-b01d1 systimmune8 84 109.26131.11 5 license-out20.00% 71 01 hlx02 ® 50 100 2023® 162.3% 202311 fda tki 2023 1,510 1.305 2024h1 2024 h1 6,100 03 02 mcl cll/ 5% sll 25 orr cll/sll btk 3.7% 11% 93% 85% 25% pfs 202384.6% 04 02  20192,116.9 20214,752.6 2023 3,371.5 2022 2019-2023 4,037.8 3,371.5 3,019.5 2,116.9 4,752.6 20192020202120222023  202373.1% 11.3%8.8%6.5% 60% 2023 —— 2023 —— 8.8% 6.5% 0.4% 11.3% 73.1% 28.6% 36.8% 4.2% 5.7% 16.2% 8.5%  1992 01 fda 2006 2017 2022 carvyktifda car-t fda • 01 • fda fda • • biotech • • ich \ \ fda ich e17 ich e17 •• car-t car-tcarvyktifda car-t • license-out58 license-in fda pd-1 fda pd-1 • 4 car-t carvyktifda bcmacar-t license-out license-out 34 2024 2024h1 • 03 01 01 2018 02 02 03 03 2020  gdp 27.4 gdp 2.5% gdp8.2 worldbank2023 2.0 23 3.4 0.5% 2022 4.5 4.1% 1.4 gdp17.3% nationalhealthexpenditure projections,2023–32 gdp 2032 gdp 19.7 22 17.3% medicare medicaid medicaid medicare 65 65.6% 6% employer-providedinsurance / 2022  fda cder fda iqa cder cber ora cder cber ora food,drug,andcosmeticactfd&cactmanufacturingpracticecgmp fda federal currentgood  gdp18.4  worldbank2023 27 0.5% 4.49 65 0.5% gdp gdp 21% 2024agingreporting 24% 4.1 2022 2070 30 211,591.93,562gdp10.9%  shi5nhs shiphishi nhsshiphinhsshiphi shinhs 01 01 02 02 mnc 03 03 ema  mrp inp ema ema cp hma cp dcp dcp mrp inp cp cp 2004520 210  01 pmda 01 80% 02 02 03mah 03 mah mah mah  worldbank gdp3.4 2023 1.25 0.5 23 65 2070 4,347 4 175 who gdp3,624 5,417.3 4.21 gdp 2023 2021 gdp 1.9% 29.0% 11% statista 2022 5,250.6 20.8%   pmda mhlwmhlw pm