2024中国生物医药出海现状与趋势蓝皮书

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%60.1%61.7% 121 26 121 22 2017201820192020202120222023 2021 2022 2023  20172018201920202021*2022**2023** *202167 **2022&2023 50% 60% 2025 90%500 2018-2023 52.0% 59.0% 53.0%53.0%52.0% 56 56.0% 62 48.0%48.0% 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%40.0% 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%2023 3.4 0.5% 2022 4.5 4.1% 1.4 GDP17.3% NationalHealthExpenditure Projections,2023–32 GDP 2032 GDP 19.7%2022 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%20211,591.93,562GDP10.9%  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%2023 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