20231228_湘财证券_创新药行业：产业高质量国际新周期_40页.pdf

创新药行业产 业 高 质 量，国 际 新 周 期分析师：张德燕登 记 编 号：S05005211200032023 12 28核 心 观 点$8$84 3 FDA 70%94%4 8 1 1 1 1 1:43.7%46.6%1.21.41.82.13.13.8131522.327.901020300242010 2015 2020 2025E 2035E 2050E 1 1 AD MASH.IO+ADC 1 1mOS:16.1m 31.5m 1 AD:60%GLP-1R:1ZXCXwPnQsRnMsMmPnQrOnMaQaO7NoMoOtRmPjMoPoMeRtRuM9PpPuMxNsPuNvPoNxP核 心 观 点 PharmaBiotech+核 心 观 点 2023 1 Pharma Pharma 2 Biotech 1 2 3 2024 2023 2024 1 2013-2027E IQVIA Market Progress,2022 9 IQVIA Institute,2022 11 2027E 1.9 CAGR5.1%40%1.1 创 新 药 开 启 国 际 化 新 周 期 2 2027E IQVIA Market Progress,2022 9 IQVIA Institute,2022 11 1480019000020004000600080001000012000140001600018000200007630,40%1940,10%9430,50%3 2023 FDA Insight 2019 2022 2023 10.30 11.09 11.16 1.1 创 新 药 开 启 国 际 化 新 周 期-2022 2 2023 3 4 2016-2023 Insight 2023.12.13 5 2016-2023 Insight 2023.12.131.1 创 新 药 开 启 国 际 化 新 周 期4 27 12 9 5715528538010151929636281840204060801000501001502002503003504002016 2017 2018 2019 2020 2021 2022 2023()-2020 2023 33.3%160 0417142205101520252016 2017 2018 2019 2020 2021 2022 2023()6 2016-2023 Insight 2023.12.13 7 ADC Insight 2023.12.151.1 创 新 药 开 启 国 际 化 新 周 期 95 84 50 25 20 20 17 16 15 12 10 9 7 5 5 8.05.01.91.81.81.70.90.70.60.40.30.30.20.2 1 3 4 3131624302016 2017 2018 2019 2020 2021 2022 2023 3134 7202650842016 2017 2018 2019 2020 2021 2022 2023-84 8 BMS ADC 8 CDE 1976 1990 2006,1980 1984 1998=ICH1993,2005MAH1998 2021 2018 ICH 722 MAH2017,2011 ICH.2023 2015 FDA1.1 创 新 药 开 启 国 际 化 新 周 期 80 1989 9 2015-2022 Wind 1.1 创 新 药 开 启 国 际 化 新 周 期 10 1995-2023 Wind 2023.12.0861 59555255 51 543946475675148 142 14015828252937 606061630%10%20%30%40%50%60%70%80%90%100%2015 2016 2017 2018 2019 2020 2021 2022 1995-2000 5 2019 ADC 449 63.5 8.5 11 2017-2023 12 2019-2023 1.2 医 保 基 金 稳 定 创 新 药 中 长 期 价 格 预 期44.00%56.70%60.70%50.64%61.71%60.10%61.70%0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%2017 2018 2019 2020 2021 2022 202326.40%14.95%0.00%5.00%10.00%15.00%20.00%25.00%30.00%2019 2020 20230%6.7%2023 2023 100 70%6.7%18 171.2 医保基金稳定创新药中长期价格预期 13 2023 2023 Y8Y4Y0 Y1 Y2 Y3 Y4 Y5 Y6 Y7 Y8 Y9 Y10 Y11 Y12 Y13 Y14 2023 2023 4 8 48 14 CDE Wind Insight 2021.7 2022 ADC 20232023 7 8 8 1.2 医保基金稳定创新药中长期价格预期 2021 7 2023 8 2023 8 15 2021-2023Q3 Wind-2.9%8%5 pct 1.3 药品商业化正本清源，行业三季度业绩触底 16 2021-2023Q3 Wind 541-112%-99%-89%-109%3%-39%-28%-13%-8%-120%-100%-80%-60%-40%-20%0%20%0100200300400500600700800 YOY 1 2023 Wind 2023 1.3 药品商业化正本清源，行业三季度业绩触底2023Q1 2023Q2 2023Q3 2023Q1 2023Q2 2023Q3 2023Q1 2023Q2 2023Q3 2023Q1 2023Q2 2023Q3 2023Q1 2023Q2 2023Q3 7%41%39%21%-67%-133%42.8%35.5%31.4%37.1%36.3%29.7%14.2%12.6%9.2%27%-8%38%28%-6%36%3.1%3.3%3.0%7.6%10.1%15.0%6.6%8.2%4.8%3%-4%15%-5%-35%-9%5.8%6.3%5.6%13.5%13.1%12.7%3.1%3.5%2.8%27%28%9%520%125%8%1.3%1.5%1.6%10.1%10.6%9.8%12.9%12.3%11.5%24%19%6%42%23%11%8.6%8.9%8.8%13.6%13.9%13.9%6.2%5.6%6.0%18%10%5%33%16%1%0.1%0.1%0.1%15.7%16.0%16.4%2.7%4.0%2.8%15%14%1%30%38%3%2.0%2.4%2.7%23.1%23.7%23.0%4.6%6.2%5.2%15%15%-2%14%-12%-12%0.3%0.3%0.3%4.0%4.1%3.5%1.9%2.1%2.1%-6%-10%-2%-21%-21%-19%6.3%6.9%7.1%13.9%15.5%14.2%7.9%9.0%8.6%CXO 11%-2%-4%9%-6%-10%5.6%5.3%5.7%2.3%2.4%2.4%9.8%10.3%9.9%6%7%-5%13%-1%-12%7.1%8.2%8.9%23.6%24.6%23.0%7.2%8.1%8.0%2%-6%-5%-35%-30%-41%5.1%6.1%6.0%8.5%7.5%7.7%6.2%7.1%7.0%IVD-77%-57%-57%-93%-80%-84%11.0%13.6%13.6%16.8%21.5%22.0%9.5%15.7%13.1%1 本章小结2024 2024 13-16%3-6%3-6%1-4%3-6%2-5%2-5%2-5%3-6%0-3%3-6%1-4%1-2%1-4%4-7%1-4%5-8%1-2%10-13%5-8%23-27CAGR3770177016801260920810740580520480420360330310290250200200170150CNS HIV 17 2027E TOP20 IQVIA Forecast Link IQVIA Institute 2022 11 1000 2.1 深度老龄化未满足临床需求显著上升 18 2020 19 2023 2.1 深度老龄化未满足临床需求显著上升0.911.21.41.82.13.13.8131522.327.905101520253000.511.522.533.542000 2005 2010 2015 2020 2025E 2035E 2050E65%454 20 Nature review 2.2 融合工程学思维技术平台开启新一轮生物技术周期 OKT3 ADC ADCRDC双抗CGT 2 IO+ADC la/mUC Insight EV-302/KEYNOTE-A39 3 Mirasol ORR 42.3%Insight IO+ADC Keytruda Padcev mPFS mOS ADC Elahere RDC Pluvicto PSMA 38%42.3 回归产品力本质，新一轮治疗方案更新来临 12.5months 6.3months31.5months 16.1months67.70%44.40%55.9%7.7%,hyperglycemia 5.0%,and 69.5%neutropenia 30.0%,and EV+P significantly improved outcomes in pts with previouslyuntreated la/mUC,nearly doubling the median PFS and OS vschemo.The safety profile was generally manageable with no newsafety signals.These results support EV+P as a new SOC for 1Lla/mUC.mPFS mOS ORR investigators choice ofchemotherapy5.62months 3.98months 42.3%16.46months 12.75months 42%54%SAE24%33%TEAE(discontinuation)9%16%mOS MIRV is the first treatment to demonstrate a PFS and OS benefit inPROC compared to IC.The efficacy data,along with the well-characterized safety profile,position MIRV as a new,standard of care mPFS(INV)ORR(INV)21 RDC Pluvicto 4 Novartis 22 Donanemab 60%Lilly 23 GLP-1R Novo Nordisk 2023Q3 IR 2023 1 anti-20 FDA anti-pGlu3-Donanemab 35%60%GLP-1R Semaglutide 23 MASH AD Ozempic FLOW 2024 GLP-1R 537 m520 m764 m25 m700 m85 m64 m200 m2.3 回归产品力本质，新一轮治疗方案更新来临2 本章小结2023 2023 24 2023 Wind 2020.8.7-2023.11.30 3 2022Q4-2023Q1 12.3%2023.9-2023.11.30 11.4%:25 Wind 2023.8.23-2023.11.30 13 12 13%4 Biotech 19.4%17.9%13.9%13.7%2023行情回顾：下半年开启震荡上行走势-20.00%-15.00%-10.00%-5.00%0.00%5.00%10.00%()A25.9 19.4 17.9 16.5 15.6 13.9 13.7 13.6 11.4 9.2 6.6 5.5 4.9 4.3(4.0)26 2000-2023.11 PE-TTM Wind 2023.11.3002000400060008000100001200014000160000.010.020.030.040.050.060.070.080.090.02000-07-072001-07-072002-07-072003-07-072004-07-072005-07-072006-07-072007-07-072008-07-072009-07-072010-07-072011-07-072012-07-072013-07-072014-07-072015-07-072016-07-072017-07-072018-07-072019-07-072020-07-072021-07-072022-07-072023-07-07PE-TTM-23.3 21.123.5 27 2000-2023.11 PB Wind 2023.11.3002000400060008000100001200014000160000.001.002.003.004.005.006.007.008.009.002000-07-072001-07-072002-07-072003-07-072004-07-072005-07-072006-07-072007-07-072008-07-072009-07-072010-07-072011-07-072012-07-072013-07-072014-07-072015-07-072016-07-072017-07-072018-07-072019-07-072020-07-072021-07-072022-07-072023-07-07PB-2.64 2.562.572023行情回顾：下半年开启震荡上行走势3 本章小结2023 2023 Pharma Biotech Pharma 2018-2022 9 29 2019-2023Q3 Wind 28 2019-2023Q3 Wind 4.1 Pharma转型创新步入兑现期7.9 14.5 10.6 8.0-8.4-0.7-1.0 1.0 17.5 9.1 5.9 4.6 3.0-0.1 3.5 2.6 5.2 3.6-4.7-10.0-5.00.05.010.015.020.0收入同比增速28.8 29.6 47.3 27.9 11.3 14.3 17.1 31.2 25.4 10.1-14.8-31.4-20.9-25.4-17.2-6.6 0.3 19.5 2.2-40.0-30.0-20.0-10.00.010.020.030.040.050.060.0 Pharma ROE 15%2021 ROE Pharma 31 2003-2023Q3 ROE(%)Wind 30 2003-2023Q3 ROE(%)Wind 4.1 Pharma转型创新步入兑现期0.005.0010.0015.0020.0025.0030.0035.00200320042005200620072008200920102011201220132014201520162017201820192020202120222023Q30.005.0010.0015.0020.0025.0030.0035.0040.0045.0050.00200320042005200620072008200920102011201220132014201520162017201820192020202120222023Q3:2023-12-07 JAK1:2023-12-12 SHR2554 III EZH2:2023-12-12 III HER2:2023-11-29 TQ-B3525 PI3K PI3K:2023-11-28 PD-L1:2023-12-19 TQB3454 III IDH1:2023-11-10 III PPAR:,;:2023-12-12 IL4R:2023-12-14 FcRn:2023-12-15 Anbenitamab III HER2:2023-12-05 BCMA:2023-12-20 III EGFR/HER2 2023-06-16 FCN-159 III MAP2K1/MAP2K2:2023-10-20 MRG003 III EGFR:;:2023-12-04 SKB264 TROP2:2023-12-20 License Out License In HS-20093 1.85 15.25 B7-H3 I/II 2023-12-20 HBM9033 0.53 10.5 MSLN 2023-12-15 BMS BL-B01D1 8 76 EGFR HER3 III 2023-12-12 SHR-A1904 HRS-1167 1.75 13.55 CLDN-18.2 PARP1 I/II I 2023-10-30 HS-20089 0.85 14.85 B7-H4 II 2023-10-20 BioNTech ADC 0.7 10 HER3 II 2023-10-12 LM-305 0.55 5.45 GPRC5D I/II 2023-5-12 BB-1701/20 HER2 I/II 2023-5-08 Pyramid GQ1010 0.2 10 TROP2 2023-4-13 BioNTech DB-1303 DB-1311 1.7 15 HER2 B7-H3 II 2023-4-03 CMG901 0.63 11 CLDN-18.2 I 2023-2-23 Corbus SYS6002 0.075 6.85 Nectin-4 I 2023-2-13 Pharma Insight 41 Pharma 40%4 Pharma Insight 5 2023 ADC Insight 2023.12.20 ADC Pharma ADC ADC 2023 12 ADC 4.1 Pharma转型创新步入兑现期 2023 Biotech 2023 Biotech A H Biotech 42 225 78.9%56%200 0.56%Biotech 2023 33 2019-2023H1 Biotech Wind 32 2018-2023H1 Biotech Wind 4.2 Biotech持续成长，海外注册催化0.0%20.0%40.0%60.0%80.0%100.0%120.0%140.0%0.050.0100.0150.0200.0250.0300.0350.02018 2019 2020 2021 2022 2023H1Biotech YOY01002003004005002019 2020 2021 2022 2023H1 6 2021-2023H1 Biotech 2023 CLL SLL 3.62 131.8%PD-1 38%50%70%6.1 EGFR TKI 7.5 149%2021 2022 2023H1YOY 14.0 38.0 36.2 123%16.0 28.0 18.4 38%28.4 19.9/3.6 4.8 3.9 12%0.8 2.2 1.6 66%0.8 1.5 1.5-5%7.4 4.5 50%1.1/0.7/6.4 9.9 5.9 35%2.6 3.2 1.9 11%1.0 0.8 0.6 147%0.7 393%4.0/APRIL,BAFF 3.3/2.2 5.7 3.2 48%1.0 2.9 1.9/5.5 6.1/1.8 1.4 37%3.2 7.9 7.5 149%10.2 8.1 115%5.7 3.5 70%4.2 Biotech持续成长，海外注册催化投资建议 2023 1 Pharma Pharma 2 Biotech 4 本章小结 Pharma Biotech+风险提示 湘财 证券 投资 评级 体系（市场 比较 基准 为沪 深300 指数）重要 声明 2023 12 27 2024 分 析师声 明 6-12 15%6-12 5%15%6-12-5%5%6-12 5%6-12 15%