资源描述
2022-2023 2021 1800 400 20%BT+IT PROTAC 1 2 3 4 5 FDA)New Moleculer Entity NME Biologic License Application,BLA)Discovery research Pre-Clinical Hit Lead Target(Candidate)Clinical Trail/PK/PD Safety Toxicology Preparation CMC I II II Drug IV 10000+250 10 1 3-6 6-7 0.5-2 1000-5000 100-500 20 FDA NMPA IND NDA 8-23 8-12-3 40/81 1.5 2007 2016 3 2020 7 1 2 1 2 3 4 5 1 2 3 Copy 21 Me-too,Me-better,Fast follow 2015 Best-in-Class First-in-class“”1950-1999 2000-2015 2016-Copy.Me-too/Me-better/Fast-fllow 原 始 新 段 Best-in-Class/First-in-Class 0 1 2015 2018-2021 2018 64 2021 30 24 6 17 7 2021 501 III 106 3-5 2018-2021 ATC L 33%N 18%A 16%J 10%V 3%R 7%B 9%C 2%D 2%17 24 2 6 8 7 19 2018 2021 2018-2021 30 2019 2020 228 39 104 106 12 11 1 1+2 4 2021 2 3)1 2 3 4 5 1000 10-15 7 7 9 20 15 44 70 144 161 157,()2019 20118 15 16 18 20 26 32 89 812 9 14 26 6 12 32 31 30 5562 68 2000 60.8%2019 73.6%2021 WHO 2019 10 7 2019 8 80%2000 2019 2019 2000 2019 487940 538580592963643563688858 5.0%5.2%5.3%5.5%5.9%6.2%6.3%6.4%746395832036919281 6.7%7.1%98651510159866.0%60 2011 13.7%2019 18.1%2040 60 25%2020 GDP 100 2020 7 2010 201 1-2020 GDP 2011 5.0%2020 7.1%2020 8.7%-2 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020()/(%)2013-2020 2011-2020 23.5%32.9%29.9%12.1%23.0%32.4%30.2%12.7%22.6%32.0%30.6%13.1%22.2%31.5%30.7%13.7%22.0%31.1%30.8%14.2%22.0%30.6%30.8%14.7%22.0%30.2%30.5%15.3%21.9%29.4%30.8%15.8%21.9%28.8%31.1%15.9%2011 2012 2013 2014 2015 2016 2017 2018 2019 2011-2019 40-59%0-19%60-79%20-39%80%17111 18322 6.9%7.2%7.4%7.6%7.9%8.5%19853 8.8%21559 8.7%21210 13220 14491 15712 2013 2014 2015 2016()2017 2018 2019/2020%2015-2020 68%2021 13 10%68.4%11.8%2015-2020 19.8%2021 21.1%3.3%0.8%8.6%8.1%7.7%11.5%9.3%15.3%15.2%20.0%30.0%28.2%-47.9 55.5 41.6 133.4 81.6 71.5 41.039.1 37.4 32.430.1 28.6 12.512.2 11.7 11.0 5.9 63.8 2020 2020 2020 100 21 6000 5 2020 457 300 I II III IV+EGFR ALK 9 8-40 4 5-50 DRG/DIP“”2021 74 11/2015 2017 2019 2018 2020 2021 2016 I II,III ICH 18 1 2 3 4 5 1860s-1960s 1960s-1990s 1 2 21 3 2001 Imatinib FDA 120 2005 201 1 Conmana BCR-ABL/PDGFR/KIT 1500 500 KINASE INHIBITORS EPIGENETIC INHIBITORS PROTEASOME INHIBITORS RECEPTOR TYROSINE KINASE INHIBITORS NON-RECEPTOR TYROSINE KINASE INHIBITORS/SERINE/THEONINE KINASE INHIBITORS ALK inhibitors c-Met inhibitors EGFR inhibitors FLT3 inhibitors VEGFR/FGFR/PDGFR inhibitors TRK inhibitors Bcr-Abl1 inhibitors BTK inhibitors JAK inhibitors BRAF/MEK/ERK inhibitors CDK inhibitors PI3K/AKT/mTOR inhibitors EZH2 Inhibitors HDAC inhibitors IDH1/2 inhibitors BCL-2 INHIBITORS HEDGEHOG PATHWAY INHIBITORS PROTEASOME INHIBITORS PARP INHIBITORS 80%/80%-(UPS)DNA UPS 15 9 EGFR 16 EGFR III EGFR EGFR EGFR NSCLC 40%-50%EGFR EGRF 3-4 2021 3 EGRF EGFR EGFR 2021 12 III EGFR SH-128 I 2011/6/1 2004/12/1;2006/3/1 II 2019/5/1 2017/2/1 III 2020/3/1 2017/3/1 2021/3/1/EGRF III SH-1028 62.7%68.9%74.1%Array BioPharma 88.6%93.4%93.6%AstraZeneca Genomics Institute of the Novartis Research Foundation 9.7 12.3 9.6()69.6%60.9%65.5%Exelixis FHND-9041()91.3%91.3%100.0%BTK Merck KGaA Genentech pirtobrutinib Redx Pharma Principia Biopharma tolebrutinib Principia Biopharma BTK B BTK B B BTK 2017 2018 2020 94 BTK 2020 4170 2014 2017 2020 23.90 2 5/III 5 BTK III BTK 15 5 BTK 18 III BTK/2017/8/1 2020/6/2 B 2020/12/25 Tirabutinib/JAK JAK-STAT JAK JAK JAK/STA T 8 JAK JAK 3 10 JAK III JAK JAK JAK ARQ-252/SHR-0302/jaktinib/;/2019/7/1 1/2015/10/1 2017/3/1 2;Galapagos/TargeGen/;La Abbotties borator/22 29 10 JAK III JAK CDK4/6 CDK4/6 4 6 DNA CDK4/6(HR)CDK4/6 CDK4/6 G1 Therapeutics Trilaciclib Cosela CDK4/6 dalpiciclib NMPA CDK4/6 III CDK4/6 9 7 3 I II III CDK4/6 III CDK4/6 2020/12/29 Onyx 2019/12/20/Trilaciclib G1/FCN-437;TQB-3616;birociclib;适应症（部分）BGP-15 N-Gene Research Laboratories Inc senaparib;IMPACT Therapeutics Inc;Abbott Laboratories/Octamer Inc PARP BRCA PARP DNA PARP 6 Clovis 4 III PARP 4 PARP III PARP;2020/9/1;2020/1/1;/;2021/5/1 2020/12/1 12 8 4 I III PARP II BT+IT PROTAC-AI 3D TGRX-678 Asciminib HC-1119 II III ARV-110/ARV-471 II CG001419 PROTAC-ADC 14 150 Antibody-drug Conjugate(ADC)1 2 3 4 5 DTP CRO CRO CMO&CDMO-MNC DTP Direct to Patient 70-90%10-20%CRO70%CMO15-30%CDMO80%15-30%/“”17%2021 41.42 20.5%1970 1978 2000 2014 2018 2019 PD-1 2021 8 1969 1988 2004 2010 2018 2021/PD-1 2020 20 12%1958 1982 1987 1993 2010 2016 2019 2021 12%40 12%FDA BTK 2021 EGFR 2004 2009()2012 1 2020 2021 2010 2011 PARP RAF 2012 PD-1 BTK 2016 2017 2018 2019 2020 2003 2011 2016 2020 2018 5.9 2019 6.8 2020 7.4 39.7%BTK A 2018 2021 463.32%318.74%622.53%176.47%EGFR 2021 76.27%/License in/out 2017“Lise n ce in”“”“Lise n ce in”“VIC”2014 2017 2020/28 Lisence in/in House 2017 2020 17 Lisence in 2016 2019 15 VC+IP+CRO 03 01 04 02/VI C/NA S H RA S BCL-2 M2 M AI+ADC PRO TAC(T CI)(PPI)1 2 3 4 5 80 47%262 JAK CDK4/6 2009-2020 20 8 4 11 3 7 4 11 10 20 23 34 45 32 45 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 19 73.68%19 73.68%89 65.17%19 57.89%75 56.00%84 46.43%23 39.13%63 38.10%27 33.33%23 30.43%/FIC/BIC“”FIC/BIC FIC/BIC 2007-2021 FIC 63 “”“”“”A 2015 189 2020 690 2021 80%A 6 10 41.42 2021 39.2%in-house 2021 20%189 690 2015 2020 2015&2020 A BigPhama Biotech/NDA 2019 5 1 BTK/2019 11 L-type cabciumchannel 2019 12 1 CSF.1RVEGFRIFGFR1 NDA 2020 12 1 a G-CSF NDA 2021 3 1 2019 FDA 5 FDA FDA Johnson&Johnson Biogen AbbVie Bayer Arribent Blucprint UNION 2021 12 C 5 2021 12 b 6100 Octagon Capital Sage Partners Laurion Capital 2020 12 pre-IPO 2021 Lisence in/out LCAR-B38M 3.5+1.25+SHP2 4500+GKA 3+4000+avapritinib 4000+Orismilast 2000+4/3600+BTK/1200+/1+EGFR TKI/2 HQP1351/3000+GFH925/2200+NTRK/ROS1/1.89 THANKS
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