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20230615_民生证券_医药行业证券研究报告:GLP_1药物蓬勃发展产业链机遇全景梳理_61页.pdf

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20230615_民生证券_医药行业证券研究报告:GLP_1药物蓬勃发展产业链机遇全景梳理_61页.pdf

*01*2023 6 14 GLP-1*-1 GLP-1-1 GLP-1 2 GLP-1 2 GLP-1 2014 FDA GLP-1 GLP-1 2030 GLP-1 200 200 8 GLP-1 GLP-1 Tirzepatide NDA 6 III IBI362 GX-G6 ecnoglutide HR170331 TTP273 II 2026 GLP-1 GLP-1R/GIPR GLP-1R/GCGR GLP-1R/GIPR FDA GLP-1R/GIPR/GCGR CDMO CDMO GLP-1 1WUDWzQsPpMqRqOpMtOpQpO6M8Q8OmOoOpNoNfQoOsMeRoPrM9PnNzQNZnMmOxNqMsQ*C O N T E N T SGLP-1 02GLP-1 03GLP-1 0104GLP-1 052 06*GLP-1 01.3*GLP-1 01 GLP-1 PubMed 4 1 glucagon-like peptide-1 GLP-1 GLP-1 L GLP-1 12min 4 DPP-4 GLP-1 GLP-1 GLP-1 GLP-1 GLP-1 GLP-1-*GLP-1 01 GLP-1 PubMed 5 GLP-1 GLP-1 GLP-1 GIP 42 K GCG GLP-1 GLP-1 GLP-1/GIP GCGR GLP-1 GIP GLP-1 GCGR GLP-1 PubMed PubMed*GLP-1 02.6*2020 1 2 2 90%2 2 02 2 7 PubMed*IDF 10 2021 20-79 5.37 10.5%10 1 IDF 2030 6.43(11.3%)2045 7.83(12.2%)IDF 10 10 2011 2021 9000 1.4 56%7283 51.7%IDF 20 2030 1.64 2045 1.74 02 2019-2045 20-79 10%8 IDF2020 01002003004005006007008002019 2030 2045 2000-2045 IDF2020*2+1+SGLT-2 GLP-1 2+SGLT-2 SGLT-2i GLP-1 3 2 4 02 2 GLP-1 2 9 2 2020 2 GLP-1 SGLT-2*/3 BMI 24.028.0 28 2022 2.26 2025 2.65,02 10 WHO BMI kg/28.0 24.028.0 18.524.0 18.5 2022-2025 2.262.382.512.655.1%5.2%5.3%5.4%5.5%5.6%22.12.22.32.42.52.62.72022 2023 2024E 2025E%*2016-2020 18.0 26.0 CAGR 7.6%2016-2021 2016 2.6 2021 30 CAGR 50.3%02 11 2016-2020 0.00%2.00%4.00%6.00%8.00%10.00%12.00%14.00%16.00%0510152025302016 2017 2018 2019 2020%-20.00%0.00%20.00%40.00%60.00%80.00%100.00%120.00%140.00%051015202530352016 2017 2018 2019 2020 2021%2016-2020*3 2014 FDA GLP-1 GLP-1 02 12 Xenical Saxenda Wegovy FDA 1999 2014 2021 12 120mg 3/3.0mg 1/2.4mg 1/2003 lancet NCT 01272219 NCT 03548935 BMI 28-47BMI:38.36.4()38.36.3()BMI:37.86.7()38.06.5(vs vs vs 52-10.2%vs-6.1%56-8.0%vs-2.6%68-14.9%vs-2.4%NAAE 88.1%vs 70.8%SAE 6.2%vs 3.9%AE 80.5%vs 68.2%SAE 9.8%vs 6.4%26.6%vs 1.3%22.1%vs 6.7%/20.0%vs 2.9%7.7%vs 0.9%40.2%vs 14.7%8.6%vs 9.8%20.9%vs 9.3%23.4%vs 9.5%8.7%vs 12.2%31.5%vs 15.9%NA-8.2%vs-3.9%-7.1%vs+0.1%-4.2%vs-1.5%-2.6%vs-1.9%-13.54%vs-4.13%-8.35%vs-0.48%-6.16%vs-1.06%-2.83%vs-0.42%*02 13 2019*GLP-1 8 1 5 GLP-1 Victoza 1 Trulicity 1 Ozempic 1 Bydureon 1 8 2022 218 98.7%Trulicity Ozempic Rybelsus 2023 Tirzepatide 2023 Q1 5.68 02 GLP-1 14 GLP-1()GLP-1 Victoza 793.50 18mg/3ml,x2 0.6-1.8mg 794-2381 Ozempic950-1000 2-8mg/0.25-1mg 950-1000 Rybelsus 948.84 3-14mg/tab,x30 3-14mg 949 Trulicity 943.05 0.75mg/0.5ml,x4 0.75-1.5mg 943-1886 Wegovy 1430.010.25mg/0.5ml-2.4mg/0.75ml,x4 0.25-2.4mg 1430 Saxenda 1430.01 18mg/3ml,x5 0.6mg-3mg 1430-7150 2010321731 18415153946574201589720163362021 2017 2018 201962202035(57%)202279471201552180 225921(82%)28(76%)31(65%)39(49%)33(34%)31(25%)24(15%)19(9%)20143+31%VictozaTrulicity Tanzeum GSK Bydureon Rybelsus Ozempic Wegovy*PDB GLP-1 2022 1-11 GLP-1 37 36 88%64.4%2022 GLP-1 57 02 GLP-1 15 PDB GLP-1 2022 11 GLP-1*2021 IDF 2030 1.64 2 1.48 GLP-1 9%GLP-1 2030 5%GLP-1 738 GLP-1 149-560 2030 GLP-1 100 70%3640 10 2030 GLP-1 269 02 2030 GLP-1 16 2021 IDF GLP-1 1642 90%2 148GLP-1 5%7.38/100 52 70%0.36*2030 2.65 2030 2.65 3%GLP-1 GLP-1 85%2030 GLP-1 6.76 GLP-1 149-560 2030 GLP-1 100 50%2030 GLP-1 150 50%3900 GLP-1 264 02 2030 GLP-1 17 GLP-1 265 3%7.95GLP-1 85%6.76/150 52 50%0.39*GLP-1 03.18*03 VS GLP-119 semaglutide GLP-1 GLP-1 94%GLP-1 8-DPP-4 26 C-18 34 C-18 Liraglutide AEEA 8 Aib Liraglutide 3.8kDa PubMed GLP-1*03 20 2017 12 Ozempic FDA 2 2019 9 Rybelsus FDA 2 2021 4 2 T2DM 2021 6 Wegovy FDA 1 GLP-1 2017 12 FDA 2 7 GLP-1 2019 9 FDA 2 Rybelsus GLP-1 2021 4 2021 6 FDA 2021 12 2021 2*03 21 GLP-1 2022 120 56%Ozempic/Ozempic GLP-1 Ozempic 2017 12 2021 4 29 2022 84.65 77%Rybelsus Rybelsus GLP-1 2019 9 2022 5 27 2022 16.00 134%Wegovy 2021 6 Wegovy FDA 1 GLP-1 2022 8.77 346%Rybelsus 0500010000EMEA China Rest ofworldTotal NAO2020 2021 202201000020000300004000050000EMEA China Rest ofworldTotal NAO2020 2021 202202000400060008000EMEA China Rest ofworldTotal NAO2020 2021 2022 Ozempic Wegovy*03 PubMed vs 22 GLP-1 GLP-1*03 PubMed HbA1c vs 23 SUSTAIN 7 GLP-1 40 HbA1c 1.8%,HbA1c 79%7 40 HbA1c 1.8%40 7-2.4 VS-2.0(p=0.0014)-3.0 VS-2.3(p0.0001)PubMed*03 50mg III 24 2023 5 22 50mg IIIa OASIS 1 667 50mg 1 68 5%50mg 105.4kg 50mg 17.4%1.8%89.2%50mg 68 5%24.5%50mg 50mg 15.1%2.4%84.9%50mg 68 5%25.8%50mg GLP-1 50 mg III*03 25 2023 6 3 CDE BMI 30kg/m2 27kg/m2 30kg/m2 2022 8 III CTR20202040 III 1 2.4mg/2 300 375 44%44 5%44 10%15%44 CDE*03 2026 26 CN101133082B 2026 2022 9 5 57950 22 3 80658 15 16 2*03 2026 27 2022 Ozempic 2031 2032 Rybelsus Wegovy 2026 2031 2032*03 28 205 II I 63 II 12 III 39 IV 1 32 12 5*03 29 2022 3 13 EMA Ozempic EMA 2023 Ozempic 2 Wegovy Ozempic 2022 10 19 Ozempic 2023 GLP-1 2022 Ozempic CDMO Catalent 2021 10 Catalent FDA Wegovy 2023 4 Wegovy EMA Ozempic*GLP-1 04.30*04 GLP-1 GLP-1 31 8 GLP-1 2022 5 27 GLP-1 2009 2011 2016 2017 2017 2019 2019 2020 2019 2017 2020 2019 2019 2020 2020 2021 2 2:,2011 03 2(2020 5 2 2 2 2018 1 2 II 2 2 48 287 420 250 496 149 295 560*04 PubMed FDA label Clinicaltrials.gov GLP-1 32 GLP-1 III 6.5kg(Saxenda)(Wegovy)tirzepatide IBI362 Mazdutide GLP-1 GLP-1 GLP-1/GIP GLP-1/GCGR III III III SURMOUNT-1 II 3731 1961 2539 320 BM I 3 0 BM I 2 7 BM1 30;BM I 2 7()18-75 56 68 72 24 3mg vs 2.4mg vs 5mg vs 10mg vs 15mg vs 3mg vs 4.5mg vs 6mg vs 9mg 7.4%vs 3%14.9%vs 2.4%15kg VS 3.1kg-16.0%19.5kg vs 3.1kg-21.4%20.9kg vs 3.1kg-22.5%6.4kg vs 1.1kg-7.20%9.1kg vs 1.1kg-10.60%9.9kg vs 1.1kg-11.60%14.7kg(-15.4%)5%(%)62.3%vs 34.4%86.4%vs 31.5%89.61%vs 27.87%96.18%vs 27.87%96.32%vs 27.87%58.1%vs 4.8%82.5%vs 4.8%80.3%vs 4.8%81.7%10%(%)33.9%vs 15.4%69.1%vs 12.0%73.35%vs 13.54%85.85%vs 13.54%90.08%vs 13.54%19.4%vs 0%49.2%vs 0%50.8%vs 0%65.0%15%(%)NA 50.5%vs 4.9%50.24%vs 5.98%73.61%vs 5.98%78.24%vs 5.98%9.7%vs 0%15.9%vs 0%26.2%vs 0%31.7%GLP-1*04 GLP-1 33 Phase III GLP-1R Phase III GLP-1R Phase III GLP-1R Phase III GLP-1R Phase III GLP-1REfpeglenatide Phase III 2 GLP-1RTG103 Phase II;2 GLP-1Recnoglutide Phase III/;2 GLP-1RHR17031 Phase II GLP-1R insulinHRS-7535 Phase II 2 GLP-1RTTP273 Phase II 2 GLP-1RExendin-4 Fc Phase II 2 GLP-1RGZR18 Phase II;2 GLP-1RHR20014 Phase I Phase I 2 GLP-1RHEC88473 Phase I;2 GLP-1R,FGFR21danuglipron Phase I 2 GLP-1RBPI-3016 Phase I 2 GLP-1RPF-07081532 Phase I(GLP-1RCotadutide Phase I GLP1R/GCGRPhase III Cagrilintide+Semaglutide IND amylin GLP-1RPhase III HDM1002 IND 2 GLP-1RDR10624 Phase I GLP-1R GLP-1 8 GLP-1 Tirzepatide NDA 6 III IBI362 GX-G6 ecnoglutide HR170331 HRS-7535 HRS9531 TTP273 II GLP-1*04 GLP-1 34 GLP-1/GIPR GLP-1/GCGR GLP-1/GIPR FDA GLP-1/GIPR/GCGR II GLP-1 GCGR FGF21R GLP-2R GLP-1/GIP GLP-1/GIPR GLP-1/GCG GLP-1 GLP-1R GIPRII NDA III III III Mazdutide/IBI362 GLP-1R GCGR III II III BI 456906 GLP-1R GCGR II NASH II II HRS9531 GLP-1R GIPR II SHR-1816 GLP-1R GCGR II I BGM0504 GLP-1R GIPRII I I HS-20094 GLP-1R GIPR II II cotadutide GLP-1R GCGR OXM NASH II/III efinopegdutide GLP-1R GCGR OXM NASH I TB001 GLP-1R GCGR Ib HZ010 GLP-1R GIPR II I LY3437943 GLP-1R GIPR GCGR I RAY1225 GLP-1R GIPRII I I DR10624 GLP-1R GCGR FGF21R I P29 GLP-1R GIPR II IND GMA106 GLP-1R GIPR IND MWN101 GLP-1R GIPR GCGR IND THDBH121 GLP-1R GIPR II IND HX-100101-1 GLP-1R GIPR IND*04 GLP-1RA 35 GIP GLP-1 2022 5 FDA 2 FDA GIP GLP-1 2022 10 6 FDA 3 SURMOUNT-1(5mg,10mg,15mg)72 20.9%3 20%SURMOUNT GLP-1R PubMed GIP GLP-1 SURMOUNT-1 72 PubMed*04 tirzepatideIII 30 36 2023 4 27 Tirzepatide 2 SURMOUNT-2 III 1 Tirzepatide 10mg 15mg 2 938 100.7kg A1C 8.0%1:1:1 Tirzepatide 10mg 15mg Tirzepatide 10mg 15mg 72 5%SURMOUNT-2 938 10 mg 15 mg tirzepatide 72 10 mg 15 mg tirzepatide 13.4%13.5 15.7%15.6 3.3%3.2 81.6%10 mg 86.4%15 mg tirzepatide 5%30.5%41.4%10 mg 51.8%15 mg tirzepatide 15%2.6%15 mg 21.9%21.5%13.2%9.0%3.8%10 mg 7.4%15 mg 3.8%tirzepatide III*04 37 2018 5000 Chugai GLP-1R LY3502970 Orforglipron GLP-1R Orforglipron 2 Orforglipron 36 14%15%2 Orforglipron 26 9.6%GLP-1R LY3502970*04 38 5 31 III TRIUMPH-3 GLP-1R/GCGR/GIPR Retatrutide LY3437943 GLP-1 III Retatrutide Tirzepatide 2 II Retatrutide 48 22%-24%2 Retatrutide Hb1Ac 2%15%-17%Retatrutide*04 GLP-1R/GCGR IBI362 39 2022 6 IBI362 II II 320 1875 IBI362 IBI362 24 II 20 HbA1c 1.5%3.0 mg IBI362 20 1.41%4.5 mg IBI362 20 1.67%6.0 mg IBI362 20 1.54%IBI362 HbA1c7.0%5%6.0 mg IBI362 HbA1c7.0%5%52.2%II 24 IBI362(6 mg)IBI362 Ib 12 IBI362(9 mg)IBI362 2022 11 IBI362 III 20 HbA1c IBI362 24*04 GLP-1R/GCGR IBI362 II 40 2023 5 IBI362 9mg II 24 II 80 60 20 34 96.9kg BMI 34.3kg/m2 IBI362 9 mg 24 IBI362 9mg-15.4%95%CI-18.8%,-11.9%P0.0001-14.7 kg 95%CI-17.9 kg,-11.5 kg P0.0001 IBI362 9 mg 81.7%65.0%31.7%21.7%5%10%15%20%5%IBI362 9 mg COVID-19 48 IBI362 II*04 GLP-1R/GCGR 41 IBI362 6mg III 22 Q4 2024-2025 9 mg II 23 Q2 2023 III 2026 IBI362*04 GLP-1 2b 42 2023 5 Pfizer GLP-1 danuglipron 2b danuglipron HbA1c 1.16 4.17 2b 411 2 danuglipron 316 16 danuglipron HbA1c 16 80 mg 120 mg danuglipron 2.04 4.17 GLP-1 PF-07081532 danuglipron PF-07081532 PubMed Danuglipron IIb Danuglipron IIb PubMed*04 GLP-1 43 GLP-1 2026 2021 6 CN101133082B 2022 9 5 GLP-1 2 2 2 2 2 2 IIl 2 IIl 2 IIl 2 III 2 IIl 2 BE 2 BE 2 IIl 2 I 2 I 2 IND 2 IND 2 IND 2 IND 2 IND 2*05.44*05 100 45 0.25 mg 4 0.5 mg 0.5 mg 4 1mg 1 mg 47 mg/100 47kg 5%100 49.5kg 100 Ozempic 100 RYBELSUS 3 mg RYBELSUS 30 3 mg 30 7 mg 7 mg 30 14 mg 4570mg/100 4570kg 5%100 4810.5kg*05 100 46 100 Wegovy 1-4 0.25 mg 5-8 0.5 mg 9-12 1 mg 13-16 1.7mg 17 2.4 mg 100.2 mg/100 100.2kg 5%100 105.5 kg 100 50 mg III 1-4 3 mg 5-8 7 mg 9-12 14 mg 13-16 25 mg 17-68 50 mg 14022 mg/100 14022kg 5%100 14760kg*05 47 10000 2022 2000 GMP 1200 600 GMP-IND GMP 100kg API API CDE API 408kg 766kg CDMO 92kg API DMF 300kg/-CDMO*2012 WuXi STA 1000+WuXi STA 2000+PPMO 2022 TIDES D&M 103 81%189 91%15.78 337%2023 2 27 10000 1000 2022 GMP 2022 7 05 CRDMO 48*05 CDMO 49 100/60%1200 2000 GMP 600 OEB5 GMP/QbD Scale Down Model NDA 30-PDC/540/NDA GLP-1 MMAE/MMAF Drug Linker-GMP-2022-40 3 5 12000 9500 GMP*05 CDMO50 CDMO CMC IP 2022 15 IND 2000 PCS PCS GMP 100kg 2023 4 21*05 CDMO/CMO CDMO 51 EHS API API CDE 5 CDMO 2 5 2 GMP*05 CDMO/CMO 52 30 1 6 15 7 8 DMF 7 11 408kg/a CDMO 104B 106 107 108 105 358kg/a 200kg/a 20kg/a 30kg/a 100kg/a 8kg/a CDMO 92kg/a 766kg/a CDMO 92kg/a*05 CDMO 53 2005 CDMO 2020 12 31 200 NCE 500 82566 CDMO 2020 12 31 10 20 100 300 2020 12 31 71 20 5000 6*05 54 2003 160 HATU HBTU TBTU PyBOP 350 2021 6 2021 HBTU TBTU PyBOP 87.02 2022 203.17 2022 350 2021 2022 58.05%HATU HBTU TBTU PyBOP 2020 2021 2022 592.67 751.82 973.96 134.16 60.58 159.16 462.76 613.24 728.29 100.72%89.63%91.12%*05 55 5 100 CDMO 2022 seplife 2-CTC sieber 2022 GLP-1 2021 160 2030 400*05 56 PS PMMA 100 pH C18 Uni-50XSNanoQ-15L 30-100 100%UniQ-50XS 50 Nano 30 10 15 NanoQ-15L UniPS 10-300 10-40 90%UniPS 3 50 C18 UniPS 10-300 C18 UniSil 10-120 C18 C18 UniSil GLP-1 UniSil 10-120 C18*06.57*06 58 GLP-1 GLP-1*THANKS 8 1 5F 200120 28 A 18 100005 6001 32 05 518026 S0100523050002 S0100123050028 59*12 A 300 500 15%5%15%-5%5%5%5%-5%5%5%*60

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