深度报告-20230120-国金证券-特宝生物-688278.SH-乙肝临床治愈推广有望拉动公司业绩增长_30页_3mb.pdf

1 3000 HBsAg 0 3%HBsAg 3%11%2013 2016 2022 HBsAg 33.2%AASLD2022 YPEG-GH YPEG-EPO YPEG-G-CSF 2022/2023/2024 15.90/21.99/29.56+40.43%/+38.29%/+34.45%2.76/4.49/6.53+52.55%/+62.46%/+45.35%EPS 0.68/1.10/1.61 2023 45 PE 49.50 010020030040050020.0025.0030.0035.0040.0045.0050.00220120人民币(元)成交金额(百万元)成交金额 特宝生物 沪深300 2.5.5.6.8 9000.8 HBV.10.11.13.14.14.15.16.16.17.18.19 YPEG-G-CSF III.20 YPEG-EPO II.20 YPEG-GH II/.21 ACT50 ACT60.22.23.23.25.26.27 1 ACTOne Biosensor.5 2.5 3.6 4-2b.6 5.6 6.7 3 7-11.7 8.7 9.7 10.7 11 2019 HBsAg.8 12 2013-2020.8 13 2013-2020.8 14 HBV.9 15 HBV.9 16 HBV.10 17 HBV.10 18 EASL&AASLD.11 19 HBV.11 20.12 21.13 22 HBV.13 23.13 24 2016-2021.14 25 2016-2030.14 26 2016-2030.14 27 2014-1H22.15 28 2012-2017.15 29-2 3.15 30 HBeAg.16 31.16 32 48 HBsAg.16 33 68.4%HBsAg100IU/mL.16 34.17 35.17 36.18 37.18 38.19 39-11.19 40 3 Y-PEG.19 41 YPEG-G-CSF.20 4 42 YPEG-EPO.21 43 YPEG-EPO Mircera.21 44 YPEG-GH.21 45 YPEG-GH.22 46 ACT50.22 47 ACT60.23 48.24 49.24 50.26 51 2023.1.19.26 5 ACTOne Biosensor GPCR PDE cAMP/cGMP 1 ACTOne Biosensor 2 6 3 1997 1999 2005 2016 2016 GMP 2016 14 1 40kD-2b 4 rhG-CSF 4-2b 5 GMP-11-11-11 rhIL-11 表达平台 相关技术积淀情况大肠杆菌公司拥有IPTG、热、低温、糖等诱导蛋白质药物基因高效表达的多个大肠杆菌表达载体，已成功开发上市3 个产品。酵母公司在酵母表达载体构建、整合入酵母染色体等技术方面进行了大量改进工作，目前公司酵母平台表达水平已达g 级/L 以上，已有1个产品成功上市，多个药物处于临床研究阶段。哺乳动物细胞公司已构建哺乳动物细胞高效表达载体，定向驯化了CHO 宿主细胞，已开发1 个药物处于临床阶段，多个候选药物处于开发初期。昆虫细胞 公司已建立昆虫细胞表达体系，已成功用于试剂的研发及候选药物的开发。7 6 7-11 5 69%8 9 7%-10%10-200%-100%0%100%200%300%400%0.0200.0400.0600.0800.01,000.01,200.01,400.02017 2018 2019 2020 2021 1-3Q22 yoy yoy0%20%40%60%80%100%2017 2018 2019 2020 2021 0%2%4%6%8%10%12%0.020.040.060.080.0100.0120.02017 2018 2019 2020 2021 1-3Q22 8 9000 Chronic Hepatitis B 2019 2.96 82 HBsAg 5%-6%HBV 8600 2000-3 000 100 30 11 2019 HBsAg Lancet 2013-2020 NNDRS 2013 4.4/10 2020 2.4/10 2013 41.0/10 2020 64.4/10 2020 90.87 12 2013-2020 13 2013-2020 HBV HBV 1 HBV 90%5 HBV 5%-10%HBV HBV HBV HBeAg CHB 50%9 14 HBV World J Gastroenterol 2019 CHB 2%10%HBeAg 40 ALT HBV DNA 2 000 IU/mL HBeAg C HCV HDV HIV 3%5%5 14%35%HBV 0.5%1.0%3%6%HBsAg 15 HBV HBV HBsAg IU/ml 1 104+1103+-HBs-HBeAg e+-+/-HBe e-+/-HBc+HBV DNA IU/ml 2 107 2 104 2 103 2 103 ALT/2019 2019 HBV 4 HBV HBeAg CHB HBsAg HBeAg CHB)HBV CD8+T HBV DNA/HBV T/10 16 HBV Science 2019 AASLD 2018 EASL HBV 5 4 HBeAg+HBeAg+HBeAg-HBeAg-2019 4 5 HBV HBV DNA relaxed circular DNA rcDNA cccDNA HBcAg cccDNA 3.5 kb RNA pregenomic RNA pgRNA mRNA P P rcDNA rcDNA rcDNA cccDNA cccDNA HBV NAs CHB cccDNA cccDNA NAs HBV 17 HBV Science 2019()()()HBsAg HBV DNA(cccDNA 11 HBV DNA)-HBc-HBs cccDNA cccDNA HBsAg HBV DNA HBeAg HBsAg cccDNA HBV 18 EASL&AASLD 6 HBsAg HBV DNA HBsAg-+-HBs-/+-/+-HBeAg-HBV DNA cccDNA cccDNA HBV DNA 2019 EASL-AASLD HBV 2019 HBV 19 HBV 2019 2019 Peg-IFN-ETV LAM LdT ADV TDF TAF 12 20 Peg-IFN-HBV HBV RNA cccDNA HBV HBsAg HBV HBV DNA 7-19%HBeAg 29-35%HBsAg 3-11%HBV DNA 67-94%HBeAg 10-21%HBsAg 0-3%HBeAg HBeAg CHB Peg-IFN-24 HBV DNA 20000 IU/ml Peg-IFN-NAs A1 48 96 B1 HBeAg TDF TAF 1 HBV DNA ALT HBeAg 3 6 1 A1 HBeAg HBeAg CHB Peg-IFN-12 HBV DNA 2 lg IU/ml HBsAg 1lg IU/ml Peg-IFN-NAs B1 48 96 B1 HBeAg CHB TDF TAF HBsAg HBV DNA A1 TDF TAF PeglFN-A1 TDF A1 TAF C1 2019 HBsAg HBsAg 0 3%HBsAg 3%11%HBsAg(),Peg-IFN-HBsAg 1500 IU/ml HBsAg 12 24 HBsAg1lgIU/ml HBsAg 13 21 Peg-IFN-Peg-IFN Peg-IFN HBsAg Peg-IFN-Peg-IFN-NA Peg IFN HBsAg NA NA HBsAg()HBsAg HBsAg HBV DNA/cDNA HBsAg 22 HBV EASL 23 HBsAg NTCP HBV Bulevirtide/HBV RNA HBV HBV cccDNA JNJ-379 RO7049389 vebicorvir ABI-2158 HBV/HBV HBV RNA(siRNA)(ASO)JNJ-3989 GSK836 14 cccDNA HBV cccDNA EYP001 HBsAg HBsAg HBsAg REP2139 ClinicalTrails 2016-2021 CAGR 60%-2b 2016 2016 0.72 2021 7.70 CAGR 60.45%24 2016-2021 3231.50 350 11%2022 109.5 94.7 80%25 2016-2030 26 2016-2030 820.48-862.89/48 3.94-4.14 2021 7.70 1.86-1.95 0.6%72 87 187 363 458 770 20%116%94%26%68%0%20%40%60%80%100%120%140%01002003004005006007008009002016 2017 2018 2019 2020 2021()yoy 15 PDB 2021 2.85 1.93 68%32%2021 2.7 0.77%27 2014-1H22 28 2012-2017 PDB 2013 2016 2.59 2.82 0.63 2017 2016 2016 2 1 PDB 2014 2018 2018,2017 5%2021 68%2022 9 2022 12 31 2 3 29-2 3 CTR20213197-2 HBV 72 HBsAg HBsAg LLOQ 0.05 IU/mL 1 48 336 2021-12-28 chinadrugtrials 24 HBeAg HBeAg P0.05 0.001.002.003.004.005.006.007.002014 2015 2016 2017 2018 2019 2020 2021 1H22-0.002.004.006.008.0010.0012.0014.0016.0018.0020.002012 2013 2014 2015 2016 2017罗氏-派罗欣 默沙东-佩乐能 16 30 HBeAg 31 32 48 HBsAg 33 68.4%HBsAg 100IU/mL AASLD2022 AASLD2022 HBsAg 33.2%2021 12 31 25 2022 2022 7 399 44 355 106 2.3 22507(48)3803 36 48 HBsAg 33.2%()2022 11 73 AASLD2022 1 HBV DNA 100IU/mL HBeAg HBsAg 1500IU/mL-2b 48 96 48 HBsAg 2020 4 1 48 mITT 5648 PP 3988 PP 81%40.9 HBsAg 380.6 lU/mL 48 mITT HBsAg 23.5%PP 48 HBsAg 33.2%HBsAg 48 HBsAg 68.4%HBsAg 100IU/mL 1997 rhGM-17 CSF rhGM-CSF 5 40 2020 2021 136 34 2021 86.34%2.38%11.28%2020 2021 35 PDB 1999 4 rhG-CSF GMP 5 22-26 01020304050607080901000204060801001201401601802016 2017 2018 2019 2020 2021/05001,0001,5002,0002,5003,0003,5004,0002016 2017 2018 2019 2020 2021 2022H1 18 36 rhG-CSF 17 2020 21 37 PDB 2005 5-11 rhIL-11 GMP 5 20 5 2021 196 2021222324252627010020030040050060070080090010002016 2017 2018 2019 2020 2021/010,00020,00030,00040,00050,00060,0002012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022H1Kyowa Kirin Co Ltd 19 38 2021 9.8%63.5%13.6%10.3%rhIL-11 4 2016-2019 3.5 2020 2021 3 39-11 PDB 3 Y YPEG-G-CSF Y YPEG-EPO Y YPEG-GH 3 40 3 Y-PEG YPEG 40455055606570750501001502002502016 2017 2018 2019 2020 2021/05,00010,00015,00020,00025,00030,00035,00040,0002012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022H1 20 YPEG-G-CSF N 17 K17 N YPEG-G-CSF YPEG-EPO Roche Mircera YPEG-EPO Mircera YPEG-GH YPEG-GH YPEG-G-CSF I I I YPEG-G-CSF III 2022 4 YPEG-G-CSF 40kD Y PEG rhG-CSF N 17 K17 YPEG-G-CSF 41 YPEG-G-CSF YPEG-G-CSF III FN 4 0.25 0.54-0.61 4 14.29%10.30%30.0-33.0%3 0.61 1.36-1.37 0.18-1.33 3 25.00%16%63.03-65.50%9.09-50.91%FN 1.79%0.30%5.85-6.06%0-4.50%YPEG-EPO II EPO rhEPO 4-13 2-3 50%21 42 YPEG-EPO 2012 CKD 10.8%1.2 CKD CKD 1-5 22.0 37.0 45.4 85.1 98.2 6840 2017 21.10 50%2017 27 53.26%Roche Mircera 2018 7 Y 40kD Y Y Mircera 40kD PEG Mircera 100.3 164.0 2-4 1 PEG pH PEG PEG YPEG-EPO 43 YPEG-EPO Mircera YPEG-EPO Y 40kD 100.3-164h Mircera 30kD 119-124h YPEG-GH II/GH GHD Turner 44 YPEG-GH 4-15 22.6 2003-2014 460 4.5%22 2017 rhGH 27.5 30%10%300 25 N-40kD Y YPEG rhGH 2022 YPEG-GH 45 YPEG-GH YPEG-GH Y 40kD N N 140 K140 YPEG-GH PCT PCT/CN2008/000674 U 40kD N 2 CN101385858 CN101491681 WIPO ACT50 ACT60 ACT50 5-10 ACT50 PEG v 3 v 3 v 3 ACT50 46 ACT50 VEGF/VEGFR RTK Roche Avastin v3 23 ACT50 v3 A A IMD ACT50 2019 57.26/10 80/80%85%64 68/Avastin 2017 70 ACT60 IL-2 Treg T 47 ACT60 E IgE ACT60 IL2 2 6 10%5%5 3 1.5 3000 ACT60 IL2 2014 72 2015 2016 87 100 17.89%1997 Nasonex 2014 Nasonex 10.55 24 2021 135.68 77%2022-2024 62%55%45%2022E-2024E 5%22-24 54%47%38%22E-24E 90.0%89.5%89.0%48 2019A 2020A 2021A 2022E 2023E 2024E a 330 363 399 439 483 531(b 30 33 36 40 44 48 c 1.3%1.4%1.5%1.6%1.8%1.8%d=a*c 4.3 5.1 6.0 7.0 8.7 9.6 3 22E-24E 19.2%15.2%12.2%19 20 22E-24E 22E-24E 11.6%10.0%7.0%13.3%13.0%8.50%49 2018A 2019A 2020A 2021A 2022E 2023E 2024E 448.2 729.7 793.9 1,132.2 1,604.66 2,220.33 2,985.96 YoY 38.8%62.8%8.8%42.6%41.73%38.37%34.48%392.4 649.7 710.3 1,007.1 1,433.05 1,976.68 2,648.78 YoY 39.4%65.6%9.3%41.8%42.30%37.94%34.00%87.5%89.0%89.5%89.0%89.31%89.03%88.71%187.4 363.3 458.4 770.2 1,185.26 1,745.30 2,404.15 YoY 115.7%93.9%26.2%68.0%53.90%47.25%37.75%41.8%49.8%57.7%68.0%73.86%78.61%80.52%84.6%86.9%88.7%89.6%90.00%89.50%89.00%158.4 315.6 406.7 690.1 1,066.73 1,562.04 2,139.69 127.4 191.6 171.3 189.6 226.18 260.68 292.65 YoY 7.6%50.3%-10.5%10.7%19.25%15.26%12.26%28.4%26.2%21.5%16.7%14.10%11.74%9.80%86.9%89.3%88.1%85.2%85.25%85.25%85.25%110.8 171.1 150.9 161.7 192.82 222.23 249.48 25 49 83.8 118.8 114.2 110.0 122.85 135.13 144.62 YoY 23.3%41.7%-3.9%-3.6%11.66%10.00%7.02%18.7%16.2%14.3%9.7%7.66%6.09%4.84%94.2%94.4%94.2%92.9%92.92%92.92%92.92%79.0 112.3 107.6 102.2 114.15 125.57 134.38 47.5 51.5 45.4 52.8 59.93 67.72 73.47 YoY 4.0%8.5%-11.8%16.3%13.30%13.00%8.50%10.6%7.0%5.7%4.6%3.73%3.05%2.46%88.5%89.7%89.0%86.8%86.82%86.82%86.82%42.0 46.2 40.4 45.9 52.03 58.79 63.79 YPEG-G-CSF 58.4 YoY 1.9%90.0%52.5 2.1 4.4 4.5 9.5 10.4 11.5 12.6 YoY 318.4%107.5%3.1%109.2%10.0%10.0%10.0%0.5%0.6%0.5%0.8%0.6%0.5%0.4%95.6%96.8%97.8%75.2%70.0%70.0%70.0%2.0 4.2 4.4 7.15 7.3 8.0 8.8 2022 26 50 2022-2024 2.8/4.5/6.5 53%/62%/45%2023 45 PE 49.50 51 2023.1.19 EPS PE 2020A 2021A 2022E 2023E 2024E 2020A 2021A 2022E 2023E 2024E 300357 56.37 0.53 0.65 0.77 0.97 1.24 144.22 88.76 72.91 57.87 45.55 688319 17.20 0.10 0.28 0.25 0.42 0.63-134.42 67.94 40.84 27.15 300142 40.99 0.65 0.27 0.74 1.12 1.36 59.43 210.39 55.57 36.55 30.29 72.59 45.08 32.48 688278 43.37 0.29 0.45 0.70 1.10 1.61 119.00 65.73 56.69 34.89 24.01 Wind 2023/01/19 0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%2019A 2020A 2021A 2022E 2023E 2024E 27 2023 1 17 IPO 45.26%138.0 33.94%32.5 8%1.6 0.38%0.5 0.13%28 2019 2020 2021 2022E 2023E 2024E 2019 2020 2021 2022E 2023E 2024E 730 794 1,132 1,590 2,199 2,956 206 197 285 339 652 1,081 8.8%42.6%40.4%38.3%34.5%157 197 228 274 379 510-80-84-125-170-241-334 71 100 116 145 205 284%11.0%10.5%11.1%10.7%11.0%11.3%12 279 205 209 214 220 650 710 1,007 1,420 1,957 2,622 445 773 834 967 1,450 2,095%89.0%89.5%88.9%89.3%89.0%88.7%56.4%64.8%58.6%56.3%65.7%73.3%-4-4-6-8-11-15 0 0 0 0 0 0%0.5%0.5%0.5%0.5%0.5%0.5%96 127 179 281 282 286-420-429-598-844-1,106-1,416%12.2%10.6%12.6%16.4%12.8%10.0%57.5%54.0%52.8%53.1%50.3%47.9%220 251 316 354 357 359-62-74-103-132-176-228 345 420 590 750 755 762%8.5%9.4%9.1%8.3%8.0%7.7%43.6%35.2%41.4%43.7%34.3%26.7%-53-77-82-114-154-208 790 1,193 1,424 1,717 2,206 2,856%7.3%9.7%7.2%7.2%7.0%7.0%60 19 16 61 64 9 EBIT 111 127 219 322 511 756 25 34 54 61 89 125%15.2%15.9%19.4%20.2%23.2%25.6%66 62 107 112 152 199-8-1 1 0 0 5 151 115 177 233 306 333%1.1%0.1%-0.1%0.0%0.0%-0.2%0 0 0 0 0 0-3 1 2 0 0 0 76 77 86 87 95 105 0 4 2 0 0 0 226 192 263 320 400 439 0 1 5 3 3 4 564 1,000 1,161 1,397 1,805 2,417%0.0%0.6%2.3%0.9%0.6%0.5%360 407 407 407 407 407 116 158 249 360 550 803 72 168 312 548 956 1,568 15.9%19.9%22.0%22.6%25.0%27.2%0 0 0 0 0 0-25-19-33-31-22-34 790 1,193 1,424 1,717 2,206 2,856 91 139 215 328 528 770 12.5%17.5%19.0%20.7%24.0%26.0%-27-22-34-52-79-117 2019 2020 2021 2022E 2023E 2024E 29.4%16.2%15.8%15.8%15.0%15.2%64 117 181 276 449 653 0.178 0.287 0.445 0.679 1.104 1.605 0 0 0 0 0 0 1.564 2.459 2.855 3.434 4.438 5.943 64 117 181 276 449 653 0.342 0.228 0.577 0.704 1.041 1.493 8.8%14.7%16.0%17.4%20.4%22.1%0.025 0.050 0.100 0.100 0.100 0.100 11.41%11.65%15.60%19.79%24.87%27.00%2019 2020 2021 2022E 2023E 2024E 8.14%9.77%12.72%16.10%20.36%22.85%64 117 181 276 449 653 12.57%10.37%15.60%18.49%23.12%26.33%0 0 0 0 0 0 40 38 42 50 46 44 62.77%8.81%42.61%40.43%38.29%34.45%6 0-11 22 21 31 EBIT 282%13.76%73.18%46.85%58.67%48.02%13-62 23-62-92-120 302%81.31%55.44%52.55%62.46%45.35%123 93 235 287 424 607 11.59%51.01%19.40%20.57%28.44%29.50%-45-119-191-231-70-82 0-264 79 0 0 0 58.9 66.0 56.3 50.0 50.0 50.0 0 1 0 3 3 4 287.2 371.4 315.2 310.0 310.0 310.0-45-382-112-228-67-78 69.2 85.4 84.8 82.0 82.0 82.0 0 348 0 0 0 0 29.5 26.8 19.7 28.3 14.8 6.6-10-41-9 41 3-56-8-26-25-43-45-43/-25.87%-44.63%-40.13%-33.97%-43.44%-52.47%-18 281-34-2-42-99 EBIT 13.8 148.5-200.7 732.1 1,763.7-146.6 61-9 88 56 315 430 28.65%16.13%18.46%18.64%18.14%15.37%29 1 2 3 4 1.00=1.012.0=2.013.0=3.014.0=6 12 15%6 12 5%15%6 12-5%5%6 12 5%30 C3(C3 021-60753903 021-61038200 201204 1088 7 010-85950438 100005 26 8 0755-83831378 0755-83830558 518000 1-1 T3-2402