三生制药2023 年度报告

(於開曼群島註冊成立的有限公司)股份代號：1530 年度報告 rhEPOrhTPOIQVIA1265.0%rhEPOrhEPO42.2%CPA72.6%TNFTNF22.7%CDMO 292515771311RABRVO41 25pegsiticase1PD-1 5,41210,000 Cricket Square, Hutchins DrivePO Box 2681Grand Cayman, KY1-1111Cayman Islands 3485 13 Conyers Trust Company (Cayman) LimitedCricket Square, Hutchins DrivePO Box 2681Grand Cayman, KY1-1111Cayman Islands •97914 183171712–1716 77334 77 Conyers Dill & Pearman8129 97927 01530 www.3sbio.com 5TNF(301S)(TRK820)(MN709)29 •NuPIAO (rESP, SSS06)NDA (TRK820) •VEGF(601A)BRVO •(WS204)IND •®ITPIL-4R(611)ADIL-1(613)AG •(302H)HER2•IL-5(610)II•IL-17A(608)IIIND•IL-4R(611)ADCOPDADIND•IL-1(613)IND•PD-1VEGF(707)•IL-33(621)COPDIND 2616PD-1Nofazinlimab (CS1003)CDMOCS1/BCMACAR-T (SA102) MSCI ESG ESGMSCI ESGAA84% 3 III III78%(TPO) ®NDA ®OD2.5gNDAHJ202300912023LP00912 PD-1Nofazinlimab 2616PD-1Nofazinlimab (CS1003)nofazinlimab(HCC)III601CDMO 5% IIIROGAINE® ITP ITPITP rhTPOCITITPCITITP CITITP(CSCO)CTIT20224rhTPOI20205rhTPOITPITPITP20196rhTPOCITrhTPO 1IL2333.4%65.0%ITPNDAIII CKDCIArhEPOrhEPO10,000IU12345 IITNFRAASRAASTNFTNF22.7%CMATNFRATNFRATNFEULAR2022(GRAPPA)202172024301SNDA FcHER2HER2HER2(CSCO)2022HER2I2022(ASCO)82024 OTCAGAFDA123AGA20225%(FAGA) 72.6%25.8%123ROGAINE®5% 2.53-4% ® TRK-820Remitch®NDATRK-820 DOPPS (Dialysis Outcomes and Practice Patterns Study)39%19% TRK-820(kappa)-opioidTRK-820TRK-8205μg2.5μgTRK-820 TRK-8209HBV9,000HCV1,00070017,300–31,0006,2004620%–70%20%–60%20%–50%5.1%–58.4%HCV8%–36.2%HBV1057.8%Remitch TRK-820 CDMO CDMO)Sirton Pharmaceuticals S.p.A.Sirton500GMPCDMO7.6 CDMOmRNA(CMC)10L10KL2DMFCDMOPIC/SSirtonGMP CDMOCDMO1.742 Winlevi® Cosmo Pharmaceuticals N.V.Cosmo1%WS204CosmoCassiopeaWinlevi® 201995%3%–7%11025 WS2041%CosmoAR12Winlevi®FDA40FDA(MOA)1%CosmoWinlevi®15,000670,000WS204AR SSS06NuPIAOrhEPO608IL-17ACS1003PD-1601ABRVOVEGF613IL-1ßRD-01rhEPO611IL4R610IL-5SSS07RATNFpegsiticaseHIF-117SSS17HIF(Winlevi) 600 292515771311RABRVO41 (1) (MN709)MN709ROGAINE®MN709ROGAINE®NDA (TRK820)NDAIIINDA (TPO)rhTPOITPITPNDAIIINDA Pegsiticase (SSS11)Swedish Orphan Biovitrum ABSOBISobiSEL-212SEL-212pegsiticasepegadricaseSSS11b NuPIAO (EPO, SSS06)SSS06 IL-17A(608)608BLAIND VEGF(601A)601ABRVO IL-4R(611)aAD611ADIND611(CRSwNP)IND611COPDIND IL-1ß(613)613IND (WS204)WS204IND IL-5(610)610Ib32 HER2 HIF-117 (SSS17)SSS17HIFHIFSSS17rhEPO IND PD-1/VEGF(707)707CLF2PD-1/VEGFFDA NGF(SSS40)(NGF)aSSS40Ib/IIa IL-33(621)COPDINDCOPDIND (SSS39)SSS39 2,7241,1462,0612,9007,30025 20222023–2027CDMO ®608IL-17ACDMO 7,815.96,865.7950.213.8% 4,204.63,397.2807.423.8%53.8% 940.31,129.5189.216.8%725.3843.2117.914.0%215.0286.271.224.9%12.0% 1,142.3907.5234.825.9%1,124.1893.7230.425.8%14.6% 565.3511.653.710.5%7.2% CDMO174.0165.98.14.9%CDMO (1)(2)827.7790.337.44.7%226.0159.466.641.8% 1,194.21,174.315.0% 6,641.65,671.6970.017.1%82.6%85.0% 305.1749.9444.859.3% 3,006.22,580.5425.716.5%38.5%37.6% 480.8393.487.422.2%6.2%5.7% 794.8693.8101.014.6%10.2%10.1% 444.3337.1107.231.8% 212.3102.7109.6106.7%320,000,000188.448.1140.3291.7%12 392.2370.721.55.8%19.8%16.3% EBITDA EBITDA2,615.1226.08.6%2,389.1EBITDAEBITDA(a)(b)(c)(d)(e)(f)(g)(h)EBITDA2,303.8464.620.2%2,768.4 1,549.21,915.7366.519.1%(a)(b)(c)(d)(e)(f)(g)(h)1,952.41,659.1293.317.7% 0.640.7817.9% 2,082.92,134.351.42.4%4,900.3 5,465.17,906.62.55.3 3,574.32,315.01,990.9803.2 1,226.032 29.4%29.3% 1,206.41,210.590.34% 993.61,320.5 (1) Sirton(2)94.71.2%Sirton(1)102.7727.2(2)89.581.1(3)5.442.2 (i)521.7(ii)3,302.65% 1,0001,200 5,4115,2131,271.51,254.4 • • • • 61 1)2)3)4)5)6)7)8)9)10)11)12)13)Strategic International Group LimitedStrategic International 14)15)16)17)18)19)20)21) Fordham University 54 (i)(ii)(iii)(iv)(v)Strategic International(vi)(vii)(viii)(ix) 63 (i)(ii) 56 ATHM2518One Connect Financial TechonologyOCFT6638)ANPCRENNKXINLKZPIN(Northwestern University Kellogg School of Management) 5428Deutsche Bank Asia LimitedUBS Investment Bank Asia 591299JFJF 61(Quintiles Transnational Corp.)SigmaTauresearch Inc.(i)(ii)(iii) ICH E19 IFPMAICH 40152008 43 59 43 41 0.00001 1 91 2510 9356061 5 14.5%15.1%3.9%3.6% 39.7%39.6%12.3%11.9% 5% 14 34 36 9596 3,382.43,624.9 30 84(1) 83(3) 3641 3.133.13 42 89 1033 13.51(2)(a)(e)(g) XVXV78352C3 (i) (L)(1)2,438,920,412(2)440,000440,00041,746,0009,410,895476,774,553(3)24,384,630440,000440,000(4)Known Virtue International LimitedKVIKVI32,197,350 (ii) (L) (1)4.08% (2)0.036%0.032% XVXV78352 Strategic International Group Limited287,600,0001,400,000 336 (L)(1)2,438,920,412(2)DSLCSLCSLDSL476,774,553Lambda International LimitedCSL 42.52%35.65%476,774,553(3)(4)TMF (Cayman) Ltd.476,774,55351,156,89516,486,00032,668,480TMF (Cayman) Ltd. 336 5.242,439,8579.94%225,903,857225,953,857 121%1.00 1 *The Empire TrustThe Empire TrustThe Empire Trust**# 1% 36 Tricor Trust (Hong Kong) LimitedTricor Trust (Hong Kong) Limited (i)40,357,688487,769,0821.65%20.00%(ii)40,357,688487,784,0821.65%20.00% 5 36