圣诺医药-B2023年度报告

2023 目錄 2467344484102108109111114116206211 公司資料 David Mark Evans Michael V. Molyneaux20231130 2023831 Sirnaomics, Inc.20511 Seneca Meadows Parkway, Suite 200GermantownMD 20876U.S. 218A4415 18346 公司資料 1 PO Box 309, Ugland HouseGrand Cayman, KY1-1104Cayman Islands Wells Fargo Bank, N.A.420 Montgomery StreetSan FranciscoCA 94104U.S. Maples Fund Services (Cayman) LimitedPO Box 1093, Boundary HallCricket SquareGrand Cayman, KY1-1102Cayman Islands 127 183171712–1716 A23 8835 Maples and Calder (Hong Kong) LLP1826 99 www.sirnaomics.com 12 Marina BoulevardDBS Asia CentralMarina Bay Financial Centre Tower 3Singapore 018982 2257 主席報告 20231231Sirnaomics 2023FDASTP705isSCC IIaIIbSTP705IRNAi2023STP70750 I11siRNAPNPRNAGalAhead™muRNA™STP122GI 主席報告 RNA Sirnaomics 管理層討論與分析 Sirnaomics2007RNASirnaomics— PNPGalAheadTM STP705STP707(NMSC)PNP2023FDAIIFDASirnaomicsSTP705SirnaomicsFDAII/IIIIIIFDASTP705 STP707IFDA1150STP707(SD)10SD3.512mg24mg48mg48mgSD4.5STP707T(TME)SDSTP707 STP705STP707RNAi 管理層討論與分析 STP705isSCCsiRNAIFDAIIGalNAcGalAhead™mxRNAmuRNAGalAhead™ mxRNASTP122GFDAISTP122GGalAhead™STP122GGalAheadTMmuRNARNA RNAi RNARNAimRNARNAe RNASirnaomicsRNAimmunemRNAEDIRNA 管理層討論與分析 SirnaomicsSTP705STP707STP122GsiRNARNAimmunemRNARV-1730RV-1770FDAIND 1.RNAimmune isSCC =BCC =PNP=(PNP) RNAiPNP-IT =PNPPNP-Subcu =PNPPNP-ID =PNPPNP- IV =PNPGalAheadTM=GalNAcRNAiGalNAc RNAiLNP-IM =mRNA(LNP)RSV =mxRNA-= mxRNA™RNAimuRNA-= muRNA™RNAi 管理層討論與分析 STP705NMSC STP705(STP705)-1(TGF-ß1)2(COX-2)pixofisiran INNlixadesiran INNPNPTGF-ß1COX-2TGF-ß1COX-2STP705PNPNMSCSTP705 STP705 (RF)(DCA)LSRLSRTGF-1COX-2/PTGS2PNPsiRNASTP705LSR(ECG)32STP705LSR DCALSRSTP705DCASTP705LSRSTP705DCASTP705STP705DCALSRSTP705ILSRDCA 管理層討論與分析 STP707 STP707(STP707)STP705siRNAIFDA1150STP707SD10SD3.512mg24mg48mg48mgSD4.5STP707TTMESDSTP707 STP122G STP122GGalAhead™(FXI)siRNAGalNAcISTP122G(DVT) STP705STP707STP122G LNP RV-1770 RV-1770RNAimmunemRNA(RSV)RV-1770mRNAAIRSVRSV AB202312INDFDA 管理層討論與分析 RV-1730 RV-1730(SARS-CoV-2)LNPDeltaSARS-CoV-2mRNA20234INDFDARV-1730RNAimmunemRNA siRNAPNPGalAhead™RNAimmuneLNP PNP STP355 STP355TGF-ß1VEGFR2 siRNATMESTP355PNPSTP355STP355INDSTP355 (3mpk, Q2D)(P<0.05)TGF-1 siRNA(siTF1)FACSSTP355TNKSTP355IND 管理層討論與分析 STP369 STP369BCL-xLMCL-1 siRNAPNPSTP369STP369——STP369 GalAhead™ STP125G STP125GC3(APoC3)siRNAsiRNAGalNAcAPoC3-GalNAc-siRNAGMP STP144G STP144GB(CFB)siRNAsiRNAGalNAcSTP144GGMP STP136G STP136G(AGT)siRNAsiRNAGalNAcSTP136G 管理層討論與分析 STP237G STP237GAGTAPoC3siRNAsiRNAGalNAcSTP237G STP247G STP247GCFB5 (C5)siRNAsiRNAGalNAcSTP247G RNA(1)PNPRNAi(2)GalNAcRNAiGalAhead™siRNA PNP18PNPPNP——RNA—RNAPNP STP705STP707IIIsiRNAsiRNAPNPPNPRNA 管理層討論與分析 GalNAcRNAiGalAhead™SirnaomicsRNAiRNAmRNAmxRNA™RNAimuRNA™RNAimxRNA™30 ntmuRNA™ASGPRsiRNA GMPPNPPNPPNPCDMO(API)(PPQ)PNP GalAhead™CDMO 202120222023PNP2023GalAhead™STP122GGalAhead™Sirnaomics 管理層討論與分析 20232024isSCCSTP705 STP122G2023 STP705 isSCCSTP705 69isSCCSTP705 IIaIIb30BCCIIFDAIIFDAIIaIIbSTP705isSCC20236192024FDAII/III2024FDA BCCSTP705II 2021BCCII2023STP705BCCIISTP705 FDAIISTP705BCCisSCCFDA isSCCBCCsiRNANMSC2024II 管理層討論與分析 STP705I 20225RNAiSTP705I20236ISTP705LSR98STP705(P < 0.05)240g/1.0ml 2023I STP705STP705STP705STP705 STP705 管理層討論與分析 STP707 STP707I STP70750STP707283 mg6 mg12 mg24 mg36 mg48 mg284STP70720238I(RECIST)74%2023850103.512mg24mg48mg48mg4.5STP707TSTP707 TMETGF-ß1COX-2TSTP707PD-L1ISTP707 STP122G STP122GI 20234GalNAcSTP122GIGalNAcsiRNA 管理層討論與分析 20241STP122GI8140PPT140STP122GSTP122G SirnaomicssiRNAGalNAc RNAiGalAhead™ RV-1770 RV-1770 RSVFDAIND 202312RNAimmunemRNAmRNARV-1770FDARV-1770mRNA18-4960-79RV-17701628112RV-1770 RV-1730 RV-1730FDAIND 20234RNAimmuneFDAINDRV-1730SARS-CoV-2IRV-1730mRNASARS-CoV-2RV-1730IFDARNAimmuneRV-1730RNAimmunemRNA 管理層討論與分析 IND 2025STP125GSTP144GINDINDCMCIND 202112 GMP2023STP707GMPGMP50,000150,000200,000 20232RGalAhead™STP122GPNPGalAhead™ EDIRNA EDIRNA2022RNASirnaomicsEDIRNAEdit-to-Cure Therapeutics™RNARNARNAEDIRNA 管理層討論與分析 SirnaomicsPNP2020PCTPCTPNPSirnaomicsRNAimmunemRNARNAimmunePCT 2023GalAhead™RNAiGalAheadTM2023Sirnaomics 20237Francois LebelLebelLebel202312Michael V. MolyneauxLebelLebel30LebelSirnaomics 20238RNAi 管理層討論與分析 SirnaomicsRNARNAi Sirnaomics (1)(2)(3) 管理層討論與分析 STP705STP707 STP705STP705isSCCSTP705BCCSTP707STP705 isSCCSTP7052023IIFDAIIaIIbFDASirnaomicsSirnaomicsFDAIIIIIIIIFDAFDA20242024IIIBCCSTP70520232024STP705STP705 NMSCSTP705STP705 STP705isSCCBCCSTP707IPNPSTP707PNPSirnaomicsRNASTP707STP707IISTP707CCAHCCIISTP707 管理層討論與分析 STP707 — 20236ISTP7052023IRNAiFDA2024II siRNA 2023GalAhead™STP122GmRNARV-1730RV-1770IND GalAhead™GalAhead™STP122GGalAhead™STP125GSTP144G2025IND 管理層討論與分析 STP705STP707GalAhead™ STP705isSCCisSCCSTP705LebelSTP7052027FDAFDAFDAFDA (i)(ii)(iii)(iv)(v)(vi)(vii)(viii)(ix)(x)(xi)(xii)(xiii) 管理層討論與分析 202312312023123185.02022123197.4 20231231 (i)(ii) 管理層討論與分析 202312311.4202212312.10.733%(i)202212311.4202312311.0(ii)202212310.7202312310.4 (