歌礼制药-B2024中期报告

中 期 報 告2024 2 5 30 35 36 37 38 40 42 43 55 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 198D12 24840 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 183171712-1716 1526 1672 www.ascletis.com 108 2,117.22,516.4 92.343.5%132.4 16.6687.0%130.3 46.5100%75.034.7%49.0121.559.7%49.0 (i)THRβASC41NASH52II(ii)SagimetF2/F3NASHASC40IIbFASCINATE-2(iii)ASC40III(iv)(v)2024ASC40II(vi)2024ASC41MASH52II12 1.ASC22 mAbPD-L11CHBHIVRdRpCOVID-193CLPro 1.NASH 2.SagimetASC40 FASNTHRββNASH 1.SagimetASC40 FASNVEGFPD-L11 1.SagimetASC40 FASN ASC22 ASC2249HBsAg≤100 IU/mL24 ASC2249HBsAg≤100IU/mL(Q2W)1.0ASC22ASC22n=40n=94:124(NAs)24ASC2224HBsAgNAsHBsAg50%24ASC22ASC22NAsHBsAg2421.1%(4/19)HBsAgASC22 8,6001591NAsRNADNAcccDNARNAHBsAgASC22PD-1/PD-L1HBsAg ASC22CHB 1.Lim J K, Nguyen M H, Kim W R, et al.Prevalence of Chronic Hepatitis B Virus Infection in the United States J. TheAmerican journal of gastroenterology 2020, 115(9): 1429-38. (RSV)ASC10 FDAASC10RSVIIa ASC10ASC10ASC10-ANHCEIDD-19311ASC10-A(NHC)HEp-2(EC50)0.510.6uM1ASC10-A(NHC) 6,400162AstuteAnalytica14.9%423 ASC10RSV IIa HIVASC22 ASC22HIVII(ClinicalTrials.gov: NCT05129189)15HIV124ASC22110ARTIIASC22HIV812CAHIVRNA4.273.41(P =0.001,P =0.006)CA HIV RNADNAP =0.038,P =0.017) IIASC224112.5ARTHIV-11212II 1.Jeong-Joong Yoon, Mart Toots, Sujin Lee, et al. Orally Efficacious Broad-Spectrum Ribonucleoside Analog Inhibitorof Influenza and Respiratory Syncytial Viruses. Antimicrob Agents Chemother. 2018; 62(8): e00766-18.2.https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv3.https://www.astuteanalytica.com/industry-report/respiratory-syncytial-virus-market 3,900HIV63HIV1301 ASC22HIV ASC10ASC11 ASC10IIIASC11IIIIIASC10 IIIASC11 IIIII ASC10ASC11 ASC40 SagimetASC402/3NASHIIbFASCINATE-216823NASH52ASC4036%NASHNAS≥213%(p=0.002)52%NAS≥220%(p=0.0001)ASC40 2bFASCINATE-252168NAS≥4F2F3NASH 2:150 2bASC40F2F3NASH 1.UNAIDS. Global HIV & AIDS statisticsFACT SHEET. 2022.https://www.unaids.org/en/resources/fact-sheet ASC41 NASHASC41II MRI-PDFFASC41ASC4193.3%30%30%NASHTHRβNASHASC411268.2%12(ALT)(AST)37.8%41.5%12(LDL-C)(TC)(TG)27.7%23.4%46.5%ASC41(AE)(GI) ASC41THRβASC41ASC41 II(ClinicalTrials.gov:NCT05462353)180NASH1:1:1ASC41245244212ASC41 ASC41II rGBMASC40 ASC40rGBMIII ASC40FASNFASN(DNL)ASC40DNL1 IIIClinicalTrials.govNCT05118776rGBM1801:11ASC40+2+12093 GBMIV2GBM57%2.854.561046.4GBM3GBM56.6%3.2110490%GBMrGBM ASC40rGBMIII ASC61 ASC61I ASC61IIII 1.Fhu CW, Ali A. Fatty Acid Synthase: An Emerging Target in Cancer. Molecules. 2020;25(17):3935. doi:10.3390/molecules 25173935.2.Louis N, Perry A, Reifenberge RG, von Deimling A, Figarella-Branger D, Cavenee WK, et al. The 2016 World HealthOrganization classification of tumors of the central nervous system: A summary. Acta Neuropathol. 2016;131:803-20.3.20174.Ostrom Q T, Gittleman H, Truitt G, et al. CBTRUS Statistical Report: Primary Brain and Other Central NervousSystem Tumors Diagnosed in the United States in 2011-2015[J]. Neuro Oncol 2018, 20 (suppl_4): iv1-iv86. DOI:10.1093/neuonc/noy131. ASC61PD-L1PD-L1PD-1/PD-L1ASC61(AtezolizumabFDAPD-L1 PD-1/PD-L1PD-L1ASC61(1)(2)(3)(4)(5) ASC61I ASC40 ASC40IIIFASNASC40II IIIASC404801:150ASC4012 ASC40FASNASC40(1)DNL(2)Th17SagimetASC40 6.4130%40%2AASC40 1.Tan J K, Bhate K. A global perspective on the epidemiology of acne[J]. Br J Dermatol 2015, 172 Suppl 1(3-12).DOI: 10.1111/bjd.13462.2.Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the AcneTreatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055. ASC40III 18A.05 17,000 11 1.ASC41NASHII 2.ASC40F2F3NASH3.ASC40III4.ASC40rGBMIII5.6.7. 2,117.22,516.4 46.5100.0% 75.034.7%49.0(i)24.5SagimetSagimet24.55(ii)Sagimet14.4(iii)17.987.0%2.321.1Sagimet 25.959.4%41.4 (i)(ii)(iii) 92.343.5%132.4 1.PBC 0.10.07 0.560.4%0.2 6.16.8%6.5 5.4100.0%® 3090 3.812.9 14.311.5%12.6 4.17.9%4.5 1.4 40.3SagimetSagimet5 24.85.0 34.09.5%37.2 40.930.5 56.112.0 7.16.4 203.4149.1 261.6243.0 45.5 5.272.6%1.4 VikingASC41ASC43FVikingViking 0.9 (1)(2)(3)100% 16.624.416.524.3 4.2%6.0% 21921779.5% 76.855.3 17 a) b)4,563,000855,000 (%)0.00(%)73%(%)3.36%2.20-2.801.30(%)0.00 92,055,34598,355,345 6,300,000 0.0062 C.2.1 29,963,00045,846,210.00 29,963,000 (1)SagimetSGMT(2) 13.51B(1) XV352 (1)L(2)1,012,758,000(3)JJW12Limited(BVI)514,393,664(4)1,155,5001,000,000(5)LakemontHolding LLC82,827,414Lakemont Holding LLCLakemontRemainder Trust45.95%Northridge Trust53.52%Lakemont Remainder TrustNorthridge TrustLakemont Holding LLC(6)1,155,5001,000,000 352 336 (1)L(2)1,012,758,000(3)JJW11 Limited(4)JJW12Limited(BVI)514,393,664(5)Lakemont Holding LLCLakemont Remainder Trust45.95%Northridge Trust53.52%Lakemont Holding LLC(6)C-Bridge Capital GP, Ltd.64,154,727C-Bridge Capital GP, Ltd.TF Capital II, Ltd.TF Capital,Ltd.38.34