歌礼制药有限公司2025年度报告

2345830346177124129130131133135136201 24840 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 183171712-1716 1526 108 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 1672 www.ascletis.com (i)ASC30GLP-1IIIII(ii)ASC30GLP-124(iii)GLP-1R/GIPRGLP-1R/GIPR/GCGR AI(ArtificialIntelligence-assisted Structure-Based Drug Discovery AISBDD)(Ultra-Long-Acting PlatformULAP)(Peptide Oral Transport ENhancementTechnologyPOTENT) (i)ASC30GLP-17.7%III(ii)ASC30GLP-113II(iii)ASC30GLP-1(depot)13(lead-in)167.5%(depot)(observedhalf-life)4675ASC304(iv)ASC47THRβ2956.2%ASC4740ASC35II(v)ASC39eloralintideFDAASC39IND(vi)ASC36FDAASC36IND(vii)ASC36FDAASC36IND(viii)ASC35GLP-1R/GIPRFDAASC35IND(ix)ASC36ASC35GLP-1R/GIPRFDAASC36_35FDCIND(x)ASC37GLP-1R/GIPR/GCGRFDAASC37IND(xi)ASC36ASC37GLP-1R/GIPR/GCGRFDAASC36_37FDCIND(xii)ASC50IL-17A104IL-17AASC50710600ASC50(dose-proportional)SADASC50(xiii)(ASC40)FASN12(ASC40)33.2%14.6%(ASC40)57.4%35.4%(ASC40)63.5%43.2%(ASC40)III(ASC40) IIIIII(ASC40) 1,932.61,980.8 302.435.3%409.1300.919.6%359.9 35.3%19.6%(i)(ii)(iii) 1.SagimetASC40 GLP-1R-1GIPRGCGRTHRββIL-1717FASN ASC30 GLP-1RASC3013II(NCT07002905)125BMI≥30.0 kg/m2BMI≥27.0 kg/m2 ASC3013ASC302040605.4%7.0%7.7% 80.0%60ASC30≥5%4.2%45.0%60ASC30≥7%4.2% ASC30ASC30(LDL-C)ASC30 (titratedweekly)ASC30orforglipronASC30orforglipronIIIATTAIN-1(titrated every four weeks)ASC30II(AE)123ASC30II3(SAE)(ALT)(AST)(TBL)QTc IIASC30 ASC30GLP-1RASC30(NCE) ASC30III ASC30 GLP-1RASC30213II(NCT07321678) II10022:3:3:2406080ASC30ASC301(titrated weekly)406080 ASC3013II ASC30 GLP-1RASC30II24(NCT06679959)65A1A2BMI≥30 kg/m227kg/m2≤BMI<30 kg/m2 II3ASC30A112p <0.056.3%ASC30A11316p <0.057.5% ASC30A112Ib(NCT06679959)4675A1(therapeuticdrug exposures) ASC30A1ASC30A11294578400ASC30A14812162.7%5.5%6.3%7.5% ASC304 ASC30A1816ASC30A11685.5%2036.4%2445.8% ASC30A1A2GLP1ASC30A1A2(AE)(GI)12QTc ASC30(lead-in)4GLP-1 ASC30ASC30 ASC30 ASC47 ASC47 29ASC47BMI≥30 kg/m256.2% ASC47-103(NCT06972992)ASC470.5(volume-matched)0.54628ASC471030600.528ASC47 ASC47ASC47ASC47 ASC47ASC47ASC476.7%57.1%(TSH)(FT3)(TT3)(FT4)(TT4)TEAE(telemetry)(ECG)QTc (titration)TEAE T H RβA S C 4 756.2%II ASC47ASC35II ASC39 ASC39 eloralintide(cAMP)ASC39eloralintideASC39eloralintide1(hAMY1R)EC5021.4pM21.2 pMASC39eloralintide(hCTR)EC50846.1 pM1,350.8 pMhCTRASC39eloralintidehAMY1R eloralintide(DIO)ASC39eloralintideASC396.6%eloralintide5.6% FDAASC39IND ASC36 ASC36 (NHP)ASC36MET-233i6 DIOASC36petrelintide91% ASC36pH(no fibrillation around neutral pH)GLP-1R/GIPRASC35 FDAASC36IND ASC36 ASC36 (POTENT)ASC366%8% 167 ASC36713.2%ASC36 DIO7eloralintidepetrelintideASC3632%91% ASC36ASC36 ASC36AIArtificial Intelligence-assisted Structure-Based DrugDiscoveryAISBDDASC36POTENT FDAASC36IND ASC35 GLP-1R/GIPRASC35 (NHP)ASC35146 ASC3580%70% ASC35GLP-1RGIPR4 DIOASC3571% FDAASC35IND ASC36_35 FDC ASC36GLP-1R/GIPRASC35 ASC36GLP-1R/GIPRASC35ASC36ASC35(ULAP) DIOASC36eloralintide32%DIOASC3571% DIOASC36ASC35eloralintide51% DIOASC36ASC35MET-233i47%eloralintide98% ASC36ASC35pH FDAASC36_35FDCIND ASC37 GLP-1R/GIPR/GCGRASC37 (NHP)ASC37156 GLP-1RGIPRGCGRASC37retatrutide12116 FDAASC37IND IL-17ASC50 I(NCT07024602)(SAD)ASC50IL-17A 1 03 01 0 02 0 04 0 06 0 0A S C 5 0(elimination half-life)4389 91 87 10485 ASC50IL-17AASC507 10600ASC50(dose-proportional) LY4100511DC-853IL-17ASC50 SADASC50(AE)1(SAE) ASC50 ASC50IL-17IL-17ASC50(NCE)2043 ASC50(MAD) (ASC40) F A S N(ASC40)III(NCT06192264)III(NCT06248008)(ASC40)(NMPA) III(NCT06192264)(ASC40)4801:150(ASC40)12(ASC40) FASN(ASC40)12(ASC40)33.2%14.6%p <0.0001(ASC40)57.4%35.4%p <0.0001(ASC40)63.5%43.2%p <0.000112(ASC40)51.9%28.9%p <0.0001 50(ASC40)12(ASC40)(TEAE)TEAE10%TEAE5%(ASC40)6.3%2.9%(ASC40)5.9%3.8%(ASC40)(AE)(ASC40)34(ASC40)(SAE) (ASC40,18.6%)(FDA)sarecycline9.4%doxycycline6.7%98%178% ( A S C 4 0 , 1 8 . 6 % )F D A(clascoterone)(11.6%)60% III(NCT06248008)(ASC40)24024040(ASC40)12(ASC40) (ASC40)(TEAE)12(ASC40)34AE(ASC40)SAE (ASC40)(1)(DNL)(2)Th17(ASC40)(ASC40) (ASC40)IIIIII NMPA(ASC40)(NDA) (i)AI(AISBDD)(ii)(ULAP)(iii)(POTENT) 18A.08(3) 17,000 10 1.ASC30III2.ASC3013II3.ASC304.ASC47ASC35II5.FDAASC39IND6.FDAASC36IND7.FDAASC36IND 8.FDAASC35IND 9.FDAASC36_35 FDCIND 10.FDAASC37IND 11.FDAASC36_37 FDCIND 12.ASC50(MAD) 13.NMPA(ASC40)(NDA) 14. 15. 121.1127.4 119.84.6%125.3(i)22.7SagimetSagimet1.7(ii)SagimetSagimet24.524.5(iii)21.137.321.1Sagimet 101.726.1%75.2 (i)(ii)(iii) 302.435.3%409.1 0.20.2 11.893.4%0.8 1 1. 0.5 4.457.1%1.9 0.2 3090 9.19.1%9.9 1.2184.0%3.5 53.556.4 7.426.1 66.069.4 45.730.6 13.717.2 15.34.011.2 416.8421.24.4 662.2580.1 345.2428.0 2.032.0%1.3 (a)Viking Viking Therapeutics, Inc.VikingASC41ASC43FITCUSDC ITCITCASC41ASC43F1930337567,0004,038,000 USDCVikingUSDC (b) 25(i)(ii)(iii) 0.60.6 (1)(2)(3) (1)(2)(3)100% 12.915.112.815.0 7.5%6.4% 20280.2% 188.1136.1 7.06.4 63 •PowerTree••••••AP11 Limited•SoundRidge