亚盛医药-B2023年中期报告

（於開曼群島註冊成立的有限公司）股份代號：6855 2101213143255565758606162 97927 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands David Sidransky FCPA, FCG, HKFCG 68 FCPA, FCG, HKFCG 9517B 1 Wilson Sonsini Goodrich & Rosati1151509 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 1617 6855 ascentage.cn •2023630202263095.846.949.0%142.7®36.7%2023630 •2023630202263037.020.054.1%17.0(i)202171420236302.8202263016.6(ii)20236307.5202263012.9 •202263071.312.016.8%202363083.3® •2022630341.431.69.3%2023630309.8 •2023630202263082.39.010.9%91.3 •20236304.2202263015.911.773.6%(i)20236300.520226307.4(ii)20236300.220226307.1 •20236302022630406.74.4402.3 •20236301,581.6202212311,492.289.46.0% •2023630®BCR-ABL202111303.9®®202312022 •20237®(NMPA)(CDE)(Ph+ALL)III®CDE(SDH-deficientGIST)2023ASCO®SDHGISTIb/IITKISDHGIST •20238FDAlisaftoclax(APG-2575)(CLL/SLL)IIIlisaftoclax(APG-2575)2023ASCOlisaftoclax(APG-2575)(WM)Ib/IIAACR(HQP1351)lisaftoclax(APG-2575)(GISTs) •2023ASCOalrizomadlin(APG-115)(pembrolizumab)(IO)IIalrizomadlin(APG-115)(pembrolizumab)(MPNST)II2023AACRalrizomadlin (APG-115)(mitogen-activated protein kinase, MAPK) •ASCOAPG-2449(NSCLC)ALKI •EEDAPG-5918 •(FDA)(EC)(RPD)(ODD)ODD •20234(QualifiedPerson,QP)GMPQPGMP • Bcl-2Bcl-2/Bcl-xLIAPMDM2-p53FAK/ALK/ROS140I/II® M DD a n a -Farber(UNITY) 2023630 ® ®BCR-ABLBCR-ABLT315I®T315ICMLBCR-ABL(Best-in-class)®T315ICML®202312022 ®CDECDE®FDACML(AML)(ALL)(GIST)(ODD)(FTD)TKICML®EMA ®2023 •20237®CDE(Ph+ALL)III®Ph+ ALLTKI •202362023ASCO®GISTIb/IITKISDHGIST•20235®CDEGIST•202342023AACR®®(RCC)CPI•20231®2022T315I(CML)(CP)(CML-CP)(AP)(CML-AP)®CML•TKICML(Ph+ALL)Ib2022 ASH ®2023 •2023(Ph+ ALL)III •FDA•®TKICML-CP2023CDE Lisaftoclax (APG-2575) lisaftoclax (APG-2575)Bcl-2Bcl-2lisaftoclax(APG-2575)Bcl-2Bcl-2lisaftoclax(APG-2575)19Ib/II(CLL)(NHL)(AML)(MM)(WM)600lisaftoclax(APG-2575)300CLL/SLLlisaftoclax(APG-2575)FDA(FL)(WM)(CLL)(MM)AML lisaftoclax (APG-2575)2023 •20238FDAlisaftoclax(APG-2575)CLL/SLLIII•20236ASCOlisaftoclax(APG-2575)WMIb/IIlisaftoclax(APG-2575)BTKiWM•20234AACR(HQP1351)lisaftoclax(APG-2575)(GIST)lisaftoclax(APG-2575)GIST•lisaftoclax (APG-2575)AML/MDSIb/II•lisaftoclax (APG-2575)AML/MDSIb/II•lisaftoclax (APG-2575)MMIb/II•lisaftoclax (APG-2575)MMIb/II •lisaftoclax(APG-2575)WMIb/II lisaftoclax (APG-2575)2023 •2023CLL/SLLII2024•lisaftoclax (APG-2575)CLL/SLLIII 18A.08(3)LISAFTOCLAX (APG-2575) Alrizomadlin (APG-115) alrizomadlin(APG-115)MDM2-p53PPIMDM2-p53p53alrizomadlin(APG-115) alrizomadlin (APG-115)FDAAMLIIB-IValrizomadlin(APG-115)FDA alrizomadlin (APG-115) •alrizomadlin (APG-115)Ib/II•alrizomadlin(APG-115)(Azacytidine)AML(CMML)MDSIb/II•alrizomadlin (APG-115)II CDEalrizomadlin (APG-115) •alrizomadlin (APG-115)PD-1(JS001)(LPS)Ib/II•alrizomadlin(APG-115)AMLMDSIb•alrizomadlin(APG-115)lisaftoclax(APG-2575)I alrizomadlin (APG-115)2023 •20236ASCOalrizomadlin(APG-115)(pembrolizumnb)(IO)IIalrizomadlin (APG-115)(pembrolizumnb)PD-1/PD-L1IO •20236ASCOalrizomadlin(APG-115)(pembrolizumnb)(MPNST)IIalrizomadlin(pembrolizumnb) •20234AACRMDM2alrizomadlin(APG-115)(mitogen-activatedprotein kinase,MAPK)(UM)alrizomadlinMAPK 18A.08(3)ALRIZOMADLIN (APG-115) Pelcitoclax (APG-1252) p e l c i t o c l a x( A P G -1252)B c l -2B c l - x L(SCLC)(NSCLC)(NET)(NHL)APG-1252FDASCLC 2023630205pelcitoclax(APG-1252)SCLCIpelcitoclax (APG-1252) pelcitoclax (APG-1252) •pelcitoclax (APG-1252)EGFRNSCLCIb•pelcitoclax (APG-1252)Ib•pelcitoclax(APG-1252)(NHL)Ib/II 202310ESMOpelcitoclax(APG-1252)EGFR(NSCLC) 18A.08(3)PELCITOCLAX (APG-1252) IND APG-1387 APG-1387(IAP)IAP APG-1387260APG-13872023 •APG-1387(CHB)I •APG-1387CHBIIIIIAPG-1387 •APG-1387PD-1I•APG-1387PD-1Ib/IIIbII(NPC)10PD-1NPCRicist 1.141CR3PR•APG-1387I/II3AG2PR 18A.08(3)APG-1387 APG-2449 APG-2449FAK/ALK/ROS1ALKALKEML4-ALKL1196MBa/F3APG-2449ALK(P-ALK)APG-2449ALKALK TKI APG-24492023 •APG-2449 I2023ASCO oAPG-2449TKITKIALKNSCLCROS1NSCLCoFAKALKNSCLC•APG-2449Ib/II 18A.08(3)APG-2449 APG-5918 APG-5918EEDAPG-5918APG-5918ß-ß-APG-5918(DMPK)(TOX) APG-59182023 •20231APG-5918CDE 18A.08(3)APG-5918 Bcl-2 Bcl-2Bcl-2 20222023630341.4309.8 2023630468336 2023630®303.9100(HK.1801)117260DTP800 2023(HCP)®® ®202312022T315ICML-CPCML-AP202331®CML®® 20212022 20,0002.52022ABiotechBiopharma 20234(QualifiedPerson,QP)GMPQPGMP 4,500 2023 2023 20236302022630 2023630142.7202263095.8362.62022630363.52023630402.32022630406.7202363083.3202263071.32023630309.82022630341.4202363091.3202263082.3 2023630142.7202263095.846.949.0%36.7% (i)(ii)(iii) 202263037.020.054.1%202363017.0(i)20236302.82021714202263016.6(ii)20236307.5202263012.9 202363012.016.8%83.3202263071.3® 20236302022630341.431.69.3%309.8 2023630202263082.39.010.9%91.3 2023630202263019.133.6175.9%52.7 (i)(ii)(iii)(iv) 20236304.2202263015.911.773.6%(i)20236300.520226307.4(ii)20236300.220226307.1 Unity 2022630406.74.42023630402.3 2023630368.52022630335.2® 202363064.8(i)34.8(ii)30.02022630142.614