亚盛医药-B2023年报

Ascentage Pharma Group International （於開曼群島註冊成立的有限公司）股份代號：6855 2 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 www.ascentagepharma.com * 20231231 2023®BCR-ABL1202312022202332022®2023259%567%®123%2023®362.1 ®(NMPA)(CDE)(TKI)(CML)(CP)(CML-CP)®(NCCN)(CML) ®402023 (FDA)(CDE)5(i)20242®(FDA)(HQP1351)(CML-CP)T315I3(ii)20237®(NMPA)(CDE)(Ph+ALL)III(iii)202312(NMPA)(CDE)lisaftoclax(APG-2575)(AML)III(iv)202310(NMPA)(CDE)lisaftoclax(APG-2575)(CLL/SLL)III(v)20238FDAlisaftoclax(APG-2575)(CLL/SLL)III 2023®lisaftoclax(APG-2575)alrizomadlin(APG-115)pelcitoclax(APG-1252)APG-24492023(ASCO)(ASH)(AACR)(ESMO)®ASHASHlisaftoclax(MM)(AML)(MDS) 20234(Qualified Person, QP)GMPQP2023lisaftoclax(APG-2575)GMPFDA ®lisaftoclax 2024327 BCR-ABL1TKI,Bcl-2Bcl-2/Bcl-xLIAPMDM2-p53FAK/ALK/ROS140I/II® M DD a n a -Farber(UNITY) 20231231 ® ®BCR-ABLBCR-ABLT315I®T315ICMLBCR-ABL®(Best-in-class)CML,Ph+ALL®202312022 ®CDECDE®FDACML(AML)(ALL)(GIST)(ODD)(FTD)TKICML®EMA ® (NCCN)(CML) •202311®CDE(TKI)(CML-CP) •20235®CDEGIST •20231®2022T315I(CML)(CP)(CML-CP)(AP)(CML-AP)®CML •20242FDA(CML-CPT315IIII(POLARIS-2) •20237®CDE(Ph+ALL)III®Ph+ALLTKI •20231265ASH®(TKI)(CML-CP)IIPh+ALLII•2023102023(ESMO)®(TKI)(GIST)•202362023ASCO®GISTIb/IITKISDHGIST•202342023AACR®®(RCC)CPI ®2024 •( C M L )( C P )I I I(POLARIS-2)•(Ph+ALL)•CDEGIST Lisaftoclax(APG-2575) lisaftoclax(APG-2575)Bcl-2Bcl-2lisaftoclax(APG-2575)Bcl-2Bcl-2lisaftoclax(APG-2575)21Ib/II(CLL)(NHL)(AML)(MM)(WM)800lisaftoclax(APG-2575)400CLL/SLLlisaftoclax(APG-2575)FDA(FL)(WM)(CLL)(MM)AML Lisaftoclax(APG-2575) •2 0 2 31 2( N M P A )( C D E )lisaftoclax(APG-2575)(AML)III•2 0 2 31 0( N M P A )( C D E )l i s a f t o c l a x(APG-2575)(BTK)III(CLL/SLL)•20238FDAlisaftoclax(APG-2575)BTKCLL/SLLIII•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 •202312ASH(CLL)BTKCLLlisaftoclax(R/R)(MM)AML MDS •20236ASCOlisaftoclax(APG-2575)WMIb/IIlisaftoclax(APG-2575)BTKiWM•20234AACR(HQP1351)lisaftoclax(APG-2575)(GIST)lisaftoclax(APG-2575)GIST lisaftoclax(APG-2575)2024 •2024•CLL/SLL 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) 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 •20236ASCOalrizomadlin(APG-115)(pembrolizumnb)(IO)IIalrizomadlin(APG-115)(pembrolizumnb)PD-1/PD-L1IO•20236ASCOalrizomadlin(APG-115)(pembrolizumnb)(MPNST)IIalrizomadlin(pembrolizumnb)•20234AACRMDM2alrizomadlin(APG-115)(mitogen-activated proteinkinase, 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 20231231205pelcitoclax(APG-1252)SCLCIPelcitoclax(APG-1252) pelcitoclax (APG-1252) Pelcitoclax(APG-1252) pelcitoclax(APG-1252)(EGFR )NSCLCIb pelcitoclax(APG-1252)Ib •pelcitoclax(APG-1252)(NHL)Ib/II •2023102023(ESMO)(minioral)Bcl-2/Bcl-xLAPG-1252EGFR(NSCLC)EGFRNSCLC•(ClinicalCancer Research)BCL-2/BCL-xLPelcitoclax 18A.08(3)pelcitoclax(APG-1252) IND APG-1387 APG-1387(IAP)IAP 20231231APG-1387260 APG-1387 •APG-1387(CHB)I •APG-1387CHBIIIIIAPG-1387 •APG-1387I •APG-1387PD-1Ib/IIIbII(NPC)10PD-1NPCRicist1.151CR4PR•APG-1387I/II4AG2PR 18A.08(3)APG-1387 APG-2449 APG-2449FAK/ALK/ROS1ALKALKEML4-ALKL1196MBa/F3APG-2449ALK(P-ALK)APG-2449ALKALKTKI APG-2449 •APG-2449I2023ASCOAPG-2449TKITKIALKNSCLCROS1NSCLCFAKALKNSCLC •APG-2449Ib/II 18A.08(3)APG-2449 APG-5918 APG-5918EEDAPG-5918APG-5918ßßAPG-5918(DMPK)(TOX) APG-5918 •20231APG-5918CDE•202311ASHAPG-5918(CKD) 18A.08(3)APG-5918 PROTACsMDM2 (PROTACs)MDM2APG-265MDM2 Bcl-2 Bcl-2Bcl-2 20231231743.1707.0 20231231498352 100(HK.1801)1178002023DTP526 2023(HCP)®® ®202312022(NRDL)T315ICML-CPCML-AP202331® 202311®TKICML-CP2024 (NCCN)(CML) 20212022 20,0002.52022ABiotechBiopharma 20234(QualifiedPerson,QP)GMPQPGMP 2023lisaftoclax(APG-2575)GMPFDA 4,500 1. 20231231222.020221231209.7899.520221231821.420231231925.720221231882.920231231195.420221231157.420231231707.020221231743.120231231181.120221231170.6 2. 20231231222.020221231209.712.35.9% 3. (i)(ii)(iii) 2022123167.07.711.5%2023123159.3(i)2022123133.62023123119.4(ii)202312312.820217142022123119.4(iii)2023123132.4202212319.7 4. 2023123138.024.1%195.420221231157.4 5. 2023123120221231743.136.14.9%707.0 6. 2023123120221231170.610.56.2%181.1 7. 202312312022123152.84