亚盛医药-B2025年报

Ascentage Pharma Group International （於開曼群島註冊成立的有限公司）股份代號: HKEX: 6855 NASDAQ: AAPG 2025年 報 211131415435086102106107108110112114 202512Debra Yu202512 202512David Sidransky202512Marc E. Lippman, MD202512Debra Yu20251226 David Sidransky20251230Marina S. BozilenkoDebra YuMarc E. Lippman, MD202512 MarcE.Lippman,MD20251226David Sidransky2025122620251226 FCPA, FCG, HKFCG2025225ACG (CS, CGP), HKACG (CS, CGP)2025225202641CPA202641 97927 FCPA, FCG, HKFCG2025225ACG (CS, CGP), HKACG (CS, CGP)2025225202641CPA202641 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 202512Marina S. Bozilenko202512 68 19906 1 Wilson Sonsini Goodrich & Rosati1151509 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 1617 6855AAPG https://www.ascentage.cn/ 2025202512817.2533.577,325,00029,300,000132.51,031.8202571722,000,000190.11,492.5 2025® ®20257®(BTK)(CLL/SLL)®® 2025®(FDA)(EMA)(HR-MDS)III®HR-MDS®FDAEMA(1LPh+ALL)III®®APG-2449EMAFDA ®®2026 2026325 ®(CML)(ALL)®(CLL)(SLL)(AML)(HR-MDS)(Frost & Sullivan)20351,660 ®BCR-ABL1(TKI)T315ICMLBCR-ABL1TKIT315I(CML)(-CP)(-AP)TKICML-CP®20251®CDEFDAEMATKICMLIIIPOLARIS-2FDAEMAPh+ALLIIIPOLARIS-1(SDH-)(GIST)III Bcl-22025710BTKCLL/SLLCLL/SLLBcl-2Bcl-2®III(1)®BTKBTKCLL/SLL12GLORA(2)CLL/SLLGLORA-2(3)(AZA)AMLGLORA-3(4)AZAHR-MDSGLORA-4 Bcl-2Bcl-2/Bcl-xLIAPMDM2-p53BCR-ABL1ALKFAKROSPRC2(PROTAC)Bcl-2(IAP)MDM2-p53 202512315125020251231374 Dana-FarberMD 720251231 1.202111T315ITKICML-CPCML-AP2022(NRDL)202331 2.202311TKICML-CP2024(NRDL)202511 3.20257NMPABTK(CLL/SLL) ® ®(TKI)®T315ICML-CPCML-APBCR-ABL1(TKI)CML-CP®20251® ®FDACML(ALL)(AML)GISTTKICML®EMA®2024(NCCN)CML2025®2025(CACA)2025(CSCO)2025 ® 1.202111T315ITKICML-CPCML-AP2022(NRDL)202331 2.202311TKICML-CP2024(NRDL)202511 ® •20251231®20241231241.033.080.6%435.362.220251®(NRDL)•20251231®DTP8252024123173412.4%®2024123126036.5%20251231355 •FDAEMAPh+ALLIII(POLARIS-1)•POLARIS-1TKIPh+ALLIII(POLARIS-1)•CML-CPT315IFDAIII(POLARIS-2)•(SDH)(GIST)III(POLARIS-3)•20253(NMPA)(CDE)Ph+ALL•Bcl-2 •20251267ASHPOLARIS-11Ph+ALLIIIMRD64.2% 144TKICML-CP4(BAT)II(EFS)BATCML-CPBATEFS21.22.9T315ICML-CP(EFS)11.9BAT3.17% 47CML-CPCML-CPTKITKI(CCyR)76.7%(MMR)43.3%21(MMR)60% FGFR11713/17(76.5%)(CR)(CRh)(CHR)12(CCyR)2(CMR)1123811 64CMLCMLASH2025TKIMMR61.9%16.3%p<0.001CMR23.8%4.7%p<0.05OSPFS87.1%75.8%TKI57.2%52.6% •20251152.7(GIST)IbSDHGIST •M R DB C R - A B L 1( P h /BCR-ABL1+ALL)(HSCT)202512117Ph+ALL15(83.3%)856288.2 ± 7.8%79.4 ± 10.9%12 •20256®2025Ph+ALL(CR)(OS)(EFS)100%91.6%FGFR1(CR)(CHR) •202542025(AACR2025)AMLT-ALL ® •2026POLARIS-1POLARIS-2POLARIS-3 ® ®Bcl-2Bcl-220257®BTK(CLL/SLL)®Bcl-2Bcl-2®2025CSCOCLL/SLL®CLL/SLL(NHL)AMLMMMDSWMFDA®(FL)WM CLL MM AML ® ® •2025710®BTKCLL/SLL®CLL/SLLBcl-2Bcl-2®20251231®70.610.1 •AZAHR-MDSIII(GLORA-4)GLORA-4FDAEMA •AZAAMLIII(GLORA-3) •BTKCLL/SLLIII(GLORA-2)•BTKBTKCLL/SLLFDAIII(GLORA)•(MM)Ib/II•AML/MDSIb/II•AML/MDSIb/II•BTKWMIb/II •20251267ASHBTKCLL/SLL2(ORR)BTKBTK202572572R/RCLL/SLLORR62.5%(mPFS)23.8922.01del(17p)/TP53IGHV21.8%(MRD)11MRD6MRDBTKiAZAAZAAML/HR-MDS •2025661ASCOIb/IIAZA(TN)20254103TNR/R AMLMDSR/R AML(MPAL)ORR31.8%ASCO 1.2.2026GLORAGLORA-2 GLORA-3 GLORA-43.2026 APG-2449 APG-2449(FAK)(ALK)C-ROS1(ROS1)(TKI)CDEFAKPKAPG-2449APG-2449ALKTKI(NSCLC)APG-2449ALKTKINSCLCFAK(pFAK)APG-2449PFSpFAKALK TKIMAPKRASMEKBRAF APG-2449 1.(CDE)IIIAPG-2449(ALK) TKI(NSCLC)ALKNSCLC 2.APG-2449Ib/II 1.20254AACR2025APG-2449FAK(SCLC) 2.2 0 2 51 0•( e C l i n i c a l M e d i c i n e )A P G - 2 4 4 9IAPG-2449TKIALKNSCLCFAKAPG-2449FAKALK 18A.08(3)APG-2449 Alrizomadlin (APG-115) Alrizomadlin(APG-115)MDM2-p53MDM2p53p53alrizomadlin(APG-115) AlrizomadlinFDA(ODD)AMLIIB-IValrizomadlinFDA(RPDD) alrizomadlin alrizomadlin 1.alrizomadlinIb/II2.alrizomadlinT(R/RT-PLL)(NHL)IIa3.alrizomadlinII CDEalrizomadlin 1.alrizomadlinPD-1JS001(LPS)Ib/II2.alrizomadlinAMLMDSIb3.alrizomadlinIalrizomadlin(RMS)(STSs) 1.2025661(ASCO)alrizomadlinPD-1(ACC)II1712ACCORR16.7%DCR100%5MPNSTDCR80%4SD296BTCORR16.7%DCR100%6LPSORR16.7%DCR66.7% ALRIZOMADLIN(APG-115) Pelcitoclax (APG-1252) PelcitoclaxBcl-2Bcl-xL(SCLC)(NSCLC)(NHL)APG-1252FDA(ODD)SCLC PelcitoclaxPelcitoclax Pelcitoclax Pelcitoclax 1.Pelcitoclax(EGFR)NSCLCIb2.Pelcitoclax(R/R NHL)Ib/II3.PelcitoclaxcobimetinibI APG-1252 1.IAPG-1252R/R AMLPK 2.IIT 18A.08(3)PELCITOCLAX (APG-1252) APG-5918 APG-5918(EED)EED2(PRC2)APG-5918(CKD)(Hb) (FDA)IAPG-5918 1.APG-5918I 2.APG-5918I(SAD)(MAD) 1.202512ASH2025APG-5918APG-5918(IMiD)MMIMiDE3(CELMoD) 2.20256EHA 2025APG-5918T(TCL) 20254AACR2025APG-5918APG-5918 APG-5918 1.2026APG-5918 18A.08(3)APG-5918 APG-3288 APG-3288(PROTAC)BTKBTK-PROTAC-CereblonE3BTKBTKAPG-3288BTKBTKBCR-BTKBTKBTKBTKAPG-3288BTKPK APG-3288 APG-328820261FDAIND20262CDEIND 2026IAPG-3288BPK 18A.08(3)APG-3288 PK/PD 2026BTKAPG-3288FDACDEIND(TPD)p53-MDM2p53MDM2Alrizomadlinp53MDM2MDM2 Bcl-xLBcl-xLBcl-xLBcl-xLBcl-xL (SAB)SABSAB 202420251231947.2129.81,137.4162.7 202512315125020251231374 2025 •20