亚盛医药-B2025年中期报告

2025 中期報告 Alrizomadlin（APG-115） Pelcitoclax（APG-1252） Olverembatinib奥雷巴替尼（耐立克®） Lisaftoclax利沙托克拉（利生妥®） 202512David Sidransky202512Marc E. Lippman, MD202512 97927 David SidranskyMarina S. BozilenkoDebra YuMarc E. Lippman, MD202512 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands FCPA, FCG, HKFCG2025225ACG (CS, CGP), HKACG(CS, CGP)2025225 68 FCPA, FCG, HKFCG2025225ACG (CS, CGP), HKACG (CS, CGP)2025225 9517B 202512Marina S. Bozilenko202512 1 202512Debra Yu202512 Wilson Sonsini Goodrich & Rosati1151509 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 1617 6855AAPG www.ascentage.com •2025630233.732.62024630590.080.771.6%2024630678.495.3®2024630112.915.5104.514.993%2025217.430.3 •20256302024145.321.523.4%766.0106.984.512.719.0%2025630528.673.848.26.953.7%2025630137.819.2®® •2025630590.882.52024630162.822.4 •20256301,661.5231.9202412311,261.2172.8400.259.131.7%20251132.52025720251,492.5190.1 ®(CLL/SLL) 1.2025710®(NMPA)(BTK)(CLL/SLL) 2.®®CLL/SLLBcl-2Bcl-2 ® 1.2025630®2024630112.915.593%217.430.32.20251®(NRDL)3.2025630®DTP782202463017%®202463020147%2025630295 ®(CML)(ALL)®(CLL)(SLL)(AML)(MDS)(MM)(Frost&Sullivan)20351,600 ®BCR-ABL1(TKI)T315ICMLBCR-ABL1TKIT315I(CML)(-CP)(-AP)TKICML-CP®20251®®CMLFDAIII(POLARIS-2)Ph+ALL(SDH)(GIST)III20246TakedaPharmaceuticals International AG®® ®Bcl-22025710(NMPA)(BTK)(CLL/SLL)®CLL/SLLBcl-2Bcl-2®III(1)®BTKBTKCLL/SLL12GLORA(2)CLL/SLLGLORA-2(3)(AZA)(AML)GLORA-3(4)AZA(HR MDS)GLORA-4 Bcl-2Bcl-2/Bcl-xLIAPMDM2-p53BCR-ABL1ALKFAKEED(PROTACs) 202563047820342 Dana-FarberMD 62025731 1.FDA 2. BTK(CLL/SLL) 4.CLL/SLLAMLMDSMM2 5.NSCLC2 ® ®(TKI)®T315ICML-CPCML-APBCR-ABL1(TKI)CML-CP®20251® ®2024(NCCN) CML(CSCO)CMLPh+ALL®FDACML(ALL)(AML)GIST(ODD)(FTD)TKICML®EMA ® 1.FDA ® 1.2025630®93%217.430.32024630112.915.52.20251®3.2025630DTP782202463017%®202463047%4.20254®CSCOCSCO 1.POLARIS-1Ph+ALLI I I(POLARIS-1)2.CML-CPT315IFDAIII(POLARIS-2)3.(SDH)(GIST)III(POLARIS-3)4.20253(NMPA)(CDE)(BTD)(Ph+ALL) 1.20256®2025(EHA2025Ph+ALLPh+ALLFGFR1®(CR)(CMR)+VPPh+ALL 2.202542025(AACR2025AMLT-ALL ® 1.FDA(Ph+ALL)III ® ®Bcl-2Bcl-220257®(NMPA)BTK(CLL/SLL)®CLL/SLLBcl-2Bcl-2®(CLL/SLL)(NHL)(AML)(MM)MDS(WM)®FDA(ODD)(FL)(WM)(CLL)(MM)AML 1.FDA 2.BTK(CLL/SLL) ® 1.2025710®(NMPA)BTK(CLL/SLL)®CLL/SLLBcl-2Bcl-2® 2.20254®CSCO(R/R)CLL/SLL 1.AZA(HR)(MDS)III(GLORA-4)GLORA-4FDAEMA2.AZA(AML)III(GLORA-3)3.(BTK)CLL/SLLIII(GLORA-2)4.BTKBTKCLL/SLLFDAIII(GLORA)5.(MM)Ib/II6.AML/MDSIb/II7.AML/MDSIb/II8.BTKWMIb/II 1.20256®AZA(TN)(VEN)61(ASCO)Ib/II20254103R/RAMLMDSR/RAML(MPAL)(ORR)31.8%ASCO ® 1. APG-2449 APG-2449(FAK)(ALK)C-ros1(ROS1)(TKI)CDEFAKPKAPG-2449APG-2449ALK TKINSCLCAPG-2449ALKTKINSCLCFAK(pFAK)APG-2449PFSpFAKALK TKI APG-2449 1.(CDE)IIIAPG-2449(ALK) TKI(NSCLC)ALKNSCLC 2.APG-2449Ib/II 1.20254AACR2025APG-2449FAK(SCLC) 18A.05APG-2449 Alrizomadlin (APG-115) Alrizomadlin(APG-115)MDM2-p53MDM2p53p53alrizomadlin(APG-115) AlrizomadlinFDA(ODD)AMLIIB-IVAlrizomadlinFDA(RPDD) alrizomadlin alrizomadlin 1.alrizomadlinIb/II 2.alrizomadlinT(R/RT-PLL)(NHL)IIa3.alrizomadlinII CDEalrizomadlin 1.alrizomadlinPD-1(JS001(LPS)Ib/II2.alrizomadlinAMLMDSIb3.alrizomadlinI 1.2025661(ASCO)alrizomadlinPD-1(ACC)II 18A.05ALRIZOMADLIN(APG-115) Pelcitoclax (APG-1252) PelcitoclaxBcl-2Bcl-xL(SCLC)(NSCLC)(NHL)APG-1252FDA(ODD)SCLC pelcitoclaxPelcitoclax pelcitoclax Pelcitoclax 1.pelcitoclax(EGFR)NSCLCIb 2.pelcitoclax(R/R NHL)Ib/II3.pelcitoclaxcobimetinibI 18A.05PELCITOCLAX (APG-1252) APG-5918 APG-5918(EED)EED2(PRC2)APG-5918(CKD)(Hb) (FDA)IAPG-5918 APG-5918 1.APG-5918I 2.APG-5918I(SAD)(MAD) 1.20256EHA2025APG-5918APG-5918T(TCL) 2.20254AACR2025APG-5918APG-5918PCa 18A.05APG-5918 (PK/PD) (TPD)p53-MDM220MDM2p53alrizomadlin(APG-115)p53MDM2MDM2 Bcl-xLBcl-xLBcl-xLBcl-xLBcl-xL (SAB)SABSAB 20242025630444.1528.6 2025630478202025630342 20252025®20257®20257311401,000®®®CLL/SLLBcl-2 2025630®217.42024630112.9104.593%2025TKIs(CML-CP)® (HK.1801)8672902025630DTP782202463017%®202463020147%2025630295 2025(CACA)2025CSCO(CML)(Ph+ALL)20254BCR-ABL1T315I(Ph+ALL)2025CSCO®2024(NCCN)CML2025 ®2025710NMPA®®CDE15® ®2025CSCOCLL/SLL®CSCOCSCOBcl-2 20212022 200,0002.52022A2024ABCGMP 20234(QualifiedPerson,QP)GMPQPGMP 2023®®GMPFDA 2025®(CDMO)®NDA 50,000 2024614®®®11212%~19%202472 ® 2024620202461424.098503.0854924,307,32275585.7719.2625.12%20256202025123180 20246142024621202474 202512817.257,325,00029,300,000126.4983.8202521317.25935,1443,740,57616.13125.64AAPG 8,260,14433,040,576315,226,005348,266,581142.51,109.410.077.7132.51,031.8 20241229202512120251242025222025213 2025 202572568.6022,000,0001,492.517.85190.1 2025 (i)40%(ii)35%(iii)25% 20257152025725 20256302024630 1. 2025630233.72024630823.7591.82024630165.12025630590.82024630162.82025630137.8202463089.62025630528.62024630444.1202563099.7202463087.0 2. 2025630233.72024630823.7590.071.6% 3. (i)(ii) 202463017.319.4111.4%202563036.7(i)202563031.420246309.4(ii)20256