德琪医药-B2023 中期报告

(於開曼群島註冊成立的有限公司)股票代號: 6996 2 4 6 9 24 30 43 44 45 46 47 48 50 John F. Chin 2023414 Maples Corporate Services LimitedPO Box 309, Ugland HouseGrand Cayman, KY1-1104Cayman Islands Rafael Fonseca2023414Mark J. Alles2023414 1065SOHOB1206-1209 Rafael Fonseca 110 Rafael Fonseca 881739901 2023414 Rafael Fonseca 97927 Maples Fund Services (Cayman) LimitedP.O. Box 1093, Boundary HallCricket SquareGrand Cayman, KY1-1102Cayman Islands 6996 183171712-1716 www.antengene.comwww.antengene.cn Davis Polk & Wardwell3A10 20201120 2125B 161 3 20236302022630 202263054.018.0202363072.0XPOVIO® 2022630167.846.72023630121.1 2022630179.446.72023630226.1 202263090.42.2202363088.2 202263085.92.1202363083.8 2022630144.574.22023630218.7 2022630126.363.12023630189.4 2023630 •ATG-010XPOVIO®®XPO1 •20235(BPOM)XPOVIO®(NDA)(rrMM)B(rrDLBCL)•20236XPOVIO®(XVd)(PBS)•20237XPOVIO®NDA(Xd)(PI)(IMiD)CD38(rrMM) •OnatasertibATG-008 mTORC1/2 •20235I/IITORCH-22023(ASCO2023)ASCO2023 •EltanexorATG-016XPO1ATG-016II •TizaterkibATG-017 ERK1/2 ATG-017IERASER •ATG-101PD-L1/4-1BB ATG-101PD-L1/4-1BBB(B-NHL)IPROBE-CNPROBE •ATG-037CD73 ATG-037ISTAMINA •ATG-018ATR ATG-18IATRIUM •ATG-022Claudin18.2 20231ATG-022CLINCHBellberryHREC 3CLINCHIIND 20233CLINCH 20235ATG-022(FDA)(ODD) 20235CLINCH •ATG-031CD24 20235FDAINDATG-031B-NHLI ATG-027B7H3/PD-L1ATG-032LILRBATG-041Axl-Mer ••20231Calithera Biosciences, Inc.CalitheraATG-03720215CalitheraATG-037CalitheraCalitheraATG-037 2017 936XPOVIO®NDABPOMXPOVIO®NDArrMMrrDLBCL 202320235XPOVIO®NDA20237NDAXPOVIO®(XVd)BsNDA ATG-010XPOVIO®®XPO1 XPOVIO®(SINE)Karyopharm Therapeutics Inc.KaryopharmXPOVIO® Karyopharm201973FDAXPOVIO®(IMiD)CD38 2020622XPOVIO®FDABB20201218FDAXPOVIO® 20217MFDSXPOVIO®CD38NDAB202112MFDSsNDAXPOVIO® 202112XPOVIO®CD38 XPOVIO®NDAXPOVIO®(Xd)(XVd)PBSBPOMXPOVIO®NDA XPOVIO® BIISEARCH2020SEARCH IIIBENCH2020IND20217 R-GDPBII/IIIKaryopharm(XPORT-DLBCL-030)20211IND202112 XPOVIO®ICEGemOxPD-1TNK/TIbATG-008(onatasertib)BIbS-R2I/II OnatasertibATG-008 mTORC1/2 ATG-008(onatasertib)Celgene Corporationonatasertib2020HCC3202144TORCHonatasertibPD-1I/IITORCH-2 202211ATG-008(onatasertib)PD-1TORCH-2(NCT04337463)(ORR)52.4%PD-L12110(PR)1(CR)105(SD)2(PFS)5.5TORCH-2PD-L1ORR77.8%(7/9)2(CPI)1PR(HBV+)(HCC)IITORCH(NCT03591965)45(mg)183PRATG-008ORR16.7%(DOR)4.3TORCH3PR2 20235I/IITORCH-22023(ASCO2023)ASCO2023 ATG-008(ONATASERTIB) EltanexorATG-016XPO1Karyopharmeltanexor2020MDSI/IIIND2021520215I/IIIND20223ATG-016(MDS)IIINDI/IIeltanexor(ATG-016)HMAIPSS-RMDSHATCH TizaterkibATG-017 ERK1/2AstraZeneca ABAstraZenecaATG-0172020IATG-017PD-1ERASER202112ATG-017PD-1Opdivo®202210FDAERASER20237 ATG-101PD-L1/4-1BB20223ATG-101IIND2022820229ATG-101FDAODD ATG-037CD7320222HRECI20226202211ATG-037I202212STAMINA-001ATG-037PD-1®I20237ISTAMINA ATG-018ATR20226HRECATG-018I20228 ATG-022Claudin18.2202212HRECATG-022I2023320233IND2023520235ATG-022FDAODD ATG-031CD2420235FDAINDATG-031B-NHLI ATG-027B7H3/PD-L1ATG-027IND/CTA2024 ATG-032LILRBATG-032IND/CTA ATG-041Axl-MerIND/CTA 2023630168ATG-010XPO1ATG-008onatasertibmTORC1/2ATG-016eltanexorXPO1ATG-017ERK1/2ATG-101PD-L1/4-1BBATG-037CD73ATG-018ATRATG-022Claudin18.22023630XPOVIO®NDA20237XPOVIO®NDAXPOVIO®BPOMNDAXPOVIO®(Xd)(XVd)PBS 20232022630207.7170.0202363057 20215CalitheraATG-037Calithera20231CalitheraATG-037CalitheraATG-037 20237XPOVIO®NDA(Xd)(PI)(IMiD)CD38(rrMM) 20237ATG-017IERASER 20237ATG-037ISTAMINA 20238XPOVIO®XPOVIO®XPOVIO®2115.35XPOVIO® ATG-008mTORC1/2IITORCH-2(CPI)CPI202382331CPI28(ORR)46.4%17CPI15ORR26.7%11 ATG-022Claudin18.2 ATG-101PD-L1/4-1BB ATG-031CD24IMD ATG-037CD7313 ATG-017ERK1/2II(RP2D) ATG-018ATR127 2021XPOVIO®NDA20222023XPOVIO®NDA20235FDAINDATG-031IATG-031B-NHLCD2420232023XPOVIO® NDAXPOVIO® 202263054.018.0202363072.0XPOVIO® 2022630167.846.72023630121.1202363092.32022630144.4 2022630179.446.72023630226.1(i)27.3202363040.5CalitheraATG-037(ii)27.2 202263090.42.2202363088.2(i)2023630XPOVIO®21.3(ii)XPOVIO®2022202363020.5 202263085.92.1202363083.8 2023630 202363031940 20236301,322.4202212311,789.62023630202320221231135.8 2023630 20236301,445.21,322.4122.82023630158.7141.916.8 100%2023630910.4%20221231496.6% 100%202363015.8%2022123120.0% 20236302023630 2023630 2023630 202363043.9 5820188282020818() 3070 2001820012Johnson & Johnson Pharmaceutical Research & Development,L.L.C.20064200810NovartisAGNOVN.SIXNVS.NYSENovartis Oncology20081020173CelgeneBMY.NYSE®POMALYST®IDHIFA®201411202012201742022224SanRenoTherapeutics Holding Limited 19897199412006 John F. Chin572020122020818Chin Chin1990Merck, Sharp and Dohme CorpBMY.NYSE1992119987199810Aventis Pharmaceutical Holdings Inc.1999Rhône-Poulenc Rorer2005120201ChinCelgeneBMY.NYSE Chin19891219984 412020682021618 16200462008112012820176Pine River Capital Management201782019820191020206BFAM Partners(Hong Kong) Limited 20045201511 422021326 201211201492014102016120162A20201228202012Connect Biopharma Holdings LimitedCNTB202012688176 2004620091 482020119