再鼎医药2023中期报告

2023中期報告 245275153545556587376 510232301 John DiekmanRichard Gaynor頴William LisScott W. MorrisonLeon O. Moulder, Jr.Michel Vounatsos202317Peter Wirth Harbour Place, 2nd Floor103 South Church StreetP.O. Box 472George TownGrand Cayman KY1-1106Cayman Islands International Corporation Services Ltd.Harbour Place, 2nd Floor103 South Church StreetP.O. Box 472George TownGrand Cayman KY1-1106Cayman Islands 1831717121716 314 Main Street4th Floor, Suite 100Cambridge, MA 02142USA 20236262920 Richard GaynorWilliam LisMichel Vounatsos202317 456014201210 * Michel VounatsosWilliam LisLeon O. Moulder, Jr. *202317 3485 9688ZLAB KPMG Scott W. MorrisonJohn DiekmanPeter Wirth KPMG LLP Peter WirthLeon O. Moulder, Jr.John Diekman http://www.zailaboratory.com/ Leon O. Moulder, Jr.John DiekmanWilliam Lis (1)(2)(3)(4)(5)(6) 2022 ®®®®® 2023202220231202331 2023 20235GBMMAA gMGFcFcRn20236NMPAαBLAAChRgMG20239 PARP20237JAMA Oncology3PRIME300 mg200 mg300 mgISDPFS55%27.5ITTPFSmPFS24.88.3HR0.4595%CI0.34–0.60p<0.001ITTOS≥3TEAESAE54.5%17.8%18.8%8.5%TEAE6.7%5.4% oNSCLC20236NovoCure LimitedNovoCure3LUNARNSCLCOSLUNAROS3(HR 0.74P = 0.035)(n = 137)OS13.2(n = 139)OS9.9ICIOSICI(n = 66)OS18.5ICIOS10.8(n = 68HR = 0.63 P = 0.03)(n = 71)OS11.1(n = 71)OS8.7345NovoCure202362023ASCO o20237NovoCure3PANOVA-3DMCPANOVA-3DMC o20238NovoCure3INNOVATE-3OS KRAZATI®(adagrasib, KRASG12C)2023420235Mirati Therapeutics, Inc.MiratiadagrasibKRASG12CNCCNKRASG12CCNSNSCLCKRASG12C20234Mirati2023 ASCOadagrasibKRASG12C202362KRYSTAL-7adagrasibKRASG12CNSCLC202373KRYSTAL-10adagrasibKRASG12C (ROS1/TRK)20235Bristol Myers SquibbBMSFDA1/2TRIDENT-1TKINDAROS1NSCLCFDAPDUFA20231127NMPA2023520236NDA20238NMPACDEBTDNTRKTRK TKI1/2TRIDENT-1NTRKTKI TIVDAK®Tisotumab VedotinADC20234Seagen Inc.Seagen2023AACR2innovaTV 20720221128ORR40%(95%CI16.3 67.7)15TIVDAK20232Seagen3innovaTV 30120239SeagenGenmab A/S3innovaTV301(OS)TIVDAKOSTIVDAKinnovaTV 301 Bemarituzumab(FGFR2b)202333FORTITUDE-101CTAbemarituzumabFGFR2b202373FORTITUDE-101 Odronextamab(CD20xCD3)20233B2ELM-2 FcRn gMG20236argenx BVargenxFDAVYVGART Hytruloefgartigimod alfa-qvfcgMG20237NMPAαgMGBLA CIDP20239NMPACIDPADHEREADHERE(p = 0.000039)61%(HR0.39 95% CI 0.25 0.61)A67%IgGCIDP BP20235BP2/3BALLAD XACDURO®SUL-DUR20235Innoviva, Inc.Entasis Therapeutics, Inc.FDAXACDURONDA20231NMPA20232NMPA KarXTXanomeline-TrospiumM1/M420233KarunaTherapeutics, Inc.KarXT3EMERGENT-35Cohen’s d0.60KarXTPANSS8.4-20.6 KarXT-12.20.0001KarXT2(p<0.0001)5Cohen’s d0.60PANSSKarXT2(p<0.05)PK20231NMPAKarXT20236 20234DLL3ADCZL-1310DLL3NotchZL-1310ZL-1310 Joshua Smiley202341Smiley20228Smiley2023772021920200620212019202120162019 202377 202352023220233120233BMTPZ20235BMTPZNMPA2023420237120237 2023630 20179202092023630164.62,462.720232022128.0132.0 CROCMO 202381 2023202219.310.42,443.83,437.4 COVID-19 COVID-192022COVID202320222023CROCMOCOVID-192023 2023 32025 2022ESG(Trust for Life) 20232022 2023 202338.0COVID-19COVID-192022COVID-192023 20235.22021122022620225.8 202312.0 8.8 6.2 1.0 CROCMO10.9 202311.2 20238.7 202310.0 4.3 1.2 202310.0 202319.0 20231.4 202310.2MacroGenics11.31.5 20232022 202363020221231 2023630876.4(1)850.3(2)22.0(3)4.1 20236307.347.32023 4.736.4 6301.556.4 20236301.067.0 20236307.859.0 202363020221231859,1551,008,47015,5001,791803876,4461,009,273 20179202092023630164.62,462.720232022128.0132.020236303.9 2023630876.412 20232022 20234.0128.050.335.211.1 2023132.611.3160.310.08.345.5 20233.15.42.90.3 20236303.9 158.7316.82023630202212313%5% 200572120%20087201062010620158 19837.801.007.801.00 202363020221231859.21,008.515.5 202363031% 2023630 202363020221231 2202363020221231 2023630 2023 20236302,05720231312,036 20232022141.4129.5 202363020221231 20236302022123117 20232022 2 2023630XV(a)XV78(b)352(c)10 (1)2023630983,887,430 (2)(1)37,621,160(2)3,648,550 (3)3,061,410 2023630(DION)XV23336 (1)(L)(S)(P)(2)2023630983,887,430(3)2022330(4)202010520209285,232,7604,2025,200,946Citigroup Inc.5,080,5734,202137(5)20236292023626127,164,36636,265,25281,740,417JPMorgan Chase & Co.9,327,540263,120(6)202371202362968,777,320The Capital Group Companies,Inc.66,955,1202,219,000(i)Baillie Gifford & Co2022 7 513G(https://www.sec.gov/Archives/edgar/data/1088875/000108887522000104/ZaiLab30062022.txt)202263046,935,8004.79%20236304.77%(ii)CitigroupInc202381013F(https://www.sec.gov/Archives/edgar/data/831001/000083100123000114/xslForm13F_X02/CITIGROUP_13F_HR_INFOTABLE.xml)20236303,486,160 2023630336 3201520172022202220152017 1.20152015 201520153520164102015 202311201534,225,2702023630201530,813,8102015 (1)55(2)44(3)33(4)10(5)2015(6)10 2.20172017 2017201787201720172017 202311201752,292,8502023630201750,244,0702017 (1)55(2)44(3)33(4)10(5)10(6)10 202363020172017 202311201730,142,5002023630201721,936,3402017 (1)100%50%0%202112120251231 (2)55 (3)44 3 1 10 3.20222022 20222022622202220222022201720222017 20231120224,663,3002023630202227,264,7202022 2022 (1)55 (2)44 (3)33 (4