同源康医药-B2024中期报告

股份代號: 2410 2024 中期報告 25891130404142444547 1278A141403-2 277T28 33191901 97927 131 28826 717710 H 183171712-1716 555 14551101 2410 www.tykmedicines.com TY-9591 • 20243TY-9591EGFRNSCLCIIIIIIND 20238TY-9591IIEGFRNSCLC2024202520226TY-9591IIIEGFR21L858RNSCLC20242026NDA TY-302 TY-302II2024TY-302II •TY-2136b 20239FDATY-2136bROS1NTRKALKLTKNSCLCTY-2136bIbIIFDATY-2136b • TY-2699aTY-2699aSCLCTNBCI TY-0540TY-0540I TY-1091TY-1091RETI TY-402820234TY-4028FDANSCLCIII20236202412TY-402820NSCLCI TY-1054TY-105420244FDA20244TY-1054IND20247IND • 202482012.1047,880,000H579.3 I. 201711TY-9591TY-9591IIEGFRNSCLCTY-9591IIIEGFRL858RIIIbIVNSCLC 1L =2L +=E G F R =C D K =ROS1=ROS1NTRK=RET=YAP=yesTEAD=PROTAC=NSCLC=SCLC=TNBC=Ph=NDA=2H=Q1= (1)TY-9591TY-302(2)TY-2136b EGFRALKNSCLC 11 TY-9591EGFR-TKI TY-9591EGFRTKIEGFREGFR21L858R19L858R/T790M19T790MRas/Raf/MEK/ERK3PI3KBAKTTY-9591TY-9591TY-9591-D1(AZ5104)TY-9591-D1(AZ5104)EGFRTY-9591TY-9591-D1TY-9591I80mgTY-9591TY-9591TY-9591-D150%TY-9591IbTY-9591EGFRL858R19NSCLCPFS21.5ORR85.9%DCR94.9% TY-9591EGFRNSCLCEGFRL858RIIIbIVNSCLCEGFR-TKINSCLCTY-9591NSCLCIbII29NSCLC25PR4CRORR100%IIIFLAURANSCLC77%ORRII8.3%8.3% TY-9591EGFRL858RNSCLCEGFR19L858RPFS18.9IIIFLAURAEGFRL858RNSCLCPFS14.4EGFR19PFS21.4EGFRL858RNSCLCIbEGFRL858RNSCLCIIIFLAURATY-9591PFS3619.310414.4FLAURAEGFRL858RNSCLCPFSFLAURAFLAURAEGFRL858RNSCLC TY-9591IIEGFRNSCLC2024TY-9591IIIEGFR L858RIIIbIVNSCLC2024TY-9591EGFR-TKITY-959120243TY-9591EGFRNSCLCIIIIIIND2024II NSCLCSCLC85%2023NSCLCEGFR50.2%1921L858REGFR85%1921L858REGFR44.8%39.8%21L858REGFR-TKI20171420235626.2%2033119202320337.8%EGFR-TKIEGFRNSCLC20172023EGFR-TKI20232033 2023101.55NSCLC25%30%55%NSCLC2017202313.7616.63203321.80NSCLCNSCLC *EGFRNSCLCNSCLCEGFRNSCLC**IV2023IIIbIV46.6%50%IV 2024630EGFR-TKIEGFR1921L858R20T790MNSCLCEGFR-TKINSCLCEGFR-TKI 2024630NSCLCEGFR-TKINSCLCTY-9591EGFR-TKINSCLCEGFR-TKI TY-302 TY-3024/6CDK4/6TY-302CDK4/6RbTY-302CDK4/6I/IITY-302TY-302TY-30214DCR71.4%TY-302ER+2HER22024TY-302IITY-302mCRPC 201731.52202334.55203337.69ER+HER270% 20179.73202313.27203318.91CRPCmCRPCmCRPC 2024630CDKCDK4/6CDK4/6201732202310722.2%CDK4/620272033CDK4/61612622023202710.6%202720338.5% 202463026CDKTY-302CDK4/6 TY-2136b TY-2136bROS1ROS1NTRKTY-2136bATPROS1NTRKNSCLC203356,200 TY-2136bTY-2136bROS1/NTRKROS1NTRKROS1 G2032RNTRK G595RROS1/NTRKTY-2136bJAK/STATBa/F3ABL1(H396P)SRCROS1NTRKROS1/NTRKFDATY-2136bROS1NTRKALKLTKNSCLCTY-2136b 20222INDTY-2136bIb202111FDAINDIIFDATY-2136b ROS1/NTRK-TKI201770.72023332.029.4%ROS1/NTRK-TKI2027602.020331,052.92023202716.0%202720339.8%ROS1/NTRK-TKI201715.72023252.658.8%ROS1/NTRK-TKI2027514.22033860.52023202719.4%202720339.0% ROS1NSCLC1.5%NTRKNSCLC1.0%20172023ROS1NTRKNSCLC3.684.332.7%2033ROS1NTRKNSCLC5.6220172023ROS1NTRKNSCLC1.792.163.2%2033ROS1NTRKNSCLC2.83 2024630ROS1/NTRK-TKIFDABMSROS1/NTRK-TKI202463029ROS1/NTRK-TKIROS1NTRKII •TY-2699aCDK7TY-2699aTY-2699a2023220235FDAINDINDTY-2699aSCLCTNBCI2025Ib •TY-0540CDK2/4/6CDK4/6HR+HER220%CDK4/625CDK2/4/62023620239TY-0540IIIFDAINDINDTY-0540I2025Ib •TY-402820TKIEGFR20HER220NSCLCEGFR 20NSCLCEGFRNSCLC7.7%EGFR 2020EGFR-TKITY-4028NSCLC2023420236FDAINDIND202412TY-402820NSCLCI •TY-1091RETRETNSCLCRETMTCRET20228202212FDAINDINDTY-1091RETI TY-1054TY-1210 TY-0609TY-3200 •TY-9591TY-302TY-2136b•DMPKCMC••CADD/AIDDCADDAIDDROS1/NTRKTY-2136bCADDTY-2699aCDK7CADD/AIDDAIDD 202220232024630229.8249.3137.8 202463010756% 18A.08(3)H •TY-9591TY-9591IIEGFRNSCLC20242025TY-9591IIIEGFR21L858RNSCLC20242026NDATY-959120243TY-9591EGFRNSCLCIIIIIIND2024II2026II •TY-302TY-302II2025TY-302III2028NDA2024TY-302II2026TY-302III •TY-2136bTY-2136bIbIIFDATY-2136b •TY-2699aTY-2699aSCLCTNBCIa2025Ib2026II•TY-0540TY-0540Ia2025Ib2026II TY-1054TY-1210TY-0609 TY-9591 II. 20242023630ROS1/NTRK/ALKTY-2136b2024630 20242023630 202463011,285,000202363010,279,0001,006,000 (i)CROCDMO(ii)(iii)(iv)(v) 2024630137,758,0002023630119,436,00015.3% (i)(ii)(iii)(iv)(v)(vi) 202463040,100,000202363022,176,00080.8% (i)(ii)(iii) 20246305,431,00020236304,483,00021.1% 20242023630 2023630173,849,00026.3%2024630219,533,000 2024630105,044,00060,000,00020231231186,830,00043.8% •2024630136,281,000(i)219,533,00047,459,00014,727,00012,632,0007,035,0005,431,000(ii)1,659,000 •2024630120,136,000(i)138,000,000(ii)60,000,00091,372,000 •2024630114,652,00080,400,00050,000,000 18,268,000 202463080,480,000202312313.6%3.9%202463020,000,000 2024630 2024630 34,900,000 202463020231231 202463014432,809,000 H2024820 C.2.1C.2.1 2024630 2024820506.31 2024630 3.21D.3.33.10(2) 24102024630 13.51B(1) 13.2013.2113.22 2024630HXV78 XVXV78352 (1) (2)178,249,645192,586,173H (3)370,835,818 (4)35,000,000H65,000,00030.66%20.15%3.02%99%35,000,000H65,000,000 7,934,500H14,735,500 1,323,000H2,457,0001,680,000H3,120,00099% (i)1,323,000H2,457,000(ii)1,680,000H3,120,000 (5)2,887,500H5,362,5002,887,500H5,362,500 (6)4,951,317H9,195,3021,840,312H3,417,72383%(i)4,951,317H9,195,302(ii)1,840,312H3,417,723 3,664,004H6,804,5803,664,004H6,804,580 35