同源康医药-B2024年度报告
股份代號: 2410 2024 年度報告 2456824345375124129130132133135205 2025327 1278A141403-2 277T28 33191901 97927 555 14551101 131 28826 2410 www.tykmedicines.com 717710 H 183171712-1716 201712TY-9591 TY-9591IIEGFR2024112242025Q2NDATY-9591IIIEGFR21L858R202525282026NDATY-9591EGFRIIIIIINDTY-302II2025TY-302IITY-2136bFDATY-2136bROS1NTRKALKLTKNSCLCIFDA 20242024820Best-in-class&First-in-classINDNDA 2025327 2024820 TY-9591 • 20238TY-9591IIEGFR20241122420254Pre-NDA2025NDATY-9591IIIEGFR L858RIIIbIV2025252820252026NDATY-959120243TY-9591EGFRIIIIIIND202411II202522025II2026CDE TY-302 TY-302II20262025TY-302II TY-2136b • 202111FDAINDIIFDATY-2136b • TY-2699a TY-2699aHR+HER2(TNBC)SCLCI55mg10mg 20mg 40mg30mgbid202520251NMPA2025Ib/II TY-0540 T Y -0540I55m g10mg20mg 30mg40mgbid20252(30mg)20252NMPATY-0540TY-0540Ib/II TY-1091 TY-1091RETI TY-4028 2023420236FDAINDIND TY-1054 TY-105420244FDA20244TY-1054IND20247IND 202482012.1047,880,000H579.3 I. 201712TY-9591TY-9591IIEGFRTY-9591IIIEGFRL858RIIIbIVNSCLC 1 L =2 L + =E G F R =C D K =ROS1=ROS1;NTRK=RET=YAP=yesTEAD=PROTAC=NSCLC=LC=Ph=NDA=Q2= (1)TY-9591TY-302(2)TY-2136b 12 TY-9591EGFR-TKI TY-9591EGFRTKIEGFRTY-9591EGFR1921L858R19T790ML858R/T790MTY-9591TY-9591TY-9591-D1(AZ5104)TY-9591-D1(AZ5104)EGFRTY-9591TY-9591-D1TY-9591I80mgTY-9591TY-9591TY-9591-D150%TY-9591IbTY-9591EGFRL858R/19PFS21.5ORR85.9%DCR94.9% TY-9591EGFREGFRL858RIIIbIVEGFR-TKINSCLCTY-9591NSCLCIbII2925PR4CRORR100%IIIFLAURANSCLC77%ORRII8.3%8.3% TY-9591EGFRL858REGFR19L858RPFS18.9IIIFLAURAEGFRL858RPFS14.4EGFR19PFS21.4EGFRL858RIbEGFRL858RIIIFLAURATY-9591PFS3619.310414.4FLAURAEGFRL858RPFSFLAURAFLAURAEGFRL858R 20238TY-9591IIEGFR20241122420254Pre-NDA2025Q2NDATY-9591IIIEGFRL858RIIIbIV2025252820252026NDATY-959120243TY-9591EGFRIIIIIIND202411II202522025II2026CDE TY-302 TY-3024/6CDK4/6TY-302CDK4/6RbTY-302CDK4/6I/IITY-302 TY-302II2026TY-30214DCR71.4%TY-302ER+2HER2-ER+HER270% 2025TY-302IITY-302mCRPCCRPCmCRPCmCRPC TY-2136b TY-2136bROS1ROS1NTRKTY-2136bATPROS1NTRKNSCLC TY-2136bTY-2136bROS1/NTRKROS1NTRKROS1 G2032RNTRK G595RROS1/NTRKTY-2136bJAK/STATBa/F3ABL1(H396P)SRCROS1NTRKROS1/NTRKFDATY-2136bROS1NTRKALKLTKNSCLCTY-2136b 202111FDAINDIIFDATY-2136b •T Y -2699aC D K7TY-2699aTY-2699a2023220235FDAINDINDTY-2699aHR+HER2(TNBC)SCLCI55mg10mg20mg 40mg30mgbid202520251NMPA2025Ib/II •TY-0540CDK22023620239FDATY-0540I/IIINDTY-0540IINDTY-0540I55mg10mg20mg 30mg40mgbid20252(30mg)20252NMPATY-0540TY-0540Ib/II •TY-402820TKIEGFR20HER220NSCLC20EGFR-TKITY-4028NSCLC2023420236FDAINDIND •TY-1091RETRETNSCLCRETMTCRET20228202212FDAINDINDTY-1091RETI •TY-1054YAP-TEADHippo10%YAP/TAZTEADYAP/TAZTEADTY-105420244FDA20244TY-1054IND20247IND CDK4EGFR(PROTAC)PI3KαCDK4/2 18A.08(3)TY-9591TY-302TY-2136bTY-2699aTY-0540TY-4028 TY-1091 TY-1054 CDK4 EGFR(PROTAC)PI3KαCDK4/2 •TY-9591TY-302TY-2136b •DMPKCMC • •AIDD/CADD(AIDD)(CADD)(AIDD)(AIDD)AIDD/CADDROS1/NTRKTY-2136bCADDTY-2699aCDK7AIDD/CADDAIDD 20232024249.3235.42024123111057% II. ROS1/NTRK/ALKTY-2136b 20231231020241231107,000 2023123102024123193,000 2023123102024123114,0002024123113.1% 2024123130,542,0002023123125,428,0005,114,000 (i)CROCDMO(ii)(iii)(iv)(v) 20241231235,446,00020231231249,252,0005.5% (i)(ii)(iii)(iv)(v)(vi) 20241231108,332,0002023123159,306,00082.7% (i)(ii)(iii)(iv) 2024123112,817,0002023123122,236,00042.4% 2023123115,000202412311,131,000 202420231231 20231231383,171,0001.2%20241231387,928,000 20241231460,463,000374,988,00060,475,00025,000,00020231231186,830,000146.5% •20241231308,252,000(i)387,928,00060,758,00014,393,0005,659,00027,229,00012,467,00012,817,000(ii)7,111,000 •20241231135,858,000(i)767,168,000(ii)120,475,000774,432,000 •20241231632,080,000154,150,000580,683,000 73,622,000 20241231144,175,000202312313.2%3.9%23,771,000120,404,000202412312024123148.4%20231231253.5% 1231 2024531154,958,000 20241231 202412315%34,900,000 20241231153 III. Y A P - T E A DC D K4EGFR(PROTAC) (ADC)ADCADCADCPROTACADC ADCADCADCPROTAC AI1.5TY-9591202463020266GMP TY-9591 612017112024117 25199672009220112201710202012 1985719931212040 2004Plainfieldand Metuchen-Edison YMCASchering-PloughResearch Institute20062013 37201972024117 122009102011112011122013120156201832018320197601878 200972014520246 20129 622018620215202112024117 23Vion Pharmaceuticals, Inc.TriapineIII19979(Bristol-Myers Squibb Co.)20III20216 1985719887199481994819977 5050(PCT) 592017112024117 M a l l i n c k r o d tP h a r m a c e u t i c a l s p l cMallinckrodtInc.2020122022920215 1987199612004720177 44202112024117 20138201422014220191220236301367 20026200410201012 44202262024117 1120117201542015720172 20116 392024182025327 13201010688553201811 200682010720175 482024117 20199910200010200011200822008220121120133201441086)20145201576830)20141220173600763SH)20154201842223)20162202030812)201852024720186202166188)20193202061906)2019520223688488)20201202341472)2016102024120865) 202232020102175)20219Guanze Medical Information Industry (Holding) Co., Ltd.2427) 2018111837)20201
