同源康医药-B2025中期报告
股份代號: 2410 2025 中期報告 3638394157 23 20258312025626 2025915 1278A141403-2 277T28 2025915 2025915 33191901 2025915 14551101 131 28826 2410 www.tykmedicines.com 浤717710 H 183171712-1716 555 TY-9591 • 20238TY-9591IIEGFR20241122420254Pre-NDA2025Q4NDATY-9591IIIEGFR L858RIIIbIV202575412026Q22028NDATY-959120243TY-9591EGFRIIIIIIND202411II20252202582025Q4II2026Q1CDE TY-302 TY-302IITY-302II20257102025728CDE •TY-2136b 202111FDAINDIIFDATY-2136b • TY-2699a 20251TY-2699a20256TY-2699aHR+/HER2-(TNBC)SCLCI75mg10mg20mg 40mg30mgbid25mg35mgbid523020257(TNBC) TY-0540 TY-054020252TY-0540TY-054020252TY-0540I55m g10m g20m g30m g40mgbidI24HR+/HER2-1552HR+/HER2+12CDK4/6HR+/HER2-1(PR)20253(30mg)20256TY-05402025710TY-05402025725CDE TY-1091 TY-1091RETI TY-4028 2023420236FDAINDIND TY-1054 TY-105420244FDA20244TY-1054IND20247IND I. 201711TY-9591TY-9591NDAEGFRTY-9591IIIEGFR L858RIIIbIVNSCLC 1L=2L+=EGFR=CDK=ROS1=ROS1NTRK=RET=YAP=yesTEAD=PROTAC=NSCLC=LC=Ph=NDA= (1)TY-9591TY-302 (2)TY-2136b 11 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% II2025228257EGFRNSCLC224RECIST(BICR)(iORR)92.8% (95% CI: 86.3-96.8%)76.1% (95% CI: 67.2-83.6%)P=0.0006iORR91.0% (95% CI: 84.1-95.6%)75.2% (95%CI:66.2-82.9%)P=0.002RANO-BMiORR90.1%(95%CI:83.0%-94.9%)74.3%(95%CI:65.3%-82.1%)P=0.0023(ORR)84.7%75.2%iPFS PFS OS ≥331.5%15.0%≥3QTcf(ILD)6.3%QTcf4.5% TY-9591EGFRL858REGFR19L858RPFS18.9IIIFLAURAEGFRL858RPFS14.4EGFR19PFS21.4EGFRL858RIbEGFRL858RIIIFLAURATY-9591PFS3619.310414.4FLAURAEGFRL858RPFSFLAURAFLAURAEGFRL858R 20238TY-9591IIEGFR20241122420254Pre-NDA2025Q4NDATY-9591IIIEGFR L858RIIIbIV202575412026Q22028NDATY-959120243TY-9591EGFRIIIIIIND202411II20252202582025Q4II2026Q1CDE TY-302 TY-3024/6CDK4/6TY-302CDK4/6RbTY-302CDK4/6I/IITY-302 TY-302IITY-30214DCR71.4%TY-302ER+2HER2-ER+HER270% TY-302II20257102025728CDETY-302mCRPCCRPCmCRPCmCRPC TY-2136b TY-2136bROS1ROS1NTRKTY-2136bATPROS1NTRKNSCLC TY-2136bTY-2136bROS1/NTRKROS1NTRKROS1 G2032RNTRK G595RROS1/NTRKTY-2136bJAK/STATBa/F3ABL1(H396P)SRCROS1NTRKROS1/NTRKFDATY-2136bROS1NTRKALKLTKNSCLCTY-2136b 202111FDAINDIIFDATY-2136b •TY-2699aCDK7TY-2699aTY-2699a2023220235FDAINDIND2025120256TY-2699aHR+/HER2-(TNBC)SCLCI75mg10mg20mg 40mg30mgbid25mg35mg bid523020257(TNBC) •TY-0540CDK2/42023620239FDATY-0540I/IIINDTY-0540IIND20252TY-0540TY-054020252TY-0540I55mg10mg20mg30mg40mgbidI24HR+/HER2-1552HR+/HER2+12CDK4/6HR+/HER2-1(PR)20253(30mg)20256TY-05402025710TY-05402025725CDE •TY-402820TKIEGFR20HER220NSCLC20EGFR-TKITY-4028NSCLC2023420236FDAINDIND •TY-1091RETRETNSCLCRETMTCRET20228202212FDAINDIND •TY-1054YAP-TEADHippo10%YAP/TAZTEADYAP/TAZTEADTY-105420244FDA20244TY-1054IND20247IND CDK4EGFR(PROTAC)PI3Kα 18A.08(3)TY-9591TY-302TY-2136bTY-2699aTY-0540TY-4028 TY-1091 TY-1054 CDK4 EGFR(PROTAC)PI3Kα •TY-9591TY-302TY-2136b •DMPKCMC • •AIDD/CADD(AIDD)(CADD)(AIDD)(AIDD)AIDD/CADDROS1/NTRKTY-2136bCADDTY-2699aCDK7AIDD/CADDAIDD 20246302025630137.888.8202563011356% II. ROS1/NTRK/ALKTY-2136b2025630 20246302025630 20246302025630 2024630202563020256300 202563020,820,000202463011,285,0009,535,000 (i)CROCDMO(ii)(iii)(iv)(v) 202563088,758,0002024630137,758,00035.6% (i)(ii)(iii)(iv)(v) 202563038,775,000202463040,100,0003.3% (ii)(iii) 20256307,349,00020246305,431,00035.3% 202463070,00020256303,000 20242025630 2024630219,533,0002025630114,065,000 2025630206,082,000131,082,00050,000,00025,000,00020241231460,463,00055.2% 202563094,156,000(i)114,065,0006,444,0005,082,0004,550,0004,381,0003,408,0002,829,0002,799,000(ii)14,357,000(iii)6,665,000 2025630153,861,000490,482,000301,796,00060,475,000 20256305,702,00060,000,00016,013,000202563065,280,000 (24,408,000) 2025630138,861,00020241231144,175,0002.90%3.45%63,801,00075,060,000202563010,000,000202563054.9%2024123148.4% 2025630 2025630 202542418.014A.07A2025424 202563034,900,000 202563020256305% 20256302025630(%) 2025720256302025831 20256301632024630144 III. CDK4EGFR(PROTAC)PI3Kα (ADC)ADCADCADCPROTACADC ADCADCADCPROTACADC AI1.5TY-959120246302026GMP TY-9591 2024630 C.2.1C.2.1 202582010,000HHH14.99C3B.8C3A.3B.82025821 202582110,000HA.3B.8 2024820506.31 202412312 •70.0%354.4TY-9591 26.0%131.6TY-9591EGFR20238II131.687.4232.1076.2855.32202819.0%96.2TY-9591EGFR 21L858R20226III96.279.162.3819.4276.78202723.0%116.5TY-9591EGFRIIIII116.5115.720.040.82115.6820302.0%10.1TY-959110.110.100.990.999.112027•20.0%101.36.0%30.4TY-30230.424.55–5.8524.552029i.2.0%10.1TY-302III10.18.05–2.058.052029ii.4.0%20.3TY-302IIIII20.316.50–3.8016.5020303.0%15.2TY-2136b15.214.3811.1111.933.272028 1.2. 2025630 3.21D.3.33.10(2) 13.51B(1) 2025132025202412192025915202256030142025520257254513.51B(1) 13.2013.2113.22 2025630XVXV78352 (1)(2)20256304,608,000366,227,818H(3)202
