诺诚健华：截至2025年12月31日止年度全年业绩公告

20251231 2025123120241231 202412311,417.822.4%202512311,735.1(i)20241231420.020251231580.0(ii)20241231814.016.9%20251231951.6(iii)20241231183.910.7%20251231203.5 20241231452.920251231644.2 2025123178 20252,374.9135.3%ADC 2025BTKCD19mesutoclaxICP-248, BCL-21L CLL/SLLNRDLCLL/SLLCLL/SLLMCLMZLMZLMCLNDABTK 20255202592026 BCL-2mesutoclax1L CLL/SLLIIIBTKMCLMCLIIImesutoclaxAMLMDS 20251231®BTK oCLL/SLLMCLMZL1L CLL/SLLNRDL oMZLBTKMZLBNHL2023DOI10.1002/ajh.27058CSCO20242025MZLI o2025 oDOT 1L CLL/SLLNDA20254CDECSCO2025CLL/SLL MZLMCLNDABTK ICP-B04, CD19Minjuvi® 20255NMPABLAASCTDLBCLCD1920259II2024730IRCORR73.1%34.6%CR38.5%PR 20207FDA20218EMADLBCL20256IIIFDAtafasitamab-cxixFL 202592026ASCTDLBCLCSCOASCTDLBCL Mesutoclax (ICP-248) BCL-2mesutoclax (ICP-248)mesutoclax53 oCLL/SLLIII2025420262 oBTKMCLII202562026MesutoclaxNMPABCL-2omesutoclaxMCLIIIomesutoclaxAMLMDS mesutoclax(ICP-248)BCL-2 mesutoclax (ICP-248)42IITLS36ORR100%CRR57.1%uMRD65%III CLL/SLLMCLNHLI/II81mesutoclax (ICP-248)PKCLL/SLLMCLORR100%87.5%BTKiBTKi25MCLORR84%CRR36%ASH 2025ICP-248BTKiMCLII mesutoclaxAMLMDS2026112598AML39AML12MDS35AML85.7%cCR3DoR91.7%6OS94.1%MDSDLTTLS2026ASCO mesutoclaxAMLMDS ICP-490ICP-B05 CM369CCR8ICP-490ICP-B05(CM369)NHLI BT 3.7%20291,8502023103iHealthcareAnalyst, Inc. BT BTTYK2 BTK ITPIII2026 SLEIIb202575QD48SRI-457.1%(34.4%)SRI-4≤7.5SLE BILAG≥1A≥2BSLEDAI≥475SRI-468%43%7571.1%≤7.543.6%75QDIII2026 MS202510Zenas BioPharma, Inc.ZenasZBIOZenas120267,000,000Zenas202620 MSBTKBTK≥50424IIMSPPMSSPMSIIIPPMS2026SPMS TYK2T TYK2T Soficitinib (ICP-332) Soficitinib (ICP-332)2TYK2T20243soficitinib (ICP-332)ADII2024AAD20261JAMA Dermatologysoficitinib (ICP-332)4EASI8078.2% (p<0.0001)12072.5% (p<0.0001)16.7%soficitinib (ICP-332)80120EASI 50EASI 75 EASI 9050%75%90%IGA0/18012064%EASI 758%(p<0.0001)TRAE Soficitinib (ICP-332) osoficitinib (ICP-332)III20252026 osoficitinib (ICP-332)II/IIIII2026III oPNsoficitinib (ICP-332)PNII2025 oCSUsoficitinib (ICP-332)CSUII/IIIIIIII osoficitinib (ICP-332)II soficitinib (ICP-332)2026 ICP-488 ICP-488TYK2TYK2JH2IL-23IL12IIFNJAK1TYK2ICP-488202410ICP-488IIII2025QD69ICP-48812PASI75%PASI 75ICP-488PASI 90PASI 100sPGA0/1 o12ICP-488PASI 756977.3%78.6%(11.6%p<0.0001) o12ICP-488PASI 906936.4%50.0%(0%p<0.05)PASI 1006911.4%11.9%(0%p<0.05) TEAE III202622026CLEII20262IIINDICP-488 ICP-054IL-17 IL-17-17IL-17ICP-054IL-17AAIL-17AFIL-17R ICP-054(CIA)ICP-054IL-17 202510ZenasICP-054ICP-054IND20262CDE ICP-538VAV1 VAV1(GEF)T(TCR)B(BCR)VAV1VAV1TTBVAV1 ICP-538VAV1VAV1EAEVAV1CNSICP-538IND2026220263VAV1TBICP-538 ICP-B02CM355/PRO-203CD20xCD3 NHL202510216250%Prolium Bioscience Inc.ProliumICP-B0250%1,7505.025Prolium20263Prolium50AICP-B02ProliumICP-B022026ICP-B021/2SLELNICP-B02ProliumB (ADC) Zurletrectinib (ICP-723) zurletrectinib (ICP-723)TRK202512NMPANTRK1218Zurletrectinib (ICP-723)IIIRCORR89.1% (95% CI77.8, 95.9)TRK 2122026NDA (ADC) ADC—LPADC o— oADCDAR8 o ADCADC ICP-B794B7H3ADC ICP-B794—B7H3ADCB7H31DAR8PEGP-gp ICP-B794SCLCNSCLCDS-7300B7H3-ADC, ICP-B794NCI-H1155 NSCLCICP-B7940.15 mg/kgDS-7300 GLP267B7H3-ADC ICP-B794IND20257ADC510ICP-B794B7H3-ADCADC ICP-B208CDH17ADC ICP-B794ADCICP-B208CDH17CDH17CDH17CDH17ADC20263ICP-B208IND 2026ADC INDADC ICP-189 ICP-189SHP2IaICP-189160QD120DLT3TRAEICP-189PK120ICP-189DUSP6IC90, DUSP6MAPKICP-189201PR172023714ArriVent BiopharmaArriVentSHP2ICP-189ArriVentfirmonertinibEGFRNSCLCICP-189firmonertinibEGFRICP-189firmonertinibIbDLTSMCICP-189160firmonertinib 80982ICP-189 160firmonertinib 80 2025 2.02025 20251ProliumICP-B02ProliumICP-B02 202510Zenas BioPharmaZenasZenasIL-17AA/AFTYK2 2026 MZLMCLNDABTK BLA202552025DLBCLNHL Mesutoclax (ICP-248)CLL/SLLMCLAMLMDS BT BT ITPIII2026NDASLE2025IIbIIIZenasPPMSSPMSIIIZenas BT Soficitinib (ICP-332)IIIII ICP-488TYK2III2026IIIND 20262VAV1IND20263VAV1IL-17IND20262 ADC ADC Zurletrectinib (ICP-723)NMPANTRK ADCICP-B794B7-H3ADC20263ICP-B208INDADC ADC 2026 ADC ®BTK1L CLL/SLL2026CLL/SLLMCLMZLMZLBTK®CSCOCLL/SLL1L CLL/SLLMZLMCLBTKDLBCLpCNSL 202512312,374.9202512311,442.42024123143.4%MZL MZLMCLNDABTK 20255BLA20259BCL-2mesutoclax1L CLL/SLLIIIBTKMCLMCLIIImesutoclaxAMLMDS 1,500CLL/SLLMCLMZLMZLBTK20251L CLL/SLL 1L CLL/SLL 1L CLL/SLL 1L CLL/SLLIIICLL/SLL192CLL165SLL271:121.467418094.8%ECOG0–147.4%IGHV60.4%RaiIII/IV150 mg281150.5 mg/kg1375 mg/m2261500 mg/m2IRC2018IWCLL2014CLLSLLPFS19.4(HR=0.3295% CI0.18–0.58p<0.0001)ORR90.1%79.2%CLL/SLL MZL MZLBNHL8.3%MZLMZL 20234NMPAMZLMZLBTK 2023616ICMLMZLIRC2014ORR IV75.9%24.3IRCORR58.9%DoR34.312PFS82.8%OS91%TRAE12 IIIR2R2MZL EHA 2025—(MZL)202462025116A6B2A(CRR)66.7%B100.0%(ORR)100.0%(PFS)(OS)BTKi(AEs) 1L MCL IIIBRBRMCLPFSORROSDoRIIIMCL pCNSL 20257LeukemiaIIHD-MTXRMOpCNSLND pCNSL pCNSLBTKi 20215820239159656561(95.4%)RMORMO23(35.4%)CR37(56.9%)PR65ORR92.3%61RMOORR98.4%20RMOPR6CR1SD1RMOCRR72.2%ORR94.4%RMO0.7202412312DoRPFS OS75.0%75.0%91.7%66.7%66.7%83.3% RMO RMO4ORR92.3%CRR37.7%RMOCRR6RMOCRR72.2%RMO2PFS≥75%2OS≥85%BTKi MZLMCLNDABTK mesutoclaxICP-248, BCL-2 B