诺诚健华2023年中期报告

（於開曼群島註冊成立的有限公司）股份代號：9969 中期報告2023 183171712-1716 1 88 24840 Ogier Global (Cayman) Limited89 Nexus WayCamana BayGrand CaymanKY1-9009Cayman Islands 97926 Ogier Global (Cayman) Limited89 Nexus WayCamana BayGrand CaymanKY1-9009Cayman Islands 9969 www.innocarepharma.com 13230 tafasitamabICP-248ICP-B02 ICP-490NHLMMBDLBCL •®BTK320.7217.047.8%CSCO •MZLNDANMPAMZLBTKIRCORR58.9%DOR34.3(95% CI)12PFSOS82.8%91% •CLL/SLLIIINDA •MCLIIFDAFDANDA •MCDDLBCL1LIIIR-CHOPR-CHOPMCDDLBCL45 ICP-B04TafasitamabCD19Minjuvi® •BDLBCLII52CDENDANDAtafasitamabDLBCLtafasitamabBLAASCTDLBCLDLBCL •TafasitamabASCTDLBCLTafasitamabDLBCLDLBCtafasitamabCSCOASCTDLBCL ICP-248 •ICP-248B2BCL-2ICLL/SLLMCLNHLBCL-2PKCRuMRDCLL/SLLIND ICP-B02 (CM355) •CP-B02CD20xCD3I/IIICP-B02NHLPKIVSCIVSCICP-B02FLDLBCL ICP-490 •ICP-490MMI1DLT21CD3+TBPDAiolos (IKZF3)Ikaro (IKZF1)TICP-490MM ICP-B05 (CM369) •ICP-B05C-C8CCR8(2162.HK)IICP-B05DLTPKPDTNHLIND BT BT •ITPPoCI T PI IP o CEHA50QD40%GCIVIGBTKITPAIDBTK •SLEIIaSLESRI-4IIb •MSII2412Cmax1250QD80QD24Gd+T192.3%MS4T12480QDGd+T124TEAEMS ICP-332 •ICP-3322TYK2TIPKJAK-2AEAD80120QDIIII ICP-488 •ICP-488TYK2TYK2JH2IL-23IL12IIFNICP-488ISADMADPoCI2IIPoC ICP-192ICP-723ICP-189ICP-B05ICP-033 ICP-723 (Zurletrectinib) •I/IIICP-723NTRKTRKiPKICP-723NTRK12IIORR80%-90%ZurletrectinibTRKTRKiCDE212IND ICP-192 (Gunagratinib) •GunagratinibFGFRICCAIIASCO-GIGunagratinibIIaICP-192 ICP-189 •ICP-189SHP2IaICP-189120QDDLTPKICP-189201PRICP-189ArriVentfurmonertinibEGFRIND ARRIVENT ArriVent BiopharmaArriVentSHP2ICP-189ArriVentfurmonertinibEGFRArriVentICP-189furmonertinibNSCLCICP-189furmonertinibINDCDE 246.053.5%377.5217.047.8%320.7 99.3131.359.234.693.8 698.6815.8(i)273.5358.1(ii)264.6278.5(iii)155.0178.0 445.8429.2225.0206.3 8,688.66,518.89,011.2 Tafasitamab ®BTKCLL/SLLMCL®CSCOCLL/SLLMCLBTKDLBCLpCNSL 377.5320.747.8%330DOT tafasitamabICP-248ICP-B02 ICP-490NHLMMBDLBCL NHLNM(i)(ii)FDAEMACD19tafasitamabDLBCL(iii)BCL-2CD20xCD3 E3CCR8(iv)DLBCLtafasitamabBCL-2E3DLBCL1L DLBCLMCDtafasitamabDLBCL 850CLL/SLLMCLMZLBTKAE3 MZL MZLBNHL8.3%MZLMZL NMPAMZLMZLBTK ICMLMZLIRCORR IV75.9%24.3IRCORR58.9%DoR34.3PFS12PFS82.8%12OS91%TRAE12 MCL MCLBBMCL60MCLCR BloodBlood AdvancesBTKMCLMCL 10646.98CTORR83%35.8%CR3.8%CRu43.4%PR25.7924.94OS56.21 MCLIIFDABTDMCL 1L CLL/SLL IIICLL/SLLIRCPFS III531L CLLNDA 1L DLBCL-MCD DLBCLNHL100MCD1L DLBCLIIIR-CHOPR-CHOPMCDDLBCL45 40%DLBCLR-CHOP+XMCDBNF-KBBTKTITKCD20NKADCCR-CHOPMCDDLBCL ASCOR-CHOPMCD DLBCL14MCD DLBCL1508R-CHOPR-EPOCH6RICER-CHOPR2CRR75%66.67%MCDDLBCLMCDDLBCL CLL/SLL IICLL/SLL15080CLL/SLL52.442.5%ORR93.8%CR30%1.84DORPFS5250CLL/SLLBTKCRAE CLL/SLLGazyvaFCRBTKi7.1611.073PR/PR-LSDORR75%DCR100%BTKiCLL/CLL 1L DLBCLGCB EHAORIENTR-CHOPBBGCBDLBCL R-CHOPGCB DLBCL GCB DLBCLR-CHOP tafasitamab (CD19)ICP-B02 (CD3xCD20)ICP-490 E3DLBCL pCNSL EHAPomalidomideMethotrexateCNSII pCNSLND pCNSLPomalidomideORRpCNSL pCNSLND pCNSLCNSLpCNSLORRCR88.9%100%53.9%61.8%NDpCNSLPFSmPFS6PFS63.6%100% 60%CNSLORR60%86.7%mPFS9.83mPFS BCRMYD88MOABBB15021.6BBB58.6% pCNSL BTKCD20BTKBBCRCD20CDCADCC/ADCPBTK2TTKLNKADCC(Mol Ther Oncolytics 21: 158-1702021 BTKBTKITKBADCCMol Ther Oncolytics 21:158-1702021GazyvaADCCADCP CD20Gazyva (obinutuzumab)ADCC ADCP BTKCD20/CD19B CD20GazyvaBTafasitamabNHLII ICP-B04 (Tafasitamab) CSCOtafasitamabASCTDLBCLDLBCLCHOP tafasitamab23tafasitamabDLBCLTafasitamab TafasitamabDLBCLIIIItafasitamabDLBCLORRIRCDCRDoRPFSTTPTTROS6NDA TafasitamabASCTDLBCLTafasitamabDLBCLDLBCCD19B-NHLB-NHLRE-MIND2R2tafasitamab tafasitamabtafasitamabtafasitamabtafasitamabNMPA2CRtafasitamabBLAASCTDLBCLDLBCL TafasitamabBNHL/DLBCLtafasitamabDLBCLNHLNHL40% ICP-248 ICP-248B2BCL-2BCL-2BCL-2BCL-2ICP-248ICP-248BCL-2ICP-248CLL/SLLNHLDLBCL IIICP-248BCLL/SLLMCLNHLBCL-2CRSDCLL/SLLNDA ICP-B02 (CM355) I C P - B02BCD20xCD3TDCC I/IIICP-B02IVSCNHLPKIICP-B025IV1SCDLT1SCDLTIVSCNHLDLBCLIVSC ICP-490 ICP-490CRBN E3IMiDTPD CRL4CRBN-E3ICP-490IKZF1IkarosIKZF3AiolosICP-490MMBDLBCLICP-490CRNBICP-490ADCCCD38daratumumab AACRICP-490ICP-490MMNHLDLBCLIC50ICP-490ICP-490ICP-490MMDLBCL ICP-490ICP-490IL-2BCD38daratumumabMM NHLICP-490BTK ICP-490MMI21CD3+ TBAiolos (IKZF3)Ikaro (IKZF1)TICP-490ICP-490IberdomideCRBNICP-490MMNHL ICP-B05 (CM369) ICP-B05C-C8CCR8CCR8TMETTregsICP-B05CCR8TregsADCCTregsTMEICP-B05T IICP-B05DLTPKIICP-B05CCR8TICP-B05NHLICP-B05NHLIND BT BT CNSBITPPoCGCIVIGIIISLEIIaSLEBTKIIbMSIIPoCIINMOSDCSU TTYK2ICP-332ICP-488TADSLELNCDUC BICP-332ICP-488T B BTKTECBBCRBBTKBTK ITP ITPITPT ITP100,00023.6100,0009.5CD20 BTKBITPBBTKITPITP ITPIIIIITPIII50×109/L274 ITPPoCEHAITPII 3350QD30QDITP50QDGCIVIG 36.4%33125040%1561283.3%121014-246450x109/L22GCIVIG5075.0%86ITPTRAE12 IIITPBTKITPBTKAID SLE BTKBCRBSLE SLESLE1.060.7%SLE1.090.5% SLEIIaEULARSLE1:1:1:11250QD80QD100QD IIa508010012SRI-435.7%50.0%61.5%64.3%GC3C4 IIa40IIbIIbSLESLESLE1:1:1507548SRI-4SRI-4C3C4dsNDA4850%12 SLEBTKevobrutinibfenebrutinibRingheim, G. E., Wampole, M., & Oberoi, K. (2021)Frontiers in Immunology, 12, 662223SLEBTKSLE MS ICP-CL