诺诚健华：2022年年度报告

（於開曼群島註冊成立的有限公司）股份代號：9969 年 度 報 告2022 2022 289141721616893115122123124125127129213 IBD ICP-105 ICP-192 ICP-022 iDMC IL-23–23 IND IRC ITKT ITP iwNHL JAK MCDB(DLBCL)MYD88L265PCD79BMCD MCLB MMOSD NMPA NRDL NTRK FGFR(FGFR) TRK PD PK TTTBNKTDCCTTRKTYK22UCU.S.FDAVivoVivo Opportunity Fund, L.PVivo Capital VIII, LLCWM 183171712-1716 1 88 24840 Ogier Global (Cayman) Limited89 Nexus WayCamana BayGrand CaymanKY1-9009Cayman Islands 97927 Ogier Global (Cayman) Limited89 Nexus WayCamana BayGrand CaymanKY1-9009Cayman Islands 9969 www.Innocarepharma.com 13230 BT BT MSII12BTKII12Gd+T180QD92.1%(p=0.0006) SLEIIaSLESRI–4EULARCDESLEIIb ITPIIPoC50x109L736.4%33125040%156 ICP-332 ICP-3322TYK2TIIPK/PDJAK-2AEADII ICP-488 ICP-488TYK2TYK2JH2IL-23IL12 IIFNICP-488 ISADMAD I C P - 2 4 8I C P - 4 9 0I C P - B 0 2TafasitamabNHLMMBDLBCL NHL •®BTK565.9214.7164%CSCO •NMPAMZLNDA •CLL/SLLIII •MCLIINDA •–1PD-1EHA NHLDLBCL •MCDBDLBCLIIIR-CHOPR-CHOPR-CHOPMCD DLBCLASCO14CRR75%66.67% ICP-B04TafasitamabCD19Minjuvi® •TafasitamabDLBCLASCTDLBCLTafasitamabCSCOASCTDLBCL •TafasitamabNMPAASCTBDLBCLTafasitamabDLBCLTafasitamabDLBCL ICP-B02 (CM355) •ICP-B02CD20xCD3IICP-B02BICP-B02SCINDCDE MM ICP-490 •ICP-490INDCDEI ICP-248 •ICP-248B2BCL-2BCL-2ICP-248INDCDEI ICP-192ICP-723 ICP-192 (Gunagratinib) ASCO-GIGunagratinibCCAIIaICP-192GunagratinibFGFR2CCAFGFR(52.9%)CCAICP-192I/II ICP-723 (Zurletrectinib) I20DLTIIRP2D8NTRK75%ORR129PRRP2D77.8%ORR 97 PR12INDCDECDE ICP-189ICP-B05ICP-033 ICP-189 ICP-189SHP2IaICP-18940DLTPKICP-189201PR ICP-B05 (CM369) ICP-B05C-C8CCR8INDIICP-B05 214.7163.6%565.9625.41,043.0417.6776.0 217.9198.2(i)57.1(ii)0.078.48.5(iii)16.329.946.2(iv)135.11.8136.9 1,161.11,550.5(i)57.1290.6(ii)304.5115.4419.9273.02.5(iii)298.5140.1438.6 66.7893.72.6473.7 12 BTKi®566163.6%3001,500CSCOCSCO TafasitamabCD19 Minjuvi®ASCTDLBCLTafasitamabFDABDLBCLTafasitamabBLA2022CSCODLBCLTafasitamab 1330ASCODLBCL-MCDDLBCL-MCD75%CRIIIMSII12Gd+T180QD92.1IIRMSBTKiSLEIIaSLEBTKTICP-332TKY2 JH1IICP-488TKY2 JH2 6252991 2.0 1.02.0 ICP-248 (BCL-2)ICP-490 (E3Ligase)ICP-B02 (CD3xCD20)Tafasitamab (ICP-B04) (CD19)DLBCL BT NCEBT ICP-192ICP-723ICP-189 (SHP2)ICP-B05 (CCR8)ICP-033 (VEGFR,DDR1) Tafasitamab •163.6%DLBCLCD19TafasitamabBLA •13PoCMSITP1L DLBCL-MCD1L CLL/SLL 1L MCLMZLWMMCLICP-192SLEPoCMSPoC12ITPIIPoCBTKi •TYK2ICP-332ICP-488CD3xCD20BCL-2 E3 Ligase CCR8SHP2 CMC300 •90 ®BTKCLL/SLLMCL625.4565.9163.6%2503001,5006,000DOT ®CSCOCLL/SLLMCLBTKDLBCLpCNSL BT BT CNSBSLEIIaSLEBTKIIbMSIIPoCITPNMOSDIICSU TTYK2ICP-332ICP-488TADSLEIBDLNCDUC BICP-332ICP-488T B BTKTECBBCRBBTKBTK MS MSIIIIRMSOLERMS1:1:1:1450QD50BID80QDOLE24GdE T1 MRI12GdET1MRI 13612Gd+T150QD71.1% (p=0.0238)50BID80.8%(p=0.0032)80QD92.1%(p=0.0006) 24 1 www.clinicaltrials.gov; (2)Sanofi’s R&D held on April 23, 2020;(3) MontalbanX, et al. N Engl J Med 2019; 380:2406-2417;(4) KapposL, et al. Lancet 2011;378:1779-87 (5) Bar-Or A. et al, Neurology 2018;90:e1805-e1814; (6)Endpointwith full data (0-12 Wks) (7) Post hoc data (4-12 wks);(8) Selmaj K, et al Lancet Neurol 2013;12:756-767;(9) KapposL, et al. Lancet 2008;372(9648):1463-72;(10) Kappos L, et al. N Engl J Med 2006; 355:1124-40;(11) O’Connor P, et al.Neurology 2006;66(6) MSMS CNSPKBBBMSPKBTKevobrutinibtolebrutinibevobrutinibtolebrutinibCNS 1doi: 10.1016/j.msard.2021.103000 2Multiple Sclerosis and Related Disorders 51 (2021) 103001 Topic: Advances in therapy in MS; doi: 10.1016/j.msard.2021.103001 EAEMSMOGEAEEAE MSDMTFDABiolato M, Bianco A,Lucchini M, Gasbarrini A, Mirabella M, Grieco A. The Disease-Modifying Therapies of Relapsing-RemittingMultiple Sclerosis and Liver Injury: A Narrative Review. CNS Drugs . 2021 Aug;35(8):861-88026MS262422HBV DMTBiolato M, Bianco A, Lucchini M, Gasbarrini A, Mirabella M,Grieco A. The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: ANarrative Review. CNS Drugs. 2021 Aug;35(8):861-880ALT ALT FDAIIMSIBICFFDAiDMCiHACFDA FDA MSMS1258.125 MS90 BMSIIMSOLEMSBTK SLE BTKBCRBSLE SLEIIEULARSLE1:1:1:1125080100 II508010012SRI-435.7%50.0%61.5%64.3%GC3C4 IIaSLEIIbSLESLESLE1:1:1255048SRI-4SRI-6C3C4dsNDA SLEBTKevobrutinibfenebrutinibRingheim, G. E., Wampole, M., & Oberoi, K. (2021)Frontiers in Immunology, 12, 662223SLEBTKSLE ITP ITPITPT BTKBITPBBTKITPITP ITPIIIIITPIII50×109/L27 22GCIVIG5075.0%8636.4%331240%15650 IIITP NMOSD NMOSD45-650.445/100,0004.71:1 NMOSDB4AQP4 IgG80%AQP4 IgGBTKBBBTKBTKBTKNMOSD IITIIIIT T–TYK2 ICP-332 ICP-332TYK2TYK2JAKIL-12/IL-23IFNT17TH17TH1BADICP-332TYK2400JAK2JAKTYK2ICP-332IBD Pharma Intelligence120.96-22.6%1.2-17.1%100ICP-332 CDEICP-332IIIPK/PDJAK-2AEADII I14ICP-332532040160QDPKPD8ICP-3326280ICP-322 ICP-3325320PKCmaxAUClast14320160QDICP-332 ICP-488 ICP-488TYK2JH2JH2TYK2JH2TYK2ICP-488TYK2TYK2 JH2IL-23IL-12 I IFNICP-488SLELN IBDICP-332ICP-488TYK2 I136SADMADICP-488 I C P - 2 4 8I C P - 4 9 0I C P - B 0 2TafasitamabNHLMMDLBCL NMNHL(i)(ii)FDAEMACD19TafasitamabDLBCL(ii