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诺诚健华:港股公告:诺诚健华医药有限公司截至二零二二年十二月三十一日止年度全年业绩公告 下载公告
公告日期:2023-03-28

InnoCare Pharma Limited()

(9969)

625,4041,043,033198,199217,938(438,611)(298,463)(639,139)(721,584)(181,556)(139,815)(291,167)(1,271)(893,727)(66,679) (473,691)2,630

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419.9273.0

2.5(iii)

298.5140.1

438.6

66.7893.7

2.6473.7

(893,727) (66,679)

290,559 (57,135)129,477126,444(473,691)2,630

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MSII12

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SLESRI–4

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ICP-192 (Gunagratinib)

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Market

ICP-022/Orelabrutinib

BTKr/r WMr/r CLL/SLLr/r MCLr/r MZL

ICP-B02CD3 x CD20

ICP-248BCL-2

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CHN,SG

CHN

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202012252020122520228NDANMPA2022NDANMPA2022

202212202332022720233

NDA

IND Enabling

PH3PHIaPH2*

FiledPHIbPH2**

Market

ICP-B05

pan-FGFRpan-TRK

ICP-192/Gunagratinib

ICP-723/Zurletrectinib

VEGFR, DDR1ICP-033

SHP2ICP-189

CCR8

BTKTYK2 –JH1TYK2 –JH2

ICP-022/OrelabrutinibICP-332ICP-488

NTRK

IIPoC

20232

INDFDA

BTBT

MSITPNMOSD

CSU

ICP-332 (TYK2i-JH1)ICP-488 (TYK2i-JH2)

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T

(BTKi)B

NMOSD:

ITP:

CSU:

SLE:

AD:

IBD:

LN:

CD:

UC:

IIaIIb

IIPoCIIPoCIIMS:

III

(CNS)B

SLEIIaSLEBTKIIbMSIIPoCITPNMOSDIICSU

TTYK2ICP-332ICP-488TADSLEIBDLNCDUC

BICP-332ICP-488T

BBTKTECB

BCRBBTKBTK

MS

MSIIIIRMSOLERMS1:1:1:1

450QD50BID80QDOLE

GdE T1 MRI12GdET1MRI

13612Gd+T150QD71.1%(p=0.0238)50BID80.8%(p=0.0032)80

QD92.1%(p=0.0006)

12Gd+T1

PlaceboN=34

Orela 50mg QDN=33

Orela 50mg BIDN=34

Orela 80mg QDN=35

71.1%,

P=0.0238

80.8%,

P=0.0032

92.1%,

P=0.0006

(95% CI?)

1CIQD=BID=pPearson

RMSII

InnoCare80mg QD92.1%Cumulative Gd+lesionsatWk12Placebo-controlled(N = 136), 24Wk + ext

Sano60mg QD85%

(2)Dose-response for Gd+lesions at Wk12Placebo-controlled for 4Wk, with12Wk cross-over (N=130), 16Wk + ext

MerckKGaA75mg qd(56% at75mg bid)70%

(3)Cumulative Gd+ lesions at Wk12,

16, 20, and 24Placebo-controlled + open label DMF (N =

267),24Wk + ext

BTK

Roche600mg q6mo89%

(4)Cumulative Gd+ lesions at

Wk12, 16, 20, and 24Placebo-controlled + Inf-b1a referencearm (N=218), 24Wk + ext

Novartis60mg q12w65%

(5)(6)

91%

(7)

Cumulative Gd+ lesions at

Wk 12Placebo-controlled (N=231), 24Wk +

ext

Novartis2mg qd72%

(8)Dose-response for CUAL at

3 moPlacebo-controlled, adaptive, doseranging

(N = 297), 6m + ext

Biogen240mg tid69%

(9)Cumulative Gd+ lesions at Wk12,

16, 20, and 24Placebo-controlled(N = 257),24Wk + ext

Novartis5mg qd61%

(10)

88% atmo. 6Cumulative Gd+ lesions

monthly for 6 monthsPlacebo-controlled (N = 281), 6m + ext

Sano14mg qd61%

(11)

# of CUAL per MRI scanPlacebo-controlled (N = 179), 36Wk + ext

T1

BTKTolebrutinibBTK

CD20CD20

S1PRS1PR

(1)

1 www.clinicaltrials.gov; (2)Sanofi’s R&D held on April 23, 2020;(3) MontalbanX, et al. NEngl J Med 2019; 380:2406-2417;(4) KapposL, et al. Lancet 2011;378:1779-87 (5) Bar-OrA. et al, Neurology 2018;90:e1805-e1814; (6)Endpoint with full data (0-12 Wks) (7) Posthoc data (4-12 wks);(8) Selmaj K, et al Lancet Neurol 2013;12:756-767;(9) Kappos L, 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

CNSPKBBBMS

PKBTKevobrutinibtolebrutinibevobrutinibtolebrutinibCNS

plasmacyte

B

B

B

B

T

T

BTK+

(CNS)

AQP4

T

MoG

TT

BTK(mg)

CSF Conc. ~2h(ng/mL)

Orelabrutinib150 QD

31.3

InnoCareEvobrutinibMerck KGaA75 BID

3.21

Sano120 QD

1.87

Tolebrutinib

1 doi: 10.1016/j.msard.2021.1030002 Multiple Sclerosis and Related Disorders 51 (2021) 103001 Topic: Advances in therapy in

MS; doi: 10.1016/j.msard.2021.103001

EAEMSMOGEAE

EAE

EAEMS

MSDMTFDABiolato M, Bianco A, Lucchini M, Gasbarrini A, Mirabella M, Grieco A. TheDisease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and LiverInjury: A Narrative Review. CNS Drugs . 2021 Aug;35(8):861-880

26MS2624

HBV

DMTBiolato M, Bianco A, LucchiniM, Gasbarrini A, Mirabella M, Grieco A. The Disease-Modifying Therapies ofRelapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review. CNSDrugs. 2021 Aug;35(8):861-880ALT

ALTβ136

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62C

BC

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FDA

MS

MS

8.125

MS

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MSBTK

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SLEII

EULARSLE1:1:1:1125080100

II

508010012SRI-4

35.7%50.0%61.5%64.3%

GC3C4

IIaSLE

IIbSLESLE

SLE1:1:1255048SRI-4

SRI-6C3C4dsNDA

35.7%

50.0%

61.5%

64.3%

14.3%

25.8%

28.6%

(n=55)

0%10%20%30%40%50%60%70%80%90%

100%

(N=14)

(N=14)

(N=13)

(N=14)

SLEBTKevobrutinibfenebrutinib

Ringheim, G. E., Wampole, M., & Oberoi, K. (2021) Frontiers in Immunology, 12,662223SLEBTK

SLE

ITPITPITP

TBTKBITPB

BTKITPITP

ITPIIIIITP

III

×109/L2

22GCIVIG5075.0%8636.4%331240%15650IIITP

NMOSDNMOSD

45-650.445/100,000

4.71:1

NMOSDB4AQP4 IgG80%AQP4 IgGBTKB

BBTKBTKBTKNMOSD

IITII

IIT

T–TYK2ICP-332

ICP-332TYK2TYK2JAKIL-12/IL-23IFNT17TH17TH1BADICP-332TYK2

400JAK2JAK

TYK2ICP-332

IBDPharma Intelligence

120.96-22.6%1.2-17.1%

ICP-332

CDEICP-332I

IIPK/PDJAK-2AE

ADII

I14ICP-332532040160QDPKPD8

ICP-3326280ICP-322ICP-3325320PKCmaxAUClast

14320160QDICP-332

ICP-488ICP-488TYK2JH2JH2TYK2

JH2TYK2ICP-488TYK2TYK2 JH2IL-23IL-12IIFNICP-488SLELNIBDICP-332ICP-488

TYK2I

136SADMADICP-488

ICP-248ICP-490ICP-B02Tafasitamab

NHLMM

DLBCLNMNHL(i)(ii)FDAEMACD19TafasitamabDLBCL(iii)

CD20xCD3BCL-2E3 Ligase(iv)

DLBCLTafasitamabBCL-2 E3 LigaseDLBCL

1L DLBCLMCDTafasitamab

DLBCL

ICP-248

ICP-B02

ICP-248

Orelabrutinib

TafasitamabICP-490

ICP-B05/CM369

ICP-490

OthersCMLALLAMLPTCL/CTCLDLBCLCNSLFLWMMZLMCLCLL/SLLOthersMM

NHL

850CLL/SLLMCL

CDE

MCLAE3

1L CLL/SLL

IIICLL/SLLIRCPFS

CLL/SLLIICLL/SLL15080CLL/SLL

4756.2%ORR93.8%CR30%

1.84DOR

PFS48DORPFS

56.2%52.7%CLL/SLL

BTKCR

AECLL/SLLGazyvaFCR

BTKi

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BTKiCLL/CLL

1L MCL

IIIR-CHOPR-CHOPIRCiwNHLPFS

MCLIIMCLDORPFSOS106

39.43

83%87.8%CT

36.8%

MCLTRAE

MCLIIFDABTD

MCL

WMWMBMIgMBTKWM

MYD88L265PBTKBTK

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AE

(Lancet eClinicalmedicine)MZLII150MZL111

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DLBCLNHL100

MCD1L DLBCL

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40%DLBCL

R-CHOP+XMCDB

NF-KBBTK

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R-CHOPMCDDLBCL

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MCDDLBCL

MCDDLBCL

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60%CNSLORR60%

86.7%mPFS9.83

mPFS

BCRMYD88

MOABBB150

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BTKCD20

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ADCC(Mol Ther Oncolytics 21: 158-1702021

BTKBTKB

ADCCMol TherOncolytics 21:158-1702021Gazyva

ADCCADCPCD20CD19Tafasitamab

CD20Gazyva(obinutuzumab)ADCCADCP

BTK

CD20/CD19B

CD20GazyvaBTafasitamabNHLIIICP-B04 (Tafasitamab)

CSCOTafasitamab

CSCOASCTDLBCLDLBCL

CHOP

TafasitamabTafasitamabTafasitamabTafasitamabNMPA

2CRTafasitamab

18TafasitamabDLBCL

TafasitamabDLBCLII

IITafasitamabDLBCL

ORRIRCDCRDoRPFSTTPTTROS

TafasitamabBDLBCLNHL40%Frost & Sullivan

DLBCL59119NHL/DLBCLTafasitamab

IncyteTafasitamabFcCD19TafasitamabFDA

DLBCLDLBCLASCTIIL-MIND

57.5% ORR(40% CR)33.5mOS43.9mDoRTafasitamab

CD19B-NHLB-NHLRE-MIND2R2Tafasitamab

Incyte35Incyte

82.5

Tafasitamab

Incyte

BTKTafasitamab

TafasitamabBTafasitamabADCCADCPBCD19

IncyteTafasitamab

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CD20xCD3

TDCCICP-B02

50%ICP-B0250%

I/IIICP-B02NHLPKIICP-B02

DLT53+3

DLTICP-B02BICP-B02SCINDCDE

MMICP-490ICP-490CRBN E3TPD

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IMiDMMNHL

INDCDEI

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BCL-2ICP-248ICP-248BCL-2ICP-248ALLAMLFLCLLDLBCLBCL-210%20ICP-248

ICP-248INDCDEIIICP-248BCLL/SLLMCLICP-248ICP-248CLL/SLL

ICP-192ICP-723

ICP-189ICP-B05ICP-033

ICP-192 (Gunagratinib)

ORR52.9%DCR 94.1%

ICP-723 (Zurletrectinib)

NTRK8ORR75%

ICP-189

SHP-2

ICP-B05

CCR8

EGFRiRTKiKRASiVEGFi

ICICDK4/6i

RAFiMEKiPD-1/PD-L 1

FGFRICP-192TRKICP-723SHP2CCR8ICP-189ICP-B05ICP-033

ICP-192 (Gunagratinib)Gunagratinib

FGFRFGFR

7.1%

FGFR

GunagratinibFGFR

FGFRGunagratinibFGFR

GunagratinibCCAIIaICP-19218CCA17

5.57ORR52.9%17

9DCR94.1%1716mPFS

6.9395% CI5.42TRAE

FGFRGunagratinibCCAFGR2

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ICP-723TRK

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NTRK1NTRK2NTRK3TRK

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NSCLCROS1NSCLC

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ICP-B05

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482.077.1%

217.9

198.2

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136.9

721.6

639.1

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639,139100.0721,584100.0

(i) 273.0270.5

2.5

(ii) 167.629.2

196.8

(iii) 136.986.2223.1(iv) 39.418.858.2(v) 21.821.343.1(vi) 82.8

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139.8

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6.9(iv)9.2

15.8

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181,556100.0139,815100.0

298.5

438.6

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219.4(ii)100.7

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290.6

51.0

3.4

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0.6

2.6

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46.6

127,82545,27395,344116,14565,3229,918313,290317,0598,697,9275,928,716

9,299,7086,417,111

118,59784,6024,2426,831727,552204,8867,75712,64720,11220,3361,197,168–

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317.1304.7

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111,18684,4597,335121

6617

118,59784,602

204.9

727.6

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104.1(ii)

41.4

57.0(iii)

33.17.6(iv)23.0

51.4(v)

459.5

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286.0

430.1

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2,415.671,260.2

52.2%

50%1,207,835853,114441,116411,998

40%

*

966,268812,054115,853696,201

10%

241,56763,66616,35047,316

2,415,6701,728,834573,3191,155,515

*

(i)(ii)

Gaoling Fund L.P.YHG Investment L.P.Vivo Opportunity Fund, L.P.210,508,000

16.33%14.04%

14.45421.023,041.44210,508,000

14.45

15.723,041.843,041.44

3,041,4401,704,4981,336,942

2,919.07140.25

2,778.82

545.7

1,494,220.6–1,494,220.6

116,146.6–116,146.6

273,851.4–273,851.4

60,952.3–60,952.3

833,644.7–833,644.7

2,778,815.6–2,778,815.6

625,4041,043,033(143,397)(65,667)

482,007977,366

198,199217,938(438,611)(298,463)(639,139)(721,584)(181,556)(139,815)(291,167)(1,271)3,396(51,014)

(100)(32)

(9,711)(604)

(17,045)(2,642)(893,727)(20,121)

–(46,558)(893,727)(66,679)

(886,593)(64,545) (7,134)(2,134)

(893,727)(66,679)

0.600.05

(893,727)(66,679)

429,445(89,453)429,445(89,453)(464,282)(156,132)

(457,148)(153,998) (7,134)(2,134)

(464,282)(156,132)

653,163430,081284,103135,9993,1253,12541,30534,16611,71221,423

–304,67528,04250,9511,021,450980,42065,3229,918

127,82545,27395,344116,145313,290317,0598,697,9275,928,7169,299,7086,417,111

118,59784,602

4,2426,831727,552204,8867,75712,64720,11220,3361,197,168–2,075,428329,3027,224,2806,087,8098,245,7307,068,229

–1,200,56435,43947,442287,76137,693278,203123,611601,4031,409,3107,644,3275,658,919

23197,597,0785,604,5407,597,1015,604,559

47,22654,3607,644,3275,658,919

1.

Ogier Global (Cayman)Limited, 89 Nexus Way, Camana Bay, Grand Cayman KY1-9009 Cayman Islands

1100%–1–100%InnoCare Pharma Inc.10,000,000–100%InnoCare Pharma Australia Pty Ltd.10–100%

(a)

80,000,000–100% 10,000,000–100%

49,225,100–91.08%

4,000,000–100% 1,000,000,000–93%

(a)

30,000,000–100%(a)

2.1

(a)(b)(c)

(i)(ii)(iii)(i)

(ii)(iii)

2.2

(a) 3

3721

(b) 16

(c) 3737

(d)

1916

? 9

2.3

1, 5

2, 4

10281028

1212

7,852,0007,877,000

3.

(a)

568,035216,06657,369826,967625,4041,043,033

(b)

1,020,695674,729

7551,0161,021,450675,745

10%

A*826,967B224,090*C101,386*D81,916*

407,392826,967

*

10%4.

625,4041,043,033

(a)

–775,963566,755214,66657,36951,003

1,2801,401

625,4041,043,033

568,035216,06657,369826,967

625,4041,043,033

568,035992,03057,36951,003

625,4041,043,033

Biogen Inc.

MSBTK

7,797–(b)

3090

17,7837,797 –17,783

17,78325,580

46,15916,257136,914135,1358,48670

832,608191,642154,070

6,5576,733

–57,135198,199217,938

5.

16.5%

16.5%

2,000,0002,000,0008.25%

8.25%16.5%16. 5%

25%15%

15%15%25%

50,000,00025%26%50,000,000

30%30%

21%21%

–52,593–(6,035)–46,558

(893,727)(20,121)25%(223,432)(5,030)

97,15222,37065,183(23,565)(62,491)(56,802)

–(82,003)103,983134,18418,1484,7201,45791–52,593–46,558

1,511,700,000

6.

7.

(886,593)(64,545)

1,479,5651,366,261

8.

127,95745,304

(132)(31)

127,82545,273

127,82245,273

3–127,82545,273

31–10032

1––(1)13231

127,9570.10%132

45,3040.07%32

9.

111,18684,4597,335121

6617

118,59784,602

10.

MSBTK

(www.hkexnews.hk)(www.innocarepharma.com)

AD

ALLAMLAQP4 IgG4 ASH

BBBT

BBiogenBiogen Inc.BIIB

BTDBTKBTKCD20B CD20MS4A1

BCDCCDENMPA

CLLCNSL

9969

DLBCLB

DLT

EULARFGFR

FL

GMP

IBDICP-105ICP-192ICP-022

iDMCIL-2-2IL-5-5IL-12-12IL-23-23IND

IRCITKTITPiwNHLJAK

MCDB(DLBCL)

MYD88L265PCD79BMCDMCLB

MSMZLNDAMMOSD

NMPA

NRDLNTRKFGFR(FGFR)TRKPDPK

R/Rr/rR-CHOPRICE

264,648,217

SC

0.000002

SHP2RAS

SLESLLSRISLE

T

TTBNKTDCCTTRK

TYK22UC

U.S.

FDAFDA

VivoVivo Opportunity Fund, L.PVivo Capital VIII,

LLCWM


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