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2019:全球乙肝药物研发管线(HBV Pipeline)

Tags: 乙肝   药物      作者:不详 更新:2019-05-15

中国药企在做乙肝药物的有:

正大天晴(TLR7激动剂-强生)、恒瑞医药(TLR-7)、齐鲁制药、东阳光药、挚盟医药、歌礼药业、亚盛医药、贺普生物等等。

下边来自HBV基金会,仅供参考:

FAMILY/DRUG NAME(药物名称)

MECHANISM

(药物机制)

COMPANY

(公司)

WEBSITE

(网站)

USA STATUS

Interferons: Mimic infection-fighting immune substances naturally produced in the body.

Intron A (Interferon alfa-2b)

Immunomodulator

Merck, USA

merck.com

Approved 1991

Pegasys (Peginterferon alfa-2a)

Immunomodulator

Genentech, USA

gene.com

Approved 2005


Nucleos(t)ide Analogues: Interfere with viral DNA polymerase used for HBV replication

Epivir (Lamivudine)
*Generics available

Inhibits viral DNA polymerase

GlaxoSmithKline (GSK)

gsk.com

Approved 1998

Hepsera (Adefovir dipivoxil)
*Generics available

Inhibits viral DNA polymerase

Gilead Sciences, USA

gilead.com

Approved 2002

Baraclude (Entecavir)
*Generics available

Inhibits viral DNA polymerase

Bristol-Myers Squibb, USA

bms.com

Approved 2005

Tyzeka (Telbivudine)
*Generic available

Inhibits viral DNA polymerase

Novartis, USA

novartis.com

Approved 2006


Viread (Tenofovir)
*Generics available

Inhibits viral DNA polymerase

Gilead Sciences

gilead.com

Approved 2008

Vemlidy (TAF or tenofovir alafenamide)

Prodrug of tenofovir

Gilead Sciences

gilead.com

Approved 2016

Levovir (Clevudine)

Inhibits viral DNA polymerase

Bukwang, S. Korea

bukwang.co.kr

Approved 2006 in S. Korea

Besivo (formerly ANA 380/LB80380)

Inhibits viral DNA polymerase

Ildong Pharma, S. Korea

ildong.com/en

Approved 2017 in S. Korea

Zadaxin

Immunomodulator

SciClone, USA

sciclone.com

Approved outside USA

DIRECT ACTING ANTIVIRALS: Targets the virus and interferes in the HBV replication process

TDF Pro Drugs: A modified tenofovir drug that can get into liver cells more easily

TXL (CMX 157)

Prodrug of tenofovir

ContraVir, USA

contravir.com

Phase II

Silencing RNA’s (siRNAs): Interferes and destroys viral RNA

ARB-1467

RNAi gene silencer (1.0)

Arbutus Biopharma, USA

arbutusbio.com

Phase II

RG6004

RNAi gene silencer

Roche, Switzerland

roche.com

Phase I/II

ARO-HBV

RNAi gene silencer

Arrowhead Pharma, USA

arrowheadpharma.com

Phase I/II

AB-729

RNAi gene silencer

Arbutus Biopharma, USA

arbutusbio.com

Phase I

Vir-2218

RNAi gene silencer

Alnylam and Vir Biotech, USA

alnylam.com

Phase I/II

DCR-HBVS

RNAi gene silencer

Dicerna, USA

dicerna.com

Phase I

BB-103

RNAi gene silencer

Benitec, Australia

benitec.com

Preclinical

Lunar-HBV

RNAi gene silencer

Arcturus, USA with Janssen

arcturusrx.com

Preclinical

Entry Inhibitors: Interferes with HBV getting into liver cells

Myrcludex B
(bulevirtide)

Entry inhibitor

Hepatera, Russia with MYR GmbH, Germany

myr-pharma.com

Phase IIb

Capsid Inhibitors: Interferes with the viral DNA protein shield

Morphothiadin (GLS4)

Capsid inhibitor

HEC Pharma,
PR China(东阳光)

pharm.hec.cn/en

Phase II

JNJ 56136379

Capsid inhibitor

Janssen, Scotland

janssen.com

Phase II

ABI-H0731

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase II

AB-423

Capsid inhibitor

Arbutus Biopharma, USA

arbutusbio.com

Phase I

AB-506

Capsid inhibitor

Arbutus Biopharma, USA

arbutusbio.com/

Phase I

ABI-H2158

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase I

RG7907

Capsid inhibitor

Roche, Switzerland

roche.com

Phase I

QL-007

Capsid inhibitor

Qilu, China(齐鲁)

qilu-pharma.com

Phase I

GLP-26

Capsid inhibitor

Emory University

emory.edu

Preclinical

EP-027367

Capsid inhibitor

Enanta Pharmaceuticals, USA

enanta.com

Preclinical

QL-0A6a

Capsid inhibitor

Qilu, China

qilu-pharma.com

Preclinical

CB-HBV-001

Capsid inhibitor

ZhiMeng Biopharma, China(挚盟医药)

core-biopharma.com

Preclinical

HBsAg Inhibitors: Interferes with production of HBV surface antigen (sAg)

REP 2139

sAg inhibitor

Replicor, Canada

replicor.com

Phase II

REP 2165

sAg inhibitor

Replicor, Canada

replicor.com

Phase II

Antisense Molecules: Binds to the viral mRNA to prevent it from turning into viral protein

IONIS-HBVRx (GSK3228836)

Viral protein inhibitor

Ionis Pharma, USA with GSK

ionispharma.com

Phase II

IONIS-HBVLRx (GSK33389404)

Viral protein inhibitor

Ionis Pharma with GSK

ionispharma.com

Phase II


Ribonuclease H Inhibitors: Inhibit degradation of viral RNA

ARB-452

Viral RNase Inhibitor

Arbutus Biopharma, USA

arbutusbio.com

Preclinical

INDIRECT ACTING ANTIVIRALS: Targets the human immune system to attack the HBV virus

Therapeutic Vaccines: Vaccine technology used to stimulate the immune system as a treatment

ABX203

Therapeutic vaccine

Center for Genetic Engineering and Biotechnology, Cuba

cigb.edu.cu/en

Phase III

AIC 649

Therapeutic vaccine

AiCuris, Germany

aicuris.com

Phase I

INO-1800

Therapeutic vaccine

Inovio, USA

inovio.com

Phase I

HB-110

Therapeutic vaccine

Ichor Medical Systems with Janssen, USA

ichorms.com

Phase I

TG1050

Therapeutic vaccine

Transgene, France

transgene.com

Phase I

HepTcell

Therapeutic vaccine

Altimmune, USA

altimmune.com

Phase I

HBV (TomegaVax)

Therapeutic vaccine

TomegaVax, USA

tomegavax.com

Preclinical

HBV

Therapeutic vaccine

GeoVax Labs, USA

geovax.com

Preclinical

VR-CHB01

Therapeutic vaccine

Vical, USA

vical.com

Preclinical

VBI-2601

Therapeutic vaccine

VBI Vaccines, USA with Brii Biosciences

vbivaccines.com

Preclinical

Chimigen HBV

Therapeutic vaccine

Akshaya Bio Inc., Canada

akshayabio.com

Preclinical

CARG-201

Therapeutic vaccine

CaroGen Crop

carogencorp.com

Preclinical

Innate Immune Defense Pathway: Compounds that activate the innate immune system

RG7795

TLR-7 agonist

Roche, Switzerland

roche.com

Phase II

Inarigivir (SB9200)

RIG -1 and NOD2 agonist

Spring Bank Pharmaceuticals, USA
Gilead Sciences

springbankpharm.com
gilead.com

Phase II

GS9688

TLR-8 agonist

Gilead Sciences, USA

gilead.com

Phase I

RG7854

TLR-7 agonist

Roche, Switzerland

roche.com

Phase I

Host Acting Pathway: Compounds that induce programmed cell death (apoptosis)

APG-1387

Apoptosis Inducer

Ascentage Pharma, China(亚盛)

en.ascentagepharma.com

Phase I

CRV 431 (CPI 431-32)

Ciclofillin inhibitor

ContraVir, USA

contravir.com

Preclinical

Gene Editing

EBT106

CRISPR/Cas 9

Excision Biotherapeutics, USA

www.excisionbio.com

Preclinical

HBV

CRISPR/Cas 9

Intellia Therapeutics, USA

intelliatx.com

Preclinical

HBV

ARCUS

Precision Biopharma, USA with Gilead

precisionsciences.com

Preclinical


Other

GC1102

sAg monoclonal antibody

Green Cross, South Korea

www.globalgreencross.com

Phase II

EYP001

FXR agonist

Enyo Pharma, France

enyopharma.com

Phase I

LTCR-H2-1

T Cell immunotherapy

Lion TCR, Singapore

www.liontcr.com

Preclinical

IMMTav

T Cell immunomodulator

Immunocore, USA

immunocore.com

Preclinical

HBV

MicroRNA

Regulus Therapeutics, USA

regulusrx.com

Preclinical

HEPATITIS DELTA VIRUS (HDV)

Lambda (Pegylated Interferon)

Immunomodulator

Eiger Biopharma, USA

eigerbio.com

Orphan drug designation
Phase III

Myrcludex B
(bulevirtide)

Entry inhibitor

MYR-GmbH, Germany

myr-pharma.com

Breakthrough Therapy Designation
Phase III

Lonafarnib

Prenylation inhibitor

Eiger Biopharma, USA

eigerbio.com

FDA Fast Track Designation
Orphan drug designation
Phase II

REP 2139/ REP 2165

HBsAg inhibitor

Replicor, Canada

replicor.com

Phase II

Ezetimibe

NTCP inhibitor

Ziauddin University Hospital, Pakistan

zu.edu.pk

Phase II

ALN-HDV

RNAi gene silencer

Alnylam, USA

alnylam.com

Preclinical

GI-18000

Immune Response Stimulator

GlobeImmune

globeimmune.com

Preclinical


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