BeiGene
Pipeline

We are advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. We have three internally-developed late-stage clinical drug candidates and three marketed products in China.

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  • Global
  • China

Zanubrutinib BGB-3111, BTK Info Trials

Zanubrutinib

An investigational small molecule inhibitor of Bruton’s tyrosine kinase, or BTK, that is currently being evaluated in a broad pivotal clinical program globally, and in China as a potential monotherapy and in combination with other therapies to treat various forms of lymphoma. Zanubrutinib’s early compound name was BGB-3111.

BGB-3111, BTK

Commercial Rights

BeiGene, Worldwide

Partnerships

N/A
R/R MCL
R/R CLL/SLL
WM: zanubrutinib vs. ibrutinib
Treatment-naïve CLL/SLL: zanubrutinib vs. BR
R/R CLL/SLL: zanubrutinib vs. ibrutinib
WM
R/R MZL
R/R diffuse large B-cell lymphoma
B-cell malignancies
GAZYVA®1 (CD20)
R/R FL: zanubrutinib + GAZYVA® vs. GAZYVA®
B-cell malignancies
TISLELIZUMAB (PD-1)
Hematological tumors
ME-401
CLL/SLL or B-cell malignancies
(In collaboration with MEI Pharma)

Tislelizumab BGB-A317, PD-1 Info Trials

Tislelizumab2

An investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1 that is currently being evaluated in pivotal clinical trials globally and in China, as a monotherapy and in combination with standard of care to treat various solid and hematological cancers. Tislelizumab is designed to bind to and block downstream activity of PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T‑cells. Tislelizumab’s early compound name was BGB-A317.

BGB-A317, PD-1

Commercial Rights

Celgene has an exclusive right to develop and commercialize tislelizumab in all fields of treatment, other than hematology, in the United States, Europe, Japan, and the rest of world other than Asia. BeiGene retains Asian and hematology rights to tislelizumab.

Partnerships

Celgene
R/R cHL
Previously treated or metastatic UC
2L NSCLC
1L HCC
2L ESCC
1L GC
1L ESCC
Stage III NSCLC
2L/3L HCC
R/R NK/T-cell lymphomas
1L non-squamous NSCLC
1L squamous NSCLC
Nasopharyngeal cancer
1L UC
MSI-H or dMMR solid tumors
Solid tumors
PAMIPARIB (PARP)
Solid tumors
ZANUBRUTINIB (BTK)
Hematological tumors

Pamiparib BGB-290, PARP Info Trials

Pamiparib

An investigational small molecule inhibitor of the PARP1 and PARP2 enzymes that is being evaluated as a potential monotherapy and in combination with other therapies to treat various solid tumors. Pamiparib’s early compound name was BGB-290.

BGB-290, PARP

Commercial Rights

BeiGene

Partnerships

N/A
3L gBRCA+ ovarian cancer
2L plat-sensitive ovarian cancer maintenance
1L plat-sensitive gastric cancer maintenance
mCRPC
Solid tumors
TMZ (Chemo)
Solid tumors
RT/TMZ (RT/Chemo)
Glioblastoma

Lifirafenib BGB-283, RAF DIMER Info Trials

Lifirafenib

An investigational novel small molecule inhibitor with RAF monomer and dimer inhibition activities. Lifirafenib’s early compound name was BGB-283.

BGB-283, RAF DIMER

Commercial Rights

BeiGene

Partnerships

N/A
B-Raf-or K-RAS/N-RAS-mutated solid tumors
PD-0325901
Advanced solid tumors
(In collaboration with Springworks Therapeutics)

BGB-A333 +/– Tislelizumab PD-L1 +/– PD-1 Info Trials

BGB-A333 +/– Tislelizumab

An investigational humanized monoclonal antibody against the immune checkpoint receptor ligand PD‑L1.

PD-L1 +/– PD-1

Commercial Rights

BeiGene

Partnerships

N/A
Solid tumors

BGB-A425 +/– Tislelizumab (TIM-3)/PD-1 Info Trials

BGB-A425 +/– Tislelizumab

A humanized, IgG1-variant monoclonal antibody against TIM-3.

(TIM-3)/PD-1

Commercial Rights

BeiGene

Partnerships

N/A
Solid tumors

REVLIMID® LENALIDOMIDE/IMiD Info Trials

REVLIMID®3

REVLIMID® (lenalidomide) is an oral immunomodulatory drug that was approved in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone, in adult patients who have received at least one prior therapy. In 2018, REVLIMID® received approval in China of a new indication for the treatment of MM in combination with dexamethasone, in adult patients with previously untreated MM who are not eligible for transplant.

LENALIDOMIDE/IMiD

Commercial Rights

BeiGene has exclusive license from Celgene to market REVLIMID® in China

Partnerships

Celgene Corporation
R/R MM
MM
R/R NHL

ABRAXANE® ALBUMIN-BOUND PACLITAXEL Info Trials

ABRAXANE®3

ABRAXANE® (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free chemotherapy product, which was developed using Celgene’s proprietary nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. In China, ABRAXANE® is approved for metastatic breast cancer after failure of combination chemotherapy for metastatic disease, or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

ALBUMIN-BOUND PACLITAXEL

Commercial Rights

BeiGene has exclusive license from Celgene to market ABRAXANE® in China

Partnerships

Celgene Corporation
Breast cancer
Metastatic pancreatic cancer

VIDAZA® HYPOMETHYLATING AGENT Info Trials

VIDAZA®3

VIDAZA® (azacitidine for injection) is a pyrimidine nucleoside analog that has been shown to reverse the effects of DNA hypermethylation and promote subsequent gene re-expression. VIDAZA® was approved in China in 2017 for the treatment of intermediate-2 and high-risk myelodysplastic syndromes, or MDS, chronic myelomonocyte leukemia, or CMML, and acute myeloid leukemia, or AML, with 20% to 30% blasts and multi-lineage dysplasia.

HYPOMETHYLATING AGENT

Commercial Rights

BeiGene has exclusive license from Celgene to market VIDAZA® in China

Partnerships

Celgene Corporation
MDS
AML
CMMoL

Avadomide CC-122, CELMoD Info Trials

Avadomide

CC-122 is an investigational next‑generation Cereblon modulator currently in clinical development by Celgene. It is being evaluated in clinical trials, both as a single agent and in combination, for hematological and solid tumor cancers.

CC-122, CELMoD

Commercial Rights

BeiGene has exclusive development and commercialization rights in China from Celgene

Partnerships

Celgene Corporation
NHL
(in Phase 2 ex-China by Celgene)

Sitravatinib MULTI-KINASE INHIBITOR Info Trials

Sitravatinib4

Sitravatinib is an investigational spectrum-selective kinase inhibitor which potently inhibits receptor tyrosine kinases, including RET, TAM family receptors (TYRO3, Axl, MER), and split family receptors (VEGFR2, KIT).

MULTI-KINASE INHIBITOR

Commercial Rights

BeiGene has an exclusive license agreement for the development, manufacturing, and commercialization of Mirati’s sitravatinib in Asia (excluding Japan and certain other countries), Australia, and New Zealand.

Partnerships

Mirati Therapeutics, Inc.
Tislelizumab (PD-1)
Advanced solid tumors
(in Phase 2 ex-China by Mirati)
HCC or GC/GEJC

ZW25 BISPECIFIC ANTIBODY Info Trials

ZW255

ZW25 is an investigational bispecific antibody that can simultaneously bind two non-overlapping epitopes, known as biparatopic binding, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function.

BISPECIFIC ANTIBODY

Commercial Rights

BeiGene has exclusive development and commercial rights in Asia (excluding Japan), Australia and New Zealand from Zymeworks Inc.

Partnerships

Zymeworks Inc.
Solid Tumors
(in Phase 1b ex-China by Zymeworks)

* Some indications will not require a non-pivotal Phase 2 clinical trial prior to beginning pivotal Phase 2 or 3 clinical trials.
** Confirmatory clinical trials post-approval are required for accelerated approvals.

GAZYVA® is a registered trademark of Genentech.

Celgene has the right to develop and commercialize tislelizumab in solid tumors in the United States, European Union, Japan, and the rest-of-world outside of Asia.

3 ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene Corporation. BeiGene markets ABRAXANE® (nanoparticle albumin-bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in China under a license from Celgene Corporation.

Partnership with Mirati Therapeutics, Inc.

Collaboration with Zymeworks Inc.

ABBREVIATIONS
1L/2L/3L = first, second or third line; AML = acute myeloid leukemia; BR = bendamustine and rituximab; CLL = chronic lymphocytic leukemia; CMMoL = chronic myelomonocytic leukemia; FL = follicular lymphoma; GC = Gastric Cancer; HCC = hepatocellular carcinoma; cHL = classic Hodgkin’s lymphoma; MCL = mantle cell lymphoma; MDS = myelodysplastic syndrome; MM = multiple myeloma; MZL = marginal zone lymphoma; NK = natural killer; NHL = non-Hodgkin’s lymphoma; NSCLC = non-small cell lung cancer; R/R = relapsed/refractory; RT = radiation therapy; UC = urothelial carcinoma; SLL = small lymphocytic leukemia; TMZ = temozolomide; WM = Waldenstrom macroglobulinemia.

Last Updated: June 3, 2019

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