Overview
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Founded in Beijing in 2010 by Xiaodong Wang and chief executive officer John V. Oyler, the company has offices in China， the United States, Australia, and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecule and monoclonal antibodies for cancer. BeiGene currently markets two oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. BeiGene also markets or plans to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, and a Bristol Myers Squibb (BMS) company EUSA Pharma. It was the first Chinese-born biotech to go public on Nasdaq with a $182 million IPO.
Global investment and collaboration
In 2021,
- BeiGene announced a collaboration and licensing agreement with Novartis Pharma AG to develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in North America, Japan, EU, and six other European countries. BeiGene received a $650 million upfront payment and is eligible to receive up to $1.55 billion in potential regulatory and sales milestone payments plus royalties on product sales.
- BeiGene and Strand Therapeutics, a privately-held developer of next-generation, programmable mRNA therapeutics for cancer and other diseases, announced that they have entered into an option and licensing agreement aimed at developing and commercializing Strand’s innovative, multi-functional mRNA treatments for solid tumors. BeiGene has secured an option to exclusively develop and commercialize in Asia (excluding Japan), Australia, and New Zealand up to two immuno-oncology programs using Strand’s intratumoral or systemic delivery mechanism, which is designed to deliver a tumor microenvironment-modifying mRNA directly to the tumor site.
In 2020,
- BeiGene has entered into a collaboration in China for Assembly’s portfolio of three clinical-stage core inhibitor candidates for the treatment of patients with chronic hepatitis B virus (HBV) infection. BeiGene acquired exclusive development and commercialization rights to ABI-H0731, ABIH2158, and ABI-H3733 in China. Assembly received a $40 million upfront payment and is eligible to receive up to $500 million in potential development, regulatory, and sales milestone payments plus royalties on product sales.
- BeiGene and EUSA Pharma (UK) have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT® (siltuximab) and QARZIBA®▼ (dinutuximab beta) in Greater China. BeiGene will fund and undertake all clinical development and regulatory submissions in the territories, and will launch and commercialize both products once approved. EUSA will receive an upfront payment and be eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $160 million. EUSA will also be eligible to receive tiered royalties on future product sales.
- The company and Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company developing targeted immuno-oncology therapeutics, announced an exclusive option and license agreement for the clinical development and commercialization of DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in Asia (excluding Japan), Australia, and New Zealand. Leap will retain exclusive rights for the development, manufacturing, and commercialization of DKN-01 for the rest of the world.
R&D
BeiGene’s innovation team consists of dedicated scientists in biology, chemistry, pharmacology, translational medicine. The main study targets include:
- Molecularly targeted agents
- Zanubrutinib: BTK inhibitor; a potential mono- or combination therapy for B cell malignancies.
- Pamiparib: investigational small molecule inhibitor of PARP1 and PARP2, currently being evaluated as a monotherapy or in combinations in solid tumors.
- Lifirafenib: investigational RAF dimer inhibitor, currently being evaluated as a monotherapy and in combinations in solid tumors with MAPK pathway aberrations.
– Immuno-Oncology Therapies
- Tislelizumab: anti-PD-1 antibody, an immune checkpoint inhibitor, currently being evaluated as a monotherapy and in combinations in solid tumors and B-cell malignancies.
- Combination Therapies
Learn more on BeiGene website:
https://www.beigene.com/science-and-product-portfolio/research-development
Manufacturing
BenGene’s manufacturing sites have been deemed to be in compliance with Good Manufacturing Practice (GMP) by the US Food & Drug Administration (FDA), the National Medical Products Administration (NMPA) in China, and European regulatory agencies. They are:
- Suzhou Small Molecule Manufacturing (Suzhou, China)
- Guangzhou Biologics Manufacturing (Guangzhou, China)
- Manufacturing Collaboration with Boehringer Ingelheim (Shanghai, China)
- Manufacturing Collaboration with Catalent (Kansas City, US)
