Global oncology company with in-house development and manufacturing of cancer medicines at sites in the USA, China and Europe
BeOne Medicines Ltd.
Hopewell (NJ) · Guangzhou · Suzhou · Beijing · Shanghai · Basel · Munich · Paris · Milan · Madrid · London · Cambridge (MA) · San Carlos (CA) · Tokyo · SingaporeNew on Amplifa
About BeOne Medicines
BeOne Medicines (formerly BeiGene) is a global oncology company with headquarters and a site network spanning six continents. The company develops and produces cancer medicines across the entire value chain: from drug discovery (over 1,200 researchers) through clinical development (more than 190 studies in over 45 countries) to commercial manufacturing. Manufacturing includes small-molecule API synthesis, oral solid dosage forms (tablets and capsules), biologics via mammalian cell culture, as well as antibody-drug conjugates (ADCs) and sterile injectables. Production sites are Hopewell (New Jersey, USA) with 8,000 liters of cell culture capacity, Guangzhou (China) with 65,000 liters of capacity for biologics and ADCs, and Suzhou (China) with an annual capacity of 600 million tablets and capsules. Founded in 2010, the company employs around 12,000 people and is listed on the Nasdaq, the Hong Kong Stock Exchange and the Shanghai STAR Market. Approvals exist in over 80 countries; European offices are located, among others, in Basel, Munich, Paris, Milan, Madrid and London.
- Site
- Hopewell (NJ)
- Processes
- Small-molecule API synthesis (complex multi-step synthesis), Cryogenic chemistry (down to -90°C), Hydrogenation, Chromatography, Enzymatically catalyzed reactions, Halogenation, Milling, Micronization
- Materials
- Small-Molecule API Synthesis, Oral Solid Dosage, Biologics (Mammalian Cell Culture), Antibody-Drug Conjugates, Sterile Injectables
- Certificates
- US FDA certification (Suzhou site), EMA certification (Suzhou site), TGA certification (Suzhou site), China GMP (Suzhou site), FDA Certification, EMA Certification, TGA Certification, China GMP, ISO 9001
- Founded
- 2010
- Employees
- ~12,000
- Industries
- Oncology, Pharmaceutical Industry, Hematology, Solid Tumors
- 01
Drug research and discovery
- 02
Process development and cell line development
- 03
Analytical development
- 04
Clinical development
- 05
API synthesis or biologics production
- 06
Formulation and oral solid dosage or aseptic filling
- 07
Primary packaging
- 08
Regulatory affairs management and commercial distribution
Processes and Manufacturing Technologies
Small-Molecule API Synthesis
Complex multi-step synthesis including cryogenic chemistry down to -90 °C, hydrogenation, chromatography and enzymatically catalyzed reactions.
Oral Solid Dosage
Tablets, capsules, multi-layer tablets as well as granulation, mixing, coating and extrusion.
Biologics (Mammalian Cell Culture)
Cell culture, purification via chromatography and UF/DF, as well as lyophilization.
Antibody-Drug Conjugates
Conjugation up to 500 L at the Guangzhou site.
Sterile Injectables
Aseptic filling of vials, ampoules, prefilled syringes, cartridges and auto-injectors.
Sites
Hopewell (NJ)
USU.S. biologics manufacturing and clinical R&D (flagship site)
- Materials
- Biologics
- Cell culture with 8,000 L single-use capacity (4 x 2,000 L, space for 4 more x 2,000 L)
- ASRS storage system (2–8 °C, -20 °C, -70 °C)
Guangzhou
CNBiologics and ADC production campus
- Materials
- Biologics, ADCs
- 65,000 L cell culture capacity (2 x 500 L, 12 x 2,000 L single-use, 8 x 5,000 L stainless steel)
- ADC conjugation up to 500 L
- ASRS storage system (15–25 °C, 2–8 °C, -40 °C, -80 °C)
Suzhou
CNSmall-molecule production, oral solid dosage and primary packaging (bottle and blister)
- Materials
- Small-molecule APIs, oral solid dosage forms
- OSD facility with capacity of 300 million tablets and 300 million capsules per year
Basel
CHEuropean office (first European site, 2017)
Munich
DEOffice
Beijing
CNR&D center
Shanghai
CNR&D center
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Small-molecule API synthesis (complex multi-step synthesis)Plastics | – | – | – | – | – |
| Cryogenic chemistry (down to -90°C)Plastics | – | – | – | – | – |
| HydrogenationPlastics | – | – | – | – | – |
| ChromatographyPlastics | – | – | – | – | – |
| Enzymatically catalyzed reactionsPlastics | – | – | – | – | – |
| HalogenationPlastics | – | – | – | – | – |
| MillingPlastics | – | – | – | – | – |
| MicronizationPlastics | – | – | – | – | – |
| FermentationPlastics | – | – | – | – | – |
| BiotransformationsPlastics | – | – | – | – | – |
| Oral solid dosage – tabletsPlastics | – | – | – | – | – |
| Oral solid dosage – capsulesPlastics | – | – | – | – | – |
| Wet/dry granulationPlastics | – | – | – | – | – |
| BlendingPlastics | – | – | – | – | – |
| CoatingSurface | – | – | – | – | – |
| ExtrusionPlastics | – | – | – | – | – |
| Compression/tablet pressingPlastics | – | – | – | – | – |
| Roll compactionPlastics | – | – | – | – | – |
| Multi-layer tabletsPlastics | – | – | – | – | – |
| High-containment production / hormone manufacturingPlastics | – | – | – | – | – |
| Mammalian cell culture (biologics)Plastics | – | – | – | – | – |
| Conjugation (antibody-drug conjugates)Plastics | – | – | – | – | – |
| Purification (chromatography & UF/DF)Plastics | – | – | – | – | – |
| Lyophilization (freeze-drying)Plastics | – | – | – | – | – |
| Aseptic filling of liquid injectables (vials, ampoules, prefilled syringes, cartridges, bottles,Plastics | – | – | – | – | – |
| Analytical development (method development, structure elucidation)Testing | – | – | – | – | – |
| Process development (cell line development, process optimization, cleaning validation)Engineering | – | – | – | – | – |
| Primary packaging (bottle & blister)Plastics | – | – | – | – | – |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Biologics manufacturing facility (cell culture, single-use) | BeOne Medicines | – | 8.000L cell culture capacity (4 x 2.000L single-use), space for an additional 4 x 2.000L | – | Hopewell, NJ, USA |
| Biologics and ADC production campus | BeOne Medicines | – | 65.000L cell culture capacity (2 x 500L, 12 x 2.000L SU; 8 x 5.000L SS); ADC conjugation up to 500L | – | Guangzhou, China |
| Oral solid dosage production facility | BeOne Medicines | – | 300M tablets & 300M capsules annual capacity | – | Suzhou, China |
| ASRS storage system (Automatic Search & Retrieval) | BeOne Medicines | – | Storage 2–8°C, -20°C, -70°C | – | Hopewell, NJ, USA |
| ASRS storage system | BeOne Medicines | – | Storage 15–25°C, 2–8°C, -40°C, -80°C | – | Guangzhou, China |
Additional services
Reference customers
Quality and Certifications
The Suzhou plant is certified by the US FDA, the European EMA, the Australian TGA and China GMP. cGMP-compliant laboratories and comprehensive analytical equipment support method development and structure elucidation.
| Evidence | Suzhou |
|---|---|
| FDA Certification | |
| EMA Certification | |
| TGA Certification | |
| China GMP | |
| ISO 9001 |
Company History
- 2010
Founded by John V. Oyler and Xiaodong Wang.
- 2011
First external investment of USD 20 million by Merck KGaA; opening of the first R&D center.
- 2016
IPO on the Nasdaq.
- 2017
Opening of the first European office in Switzerland; license agreement with Celgene for tislelizumab.
- 2018
Listing on the Hong Kong Stock Exchange (06160) with over USD 900 million in offering proceeds.
- 2019
First FDA approval: BRUKINSA (zanubrutinib).
- 2020
Strategic partnership with Amgen including a USD 2.7 billion equity investment; over 5,000 employees.
- 2021
Listing on the Shanghai STAR Market (688235); EU approval for BRUKINSA; collaboration with Novartis.
- 2022
Groundbreaking for the US biologics plant in Hopewell, NJ; revenue over USD 1 billion.
- 2023
EU approval for TEVIMBRA; investment in the Suzhou production site (600 million doses/year); founding of the BeOne Care Foundation.
- 2026
US manufacturing expansion announced with a total investment of over USD 1 billion.