MA-EUSA-PHARMA
EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for QARZIBA® ▼ (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. Dinutuximab beta is a targeted immunotherapy approved by the European Medicines Agency (EMA) for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma with or without residual disease. High-risk neuroblastoma is an aggressive neoplasm and the most common childhood solid tumour that originates outside of the brain. Dinutuximab beta is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201109005558/en/
“Dinutuximab beta represents an important biologic, which is already available to patients with high-risk neuroblastoma in Europe,” commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. “For paediatric patients fighting this disease in China, we are hopeful that dinutuximab beta will soon be available as a new treatment option. Our collaboration with EUSA and the progress thus far demonstrate our joint commitment to bringing high-quality therapies to the people who need them.”
Lee Morley, Chief Executive Officer of EUSA Pharma, said, “This milestone brings us and BeiGene closer to delivering on our promise of bringing innovative cancer and rare disease therapies to patients around the world. We look forward to working with BeiGene and the NMPA to potentially make dinutuximab beta available in China.”
About QARZIBA® ▼ (dinutuximab beta)
QARZIBA® ▼ is a monoclonal antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells. Dinutuximab beta was approved by the European Commission in 2017 and is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2).
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has extensive commercial operations in the United States and Europe, alongside a direct presence in select other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information please visit www.eusapharma.com .
About BeiGene
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. Our 4,700+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.
BeiGene Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential approval, launch and opportunity of QARZIBA® in China, future development and potential commercialization activities of the products under the agreement with EUSA, and other information that is not historical information. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.
GL-DNB-2000070. November 2020
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109005558/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Allianz Reports Safety Gains From Automated Mobility and Urges EU-Wide “Driving License” for Autonomous Vehicles28.10.2025 10:05:00 CET | Press release
Strategic priorities for safe autonomous mobility: Allianz calls for EU-wide uniform testing standards for the approval of autonomous vehicles, free access to accident- and safety-related in-vehicle data, and a joint European database for critical traffic situations.Predicted Safety Improvements: Allianz forecasts a 20 percent reduction in traffic accidents by 2035, increasing to over 50 percent by 2060, thanks to autonomous technology.Allianz claims analysis confirms that currently available autonomous braking assistance systems reduce the frequency of specific accidents by 66 percent.Consumer confidence and concerns: A survey across seven European countries reveals that while consumers expect safety improvements, they remain cautious about technological maturity and reliability.Victim protection is essential: Current liability and compulsory insurance models in motor insurance across most EU countries are suitable for autonomous vehicles. The promise of autonomous mobility is not jus
Ares Management and Slate Asset Management to Acquire Polish Real Estate Portfolio Valued at Over €300 Million From Trei Real Estate28.10.2025 09:15:00 CET | Press release
Ares Management Corporation (“Ares”) (NYSE: ARES), a leading global alternative investment manager, and Slate Asset Management (“Slate”), a global investor and manager focused on essential real estate and infrastructure, today announced that a joint venture between Ares Real Estate funds (“Ares Real Estate”) and Slate has agreed to acquire a portfolio of 36 properties in Poland (the “Portfolio”) from Trei Real Estate, an internationally active developer and asset manager. The Portfolio is valued at over €300 million. The Portfolio comprises 36 recently developed and fully occupied convenience-led retail parks strategically located across major Polish metropolitan areas near large catchment populations. The assets are inflation-protected through CPI-linked lease agreements underpinned by tenants with strong covenants. Most of the Portfolio’s income is derived from large regional retailers and essential goods providers, including grocers and pharmacies. “This transaction underlines our c
SK pharmteco Achieves Highest-Level My Green Lab Certifications Across Europe and Asia28.10.2025 09:00:00 CET | Press release
Green certification is the top tier of the globally recognized My Green Lab program for laboratory sustainability excellence SK pharmteco, a global contract development and manufacturing organization (CDMO), today announced a significant milestone in its commitment to environmental sustainability by earning four My Green Lab certifications, including two at the program’s highest level, Green. The remaining two labs earned Gold certification, reflecting advanced sustainability performance and progression toward full Green maturity. The certified facilities are Small Molecule Europe (Swords, Ireland) and Small Molecule Asia (Daejeon, South Korea), and the certifications cover the areas of Quality Control, Process Research & Development, and Analytical Research & Development. My Green Lab certification is widely regarded as the global standard for laboratory sustainability, recognized by the United Nations Race to Zero campaign for its rigor in advancing credible decarbonization. Green ce
Kemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing28.10.2025 07:00:00 CET | Press release
Milestone expands India’s role in global biologics manufacturing; collaboration with Cipla underscores commitment to quality and reliability Kemwell Biopharma Pvt Ltd (“Kemwell”), a leading global biologics Contract Development and Manufacturing Organization (CDMO), announced today that its drug-product manufacturing facility in Bengaluru has successfully completed a U.S. Food and Drug Administration (FDA) pre-approval inspection (PAI) and is now cleared for the commercial manufacturing and testing of injectable products destined for the U.S. market. This milestone marks the approval of the first product to get U.S. FDA clearance for commercial supply from Kemwell’s Bengaluru drug-product facility since the site became a dedicated biologics campus eight years ago. It demonstrates the company’s ability to meet stringent current Good Manufacturing Practice (cGMP) and aseptic drug-product manufacturing standards. “Achieving FDA clearance for commercial manufacturing from our Bengaluru sit
Uzbekistan's National Payment System HUMO and Ant International’s Alipay+ Partner to Facilitate Cross-Border QR Payments28.10.2025 06:55:00 CET | Press release
HUMO will be the 10th national QR network to partner with Alipay+, enabling its network of Uzbek digital payment apps to make cross-border QR payments across Alipay+’s global merchant ecosystem.The Octomobile app by Octobank, supported by HUMO, will be the first Uzbek e-wallet to be integrated with Alipay+, with more Uzbek e-wallets expected to join by the end of the year.Alipay+ now partners with 40 e-wallets and bank apps and 10 national QR payment schemes and payment systems worldwide, connecting over 100 million merchants to 1.8 billion consumers accounts. Alipay+, Ant International’s global wallet gateway, and HUMO, the national payment system in Uzbekistan, announced the partnership in Beijing to facilitate inbound and outbound cross-border QR payments. The Octomobile app by Octobank will be the first Uzbek e-wallet integrated with Alipay+, with more HUMO-connected local e-wallets and bank apps expected to join by the end of the year. This press release features multimedia. View
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom