EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for QARZIBA®▼ (Dinutuximab Beta) in China
9.11.2020 15:04:00 EET | Business Wire | Press release
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109005558/en/
Contact information
EUSA Media
Rebecca Kerr
+44 7909 703627
media@eusapharma.com
BeiGene Investors
Craig West
+1 857-302-5189
ir@beigene.com
BeiGene Media
Liza Heapes
+1 857-302-5663
media@beigene.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
2PointZero Group Completes Majority Acquisition in Italy-Based ISEM Packaging Group for AED 704 Million5.3.2026 23:02:00 EET | Press release
2PointZero Group PJSC (ADX: 2PointZero), a next-generation investment powerhouse focused on energy and consumer sectors, announced today that it has formally completed the transaction to acquire a majority position in ISEM, a leading European packaging group serving beauty, fashion, luxury, nutraceuticals and more, for AED 704 million through a combination of secondary and primary capital earmarked to accelerate organic and inorganic growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305800523/en/ 2PointZero Group completes majority acquisition in Italy-based ISEM Packaging Group for AED 704 million (Photo: AETOSWire) 2PointZero Group now holds 60.8% of ISEM, while Peninsula Capital and minority investors own the remaining 39.2%. This marks the start of a strategic partnership between 2PointZero and Peninsula. Together, the partners will reinforce ISEM’s leadership position with a focus on category and geographic expa
Xsolla Announces Reseller Program to Help Game Developers Unlock New Revenue Streams in Local Markets5.3.2026 19:00:00 EET | Press release
Xsolla, a leading global video game commerce company, today announced the Xsolla Reseller Program, a new product designed to help game developers scale and capture untapped revenue in local markets with no development needed. The program launches with a curated cohort of resellers and distributors in Southeast Asia and Latin America, with expansion into additional regions throughout 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305047070/en/ Graphic: Xsolla As game developers pursue global growth, they face a fundamental infrastructure challenge: billions of dollars in revenue remain untapped in emerging, cash-dependent economies, such as Southeast Asia, Latin America, the Middle East, and North Africa, where players purchase digital content through local distribution partners. In mature digital economies, developers seek to extend their reach and distribute digital inventory at scale through more partners and chan
Xsolla Agency Launches to Empower Creators Across Entertainment-Based Intellectual Property5.3.2026 17:23:00 EET | Press release
Xsolla, a global video game commerce company, today launched Xsolla Agency, a comprehensive service connecting game developers with premium entertainment-based intellectual property (IP). The integrated offering addresses critical challenges for game creators: access to world-class IP, global monetization capabilities, and the operational infrastructure needed to build sustainable businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305044119/en/ Graphic: Xsolla Xsolla Agency simplifies access to entertainment-based licenses through expert-led negotiations and industry relationships, offering affordable, monetization-focused deals structured for maximum ROI. Strategic IP partnerships increase discoverability, reduce user acquisition costs, and drive higher player spend through impactful LiveOps events and promotional campaigns. The service is backed by the same commerce infrastructure powering 1,500+ game developers
Onego Bio and Sigma Foods Enter Collaboration to Strengthen Egg Protein Innovation and Supply Resilience5.3.2026 17:00:00 EET | Press release
Onego Bio, a food ingredient company producing non-animal egg protein, and Sigma Foods ("SIGMA"), a leading multinational food company, have entered into a collaboration agreement to evaluate the functionality and commercial potential of Bioalbumen®, a non-animal egg protein made with using precision fermentation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305756400/en/ The partnership focuses on advancing ingredient innovation while addressing urgent challenges in today’s egg supply chain—including volatility, rising prices, and avian flu-related disruptions. Bioalbumen® offers a shelf-stable, animal-free alternative that delivers the same functional, nutritional, and sensory performance as traditional eggs, while helping safeguard supply continuity for food manufacturers. Additionally, this collaboration supports Sigma’s commitment to offering safe, nutritious, and high-quality food, while driving science-based inno
Vertex to Present New Data on JOURNAVX ® That Demonstrates Effective Pain Management Following Aesthetic and Reconstructive Procedures5.3.2026 17:00:00 EET | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from a Phase 4 study of JOURNAVX® (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These data will be presented at the American Academy of Pain Medicine (AAPM) PainConnect 2026 meeting, March 5-8, 2026, in Salt Lake City, UT. This Phase 4 open-label, multicenter, single-arm study evaluated JOURNAVX w
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