MA-EUSA-PHARMA
9.11.2020 13:06:05 CET | 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
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
KARL LAGERFELD Reunites With Paris Hilton for Spring – Summer 2026 “From Paris with Love” Campaign12.2.2026 08:00:00 CET | Press release
KARL LAGERFELD unveils its Spring–Summer 2026 campaign, From Paris with Love, starring cultural icon Paris Hilton for the second consecutive season. Captured through the lens of long-time brand collaborator Chris Colls at the Maison’s headquarters, 21 Rue Saint-Guillaume in Paris, the global campaign spans the KARL LAGERFELD, KARL LAGERFELD JEANS, and KARL LAGERFELD PARIS collections. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211077844/en/ KARL LAGERFELD SS26 Campaign Paris Hilton - ©Chris Colls “Shooting the campaign at 21 Rue Saint-Guillaume was incredibly inspiring,” says Paris Hilton. “Stepping into Karl’s world felt personal and true to the DNA of both Karl and the brand. It wasn’t about looking back but being present in a space where his legacy continues to evolve.” Moving through the Maison with ease and confidence, Paris Hilton brings her signature glamour and charisma to KARL LAGERFELD’s universe through pla
AB InBev Reports Full Year and Fourth Quarter 2025 Results12.2.2026 07:01:00 CET | Press release
Underlying EPS increased by 6% with continued margin expansion and free cash flow generation of 11.3 billion USD Anheuser-Busch InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211688662/en/ Figure 14. Terms and debt repayment schedule as of 31 December 2025 (billion USD) Regulated and inside information1 “Beer plays an important role in bringing people together and creating moments of celebration. In 2025, we executed our strategy, made disciplined capital allocation choices and delivered growth within our outlook for the year, even as we navigated a dynamic consumer environment. We exit 2025 with improved momentum and enter 2026 well positioned to engage consumers with our megabrands and an unparalleled lineup of mega platforms. Thank you to our colleagues for their ongoing commitment, hard work and passion for our business.” – Michel Doukeris, CEO, AB InBev Revenue 4Q +
Bardasz Forms Strategic Digital Alliance with GEOLOG to Accelerate Global RTOC Delivery and Digital Well Construction Solutions12.2.2026 07:00:00 CET | Press release
HighlightsBardasz and GEOLOG form an alliance to strengthen delivery of end-to-end RTOC solutions for drilling optimization and NPT mitigation.Alliance combines Bardasz’s leadership in WITSML and ETP transmission, high-speed real-time data aggregation, and Super Store technology with GEOLOG’s global operational scale and local technical workforce.As part of the alliance, GEOLOG has made a minority investment in Bardasz, providing financial flexibility to accelerate Bardasz’s product roadmap and global expansion. Bardasz Group LLC (“Bardasz”), a provider of real-time, decision-ready intelligence for well construction—including drilling, completions, and well interventions—today announced a strategic digital alliance with GEOLOG International B.V. (“GEOLOG”), a global formation evaluation, drilling, and geochemistry services provider supporting subsurface projects in more than 40 countries. The alliance is designed to accelerate Bardasz’s global growth and enhance customer delivery by le
We Are All Sculptra: First-of-its-Kind Galderma Initiative to Demonstrate How Everyone Can Benefit from Sculptra’s Regenerative Properties12.2.2026 07:00:00 CET | Press release
Galderma unveils We Are All Sculptra, a global campaign capturing the clinical performance of Sculptra® across nine diverse patient profiles and journeys, over two years1 Backed by over 25 years of clinical use, Sculptra continues to prove its versatility as a regenerative treatment that works across all three layers of the skin2-6 The campaign captures the patients’ clinical and emotional experiences – including before & after treatment imagery – highlighting Sculptra’s adaptability and reinforcing its role in tailored, science-backed regenerative aesthetic care1 Galderma (SIX: GALD), the pure-play dermatology category leader, today unveiled We Are All Sculptra, a unique program designed to capture the clinical impact of Sculptra® across nine diverse patients – who were all new to injectable aesthetics – over two years.1 This innovative initiative will offer a rare and authentic real-life perspective on the power of regenerative biostimulation to deliver personalized outcomes, and dem
Lenovo Group: Third Quarter Financial Results 2025/2612.2.2026 05:13:00 CET | Press release
Lenovo delivers exceptional quarter, marks era of accelerated AI-driven growth and profitability Lenovo GroupLimited (HKSE: 992) (ADR: LNVGY), together with its subsidiaries (‘the Group’), today reported results for the third quarter of fiscal year 2025/26, a quarter that delivered record revenues, accelerated profitability, and continued AI revenue expansion. During the quarter, overall group revenue reached an all-time fiscal quarter high of US$22.2 billion, up 18% year-on-year, with revenue from all business groups growing double-digit year-on-year. Excluding non-operating non-cash items and one-time gains and charges in Q3 FY24/25 and Q3 FY25/26, adjusted net income (profit attributable to equity holders – non-HKFRS)[1] increased by 36% year-on-year to US$589 million, with adjusted net income margin[1] expanding to 2.7%. The results demonstrate the Group’s ability to deliver on its promise of double-digit growth and sustained profitability, while proving its ability to manage throu
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