MA-EUSA-PHARMA/BEIGENE
17.8.2021 15:25:09 CEST | Business Wire | Press release
BeiGene, Ltd. (NASDAQ:BGNE; HKEX:06160) and EUSA Pharma (UK), Ltd. today announced that the China National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval 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 a history of relapsed or refractory (R/R) neuroblastoma with or without residual disease. Dinutuximab beta is a targeted immunotherapy approved by the European Medicines Agency (EMA).i
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210817005630/en/
“Dinutuximab beta represents an important biologic therapy for pediatric patients in China, having been listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA,” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. “For these young patients fighting neuroblastoma in China, we are proud to bring the first approved treatment.”
“We are delighted that the benefit of dinutuximab beta has been recognized in China. This approval represents an important milestone in our mission and collaboration with BeiGene of bringing innovative cancer and rare disease therapies to patients,” said Carsten Thiel, Ph.D., Chief Executive Officer of EUSA Pharma.
The approval of dinutuximab beta in China for the treatment of patients with high-risk neuroblastoma was supported by clinical results available from key trials conducted by SIOPEN (The International Society of Paediatric Oncology Europe Neuroblastoma Group) in collaboration with APEIRON Biologics and EUSA Pharma. These randomized controlled trials evaluated the efficacy of dinutuximab beta by comparing the administration of dinutuximab beta with and without interleukin-2 (IL-2) in the first-line treatment of patients with high-risk neuroblastoma and in two single-arm studies in the R/R setting. In the SIOPEN trial (HR-NBL1), the five-year event-free survival (EFS) rate in patients treated with dinutuximab beta was 57% vs. 42% of historical controls (p<0.01) and five-year overall survival (OS) rate was 64% vs. 50% (p ≤0.0001).ii The safety of dinutuximab beta has been evaluated in 514 patients. The most common adverse reactions were pyrexia and pain that occurred despite analgesic treatment. Other frequent adverse reactions were hypersensitivity, vomiting, diarrhea, capillary leak syndrome, and hypotension.
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 (See EMA Summary of Product Characteristics (SmPC) ) 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 a history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilized by other suitable measures.
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 .
BeiGene Oncology
BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines to patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. The Company currently markets three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.
About BeiGene
BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of approximately 7,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal
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 planned launch, potential benefits to patients, and opportunity of QARZIBA® in China, 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.
QARZIBA® is a registered trademark of EUSA Pharma (UK), Ltd.
GL-DNB-2100014. August 2021.
__________________
References
i European Medicines Agency, Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta APEIRON Biologics). Accessed: August 2021 via https://www.ema.europa.eu/en/medicines/human/EPAR/qarziba#authorisation-details-section .
ii Ladenstein, R et al. Cancers 2020, 12, 309; doi:10.3390/cancers12020309.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210817005630/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
Mary Kay Extends Winning Streak With Fourth Year as #1 in Global Direct Selling Beauty23.6.2026 14:03:00 CEST | Press release
Euromonitor International Recognizes Mary Kay’s Sustained Leadership In Skin Care And Color Cosmetics Mary Kay Inc., the iconic beauty and entrepreneurship company, has once again been named the #1 Direct Selling Brand of Skin Care and Color Cosmetics in the World1 by Euromonitor International, sustaining its legacy of excellence for the fourth consecutive year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623487381/en/ Mary Kay Inc., the iconic beauty and entrepreneurship company, for the fourth year in a row has been named the #1 Direct Selling Brand of Skin Care and Color Cosmetics in the World by Euromonitor International. (Image Credit: Mary Kay Inc.) “Earning the #1 global ranking from Euromonitor for the fourth consecutive year comes as a powerful endorsement of the impact of our Independent Beauty Consultants around the world who drive our success every day,” said Ryan Rogers, Chief Executive Officer of Mary Kay
Kobie 2026 Heart of Loyalty Report Reveals Growing Gap Between Consumer Expectations and Brand Loyalty Strategies23.6.2026 14:00:00 CEST | Press release
Global study finds consumers are more ready for AI, more willing to share data, and more motivated by recognition and shared values than many brands realize Kobie, a global leader in loyalty technology and services, today released its 2026 Heart of Loyalty Report, which surveyed both consumers and practitioners, revealing significant gaps between consumer expectations and brand loyalty strategies across AI adoption, data sharing, recognition, advocacy, and community engagement. Kobie's 2026 Heart of Loyalty Report found that: 57% of consumers are willing to engage with AI-powered brand experiences, yet 56% of loyalty practitioners believe customers are not ready for AI. 77% of consumers want recognition from brands, but only 55% feel seen as individuals. 72% of consumers say they would refer a brand without an incentive, yet many referral strategies remain heavily dependent on rewards. Rewards are the strongest driver of willingness to share personal data, yet only 65% of practitioners
Veristat Strengthens Biostatistics, Drug Development Advisory, and People Leadership to Support Growth in Complex Clinical Development23.6.2026 13:05:00 CEST | Press release
Dr. Zhaohui Su and Dr. Gil Fine deepen Veristat’s biostatistics expertise, Scott Tarrant leads Strategic Drug Development Advisory, and Clint Wolfe joins as Chief Human Resources Officer VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, today announced four strategic leadership hires that advance its mission to accelerate novel therapy approvals in complex disease areas, including cell and gene therapy, oncology, and rare disease. Building on its 30-year foundation in biostatistics and its recent acquisition of the medical writing and regulatory submission business of Certara, Veristat is deepening its scientific expertise and expanding its operational leadership to meet growing client demand. Dr. Zhaohui Su and Dr. Gil Fine join Veristat’s Strategic Drug Development Advisory team in biostatistical leadership roles, collaborating with Scott Tarrant, who has been named Executive Vice President of the team. In addition, Clint Wolfe
Bacardi Takes Full Ownership of TEELING® Irish Whiskey23.6.2026 13:00:00 CEST | Press release
Irish whiskey brand joins family-owned company’s portfolio of premium brands Bacardi Limited has announced the completion of a transaction that makes the family-owned company the sole owner of the Teeling Whiskey Company and the TEELING® Irish whiskey brand. Founders Jack and Stephen Teeling will remain a part of the brand, shaping its future and driving growth for the long term as strategic advisors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623858211/en/ Three expressions of Teeling Irish Whiskey: Single Grain, Small Batch and Single Malt Today’s announcement follows the successful relationship the two companies have enjoyed since Bacardi acquired a minority stake in the Dublin-based whiskey company in 2017. Bacardi subsequently increased its stake to become the majority shareholder in 2022. “TEELING is the perfect fit for Bacardi,” says Mahesh Madhavan, Chief Executive Officer, Bacardi Limited. “The brand stands f
Bending Spoons S.p.A. announces launch of initial public offering23.6.2026 12:15:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the launch of its initial public offering (the “IPO”) of its ordinary shares. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 are being offered by Bending Spoons and 23,572,375 are being offered by certain selling shareholders (the “Selling Shareholders”). In connection with the offering, Bending Spoons and the Selling Shareholders have granted the underwriters a 30-day option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and an additional 3,451,626 ordinary shares from the Selling Shareholders at the IPO price, less underwriting discounts and commissions. The IPO price is currently estimated to be between $26.00 and $28.00 per share. Bending Spoons has applied to list its ordinary shares on the Nasdaq Global Select Market under the ticker symbol “BSP.” Goldman Sachs International, J.P. Morgan, and Allen & Company LLC are acting as joint l
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