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Y-mAbs' DANYELZA (Naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in Brazil

Y-mAbs' DANYELZA (Naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in Brazil

Y-mabs用于治疗高危神经母细胞瘤的DANYELZA(Naxitamab-GQGK)在巴西获得批准
GlobeNewswire ·  2023/05/23 21:00

NEW YORK, May 23, 2023 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária ("Anvisa") has granted marketing authorization for DANYELZA (naxitamab-gqgk) 40mg/10mL injection. DANYELZA will be marketed in Brazil by Y-mAbs' partner Adium Pharma S.A. ("Adium").

纽约,2023年5月23日(GLOBE NEWSWIRE)——专注于开发和商业化用于治疗癌症的新型基于抗体的治疗产品的商业阶段生物制药公司Y-mabs Therapeutics, Inc.(以下简称 “公司” 或 “Y-mab”)今天宣布,巴西卫生监管机构Agencia Nacional de Vigilancia Sanitaitaistics ria(“Anvisa”)已授予DANYELZA(naxitamab-gqgk)40mg/10ml 注射剂的上市许可。DANYELZA将由Y-mabs的合作伙伴Adium Pharma S.A.(“Adium”)在巴西销售。

DANYELZA is a recombinant humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. DANYELZA is administered to patients three times in a week and the treatment is repeated every four weeks.

DANYELZA 是一种重组人源化单克隆抗体,靶向神经节苷脂 GD2,神经节苷脂在各种神经外胚层衍生的肿瘤和肉瘤中高度表达。DANYELZA 每周对患者施用三次,每四周重复一次治疗。

"Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in Brazil. It's very exciting to see this treatment approved, creating access to DANYELZA in Brazil from the joint efforts by our partner Adium and the development team at Y-mAbs. We continue to focus on expansion of DANYELZA in other jurisdictions, working to provide access to children living with refractory or relapsed neuroblastoma," said Thomas Gad, founder, President and Interim CEO.

“对于巴西患有难治性/复发性高危神经母细胞瘤的儿童来说,今天是重要的一天。看到这种疗法获得批准真是令人兴奋,在我们的合作伙伴Adium和Y-mabs开发团队的共同努力下,它为在巴西开辟了获得DANYELZA的机会。我们继续专注于将DANYELZA扩展到其他司法管辖区,努力为患有难治性或复发性神经母细胞瘤的儿童提供机会。” 创始人、总裁兼临时首席执行官托马斯·加德说。

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.

纪念斯隆·凯特琳癌症中心(“MSK”)的研究人员开发了DANYELZA,该产品由MSK独家授权给Y-mab。MSK 拥有与该化合物和 Y-mAB 相关的机构财务利益。

About DANYELZA (naxitamab-gqgk)

关于 DANYELZA(naxitamab-gqgk)

In the United States, DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved by the US Food and Drug Administration ("FDA") under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information ( for complete Boxed Warning and other important safety information.

在美国,DANYELZA(naxitamab-gqgk)与粒细胞巨噬细胞集落刺激因子(“GM-CSF”)联合用于治疗 1 岁以上的儿科患者和骨髓中复发或难治性高危神经母细胞瘤的成年患者,这些患者与先前表现出部分反应、轻微反应或疾病稳定疗法。该适应症已获得美国食品药品监督管理局(“FDA”)的批准,并根据总体反应率和反应持续时间加速批准。该适应症的持续批准可能取决于确认性试验中对临床益处的验证和描述。DANYELZA 包括针对严重输液相关反应(例如心脏骤停和过敏反应)以及神经毒性(例如严重的神经病理性疼痛和横贯性脊髓炎)的盒装警告。查看完整的处方信息(了解完整的盒装警告和其他重要的安全信息)。

About Y-mAbs

关于 Y-mab

Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the Company's technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company's broad and advanced product pipeline includes one FDA-approved product, DANYELZA (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS (omburtamab), which targets tumors that express B7-H3.

Y-mabs是一家处于商业阶段的生物制药公司,专注于新型的基于抗体的治疗性癌症产品的开发和商业化。除传统抗体外,该公司的技术还包括使用Y-biclone平台和SADA平台生成的双特异性抗体。该公司广泛而先进的产品线包括一种经美国食品药品管理局批准的产品,即靶向表达GD2的肿瘤的DANYELZA(naxitamab-gqgk),以及一种处于注册阶段的候选产品OMBLASTYS(omburtamab),它靶向表达 B7-H3 的肿瘤。

Forward-Looking Statements

前瞻性陈述

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements with respect to the Company's product, product candidates and pipeline, including with respect to the commercialization effortts to expand access to DANYELZA; statements with respect to the benefits of DANYELZA; statements with respect to expected marketing of DANYELZA in Brazil; and other statements that are not historical facts. Words such as ''anticipate,'' ''believe,'' "contemplate," ''continue,'' ''could,'' ''estimate,'' ''expect,'' "hope," ''intend,'' ''may,'' ''might,'' ''plan,'' ''potential,'' ''predict,'' ''project,'' ''should,'' ''target,'' "will", ''would'' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with our financial condition and need for additional capital; the risks that actual results of our restructuring plan and revised business plan will not be as expected; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay in the timing of our regulatory submissions or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; the risks related to government regulation; risks related to market approval; risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock, risks associated with the COVID-19 pandemic; risks associated with the conflict between Russia and Ukraine and sanctions related thereto; including inflation and uncertain global credit and capital markets; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Annual Report on Form 10-K for the year ended December 31, 2022 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 filed with the SEC and in our other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

本新闻稿中关于未来预期、计划和前景的声明,以及任何其他关于非历史事实的陈述,可能构成1995年《私人证券诉讼改革法》所指的 “前瞻性陈述”。此类陈述包括但不限于有关公司产品、候选产品和产品线的声明,包括有关扩大DANYELZA准入的商业化努力的声明;有关DANYELZA收益的声明;有关DANYELZA在巴西的预期营销的声明;以及其他非历史事实的陈述。诸如 “预期”、“相信”、“考虑”、“继续”、“可以”、“估计”、“期望”、“希望”、“打算”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“目标”、“将” 等词语旨在识别前瞻性陈述,尽管并非所有前瞻性陈述都包含前瞻性陈述这些识别词。我们的候选产品和相关技术是癌症治疗的新方法,带来了重大挑战。由于各种因素,实际业绩可能与此类前瞻性陈述所显示的结果存在重大差异,包括但不限于:与我们的财务状况相关的风险和对额外资本的需求;我们的重组计划和修订后的业务计划的实际结果与预期不符的风险;与我们的开发工作相关的风险;我们的产品开发活动和临床试验的成本和成功;我们的监管文件提交时间延迟或药物未能获得批准的风险候选人;与任何经批准的药品商业化相关的风险,包括候选产品的市场接受率和程度;我们的销售和营销能力的发展以及与未能获得足够产品报销相关的风险;与我们在进行临床测试和产品制造等方面依赖第三方相关的风险;我们无法建立合作伙伴关系;与政府监管相关的风险;与市场批准相关的风险;与市场批准相关的风险;与之相关的风险保护我们的知识产权;与员工事务和管理增长相关的风险;与我们的普通股相关的风险,与 COVID-19 疫情相关的风险;与俄罗斯和乌克兰之间的冲突及相关的制裁相关的风险;包括通货膨胀和不确定性的全球信贷和资本市场;以及影响公司的其他风险和不确定性,包括我们截至2022年12月31日的10-K表年度报告和我们的表格季度报告中 “风险因素” 部分所述的风险和不确定性截至2023年3月31日的季度向美国证券交易委员会提交的第10季度以及我们在美国证券交易委员会的其他文件中。本新闻稿中包含的任何前瞻性陈述仅代表截至本文发布之日,公司没有义务更新任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。

DANYELZA, OMBLASTYS and Y-mAbs are registered trademarks of Y-mAbs Therapeutics, Inc.

DANYELZA、OMBLASTYS 和 Y-mabs 是 Y-mabs Therapeutics, Inc. 的注册商标。

Contact:

联系人:

Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA

Y-mabs Therapeutics, Inc
公园大道 230 号,3350 套房
纽约州纽约 10169
美国

+1 646 885 8505

+1 646 885 8505

E-mail: info@ymabs.com

电子邮件:info@ymabs.com


译文内容由第三方软件翻译。


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