/PRNewswire/ -- mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, is pleased to announce that the European Commission has granted approval for its denosumab biosimilars Denbrayce® and Izamby®. This approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and represents a major milestone in mAbxience's mission to provide high-quality, accessible, and affordable therapies worldwide..

/PRNewswire/ -- mAbxience是一家由费森尤斯卡比（Fresenius Kabi）多数控股、Insud Pharma部分持股的集团，欣然宣布欧洲委员会已批准其生物类似药Denbrayce®和Izamby®。此项批准是在人用医药产品委员会（CHMP）的积极推荐后授予的，标志着mAbxience致力于提供高质量、可及且价格合理的全球治疗方案的使命迈出了重要一步。

Jurgen Van Broeck, CEO of mAbxience

mAbxience首席执行官Jurgen Van Broeck

Denbrayce®, referencing Amgen's Xgeva®, is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone, as well as for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone.

Denbrayce®，参考安进公司的Xgeva®，适用于预防患有晚期骨相关恶性肿瘤的成人患者的骨骼相关事件，以及用于治疗患有骨巨细胞瘤的成人和骨骼成熟的青少年。

Izamby®, referencing Amgen's Prolia®, is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, a condition that causes bones to become weak and more prone to breaking.

Izamby®，参考安进公司的Prolia®，适用于治疗绝经后妇女和骨折风险增加的男性骨质疏松症，这是一种导致骨骼变得脆弱、更容易断裂的疾病。

'This approval is a testament to mAbxience's dedication to scientific excellence and our commitment to broadening access to essential biologic therapies,'

“这一批准证明了mAbxience对科学卓越的奉献精神以及我们致力于扩大基本生物疗法获取渠道的承诺。”

Jurgen Van Broeck

朱尔根·范布鲁克

, CEO of mAbxience.

，mAbxience首席执行官。

'We are proud to contribute to reducing the burden of osteoporosis, cancer-related bone conditions, and rare bone diseases in

“我们为能够减轻骨质疏松症、癌症相关的骨骼疾病和罕见骨骼疾病的负担而感到自豪，

Europe

欧洲

. This milestone brings us one step closer to ensuring that more patients across

。这一里程碑使我们向确保更多患者

Europe

欧洲

can benefit from high-quality, affordable treatment options.'

可以受益于高质量、可负担的治疗选择。

Denosumab is a human monoclonal antibody that works by inhibiting the receptor activator of nuclear factor kappa-B ligand (RANKL), thereby preventing the development of osteoclasts, the cells responsible for bone breakdown. It is a well-established treatment for osteoporosis, treatment-induced bone loss, bone metastases, and giant cell tumor of bone..

地诺单抗是一种人源性单克隆抗体，通过抑制核因子κB配体受体激活剂（RANKL）起作用，从而阻止破骨细胞的发育，破骨细胞是负责骨分解的细胞。它已被广泛用于治疗骨质疏松症、治疗引起的骨质流失、骨转移以及骨巨细胞瘤。

With the approval of these biosimilars mAbxience further demonstrates its expertise in the development and production of biosimilars, reinforcing its contribution to improving patient access to life-changing therapies and supporting the sustainability of healthcare systems across

随着这些生物类似药的获批，mAbxience进一步展示了其在生物类似药开发和生产方面的专业能力，强化了其对改善患者获得改变生命的治疗的贡献，并支持了各地区医疗系统的可持续性。

Europe

欧洲

.

。

This approval marks another important step in mAbxience's mission to provide affordable, accessible and life-changing therapies worldwide. With a robust pipeline and a growing network of partners, mAbxience continues to enhance patient access to advanced treatments while supporting healthcare systems in managing the rising costs of biologic medicines..

这一批准标志着mAbxience在提供可负担、可获得且改变生命的疗法使命中迈出了另一个重要的步伐。凭借强大的研发管线和不断扩展的合作伙伴网络，mAbxience持续提升患者获取先进治疗的机会，同时支持医疗系统应对生物药物成本不断上升的挑战。

About mAbxience

关于mAbxience

mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In

mAbxience是一家总部位于西班牙的公司，专注于生物制药的开发、生产和商业化。

August 2022

2022年8月

, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines.

费森尤斯卡比和因苏德制药达成了一项协议，根据该协议，费森尤斯的运营公司费森尤斯卡比收购了mAbxience的多数股权，使其成为一家全球性的、垂直整合的生物技术公司。凭借十多年的经验，我们的使命很明确：提供可及、可负担的药物，旨在通过确保全球高质量药物的普遍可及性来提高生活质量。

With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in .

拥有两款上市产品和强大的在研管线，我们在100多个市场建立了B2B业务。与此同时，我们与30多家合作伙伴构建了网络，并组建了一支由1000多名专业人员组成的专注团队。我们三个多产品设施位于。

Europe

欧洲

and

和

South America

南美洲

, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions.

，已获得包括FDA、EMA等权威监管机构的GMP认证。此外，作为全球生物制药领域的专家，mAbxience专注于合同开发和制造组织服务（CDMO），利用先进技术与创新平台，提供综合性的生产解决方案。