/PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals

/PRNewswire/ -- 百奥泰生物制药股份有限公司（688177:SH），一家处于商业化阶段的生物制药公司，正在开发一系列生物类似药和创新性资产，以及Hikma Pharmaceuticals PLC及其全资子公司Hikma Pharmaceuticals

Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA

Inc. 今天宣布，美国食品药品监督管理局 (FDA) 已批准 STARJEMZA。

(ustekinumab-hmny) Injection, a biosimilar referencing Stelara

(ustekinumab-hmny) 注射剂，一种参照 Stelara 的生物类似药

(ustekinumab) Injection. STARJEMZA

(乌司奴单抗) 注射剂。STARJEMZA

is Bio-Thera's third FDA approved product.

是百奥泰的第三款获FDA批准的产品。

Bio-Thera Solutions and Hikma Pharmaceuticals

百奥泰生物制药和Hikma制药公司

Bio-Thera and Hikma entered into a license and commercialization agreement for STARJEMZA

百奥泰与Hikma就STARJEMZA达成许可及商业化协议

. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Hikma is responsible for the commercialization of STARJEMZA

根据协议条款，百奥泰负责产品的开发和生产。Hikma负责STARJEMZA的商业化。

'The approval of STARJEMZA

“STARJEMZA的批准

is another significant accomplishment for Bio-Thera, establishing Bio-Thera as a premier global biosimilar developer and manufacturer,' said

是百奥泰的另一项重大成就，确立了百奥泰作为全球领先的生物类似药开发和制造商的地位，

Shengfeng Li

李盛峰

, CEO at Bio-Thera. 'As our third FDA approved biosimilar, STARJEMZA

百奥泰首席执行官说：“作为我们第三个获得FDA批准的生物类似药，STARJEMZA

demonstrates Bio-Thera's commitment to developing more biosimilars, expanding patient access to important therapies.'

展示了百奥泰致力于开发更多生物类似药，扩大患者对重要疗法的可及性。

'This approval and our partnership with Bio-Thera enables us to strongly enter the U.S. biosimilar market, building on our well-established position as a top-three domestic provider of sterile injectable medicines to U.S. hospitals, healthcare providers, and patients,' said Dr.

“此次获批以及我们与百奥泰的合作伙伴关系使我们能够强势进入美国生物类似药市场，巩固我们作为美国医院、医疗保健提供者和患者无菌注射药物前三名国内供应商的稳固地位，”博士表示。

Bill Larkins

比尔·拉金斯

, President of Hikma Injectables. 'Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it.'

Hikma注射剂部门总裁表示：“利用美国生物仿制药市场的强劲持续增长是Hikma的优先事项。我们渴望利用我们在美国出色的商业能力推出这一重要产品，并将其提供给将从中受益的众多患者。”

The FDA approval of STARJEMZA

STARJEMZA获得FDA批准

, originally known as BAT2206, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between STARJEMZA

，最初被称为BAT2206，是基于百奥泰提交给FDA的一套全面的分析、非临床和临床数据包。STARJEMZA之间进行了广泛的分析表征

and US and EU Stelara

美国和欧盟的Stelara

was conducted on structural, physicochemical, and biological properties to support bio-similarity of STARJEMZA

对STARJEMZA的结构、理化和生物学特性进行了研究，以支持其生物相似性。

. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of STARJEMZA

一项随机双盲、单剂量、三臂、平行的I期研究比较了STARJEMZA的药代动力学、安全性和免疫原性。

with both the US and EU Stelara

同时拥有美国和欧盟的Stelara

in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared STARJEMZA

在健康志愿者中。一项多中心、随机、双盲、平行组、III 期研究比较了 STARJEMZA

for efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. The totality of the evidence demonstrated that STARJEMZA

用于评估中度至重度斑块型银屑病患者的疗效、安全性和免疫原性。所有证据表明，STARJEMZA

has similar efficacy, safety, immunogenicity, and quality as the reference product ustekinumab.

具有与参考产品乌司奴单抗相似的疗效、安全性、免疫原性和质量。

About STARJEMZA

关于STARJEMZA

(ustekinumab-hmny) Injection

乌司奴单抗-hmny 注射剂

is a biosimilar to Janssen's Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 subunit from binding to the IL-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of immune cells.

是杨森公司Stelara®的一种生物类似物，它是一种人源单克隆抗体，通过阻止共享的p40亚基与免疫细胞表面的IL-12（IL-12Rβ1/β2）和IL-23（IL-12Rβ1/23R）受体复合物的IL-12Rβ1受体链结合，从而抑制人类IL-12和IL-23的生物活性。

IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation, CD4.

IL-12 和 IL-23 参与炎症和免疫反应，例如自然杀伤细胞的激活、CD4。

T-cell differentiation and following relative cytokines stimulated release. Abnormal regulation of IL-12 and IL-23 have been implicated as important contributors to chronic inflammation, including psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), and Ulcerative colitis (UC). Neutralizing human IL-12 and IL-23 by STARJEMZA.

T细胞分化及随后相关细胞因子的刺激释放。IL-12和IL-23的异常调节被认为是慢性炎症的重要因素，包括银屑病、银屑病关节炎（PsA）、克罗恩病（CD）和溃疡性结肠炎（UC）。通过STARJEMZA中和人体中的IL-12和IL-23。

to prevent the relevant cell signaling in the Th1 or Th17 lineages can effectively block the pathologic processes of these immune disorders.

预防Th1或Th17谱系相关的细胞信号传导可以有效阻断这些免疫疾病的病理过程。

About Bio-Thera Solutions

关于百奥泰生物制药

Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou,

百奥泰生物制药股份有限公司，一家位于广州的领先的创新型全球生物制药公司，

, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI.

，致力于研究和开发用于治疗癌症、自身免疫疾病、心血管疾病、眼科疾病以及其他严重未满足医疗需求的新型疗法，同时也在开发生物类似药以替代现有的品牌生物制品，用于治疗多种癌症和自身免疫疾病。作为下一代抗体发现与工程领域的领导者，该公司已将多个候选药物推进到后期开发阶段，其中包括五种已获批产品：QLETLI。

in EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit

在欧盟和中国。此外，该公司还有20多种有前景的候选药物正在进行临床试验，专注于后PD-1时代的免疫肿瘤学和靶向治疗，如抗体药物偶联物（ADC）。欲了解更多信息，请访问

About Hikma Pharmaceuticals

关于Hikma制药公司

: HIK) (OTC: HKMPY) (rated BBB/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across .

：HIK）（场外交易：HKMPY）（标普评级BBB/稳定，惠誉评级BBB-/正面）Hikma每天帮助世界各地数百万人实现更好的健康。四十多年来，我们一直致力于生产高质量的药品，并将它们提供给需要的人。我们总部位于英国，是一家全球化的公司，在各地拥有本地业务。

, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines.

，并且我们运用独特的洞察力和专业知识，将前沿科学转化为创新的解决方案，从而改变人们的生活。我们致力于服务我们的客户以及他们所关心的人群，通过创造性思考和务实行动，我们为他们提供广泛的品牌和非品牌仿制药。

Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: .

我们9500名同事共同努力，正在创造一个更加健康的世界，丰富我们所有的社区。我们是领先的授权合作伙伴，并通过我们的风险投资部门，帮助将创新的健康技术带给世界各地的人们。欲了解更多信息，请访问：。