.

。

Ongoing Studies are Evaluating Long-Term Maintenance and Durability

正在进行的研究正在评估长期维护和耐久性

THOUSAND OAKS, Calif.

加利福尼亚州千橡市

and

和

TOKYO

东京

,

，

March 8, 2025

2025年3月8日

/PRNewswire/ -- Amgen (NASDAQ:

/PRNewswire/ -- 安进 (NASDAQ:

AMGN

AMGN

) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD).

）和协和麒麟株式会社（Kyowa Kirin，东证代码：4151）今天宣布了正在进行的ROCKET第三阶段临床试验项目的最新结果，该项目正在评估研究性T细胞再平衡疗法rocatinlimab，该疗法针对OX40受体，用于中度至重度特应性皮炎（AD）。

The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. IGNITE was a 24-week, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability of rocatinlimab monotherapy every 4 weeks in 769 adults with moderate to severe AD, including patients previously treated with a biologic or systemic Janus kinase (JAK) inhibitor medication..

IGNITE 研究评估了两种剂量的 rocatinlimab，达到了共同主要终点和所有关键次要终点，两种剂量的 rocatinlimab 均对比安慰剂实现了统计学显著性。IGNITE 是一项为期 24 周的随机、安慰剂对照、双盲研究，旨在评估每 4 周一次 rocatinlimab 单药治疗在 769 名中度至重度特应性皮炎（AD）成人患者中的疗效、安全性和耐受性，其中包括曾接受过生物制剂或系统性 Janus 激酶（JAK）抑制剂治疗的患者。

At week 24, 42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo (p < 0.001). In the lower dose group, 36.3% of patients achieved EASI-75, a 23.4% difference vs. placebo (p < 0.001).

在第24周，高剂量组中42.3%的患者实现了湿疹面积和严重程度指数评分（EASI-75）较基线减少≥75%，与安慰剂相比差异为29.5%（p < 0.001）。低剂量组中，36.3%的患者达到了EASI-75，与安慰剂相比差异为23.4%（p < 0.001）。

In the higher dose group, 23.6% of patients achieved a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD

在高剂量组中，23.6%的患者达到了经过验证的研究者全球评估特应性皮炎（vIGA-AD）。

TM

商标

) score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (vIGA-AD 0/1) at week 24, representing a 14.9% difference vs. placebo (p < 0.001). In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs. placebo (p = 0.002).

在第24周时，评分达到0分（完全清除）或1分（几乎清除），与基线相比减少≥2分（vIGA-AD 0/1），这一结果与安慰剂组相比有14.9%的差异（p < 0.001）。在较低剂量组中，19.1%的患者达到了该终点，与安慰剂组相比有10.3%的差异（p = 0.002）。

In addition, IGNITE met the endpoint of revised Investigator's Global Assessment (rIGA

此外，IGNITE 达到了修订版研究者全球评估 (rIGA) 的终点。

TM

商标

) score of 0/1 with a ≥2-point reduction from baseline, a more stringent measure of efficacy than vIGA-AD 0/1. At week 24, 22.7% of patients in the higher dose group achieved this endpoint, a 14.4% difference vs. placebo (p < 0.001). In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs.

) 得分为0/1，与基线相比减少≥2分，这一疗效指标比vIGA-AD 0/1更为严格。在第24周时，高剂量组中有22.7%的患者达到了这一终点，与安慰剂组相比有14.4%的差异 (p < 0.001)。在低剂量组中，16.3%的患者达到了这一终点，与安慰剂组相比有8.0%的差异。

placebo (p = 0.01)..

安慰剂 (p = 0.01)。

Across ROCKET program results to date, safety findings were generally consistent with the safety profile of rocatinlimab previously observed. The most frequent treatment-emergent adverse events (≥5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache. A higher number of patients receiving rocatinlimab vs.

在整个ROCKET项目的结果中，迄今为止，安全性发现通常与之前观察到的罗卡替尼单抗的安全性特征一致。在罗卡替尼单抗组中，最常见的治疗相关不良事件（≥5%）且比例较高的是发热、寒战和头痛。接受罗卡替尼单抗治疗的患者中，出现不良反应的数量较多，相比之下。

placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%..

安慰剂组发生胃肠道溃疡事件，总发生率不到1%。

1

1

'Many patients with moderate to severe atopic dermatitis struggle with chronic, life-disrupting symptoms,' said

“许多中度至重度特应性皮炎患者都在与慢性、扰乱生活的症状作斗争，”

Jay Bradner

杰伊·布拉德纳

, M.D., executive vice president of Research and Development at Amgen. 'Even with currently available therapies, they may fail to reach or maintain treatment goals. We're pleased with ROCKET program results to date, which support the potential of rocatinlimab as a new treatment option.'

医学博士，安进研发执行副总裁。“即使有目前可用的疗法，患者可能仍然无法达到或维持治疗目标。我们对ROCKET项目迄今为止的结果感到满意，这些结果支持了rocatinlimab作为一种新治疗选择的潜力。”

'Looking ahead, the ASCEND trial will explore the effects of rocatinlimab beyond 24 weeks, including maintenance of clinical response with continued treatment or withdrawal, and the ASTRO and ORBIT trials will evaluate rocatinlimab in adolescent patients,' said

“展望未来，ASCEND试验将探索rocatinlimab超过24周的效果，包括持续治疗或停药对临床反应的维持，而ASTRO和ORBIT试验将评估rocatinlimab在青少年患者中的效果，”

Takeyoshi Yamashita

山下武义

, Ph.D., senior managing executive officer and chief medical officer at Kyowa Kirin. 'These findings will help define the full profile of rocatinlimab and its potential to inhibit and reduce pathogenic T cells.'

博士，协和麒麟的高级执行董事兼首席医学官。“这些研究结果将有助于全面了解rocatinlimab的特性及其抑制和减少致病性T细胞的潜力。”

The ROCKET program is also informed by the results of the SHUTTLE and VOYAGER studies. The SHUTTLE study, which evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) in 746 adults using the same co-primary endpoints as IGNITE, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths plus TCS/TCI versus placebo plus TCS/TCI at week 24..

ROCKET 项目还参考了 SHUTTLE 和 VOYAGER 研究的结果。SHUTTLE 研究在 746 名成人中评估了两种剂量强度的 rocatinlimab 联合外用皮质类固醇 (TCS) 和/或外用钙调神经磷酸酶抑制剂 (TCI) 的效果，采用了与 IGNITE 相同的共同主要终点。该研究达到了其共同主要终点和所有关键次要终点，在第 24 周时，两种剂量强度的 rocatinlimab 加 TCS/TCI 均相较于安慰剂加 TCS/TCI 取得了统计学显著性。

For EASI-75, 52.3% of patients in SHUTTLE's higher dose group achieved the endpoint, a 28.7% difference vs. placebo (p < 0.001), while 54.1% of patients in the lower dose group achieved the endpoint, a 30.4% difference vs. placebo (p<0.001).

对于EASI-75，SHUTTLE较高剂量组中有52.3%的患者达到了终点，与安慰剂相比差异为28.7%（p < 0.001），而较低剂量组中有54.1%的患者达到了终点，与安慰剂相比差异为30.4%（p < 0.001）。

For vIGA-AD 0/1, 26.1% of SHUTTLE patients in the higher dose group achieved the endpoint, a 13.8% difference vs. placebo (p<0.001). In the lower dose group, 25.8% of patients achieved the endpoint, a 13.5% difference vs. placebo (p<0.001).

对于vIGA-AD 0/1，较高剂量组中26.1%的SHUTTLE患者达到了终点，与安慰剂相比差异为13.8%（p<0.001）。在较低剂量组中，25.8%的患者达到了终点，与安慰剂相比差异为13.5%（p<0.001）。

For rIGA 0/1, 23.3% of SHUTTLE patients in the higher dose group achieved the endpoint, an 11.5% difference vs. placebo (p<0.001). In the lower dose group, 22.7% of patients achieved the endpoint, a 10.9% difference vs. placebo (p = 0.002). The higher rocatinlimab dose used in IGNITE and SHUTTLE was identical to the dose used in HORIZON..

对于rIGA 0/1，高剂量组中23.3%的SHUTTLE患者达到了终点，与安慰剂相比有11.5%的差异（p<0.001）。在低剂量组中，22.7%的患者达到了终点，与安慰剂相比有10.9%的差异（p = 0.002）。在IGNITE和SHUTTLE中使用的较高剂量的rocatinlimab与在HORIZON中使用的剂量相同。

The VOYAGER study successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations.

VOYAGER 研究成功证明了 rocatinlimab 不会干扰对破伤风和脑膜炎球菌疫苗的反应。

HORIZON, top-line results of which were previously shared, will be presented as a late-breaking abstract at the 2025 American Academy of Dermatology Annual Meeting. Results from IGNITE, SHUTTLE and VOYAGER will be presented at upcoming congresses or published in peer-reviewed journals.

HORIZON 的顶部结果之前已分享过，将于 2025 年美国皮肤病学会年会上作为最新摘要发表。 IGNITE、SHUTTLE 和 VOYAGER 的结果将在即将召开的大会上演示或在同行评审期刊上发表。

About the ROCKET Phase 3 Program

关于ROCKET第三阶段计划

ROCKET is a comprehensive, global Phase 3 clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD) as well as multiple dosing regimens.

ROCKET 是一项全面的全球 III 期临床试验计划，包含八项研究，旨在确定 rocatinlimab 在中度至重度特应性皮炎（AD）成人和青少年患者中的安全性和有效性，同时评估多种给药方案。

About Moderate to Severe Atopic Dermatitis

关于中度至重度特应性皮炎

Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful.

特应性皮炎是最常见的一种湿疹，是一种慢性炎症性疾病，会导致皮肤极度干燥、瘙痒，甚至可能引起疼痛。

2

2

People with moderate to severe atopic dermatitis experience chronic symptoms, intensified by unpredictable flare-ups that can be painful and disruptive to everyday life.

中度至重度特应性皮炎患者会出现慢性症状，不可预测的病情恶化会加剧这些症状，导致疼痛并扰乱日常生活。

3

3

More than half of these patients report severe itching, leading to repeated scratching which can cause the skin to thicken and become vulnerable to infection.

超过一半的患者报告称出现严重瘙痒，导致反复抓挠，这可能使皮肤变厚并易于感染。

4,5

4，5

Atopic dermatitis (all severities) affects 15-20% of children and up to 10% of adults.

特应性皮炎（所有严重程度）影响15-20%的儿童和高达10%的成人。

5

5

T-cell imbalance is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms.

T细胞失衡是特应性皮炎的根本原因，导致了包括疾病反复发作、不可预测症状在内的临床表现。

6

6

About Rocatinlimab

关于罗卡替尼맙

Rocatinlimab is an anti-OX40 human monoclonal antibody being investigated for the treatment of moderate to severe atopic dermatitis. Rocatinlimab has the potential to be the first and only T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. OX40 is a co-stimulatory receptor responsible for driving systemic and local inflammatory responses in atopic dermatitis and other conditions..

Rocatinlimab 是一种正在研究用于治疗中重度特应性皮炎的抗 OX40 人单克隆抗体。Rocatinlimab 有潜力成为首个也是唯一一个通过靶向 OX40 受体抑制并减少致病性 T 细胞的 T 细胞再平衡疗法。OX40 是一种共刺激受体，负责驱动特应性皮炎及其他疾病中的系统性和局部炎症反应。

3

3

It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology.

据报道，表达OX40的效应T细胞存在于特应性皮炎患者的病灶中，并在疾病病理生理学中起关键作用。

3,7

3,7

Rocatinlimab is also being studied for moderate to severe uncontrolled asthma, prurigo nodularis and potentially other conditions where T-cell imbalance is a root cause of inflammation. The initial antibody was discovered in collaboration between Kyowa Kirin and La Jolla Institute for Immunology.

Rocatinlimab 还在研究用于中度至重度不受控制的哮喘、结节性瘙痒症，以及可能其他因T细胞失衡导致炎症的病症。最初的抗体是协和麒麟与拉霍亚免疫学研究所合作发现的。

Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by the U.S. FDA or any other regulatory authority.

Rocatinlimab 目前正在临床研究中，其安全性和有效性尚未由美国 FDA 或任何其他监管机构评估。

About Amgen

关于安进公司

Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases..

安进公司发现、开发、生产和提供创新药物，帮助数百万患者对抗一些世界上最棘手的疾病。40多年前，安进公司帮助建立了生物技术行业，并始终站在创新的前沿，利用技术和人类基因数据突破当今已知的界限。安进公司正在推进广泛而深入的药物研发管线，依托其现有的药物组合，治疗癌症、心脏病、骨质疏松症、炎症性疾病和罕见病。

In 2024, Amgen was named one of the 'World's Most Innovative Companies' by Fast Company and one of 'America's Best Large Employers' by Forbes, among other

2024年，安进公司被《快公司》评为“全球最具创新力公司”之一，并被《福布斯》评为“美国最佳大型雇主”之一，此外还获得了其他荣誉。

external recognitions

外部认可

. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average

安进是构成道琼斯工业平均指数的30家公司之一。

®

®

, and it is also part of the Nasdaq-100 Index

，而且它也是纳斯达克100指数的一部分

®

®

, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

，其中包括根据市值计算的纳斯达克股票市场上最大和最具创新性的非金融公司。

For more information, visit

欲了解更多信息，请访问

Amgen.com

安进公司官网

and follow Amgen on

关注安进公司

X

X

,

，

LinkedIn

领英

,

，

Instagram

Instagram

,

，

YouTube

YouTube

and

和

Threads

线程

.

。

About Kyowa Kirin

关于协和麒麟

Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a

协和麒麟致力于发现和提供具有改变生命价值的新型药物和治疗方法。作为一家

Japan

日本

-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases.

基于全球专业制药公司，我们已经在药物发现和生物技术创新领域投资了70多年，目前正致力于开发下一代抗体、细胞和基因疗法，有望帮助那些具有高度未满足医疗需求的患者，例如骨骼与矿物质疾病、难治性血液病/血液肿瘤以及罕见病。

A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: .

我们全球各地的员工都秉承共同的价值观，致力于可持续发展，并且致力于让人们微笑。您可以在以下网址了解更多关于协和麒麟的业务信息：。

https://www.kyowakirin.com

https://www.kyowakirin.com

.

。

Amgen and Kyowa Kirin Collaboration

安进和协和麒麟合作

On

开

June 1, 2021

2021年6月1日

,

，

Kyowa Kirin

协和麒麟

and

和

Amgen

安进公司

entered into an agreement to jointly develop and commercialize

达成协议，共同开发和商业化

rocatinlimab

罗卡替尼맙

. Under the terms of the agreement,

根据协议条款，

Amgen

安进公司

will lead the development, manufacturing, and commercialization for KHK4083/

将领导KHK4083/的开发、制造和商业化工作，

AMG

AMG

451 for all markets globally, except

全球所有市场均为451，除了

Japan

日本

, where

，其中

Kyowa Kirin

协和麒麟

will retain all rights. If approved, the companies will co-promote the asset in

将保留所有权利。如果获得批准，这些公司将在

the United States

美国

and

和

Kyowa Kirin

协和麒麟

has opt-in rights to co-promote in certain other markets including

在包括某些其他市场在内的地区拥有选择性加入的联合促销权利

Europe

欧洲

and

和

Asia

亚洲

.

。

Amgen Forward-Looking Statements

安进前瞻性声明

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd.

本新闻稿包含基于安进当前预期和信念的前瞻性声明。所有声明，除历史事实陈述外，均为可能被视为前瞻性声明的陈述，包括有关与其他公司（包括百济神州有限公司）合作或潜在合作的结果、益处和协同效应的任何声明。

or Kyowa Kirin Co., Ltd.), the performance of Otezla.

或协和麒麟公司），Otezla的表现。

®

®

(apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), Amgen's acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on Amgen's acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on Amgen's business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K.

(apremilast)（包括预期的Otezla销售增长和非GAAP每股收益增值的时间），安进公司对Teneobio, Inc.、ChemoCentryx, Inc.或Horizon Therapeutics plc的收购（包括Horizon业务的预期表现与前景、业绩与机会，因该收购可能带来的任何潜在战略利益、协同效应或机会，以及Horizon收购预计对安进未来收购相关费用的影响），以及对收入、营业利润率、资本支出、现金、其他财务指标、预期法律、仲裁、政治、监管或临床结果或实践、客户和处方模式或实践、报销活动和结果、流行病或其他广泛健康问题对安进业务的影响、结果、进展及其他此类估计和结果的预测。前瞻性陈述涉及重大风险和不确定性，包括下文讨论的内容及在安进向证券交易委员会提交的报告中更全面描述的内容，特别是其最近的Form 10-K年度报告以及任何后续的Form 10-Q季度报告和Form 8-K当前报告。

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise..

除非另有说明，安进公司提供此信息的日期为本新闻稿发布之日，并且不承担因新信息、未来事件或其他原因更新本文件中包含的任何前瞻性声明的义务。

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.

任何前瞻性声明都无法得到保证，实际结果可能与安进公司的预测存在重大差异。发现或识别新的产品候选者或为现有产品开发新适应症无法得到保证，从概念到产品的推进具有不确定性；因此，无法保证任何特定的产品候选者或现有产品的新适应症开发会取得成功并成为商业化产品。

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future.

此外，临床前结果并不能保证产品候选物在人体中的安全性和有效性。人体的复杂性无法被计算机或细胞培养系统或动物模型完美地，甚至有时是充分地模拟。安进完成临床试验并获得产品上市的监管批准所需的时间在过去有所不同，安进预计未来也会存在类似的差异。

Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship.

即使临床试验取得成功，监管机构也可能对安进公司选择的试验终点是否足以支持批准提出质疑。安进通过内部研发以及许可合作、伙伴关系和合资企业开发候选产品。源于这些关系的候选产品可能会引发双方之间的争议，或者可能证明不如安进在建立此类关系时所认为的那样有效或安全。

Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market..

此外，安进或其他公司可能会在其产品上市后发现其产品的安全性、副作用或生产问题，包括其设备。

Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions.

安进公司的业绩可能受到其在国内外成功推广新产品和现有产品的能力、涉及当前和未来产品的临床和监管动态、近期推出产品的销售增长、来自包括生物仿制药在内的其他产品的竞争、产品生产中的困难或延迟以及全球经济状况的影响。

In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment.

此外，安进公司产品的销售受到定价压力、政治和公众监督以及第三方支付者（包括政府、私人保险计划和管理式医疗提供商）施加的报销政策的影响，并可能受到监管、临床和指南发展的影响，以及国内外趋向于管理式医疗和医疗成本控制的趋势的影响。

Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities.

此外，安进公司的研究、测试、定价、营销及其他业务运营均受到国内外政府监管机构的严格监管。安进的业务可能受到政府调查、诉讼及产品责任索赔的影响。此外，安进的业务也可能受到新税收法规实施或额外税务责任的影响。

If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation.

如果安进未能履行其与美国政府之间的企业诚信协议中的合规义务，安进可能会面临重大制裁。此外，尽管安进通常会为其产品和技术申请专利，但其专利和专利申请所提供的保护可能受到竞争对手的挑战、无效化或规避，或者安进可能无法在当前和未来的知识产权诉讼中胜诉。

Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in .

安进在少数几个关键设施进行大量的商业制造活动，包括在 。

Puerto Rico

波多黎各

, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations.

，并且其部分制造活动依赖第三方，供应限制可能会制约其某些现有产品的销售和产品候选开发。疾病暴发或类似的公共卫生威胁（如 COVID-19）以及公众和政府为遏制此类疾病传播所作的努力，可能对安进的制造活动的材料供应、安进产品的分销、安进产品候选的商业化以及安进的临床试验操作产生重大不利影响，任何此类事件都可能对安进的产品开发、产品销售、业务和经营结果产生重大不利影响。

Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products.

安进依靠与第三方的合作来开发部分产品候选药物，并实现部分商业产品的商业化和销售。此外，安进在许多已上市产品的市场竞争中与其他公司竞争，同时在新产品的发现和开发方面也存在竞争。

Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations.

此外，安进产品的一些原材料、医疗器械和零部件由单一的第三方供应商提供。安进的一些分销商、客户和支付方在其与安进的交易中拥有强大的采购杠杆。如果发现与其产品类似的产品存在重大问题，且该问题涉及整个类别的产品，可能会对受影响产品的销售及其业务和经营结果产生重大的不利影响。

Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. There can be no gu.

Amgen与其他公司、产品或技术合作或收购的努力，以及整合公司运营或支持Amgen已收购的产品或技术的举措，可能不会成功。无法保证。

The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates..

本新闻稿中讨论的与安进产品候选物相关的科学信息是初步且正在研究中的。这些产品候选物尚未获得美国食品药品监督管理局的批准，因此不能也不应就这些产品候选物的安全性或有效性得出任何结论。

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SOURCE Kyowa Kirin

来源：协和麒麟

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