THOUSAND OAKS, Calif.

加利福尼亚州千橡树。

,

,

Jan. 17, 2025

2025年1月17日

/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved

/PRNewswire/-Amgen（纳斯达克：AMGN）今天宣布，美国食品和药物管理局（FDA）已经批准

Lumakras

卢马科拉斯

(

(

sotorasib

士兵

) in combination with

)结合

Vectibix

维克替比

(

(

panitumumab

帕尼通单抗

) for the treatment of adult patients with

)用于治疗成年患者

KRAS

KRAS

G12C-mutated metastatic

G12C突变转移

colorectal cancer

结直肠癌

(mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that Lumakras plus Vectibix is the first and only targeted treatment combination for chemorefractory .

（mCRC），由FDA批准的测试确定，他们之前接受过氟嘧啶，奥沙利铂和伊立替康为基础的化疗。批准是基于关键的3期CodeBreaK 300研究，该研究表明Lumakras加Vectibix是第一个也是唯一一个针对化学难治性的靶向治疗组合。

KRAS

克拉斯

G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC).

与所研究的护理标准（SOC）相比，G12C突变的mCRC显示出优越的无进展生存期（PFS）。

1*

1*

'Colorectal cancer is the third leading cause of cancer-related deaths in the United States, and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis,' said Jay Bradner, M.D., executive vice president of Research and Development at Amgen.

安进（Amgen）研发执行副总裁杰伊·布拉德纳（JayBradner）医学博士说，结直肠癌是美国癌症相关死亡的第三大原因，被诊断患有转移性疾病的人中不到五分之一的人在诊断后存活五年以上。

2

2

'Lumakras plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced

“Lumakras plus Vectibix提供了一种靶向的生物标志物驱动的联合疗法，与所研究的护理标准相比，可以更有效地延缓疾病进展。这一新选择验证了我们的组合方法，以改善晚期患者的预后

KRAS

克拉斯

G12C-mutated metastatic colorectal cancer.'

G12C突变的转移性结直肠癌。”

The CodeBreaK 300 clinical trial compared Lumakras at two different doses (960 mg daily or 240 mg daily) in combination with Vectibix to the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory

CodeBreaK 300临床试验比较了两种不同剂量（每天960毫克或每天240毫克）的Lumakras联合Vectibix与研究者在化疗难治性患者中选择的SOC（三氟尿苷、替吡拉西或雷格拉非尼）

KRAS

KRAS

G12C-mutated mCRC. Study results demonstrated that Lumakras 960 mg daily plus Vectibix (n=53) showed an improved median PFS of 5.6 months (4.2, 6.3) compared to 2 months (1.9, 3.9) on investigator's choice of care (n=54), with a hazard ratio (HR) of 0.48 (95% Confidence Interval [CI]: 0.3, 0.78) and a .

G12C突变的mCRC。研究结果表明，Lumakras每天960毫克加Vectibix（n=53）显示，与研究者选择护理的2个月（1.9,3.9）（n=54）相比，中位PFS改善了5.6个月（4.2,6.3），风险比（HR）为0.48（95%置信区间[CI]:0.3,0.78）和a。

p

p

-value of 0.005. The study demonstrated an improved overall response rate (ORR) of 26% (95% CI: 15, 40) compared to 0% with investigator's choice (95% CI: 0, 7). The study was not statistically powered for overall survival (OS). The median overall survival (mOS) for patients treated with Lumakras plus Vectibix was not reached (NR) (8.6, NR), and mOS for patients treated with investigator's choice was 10.3 months (7, NR), with a HR of 0.7 (95% CI: 0.41, 1.18); the final analysis of OS was not statistically significant.

-值为0.005。该研究表明，总体缓解率（ORR）提高了26%（95%CI:15,40），而研究者的选择为0%（95%CI:0,7）。这项研究没有统计学意义上的总体生存（OS）。用Lumakras加Vectibix治疗的患者的中位总生存期（mOS）未达到（NR）（8.6，NR），研究者选择治疗的患者的mOS为10.3个月（7，NR），HR为0.7（95%CI:0.41,1.18）；OS的最终分析没有统计学意义。

Safety profiles were consistent with those historically observed for Lumakras and Vectibix. The most common adverse reactions (≥20%) are rash (87%), dry skin (28%), diarrhea (28%), stomatitis (26%), fatigue (21%) and musculoskeletal pain (21%). PFS of Lumakras 240 mg daily plus Vectibix (n=53) compared to investigator's choice was not statistically significant..

安全性与Lumakras和Vectibix的历史观察结果一致。最常见的不良反应（≥20%）是皮疹（87%），皮肤干燥（28%），腹泻（28%），口腔炎（26%），疲劳（21%）和肌肉骨骼疼痛（21%）。与研究者的选择相比，每天240毫克Lumakras加Vectibix（n=53）的PFS无统计学意义。。

The

The

KRAS

KRAS

G12C mutation is present in approximately 3-5% of colorectal cancers as determined by an FDA-approved biomarker test.

通过FDA批准的生物标志物测试确定，大约3-5%的结直肠癌中存在G12C突变。

3-5

3-5

This emphasizes the important role of comprehensive biomarker testing in mCRC. By detecting an actionable mutation, eligible patients are now able to receive a corresponding targeted therapy that may lead to improved responses.

这强调了综合生物标志物测试在mCRC中的重要作用。通过检测可行的突变，符合条件的患者现在能够接受相应的靶向治疗，这可能会改善反应。

'In metastatic colorectal cancer,

，

KRAS

KRAS

mutations are historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, and standard treatment options have shown minimal benefit,' said Marwan G. Fakih, M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope..

。。

3-6

3-6

'Designed for dual blockade of

“设计用于双重封锁

KRAS

KRAS

G12C and EGFR pathways, the combination of sotorasib plus panitumumab provides a needed new treatment option to better overcome cancer's escape mechanisms. The CodeBreaK 300 study showed superior progression-free survival compared to the investigated standard of care and represents a clinically meaningful benefit for patients with .

G12C和EGFR途径，索托拉西布加帕尼单抗的组合提供了一种必要的新治疗选择，以更好地克服癌症的逃逸机制。CodeBreaK 300研究显示，与所研究的护理标准相比，无进展生存率更高，对患者具有临床意义。

KRAS

KRAS

G12C-mutated metastatic colorectal cancer.'

G12C突变的转移性结直肠癌。”

'There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer,' said Michael Sapienza, Chief Executive Officer of the Colorectal Cancer Alliance. 'This new combination approach is an important breakthrough for patients with

结直肠癌联盟首席执行官迈克尔·萨皮恩扎（MichaelSapienza）说，迫切需要持续创新和精准医学来帮助治疗转移性结直肠癌这种新的组合方法对于患有

KRAS

KRAS

G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease.'

G12C突变的转移性结直肠癌，为患有这种毁灭性和挑战性疾病的患者提供了新的有益治疗选择。”

*

*

Investigator's choice for SOC included trifluridine/tipiracil or regorafenib.

研究者对SOC的选择包括三氟尿苷/替吡拉西或雷格拉非尼。

About CodeBreaK 300

关于CodeBreaK 300

The CodeBreaK 300 trial enrolled 160 participants and compared Lumakras (sotorasib) at doses of 960 mg and 240 mg in combination with Vectibix

CodeBreaK 300试验招募了160名参与者，并比较了960 mg和240 mg剂量的Lumakras（sotorasib）与Vectibix的组合

®

®

(panitumumab) to investigator's choice of standard of care (trifluridine/tipiracil or regorafenib) in patients with chemorefractory

（帕尼单抗）对研究者选择化疗难治性患者的标准治疗（三氟尿苷/替吡拉西或雷格拉非尼）

KRAS

KRAS

G12C-mutated metastatic colorectal cancer (mCRC). The study met its primary endpoint showing improved progression-free survival (PFS), and the key secondary endpoints of overall survival (OS) and overall response rate (ORR) also favored the combination.

G12C突变的转移性结直肠癌（mCRC）。该研究符合其主要终点，显示无进展生存期（PFS）改善，总生存期（OS）和总有效率（ORR）的关键次要终点也有利于联合治疗。

About mCRC and the

关于mCRC和

KRAS

KRAS

G12C Mutation

G12C突变

Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 11% of all cancer diagnoses.

结直肠癌（CRC）是全球癌症死亡的第二大原因，占所有癌症诊断的11%。

7

7

It is also the third most commonly diagnosed cancer globally.

它也是全球第三大最常被诊断出的癌症。

8

8

Patients with previously treated mCRC need more effective treatment options. For patients in the third-line setting, standard therapies yield median OS times of less than one year, and patients' response rates are less than 10%.

先前接受过mCRC治疗的患者需要更有效的治疗选择。对于三线治疗的患者，标准治疗产生的中位OS时间不到一年，患者的缓解率低于10%。

9

9

KRAS

KRAS

mutations are among the most common genetic alterations in CRC, with the

突变是CRC中最常见的遗传改变之一

KRAS

KRAS

G12C mutation present in approximately 3-5% of CRC cases as determined by a U.S. Food and Drug Administration (FDA)-approved biomarker test.

根据美国食品和药物管理局（FDA）批准的生物标志物测试，大约3-5%的CRC病例中存在G12C突变。

3-5

3-5

About Lumakras

关于Lumakras

(sotorasib)

（战争）

in Combination with Vectibix (panitumumab)

与Vectibix（帕尼单抗）联合使用

In the U.S., Lumakras is now approved in combination with Vectibix (panitumumab) for the treatment of adult patients with

在美国，Lumakras现在被批准与Vectibix（帕尼单抗）联合用于治疗成年患者

KRAS

克拉斯

G12C-mutated mCRC, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This targeted therapy combines Lumakras, a KRAS

经FDA批准的测试确定，G12C突变的mCRC先前接受过氟嘧啶，奥沙利铂和伊立替康为基础的化疗。这种靶向治疗结合了Lumakras，一种KRAS

G12C

G12C级

inhibitor, with Vectibix, a monoclonal anti-EGFR antibody. The recommended dose of Lumakras is 960 mg daily, and the recommended dose of Vectibix is 6 mg/kg IV q2 weeks.

抑制剂，与Vectibix，一种单克隆抗EGFR抗体。Lumakras的推荐剂量为每天960毫克，Vectibix的推荐剂量为第二季度静脉注射6毫克/千克。

About Lumakras (sotorasib)

关于卢马克拉斯 (sotorasib)

Lumakras received accelerated approval from the FDA on May 28, 2021. The FDA completed its review of Amgen's supplemental New Drug Application (sNDA) seeking full approval of Lumakras on December 26, 2023, which resulted in a complete response letter. In addition, the FDA concluded that the dose comparison postmarketing requirement (PMR) issued at the time of Lumakras accelerated approval, to compare the safety and efficacy of Lumakras 960 mg daily dose versus a lower daily dose, has been fulfilled.

卢马克拉斯于2021年5月28日获得了FDA的加速批准。FDA于2023年12月26日完成了对安进补充新药申请（sNDA）的审查，该申请寻求Lumakras的全面批准，并产生了完整的回复信。此外，FDA得出结论，已经满足了Lumakras加速批准时发布的剂量比较上市后要求（PMR），以比较Lumakras 960 mg日剂量与较低日剂量的安全性和有效性。

The company said Lumakras at 960 mg once-daily will remain the dose for patients with .

该公司表示，每天一次960毫克的Lumakras仍将是患者的剂量。

KRAS

KRAS

G12C-mutated non-small cell lung cancer (NSCLC) under accelerated approval. The FDA also issued a new PMR for an additional confirmatory study to support full approval that will be completed no later than February 2028.

G12C突变的非小细胞肺癌（NSCLC）正在加速批准。FDA还发布了一份新的PMR，以进行额外的验证性研究，以支持不迟于2028年2月完成的全面批准。

About Vectibix

关于Vectibix

(panitumumab)

（panitumumab）

Vectibix is the first and only human monoclonal anti-EGFR antibody fully approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.

Vectibix是FDA完全批准用于治疗mCRC的第一种也是唯一一种人类单克隆抗EGFR抗体。Vectibix于2006年9月在美国被批准作为单一疗法，用于治疗先前用含氟嘧啶，奥沙利铂和伊立替康的化疗后疾病进展后表达EGFR的mCRC患者。

.

.

In May 2014, the FDA approved Vectibix for use in combination with FOLFOX as first-line treatment in patients with wild-type

2014年5月，FDA批准Vectibix与FOLFOX联合用于野生型患者的一线治疗

KRAS

KRAS

(exon 2) mCRC. With this approval, Vectibix became the first-and-only anti-EGFR biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in first-line treatment of mCRC for patients with wild-type

（外显子2）mCRC。

KRAS

克拉斯

mCRC.

mCRC。

In June 2017, the FDA approved a refined indication for Vectibix for use in patients with wild-type

2017年6月，FDA批准了用于野生型患者的Vectibix改良适应症

RAS

RAS公司

(defined as wild-type in both

（两者均定义为野生型

KRAS

KRAS

and

和

NRAS

NRAS

as determined by an FDA-approved test for this use) mCRC, specifically as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.

根据FDA批准的用于此用途的测试确定）mCRC，特别是作为与FOLFOX联合的一线治疗，以及在先前用含氟嘧啶，奥沙利铂和伊立替康的化疗治疗后疾病进展后的单一疗法。

Lumakras

卢马科拉斯

(sotorasib)

（索托西布）

in

在里面

Combination with Vectibix (panitumumab)

与Vectibix（帕尼单抗）联合使用

U.S.

U、 S。

Indication

指示物，指示物，指示物，指示物，指示物，指示物。的，指示物，指示物，指示物。。。的，指示物，指示物，指示物，指示物，指示物，指示物，指示

Vectibix in combination with sotorasib, is indicated for the treatment of adult patients with

Vectibix联合sotorasib可用于治疗成年患者

KRAS G12C

克拉斯 G12C

-mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

-经FDA批准的测试确定，突变的mCRC先前已接受氟嘧啶，奥沙利铂和伊立替康为基础的化疗。

LIMITATIONS OF USE

使用限制

Vectibix is not indicated for the treatment of patients with

Vectibix不适用于治疗患有

RAS-

RAS公司-

mutant mCRC unless used in combination with sotorasib in

突变型mCRC，除非与sotorasib联合使用

KRAS

KRAS

G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom

G12C突变的mCRC。Vectibix不适用于mCRC患者的治疗

RAS

RAS公司

mutation status is unknown.

突变状态未知。

IMPORTANT SAFETY INFORMATION - Lumakras

重要安全信息-Lumakras

Hepatotoxicity

肝毒性

Interstitial Lung Disease (ILD)/Pneumonitis

间质性肺病/肺炎

Most Common Adverse Reactions

Drug Interactions

药物相互作用

IMPORTANT SAFETY INFORMATION - Vectibix

重要安全信息-Vectibix

BOXED WARNING: DERMATOLOGIC TOXICITY

盒装警告：皮肤病毒性

Dermatologic Toxicity:

皮肤毒性：

Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix monotherapy

90%的患者发生皮肤病毒性，15%接受Vectibix单药治疗的患者发生严重（NCI-CTC 3级及以上）

About Amgen

关于安进

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.

安进发现、开发、制造和提供创新药物，帮助数百万患者抗击世界上最严重的疾病。40多年前，安进帮助建立了生物技术产业，并保持在创新的前沿，利用技术和人类基因数据超越了当今已知的领域。

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..

安进正在推进一条广泛而深入的管道，该管道建立在其现有的治疗癌症、心脏病、骨质疏松症、炎症性疾病和罕见疾病的药物组合之上。。

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 external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average, and it is also part of the Nasdaq-100 Index, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization..

2024年，安进被Fast Company评为“世界上最具创新性的公司”之一，被福布斯评为“美国最佳大型雇主”之一，以及其他外部认可。安进是道琼斯工业平均指数的30家公司之一，也是纳斯达克100指数的一部分，该指数包括根据市值在纳斯达克股票市场上市的最大和最具创新性的非金融公司。。

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.

有关更多信息，请访问Amgen.com，在X、LinkedIn、Instagram、TikTok、YouTube和Threads上关注安进。

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期望和信念的前瞻性声明。除历史事实陈述外，所有陈述均为可被视为前瞻性陈述的陈述，包括与任何其他公司（包括BeiGene，Ltd.）合作或潜在合作的结果、利益和协同作用的任何陈述。

or Kyowa Kirin Co., Ltd.), the performance of Otezla (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our 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 our 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 our business, outcomes, progress, and other such estimates and results.

或Kyowa Kirin Co.，Ltd.），Otezla（apremilast）的业绩（包括预期的Otezla销售额增长和非GAAP EPS增长的时间），我们对Teneobio，Inc.，ChemoCentryx，Inc。或Horizon Therapeutics plc的收购（包括Horizon业务的预期业绩和前景，业绩和机会，任何潜在的战略利益，协同作用或机会，以及Horizon收购对我们未来收购相关费用的任何预期影响），以及收入，营业利润率，资本支出，现金，其他财务指标，预期的法律，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、大流行或其他广泛健康问题对我们业务的影响、结果、进展以及其他此类估计和结果。

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 our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K.

前瞻性陈述涉及重大风险和不确定性，包括下文讨论的风险和不确定性，以及安进提交的证券交易委员会报告中更详细描述的风险和不确定性，包括我们最近的10-K表年度报告、10-Q表后续任何定期报告以及8-K表当前报告。

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not .

除非另有说明，安进在本新闻稿发布之日提供此信息，但不提供。

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. 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.

无法保证前瞻性陈述，实际结果可能与我们预测的结果存在重大差异。无法保证发现或识别新的候选产品或开发现有产品的新适应症，并且不确定从概念到产品的变化；因此，不能保证任何特定的候选产品或现有产品的新适应症的开发会成功并成为商业产品。

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 us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future..

此外，临床前结果不能保证候选产品在人体内的安全有效性能。计算机或细胞培养系统或动物模型无法完美地模拟人体的复杂性，有时甚至无法充分模拟人体的复杂性。过去，我们完成临床试验并获得产品营销监管批准所需的时间长短各不相同，我们预计未来也会出现类似的变化。。

Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop 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 we may have believed at the time of entering into such relationship.

即使临床试验成功，监管机构也可能会质疑我们选择的试验终点是否足够。我们在内部以及通过许可合作、伙伴关系和合资企业开发候选产品。源自关系的候选产品可能会在双方之间产生争议，或者可能被证明不如我们在建立这种关系时所认为的那样有效或安全。

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

此外，我们或其他人可以在我们的产品（包括我们的设备）上市后发现其安全性、副作用或制造问题。。

Our results may be affected by our 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 our products and global economic conditions.

我们的业绩可能会受到以下因素的影响：我们在国内外成功营销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发展，最近推出的产品的销售增长，包括生物仿制药在内的其他产品的竞争，制造我们产品的困难或延误以及全球经济状况。

In addition, sales of our 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，我们产品的销售受到第三方付款人（包括政府、私人保险计划和管理式护理提供者）施加的定价压力、政治和公共审查以及报销政策的影响，并可能受到监管、临床和指南发展以及国内外管理式护理和医疗保健成本控制趋势的影响。

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

此外，我们的研究、测试、定价、营销和其他业务都受到国内外政府监管机构的广泛监管。我们的业务可能会受到政府调查、诉讼和产品责任索赔的影响。此外，我们的业务可能会受到新税法的通过或额外纳税义务的影响。

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

如果我们未能履行我们与美国政府之间的企业诚信协议中的合规义务，我们可能会受到重大制裁。此外，虽然我们经常为我们的产品和技术获得专利，但我们的专利和专利申请所提供的保护可能会受到竞争对手的质疑、无效或规避，或者我们可能无法在当前和未来的知识产权诉讼中胜诉。

We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a .

我们在包括波多黎各在内的几个关键设施进行了大量的商业制造活动，并且还依赖第三方进行生产。

References

参考文献

SOURCE Amgen

来源安进

Lumakras (sotorasib) FDA Approval History

Lumakras（sotorasib）FDA批准历史

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