RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive data from multiple Phase 3 studies evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases (ISPPD) in Cape Town, South Africa..

新泽西州拉赫韦（商业新闻短讯）--默克（纽约证券交易所代码：MRK），在美国和加拿大以外被称为MSD，今天在南非开普敦举行的国际肺炎和肺炎球菌病学会（ISPPD）第13次会议上，宣布了多个评估V116（该公司的研究性成人特异性21价肺炎球菌结合疫苗）的3期研究的阳性数据。。

Across the clinical studies presented, V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine in a variety of adult populations, including those who had not previously received a pneumococcal vaccine (pneumococcal vaccine-naïve), those who had previously received a pneumococcal vaccine (pneumococcal vaccine-experienced) and those with an increased risk of pneumococcal disease, including people living with human immunodeficiency virus (HIV).

在所提出的临床研究中，V116被证明对各种成年人群中疫苗覆盖的所有21种血清型都具有免疫原性，包括那些以前没有接种过肺炎球菌疫苗（未接种肺炎球菌疫苗）的人群，那些以前接种过肺炎球菌疫苗（接种过肺炎球菌疫苗）的人群以及肺炎球菌疾病风险增加的人群，包括人类免疫缺陷病毒（HIV）感染者。

V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting..

在会议上提出的所有STRIDE研究中，V116也比V116特有的血清型的研究比较者引起了更高的免疫反应。。

“Invasive pneumococcal disease and pneumococcal pneumonia can cause serious illness, especially in older adults and those with immunocompromising conditions,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee.

埃默里大学医学、流行病学、全球健康和儿科荣誉退休教授兼默克公司科学咨询委员会成员沃尔特·奥伦斯坦博士说：“侵袭性肺炎球菌病和肺炎球菌肺炎可导致严重疾病，尤其是老年人和免疫功能低下的患者。”。

“These positive data demonstrate the potential for V116 to address an unmet need in adult pneumococcal disease prevention.”.

“这些积极的数据表明V116有可能解决成人肺炎球菌疾病预防中未满足的需求。”。

Key findings from the studies include:

这些研究的主要发现包括：

In pneumococcal vaccine-naïve adults 50 years of age and older (STRIDE-3 sub-group), V116 was immunogenic for all 21 serotypes across the studied age groups (50–64, 65–74 and 75–84 years), as assessed by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30;

在50岁及以上未接种肺炎球菌疫苗的成年人（STRIDE-3亚组）中，V116对研究年龄组（50-64、65-74和75-84岁）的所有21种血清型均具有免疫原性，如第30天血清型特异性调理吞噬活性（OPA）几何平均滴度（GMT）所评估的；

In pneumococcal vaccine-experienced adults 50 years of age and older (STRIDE-6), V116 elicited comparable immune responses for the serotypes shared with PCV15 (pneumococcal 15-valent conjugate vaccine) or PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) and higher immune responses for the serotypes covered by V116 only, regardless of the previous pneumococcal vaccine received or time since prior pneumococcal vaccination, as assessed by serotype-specific OPA GMTs at Day 30;.

在经历过肺炎球菌疫苗接种的50岁及以上成年人（STRIDE-6）中，V116对与PCV15（肺炎球菌15价结合疫苗）或PPSV23（肺炎球菌疫苗，多价[23价]）共有的血清型产生了可比的免疫反应，并且仅对V116覆盖的血清型产生了更高的免疫反应，无论以前接种过肺炎球菌疫苗还是接种过肺炎球菌疫苗后的时间如何，在第30天通过血清型特异性OPA GMT进行评估；。

In adults 18 years of age and older living with HIV (STRIDE-7), V116 elicited comparable immune responses to PCV15+PPSV23 for all 13 shared serotypes and higher immune responses for the eight serotypes covered by V116 only, as assessed by serotype-specific OPA GMTs and Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at Day 30;.

在18岁及以上的HIV感染者（STRIDE-7）中，V116对所有13种共享血清型的PCV15+PPSV23产生了可比的免疫反应，并且仅对V116覆盖的8种血清型产生了更高的免疫反应，如第30天血清型特异性OPA GMT和免疫球蛋白G（IgG）几何平均浓度（GMC）所评估的；。

Across all presented studies, V116 demonstrated a safety profile comparable to the studied comparators, including PCV20 (pneumococcal 20-valent conjugate vaccine), PCV15 and PPSV23.

在所有提出的研究中，V116表现出与所研究的比较物相当的安全性，包括PCV20（肺炎球菌20价结合疫苗），PCV15和PPSV23。

“The extensive data presented this week reaffirm our confidence in the potential clinical value V116 could provide to a range of adult populations,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are encouraged by the results of these studies showing that V116 has generated immune responses to the serotypes responsible for the majority of adult invasive pneumococcal disease.”.

默克研究实验室高级副总裁、全球临床开发负责人兼首席医疗官Eliav Barr博士说：“本周提供的大量数据再次证实了我们对V116可能为一系列成年人群提供的潜在临床价值的信心。”。“我们对这些研究的结果感到鼓舞，这些研究表明V116对导致大多数成人侵袭性肺炎球菌疾病的血清型产生了免疫反应。”。

In addition to Phase 3 clinical data on V116, Merck also presented preliminary data from the real-world evidence study in the U.S., Pneumococcal Pneumonia Epidemiology, Urine Serotyping, and Mental Outcomes (PNEUMO), which found that among 2,065 adults 50 years of age and older hospitalized with community-acquired pneumonia between 2018 and 2022, 242 pneumococcal serotypes were detected.

除了V116的第三阶段临床数据外，默克公司还提供了美国现实世界证据研究的初步数据，即肺炎球菌肺炎流行病学，尿液血清分型和精神结局（肺炎球菌），该研究发现，在2065名50岁及以上的成年人中，2018年至2022年间住院治疗社区获得性肺炎，检测到242种肺炎球菌血清型。

Of these serotypes, approximately 84% were covered by V116. One fourth (approximately 25%) of the detected serotypes were covered only by V116 and not by PCV15 or PCV20..

在这些血清型中，约84%被V116覆盖。检测到的血清型中有四分之一（约25%）仅被V116覆盖，而不被PCV15或PCV20覆盖。。

Results from the PNEUMO study support that the serotypes in V116 account for the majority of pneumococcal disease (including invasive and non-invasive) in adults 50 years of age and older. These data are consistent with CDC surveillance data for invasive pneumococcal disease from 2018-2021, which show that V116 covers serotypes responsible for approximately 83% of invasive pneumococcal disease, including the eight serotypes unique to V116 which are responsible for approximately 30% of invasive pneumococcal disease in individuals 65 years of age and older..

肺炎球菌研究的结果支持V116血清型占50岁及以上成年人肺炎球菌疾病（包括侵袭性和非侵袭性）的大多数。这些数据与CDC 2018-2021年侵袭性肺炎球菌疾病的监测数据一致，该数据显示V116涵盖了约83%的侵袭性肺炎球菌疾病的血清型，包括V116特有的八种血清型，约占65岁及以上个体侵袭性肺炎球菌疾病的30%。。

Several of the studies presented at ISPPD were included in the filing submission to the U.S. Food and Drug Administration (FDA). The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.

在ISPPD上提交的几项研究已包含在提交给美国食品和药物管理局（FDA）的文件中。FDA批准V116优先审查，并于2024年6月17日颁布《处方药使用费法案》（PDUFA）或目标行动日期。如果获得批准，V116将是第一种专门为成人设计的肺炎球菌结合疫苗。

An overview of the V116 late-stage development program is available here..

此处提供了V116后期开发计划的概述。。

Summary of Findings from Select Studies Presented at ISPPD

ISPPD上提交的精选研究结果摘要

Data from STRIDE-3 Sub-group (Abstract #379)

STRIDE-3子组的数据（摘要#379）

The sub-group analysis of the pivotal STRIDE-3 (NCT05425732) trial evaluated immunogenicity in adults 50 years of age and older who had not previously received a pneumococcal vaccine (Cohort 1) by age groups (50–64, 65–74 and 75–84 years) (n=2,362). Results found that V116 was immunogenic for all 21 vaccine serotypes across the studied age sub-groups, as assessed by serotype-specific OPA GMTs 30 days post-vaccination.

关键STRIDE-3（NCT05425732）试验的亚组分析按年龄组（50-64、65-74和75-84岁）评估了50岁及以上未接种肺炎球菌疫苗（队列1）的成年人的免疫原性（n=2362）。结果发现，疫苗接种后30天，通过血清型特异性OPA GMT评估，V116对所研究年龄亚组的所有21种疫苗血清型均具有免疫原性。

There was a slight downward trend in immune responses in adults 65–74 years of age and 75 years of age and older compared to adults 50–64 years of age. V116 had a safety profile comparable to PCV20. Results from the STRIDE-3 trial were presented at the World Vaccine Congress West Coast in November 2023..

与50-64岁的成年人相比，65-74岁和75岁及以上的成年人的免疫反应略有下降。V116的安全性与PCV20相当。STRIDE-3试验的结果于2023年11月在西海岸世界疫苗大会上发表。。

Data from STRIDE-6 and STRIDE-6 Sub-group (Abstracts #353 and #520)

STRIDE-6和STRIDE-6子组的数据（摘要#353和#520）

STRIDE-6 (NCT05420961) is a Phase 3 trial investigating V116 in adults 50 years of age and older who had previously received a pneumococcal vaccine at least one year prior (n=712). Participants were enrolled based on previous pneumococcal vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and received either V116, PCV15 or PPSV23..

STRIDE-6（NCT05420961）是一项3期临床试验，研究了至少一年前接受过肺炎球菌疫苗（n=712）的50岁及以上成年人的V116。参与者根据先前的肺炎球菌疫苗接种PPSV23，PCV15，PCV13（肺炎球菌13价结合疫苗），PPSV23+PCV13，PCV13+PPSV23或PCV15+PPSV23进行登记，并接受V116，PCV15或PPSV23。。

Results showed that V116 was immunogenic across all cohorts, as assessed by OPA GMTs 30 days post-vaccination, and that V116 elicited comparable immune responses to the serotypes also covered by PCV15 and PPSV23 and higher immune responses for the serotypes covered only by V116. A STRIDE-6 sub-group analysis evaluating immunogenicity across all cohorts by time since prior pneumococcal vaccination found that V116 elicited comparable immune responses regardless of time since prior pneumococcal vaccination, including more than 10 years post-vaccination with PPSV23 (n=56), and 5–9 years post-vaccination with either PPSV23 or other pneumococcal vaccines (n=208).

结果显示，疫苗接种后30天，OPA GMT评估V116在所有队列中均具有免疫原性，V116对PCV15和PPSV23所覆盖的血清型产生了相当的免疫应答，对仅V116所覆盖的血清型产生了更高的免疫应答。STRIDE-6亚组分析评估了自接种肺炎球菌疫苗以来所有队列的免疫原性，发现自接种肺炎球菌疫苗以来，无论时间长短，V116都能引发相当的免疫反应，包括接种PPSV23后10年以上（n=56），以及接种PPSV23或其他肺炎球菌疫苗后5-9年（n=208）。

In this study, V116 had a safety profile comparable to both PCV15 and PPSV23..

在这项研究中，V116的安全性与PCV15和PPSV23相当。。

Data from STRIDE-7 (Abstract #1093)

STRIDE-7的数据（摘要#1093）

STRIDE-7 (NCT05393037) is a Phase 3, double-blind study of V116 in adults living with HIV (n=304). Results showed that V116 was immunogenic for all serotypes covered by the vaccine, as assessed by OPA GMTs and IgG GMCs 30 days post-vaccination. V116 elicited comparable immune responses to the comparator, PCV15+PPSV23, for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by V116.

STRIDE-7（NCT05393037）是一项针对HIV感染者（n=304）中V116的3期双盲研究。结果显示，疫苗接种后30天，通过OPA GMT和IgG GMC评估，V116对疫苗覆盖的所有血清型均具有免疫原性。对于所有13种共享血清型，V116对比较物PCV15+PPSV23产生了可比的免疫应答，对于仅由V116覆盖的8种血清型，V116引发了更高的免疫应答。

Fewer participants experienced adverse events (AEs) with V116 (71.6%) compared with PCV15+PPSV23 (91%), primarily due to fewer injection-site AEs..

与PCV15+PPSV23（91%）相比，V116（71.6%）发生不良事件（AE）的参与者较少，主要是由于注射部位AE较少。。

Data from STRIDE-9 (Abstract #1085)

STRIDE-9的数据（摘要#1085）

STRIDE-9 (NCT05633992) is a Phase 3, randomized, double-blind, active-comparator controlled study, which investigated V116 in Japanese adults 65 years of age and older who had not previously received a pneumococcal vaccine (n=450). Serotype-specific OPA responses were measured at baseline and 30 days post-vaccination and results demonstrated that V116 elicited noninferior immune responses for the 12 serotypes shared with PPSV23 and serotype 15B, (which is included in PPSV23 but not included in V116).

STRIDE-9（NCT05633992）是一项3期，随机，双盲，主动比较对照研究，该研究调查了65岁及以上未接种肺炎球菌疫苗（n=450）的日本成年人的V116。在基线和接种后30天测量血清型特异性OPA应答，结果表明V116对与PPSV23和血清型15B共享的12种血清型（包括在PPSV23中但不包括在V116中）引发非劣效免疫应答。

V116 also elicited higher immune responses for the serotypes only covered by V116 and not PPSV23. V116 also had a comparable safety profile to PPSV23..

V116还对仅由V116而非PPSV23覆盖的血清型引起更高的免疫应答。V116的安全性也与PPSV23相当。。

Data from PNEUMO U.S. Serotype Distribution Study (Abstract #308)

来自美国肺炎血清型分布研究的数据（摘要#308）

The PNEUMO U.S. study evaluated pneumococcal serotype distribution among adults 50 years of age and older hospitalized with community-acquired pneumonia (n=2,065), one of the non-invasive forms of pneumococcal disease, between 2018 and 2022 in three hospitals in Tennessee and Georgia. Urine samples from patients were evaluated for antigens from 30 pneumococcal serotypes using novel serotype-specific urinary antigen detection (SSUAD) assays (all serotypes in PCV15, PCV20 and V116 are included except 15B).

美国肺炎球菌研究评估了2018年至2022年间田纳西州和乔治亚州三家医院50岁及以上住院的社区获得性肺炎（n=2065）患者的肺炎球菌血清型分布，这是一种非侵入性肺炎球菌疾病。使用新型血清型特异性尿抗原检测（SSUAD）测定法（除15B外，包括PCV15，PCV20和V116中的所有血清型）评估患者尿液样品中30种肺炎球菌血清型的抗原。

Among the 242 serotypes detected by SSUAD assays, approximately 84% were covered by V116, compared to approximately 64% covered by PCV20. One fourth (approximately 25%) of the detected serotypes were covered by V116 only and not by PCV15 or PCV20..

在通过SSUAD测定检测到的242种血清型中，V116覆盖了约84%，而PCV20覆盖了约64%。检测到的血清型中有四分之一（约25%）仅被V116覆盖，而不被PCV15或PCV20覆盖。。

Additional Clinical Study Results Presented at ISPPD (Abstract #382 and #355)

在ISPPD上发表的其他临床研究结果（摘要#382和#355）

Data from Phase 3 clinical studies STRIDE-4 (NCT05464420) and STRIDE-5 (NCT05526716) were also presented at ISPPD.

ISPPD还提供了来自3期临床研究STRIDE-4（NCT05464420）和STRIDE-5（NCT05526716）的数据。

About V116

关于V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. V116 is specifically designed to address Streptococcus pneumoniae serotypes predominantly responsible for adult pneumococcal disease, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B, which account for approximately 30% of adult disease, according to CDC data from 2018-2021.

V116是一种研究性的21价肺炎球菌结合疫苗，处于3期开发阶段，用于预防成年人群的侵袭性肺炎球菌疾病和肺炎球菌肺炎。V116专门用于解决主要导致成人肺炎球菌疾病的肺炎链球菌血清型，包括八种独特的血清型，15A，15C，16F，23A，23B，24F，31和35B，约占成人疾病的30%，根据CDC 2018-2021年的数据。

The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data. V116 is designed to be administered as a single dose to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults..

根据CDC的相同数据，V116所涵盖的血清型约占65岁及以上人群侵袭性肺炎球菌疾病的83%。V116被设计为单剂量给药，以帮助预防成人侵袭性肺炎球菌疾病和肺炎球菌肺炎。。

The V116 Phase 3 program includes multiple studies, including STRIDE-3 (NCT05425732), STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037), STRIDE-8 (NCT05696080), STRIDE-9 (NCT05633992) and STRIDE-10 (NCT05569954).

V116第三阶段计划包括多项研究，包括STRIDE-3（NCT05425732），STRIDE-4（NCT05464420），STRIDE-5（NCT05526716），STRIDE-6（NCT05420961），STRIDE-7（NCT05393037），STRIDE-8（NCT05696080），STRIDE-9（NCT05633992）和STRIDE-10（NCT05569954）。

About Pneumococcal Disease

关于肺炎球菌疾病

Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae. There are more than 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Certain serotypes threaten to put more people at risk for invasive pneumococcal illnesses, such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord), as well as non-invasive pneumonia (when pneumococcal disease is confined to the lungs)..

肺炎球菌病是由称为肺炎链球菌的细菌引起的感染。肺炎球菌有100多种不同类型（称为血清型），对成年人的影响与儿童不同。某些血清型可能会使更多人面临侵袭性肺炎球菌疾病的风险，例如菌血症（血液感染）；菌血症性肺炎（肺炎伴菌血症）；脑膜炎（脑部和脊髓覆盖物的感染），以及非侵袭性肺炎（肺炎球菌疾病局限于肺部）。。

While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include older adults and those with certain chronic or immunocompromising health conditions, such as heart disease, lung disease and liver disease. Mortality from invasive pneumococcal disease is highest among adults 50 years of age and older..

虽然健康成年人可能患有肺炎球菌疾病，但特别容易感染的患者人群包括老年人以及患有某些慢性或免疫功能低下的健康状况（如心脏病，肺病和肝病）的患者。侵袭性肺炎球菌病的死亡率在50岁及以上的成年人中最高。。

Merck’s Commitment to Pneumococcal Disease Protection

默克公司对肺炎球菌疾病保护的承诺

Merck has been at the forefront of pneumococcal disease prevention through vaccination for more than four decades and remains committed to helping to protect people of all ages from this disease. Merck’s ongoing pneumococcal vaccine development program is designed to provide options that address the specific needs of different populations, including infants and children, healthy adults and at-risk sub-groups.

40多年来，默克一直站在通过疫苗接种预防肺炎球菌疾病的最前沿，并致力于帮助保护所有年龄段的人免受这种疾病的影响。默克正在进行的肺炎球菌疫苗开发计划旨在提供解决不同人群（包括婴儿和儿童，健康成年人和高危人群）特定需求的选择。

This approach recognizes that disease burden in pediatric and adult populations is often driven by different bacterial strains, or serotypes, and aims to address unmet needs by offering vaccine options that target serotypes posing the greatest global risk to each population. To learn more about Merck’s pipeline, visit www.merck.com..

这种方法认识到，儿科和成人人群的疾病负担通常由不同的细菌菌株或血清型驱动，旨在通过提供针对对每个人群构成最大全球风险的血清型的疫苗选择来解决未满足的需求。欲了解有关默克公司管道的更多信息，请访问www.Merck.com。。

About Merck

默克

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在美国和加拿大以外被称为MSD的默克公司，我们的目标是团结一致的：我们利用尖端科学的力量来拯救和改善世界各地的生活。130多年来，我们通过开发重要的药物和疫苗给人类带来了希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为世界上领先的研究密集型生物制药公司，今天，我们处于研究的前沿，以提供创新的健康解决方案，促进人类和动物疾病的预防和治疗。我们培养了一支多元化和包容性的全球劳动力队伍，并每天负责任地运作，为所有人和社区创造一个安全、可持续和健康的未来。

For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn..

有关更多信息，请访问www.merck.com，并通过X（以前的Twitter）、Facebook、Instagram、YouTube和LinkedIn与我们联系。。

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

美国新泽西州拉赫韦默克公司的前瞻性声明

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties.

美国新泽西州拉赫韦市默克公司（以下简称“公司”）的本新闻稿包括1995年《美国私人证券诉讼改革法案》安全港条款所指的“前瞻性声明”。这些声明基于公司管理层当前的信念和期望，并且存在重大风险和不确定性。

There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements..

对于管道候选人，不能保证候选人将获得必要的监管批准，或者证明他们在商业上取得了成功。如果基础假设不准确或风险或不确定性具体化，实际结果可能与前瞻性声明中规定的结果存在重大差异。。

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions..

风险和不确定性包括但不限于一般行业条件和竞争；一般经济因素，包括利率和货币汇率波动；美国和国际上制药行业监管和医疗保健立法的影响；医疗保健成本控制的全球趋势；竞争对手取得的技术进步、新产品和专利；新产品开发固有的挑战，包括获得监管部门的批准；公司准确预测未来市场状况的能力；制造困难或延误；国际经济金融不稳定和主权风险；依赖公司专利和其他创新产品保护的有效性；以及诉讼风险，包括专利诉讼和/或监管行动。。

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov)..

公司没有义务公开更新任何前瞻性声明，无论是由于新信息、未来事件还是其他原因。可能导致结果与前瞻性声明中描述的结果产生重大差异的其他因素可以在公司截至2023年12月31日的10-K表年度报告以及公司向证券交易委员会（SEC）提交的其他文件中找到，这些文件可在SEC的互联网网站（www.SEC.gov）上找到。。