RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) in China has approved WELIREG® (belzutifan), for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

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，今天宣布，中国国家医疗产品管理局（NMPA）已批准WELIREG®（belzutifan），用于治疗需要治疗相关肾细胞癌（RCC），中枢神经系统（CNS）血管母细胞瘤或胰腺神经内分泌肿瘤（pNET）的成年von Hippel-Lindau（VHL）病患者，无需立即手术。

WELIREG is a first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor and is the first and only approved HIF-2α inhibitor in China. This approval is based on objective response rate (ORR) and median duration of response (DOR) results from the Phase 2 LITESPARK-004 trial and is the 17th approval of WELIREG for these patients globally..

。该批准基于第2阶段LITESPARK-004试验的客观缓解率（ORR）和中位缓解期（DOR）结果，是WELIREG在全球范围内对这些患者的第17次批准。。

“This approval of WELIREG brings the first and only systemic therapy to adult patients in China with certain VHL disease-associated tumors who, to date, have not had access to a non-surgical treatment option to help manage manifestations of VHL disease,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.

默克研究实验室（Merck Research Laboratories）全球临床开发高级副总裁兼肿瘤学负责人马乔里·格林（Marjorie Green）博士表示：“韦利格的批准为中国患有某些VHL疾病相关肿瘤的成年患者带来了第一次也是唯一一次全身治疗，迄今为止，这些患者尚未获得非手术治疗选择来帮助管理VHL疾病的表现。”。

“We are committed to bringing innovative treatment options to patients in need around the world and are proud to offer eligible adult patients in China a first-in-class HIF-2α inhibitor as a possible treatment option.”.

“我们致力于为世界各地有需要的患者提供创新的治疗选择，并为中国符合条件的成年患者提供一流的HIF-2α抑制剂作为可能的治疗选择而感到自豪。”。

In August 2021, WELIREG was approved in the U.S. for the treatment of adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas or pNET, not requiring immediate surgery. The efficacy of WELIREG was evaluated in LITESPARK-004, an open-label clinical trial in 61 patients with VHL-associated RCC.

2021年8月，WELIREG在美国被批准用于治疗成年VHL患者，这些患者需要治疗相关的RCC，中枢神经系统血管母细胞瘤或pNET，不需要立即手术。在LITESPARK-004中评估了WELIREG的疗效，LITESPARK-004是一项针对61例VHL相关RCC患者的开放标签临床试验。

In the LITESPARK-004 trial, WELIREG showed an ORR of 49% (95% CI, 36-62) in patients with VHL-associated RCC (n=30/61); all responses were partial responses (PR). Median DOR for these patients was not reached, with ongoing responses ranging from 2.8+ to 22.3+ months; among responders, 56% (n=17/30) maintained a response for at least 12 months..

在LITESPARK-004试验中，WELIREG显示VHL相关RCC患者的ORR为49%（95%CI，36-62）（n=30/61）；所有反应均为部分反应（PR）。这些患者的中位DOR未达到，持续反应范围为2.8个月以上至22.3个月以上；在应答者中，56%（n=17/30）维持应答至少12个月。。

Patients enrolled in LITESPARK-004 had other VHL-associated tumors, including CNS hemangioblastomas and pNET. In patients with VHL-associated CNS hemangioblastomas (n=24) in this trial, WELIREG showed an ORR of 63% (95% CI, 41-81) (n=15/24), with a complete response (CR) rate of 4% (n=1/24) and a PR rate of 58% (n=14/24).

参加LITESPARK-004的患者还有其他与VHL相关的肿瘤，包括中枢神经系统血管母细胞瘤和pNET。在该试验中，VHL相关中枢神经系统血管母细胞瘤患者（n=24）的ORR为63%（95%CI，41-81）（n=15/24），完全缓解率（CR）为4%（n=1/24），PR率为58%（n=14/24）。

Median DOR for these patients was not reached, with ongoing responses ranging from 3.7+ to 22.3+ months; among responders, 73% (n=11/15) maintained a response for at least 12 months. In patients with VHL-associated pNET (n=12) in this trial, WELIREG showed an ORR of 83% (95% CI, 52-98) (n=10/12), with a CR rate of 17% (n=2/12) and a PR rate of 67% (n=8/12).

这些患者的中位DOR未达到，持续反应范围为3.7个月以上至22.3个月以上；。在该试验中，VHL相关pNET患者（n=12）的ORR为83%（95%CI，52-98）（n=10/12），CR率为17%（n=2/12），PR率为67%（n=8/12）。

Median DOR for these patients was not reached, with ongoing responses ranging from 10.8+ to 19.4+ months; among responders, 50% (n=5/10) maintained a response for at least 12 months..

这些患者的中位DOR未达到，持续反应范围为10.8个月以上至19.4个月以上；在应答者中，50%（n=5/10）维持应答至少12个月。。

WELIREG is also approved in the U.S. for the treatment of adult patients with advanced RCC following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI), based on results from the Phase 3 LITESPARK-005 trial.

。

Merck is evaluating WELIREG in advanced RCC and other tumor types through a broad clinical development program, including in Phase 2 and 3 trials evaluating WELIREG as monotherapy and in combination with other medicines..

默克公司正在通过广泛的临床开发计划评估WELIREG在晚期肾细胞癌和其他肿瘤类型中的作用，包括在评估WELIREG作为单一疗法和与其他药物联合使用的2期和3期试验中。。

About LITESPARK-004

关于LITESPARK-004

LITESPARK-004 is an open-label Phase 2 trial (ClinicalTrials.gov, NCT03401788) evaluating WELIREG for the treatment of patients with VHL disease who had at least one measurable solid tumor localized to the kidney and who did not require immediate surgery. The study enrolled 61 patients who received WELIREG (120 mg orally once daily) until disease progression or unacceptable toxicity.

LITESPARK-004是一项开放标签的2期临床试验（ClinicalTrials.gov，NCT03401788），评估WELIREG治疗VHL疾病患者，这些患者至少有一个可测量的实体瘤位于肾脏，不需要立即手术。该研究招募了61名患者，他们接受了WELIREG（每天一次口服120毫克），直到疾病进展或不可接受的毒性。

The primary endpoint is ORR in VHL disease-associated RCC. Secondary endpoints in RCC tumors include disease control rate, DoR, time to response, progression-free survival, time to surgery and safety. Additionally, this study evaluated response rates in other common VHL disease-associated tumors including pNET and CNS hemangioblastomas..

主要终点是VHL疾病相关RCC中的ORR。RCC肿瘤的次要终点包括疾病控制率，DoR，反应时间，无进展生存期，手术时间和安全性。此外，这项研究评估了其他常见VHL疾病相关肿瘤（包括pNET和中枢神经系统血管母细胞瘤）的缓解率。。

About von Hippel-Lindau disease

关于von Hippel-Lindau病

Von Hippel-Lindau disease is a rare genetic disease that impacts an estimated 200,000 people worldwide. Patients with VHL disease are at risk for recurrent, benign blood vessel tumors as well as some cancerous ones. The most commonly occurring tumor is renal cell carcinoma, a form of kidney cancer, which occurs in about 70% of patients with VHL disease..

冯·希佩尔·林道病是一种罕见的遗传病，估计影响全球20万人。VHL疾病患者有复发性良性血管肿瘤以及某些癌症的风险。最常见的肿瘤是肾细胞癌，这是一种肾癌，约70%的VHL患者发生这种肿瘤。。

About WELIREG® (belzutifan) 40 mg tablets, for oral use

关于WELIREG®（belzutifan）40 mg口服片剂

Indications in the U.S.

美国的适应症。

Certain von Hippel-Lindau (VHL) disease-associated tumors

某些von Hippel-Lindau（VHL）疾病相关肿瘤

WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

。

Advanced Renal Cell Carcinoma (RCC)

晚期肾细胞癌（RCC）

WELIREG is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

WELIREG适用于程序性死亡受体-1（PD-1）或程序性死亡配体1（PD-L1）抑制剂和血管内皮生长因子酪氨酸激酶抑制剂（VEGF-TKI）治疗成人晚期肾细胞癌（RCC）患者。

Selected Safety Information for WELIREG

为WELIREG选择的安全信息

Warning: Embryo-Fetal Toxicity

警告：胚胎-胎儿毒性

Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective.

怀孕期间接触WELIREG会导致胚胎-胎儿伤害。在开始WELIREG之前验证妊娠状态。告知患者这些风险以及需要有效的非激素避孕药，同时也可能导致一些激素避孕药无效。

Anemia

贫血

WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment. Transfuse patients as clinically indicated. For patients with hemoglobin <8 g/dL, withhold WELIREG until ≥8 g/dL, then resume at the same or reduced dose or permanently discontinue WELIREG, depending on the severity of anemia.

韦利雷可导致严重贫血，需要输血。在开始治疗之前和整个治疗过程中定期监测贫血。根据临床指示为患者输血。对于血红蛋白<8 g/dL的患者，根据贫血的严重程度，保留WELIREG直至≥8 g/dL，然后以相同或减少的剂量恢复或永久停止WELIREG。

For life-threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥8 g/dL, then resume at a reduced dose or permanently discontinue WELIREG..

对于危及生命的贫血或需要紧急干预时，停止服用WELIREG，直到血红蛋白≥8 g/dL，然后减少剂量或永久停用WELIREG。。

In LITESPARK-004 (N=61), decreased hemoglobin occurred in 93% of patients with VHL disease and 7% had Grade 3 events. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months).

在LITESPARK-004（N=61）中，93%的VHL患者血红蛋白降低，7%的患者发生3级事件。贫血发作的中位时间为31天（范围：1天至8.4个月）。

The safety of erythropoiesis-stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established.

红细胞生成刺激剂（ESAs）治疗用WELIREG治疗的VHL疾病患者贫血的安全性尚未确定。

In LITESPARK-005 (n=372), decreased hemoglobin occurred in 88% of patients with advanced RCC and 29% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% received ESAs only, and 12% received both transfusion and ESAs..

在LITESPARK-005（n=372）中，88%的晚期RCC患者血红蛋白降低，29%的患者发生3级事件。贫血发作的中位时间为29天（范围：1天至16.6个月）。在贫血患者中，22%仅接受输血，20%仅接受ESA，12%同时接受输血和ESA。。

Hypoxia

缺氧

WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.

WELIREG可能导致严重缺氧，可能需要停药，补充氧气或住院治疗。

Monitor oxygen saturation before initiation of, and periodically throughout, treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same or a reduced dose.

在开始治疗之前和整个治疗过程中定期监测血氧饱和度。对于运动时血氧饱和度降低（例如，脉搏血氧仪<88%或PaO2≤55 mm Hg），考虑停止WELIREG，直到运动时脉搏血氧仪大于88%，然后以相同或减少的剂量恢复。

For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider..

对于静息时血氧饱和度降低（例如，脉搏血氧仪<88%或PaO2≤55 mm Hg）或需要紧急干预时，停止服用WELIREG直至解决，并以减少的剂量恢复或停止服用。对于危及生命或反复出现症状性缺氧，请永久停用WELIREG。。。

In LITESPARK-004, hypoxia occurred in 1.6% of patients.

在LITESPARK-004中，1.6%的患者发生缺氧。

In LITESPARK-005, hypoxia occurred in 15% of patients and 10% had Grade 3 events. Of the patients with hypoxia, 69% were treated with oxygen therapy. Median time to onset of hypoxia was 30.5 days (range: 1 day to 21.1 months).

在LITESPARK-005中，15%的患者发生缺氧，10%的患者发生3级事件。在缺氧患者中，69%接受了氧疗。缺氧发作的中位时间为30.5天（范围：1天至21.1个月）。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman.

根据对动物的研究结果，WELIREG给孕妇服用时会对胎儿造成伤害。

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective.

告知孕妇和女性生殖潜力对胎儿的潜在风险。建议有生殖潜力的女性在接受WELIREG治疗期间和最后一次服用后1周内使用有效的非激素避孕药。韦利雷可以使一些激素避孕药无效。

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose..

建议有生殖潜力的女性伴侣的男性患者在接受WELIREG治疗期间和最后一次服用后1周内使用有效的避孕措施。。

Adverse Reactions

不良反应

In LITESPARK-004, serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

在LITESPARK-004中，15%的患者发生严重不良反应，包括贫血，缺氧，过敏反应，视网膜脱离和视网膜中央静脉阻塞（各1例）。

WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each).

由于3.3%的患者出现头晕和阿片类药物过量的不良反应（各1.6%），WELIREG永久停药。

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Those which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

39%的患者因不良反应而中断剂量。超过2%的患者需要中断剂量的是疲劳，血红蛋白降低，贫血，恶心，腹痛，头痛和流感样疾病。

Dose reductions due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

13%的患者因不良反应而减少剂量。需要减少剂量的最常报告的不良反应是疲劳（7%）。

The most common adverse reactions (≥25%), including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin (93%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%).

接受WELIREG治疗的患者最常见的不良反应（≥25%），包括实验室异常，包括血红蛋白降低（93%），疲劳（64%），肌酐升高（64%），头痛（39%），头晕（38%），血糖升高（34%）和恶心（31%）。

In LITESPARK-005, serious adverse reactions occurred in 38% of patients. The most frequently reported serious adverse reactions were hypoxia (7%), anemia (5%), pneumonia (3.5%), hemorrhage (3%), and pleural effusion (2.2%). Fatal adverse reactions occurred in 3.2% of patients who received WELIREG, including sepsis (0.5%) and hemorrhage (0.5%)..

在LITESPARK-005中，38%的患者发生严重不良反应。最常报告的严重不良反应是缺氧（7%），贫血（5%），肺炎（3.5%），出血（3%）和胸腔积液（2.2%）。接受WELIREG治疗的患者中有3.2%发生致命不良反应，包括败血症（0.5%）和出血（0.5%）。。

WELIREG was permanently discontinued due to adverse reactions in 6% of patients. Adverse reactions which resulted in permanent discontinuation (≥0.5%) were hypoxia (1.1%) and hemorrhage (0.5%).

由于6%的患者出现不良反应，WELIREG永久停药。导致永久停药（≥0.5%）的不良反应为缺氧（1.1%）和出血（0.5%）。

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Of the patients who received WELIREG, 28% were 65 to 74 years, and 10% were 75 years and over. Dose interruptions occurred in 48% of patients ≥65 years of age and in 34% of younger patients. Adverse reactions which required dosage interruption in ≥2% of patients were anemia (8%), hypoxia (5%), COVID-19 (4.3%), fatigue (3.2%), and hemorrhage (2.2%)..

39%的患者因不良反应而中断剂量。在接受WELIREG的患者中，28%为65至74岁，10%为75岁及以上。。需要中断≥2%患者剂量的不良反应为贫血（8%），缺氧（5%），COVID-19（4.3%），疲劳（3.2%）和出血（2.2%）。。

Dose reductions due to an adverse reaction occurred in 13% of patients. Dose reductions occurred in 18% of patients ≥65 years of age and in 10% of younger patients. The most frequently reported adverse reactions which required dose reduction (≥1.0%) were hypoxia (5%) and anemia (3.2%).

13%的患者因不良反应而减少剂量。18%的≥65岁患者和10%的年轻患者发生剂量减少。需要减少剂量（≥1.0%）的最常报告的不良反应是缺氧（5%）和贫血（3.2%）。

The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (88%), fatigue (43%), musculoskeletal pain (33%), increased creatinine (34%), decreased lymphocytes (34%), increased alanine aminotransferase (32%), decreased sodium (31%), increased potassium (29%), and increased aspartate aminotransferase (27%)..

最常见的（≥25%）不良反应，包括实验室异常，是血红蛋白降低（88%），疲劳（43%），肌肉骨骼疼痛（33%），肌酐升高（34%），淋巴细胞减少（34%），丙氨酸转氨酶升高（32%），钠降低（31%），钾升高（29%），天冬氨酸转氨酶升高（27%）。。

Drug Interactions

药物相互作用

Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

WELIREG与UGT2B17或CYP2C19抑制剂的共同给药增加了belzutifan的血浆暴露，这可能会增加不良反应的发生率和严重程度。监测贫血和缺氧，并根据建议减少WELIREG的剂量。

Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information.

WELIREG与CYP3A4底物的共同给药会降低CYP3A4底物的浓度，这可能会降低这些底物的功效或导致治疗失败。避免与敏感的CYP3A4底物共同给药。如果无法避免共同给药，请根据其处方信息增加敏感的CYP3A4底物剂量。

Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding..

WELIREG与激素避孕药的共同给药可能导致避孕失败或突破性出血增加。。

Lactation

哺乳期

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

由于母乳喂养的儿童可能会产生严重的不良反应，因此建议女性在接受WELIREG治疗期间以及最后一次服用后1周内不要母乳喂养。

Females and Males of Reproductive Potential

生殖潜力的女性和男性

WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

WELIREG给孕妇服用时会对胎儿造成伤害。在开始用WELIREG治疗之前，验证具有生殖潜力的女性的妊娠状况。

Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose..

使用WELIREG可能会降低激素避孕药的功效。建议有生殖潜力的女性在接受WELIREG治疗期间和最后一次服用后1周内使用有效的非激素避孕药。建议有生殖潜力的女性伴侣的男性在接受WELIREG治疗期间和最后一剂后1周内使用有效的避孕措施。。

Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown.

根据动物的研究结果，韦利雷可能会损害具有生殖潜力的雄性和雌性的生育能力，这种影响的可逆性尚不清楚。

Pediatric Use

儿科使用

Safety and effectiveness of WELIREG in pediatric patients under 18 years of age have not been established.

WELIREG在18岁以下儿科患者中的安全性和有效性尚未确定。

Merck’s focus on cancer

默克专注于癌症

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms.

。作为一家领先的肿瘤学公司，我们正在寻求科学机会和医疗需求相融合的研究，并以我们超过25种新颖机制的多样化渠道为基础。

With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care.

凭借跨越30多种肿瘤类型的最大临床开发项目之一，我们努力推进突破性科学，这将塑造肿瘤学的未来。通过解决临床试验参与，筛查和治疗的障碍，我们迫切需要减少差异，并帮助确保患者获得高质量的癌症护理。

Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/..

我们坚定不移的承诺将使我们更接近为更多癌症患者带来生命的目标。有关更多信息，请访问https://www.merck.com/research/oncology/..

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.

。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 X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn..

欲了解更多信息，请访问www.merck.com并与us X（前Twitter）、Facebook、Instagram、YouTube和LinkedIn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 innovation 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；。。

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。。

Please see Prescribing Information, including information for the Boxed Warning about embryo-fetal toxicity, for WELIREG (belzutifan) at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf and Medication Guide for WELIREG at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_mg.pdf. .

请参阅WELIREG（belzutifan）的处方信息，包括关于胚胎-胎儿毒性的盒装警告信息https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf和WELIREG的药物指南https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_mg.pdf.。