更新于：2024-11-04

Merck Sharp & Dohme BV

子公司|

Netherlands

子公司|

Netherlands

更新于：2024-11-04

概览

疾病领域	数量

感染	24
内分泌与代谢疾病	10
免疫系统疾病	8
血液及淋巴系统疾病	7
肿瘤	5
神经系统疾病	4

排名前五的药物类型	数量

小分子化药	22
预防性疫苗	8
减毒活疫苗	5
联合疫苗	2
单克隆抗体	2

排名前五的靶点	数量

RT(逆转录酶)	3
NK1R(神经激肽-1-受体)	2
fungal CYP51A1(真菌细胞色素P450家族成员51)	1
PD-1(细胞程序性死亡-1)	1
PBPs(细菌青霉素结合蛋白家族)	1

关联

项与 Merck Sharp & Dohme BV 相关的药物

Sotatercept

靶点

ACVR2A x activin receptor

作用机制

ACVR2A调节剂 [+1]

在研机构

Merck Sharp & Dohme BV [+8]

原研机构

Acceleron Pharma, Inc.

在研适应症

抑郁症 [+5]

非在研适应症

先天性单纯性红细胞再生障碍性贫血 [+11]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2024-03-26

Gefapixant Citrate

靶点

P2X3 receptor

作用机制

P2X3 receptor拮抗剂

在研机构

Merck Sharp & Dohme BV [+1]

原研机构

F. Hoffmann-La Roche Ltd.

在研适应症

不明原因的慢性咳嗽 [+1]

非在研适应症

急性咳嗽 [+13]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2022-01-20

Pneumococcal 15-valent Conjugate Vaccine(Merck & Co.)

15价肺炎球菌结合疫苗（默克）

靶点-

作用机制

免疫刺激剂

在研机构

Merck Sharp & Dohme BV [+3]

原研机构

Merck & Co., Inc.

在研适应症

急性中耳炎 [+4]

非在研适应症

18型肌张力障碍 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2021-07-16

项与 Merck Sharp & Dohme BV 相关的临床试验

CTR20232647 / Recruiting临床4期

上市后泊沙康唑注射液和泊沙康唑肠溶片治疗中国侵袭性曲霉菌病患者的有效性（全因死亡率）监测研究

主要目的：评估接受了至少7天泊沙康唑注射液和/或泊沙康唑肠溶片作为一线方案治疗侵袭性曲霉病的中国成人患者中第42天的全因死亡率。次要目的：1.评估接受一线治疗方案泊沙康唑注射液和/或泊沙康唑肠溶片治疗侵袭性曲霉病的中国成人患者在泊沙康唑治疗结束时（最短治疗持续时间42天，最长治疗持续时间12周，即84天）的总应答率（完全或部分应答）。2.评估接受泊沙康唑注射液和/或泊沙康唑肠溶片作为挽救方案治疗侵袭性曲霉病的两性霉素B、伏立康唑、伊曲康唑或艾沙康唑难治性3或者对上述药物不耐受的中国成人患者在泊沙康唑治疗结束时（最短治疗持续时间7天，最长治疗持续时间12周，即84天）的总应答率（完全或部分应答）。3. 描述接受泊沙康唑注射液和/或泊沙康唑肠溶片作为一线或挽救方案治疗侵袭性曲霉病的中国成人患者的研究人群特征，包括基线、临床特征和治疗模式。

开始日期2023-11-15

申办/合作机构

Schering-Plough Corp.

[+3]

CTR20231040 / Completed临床4期

接受含多拉韦林的高效联合抗反转录病毒治疗（HAART）HIV-1中国成年患者有效性上市后研究

主要目的：旨在评价含多拉韦林的HAART对HIV-1中国成年患者的效果；次要目的：描述研究人群的人口学特征、临床特征及治疗模式。

开始日期2023-07-25

申办/合作机构

默沙东研发（中国）有限公司

[+2]

CTR20231216 / Completed临床4期

中国常规临床实践中使用诺科飞的上市后安全性监测项目

描述在中国真实使用诺科飞注射液和/或肠溶片的参与者中发生1起或多起不良事件、严重不良事件或不良反应的参与者数量和百分比

开始日期2023-05-22

申办/合作机构

Organon Heist BV

[+3]

100 项与 Merck Sharp & Dohme BV 相关的临床结果

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0 项与 Merck Sharp & Dohme BV 相关的专利（医药）

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项与 Merck Sharp & Dohme BV 相关的文献（医药）

2020-12-01·Cost effectiveness and resource allocation : C/E4区 · 医学

Cost-effectiveness analysis of pembrolizumab compared to standard of care as first line treatment for patients with advanced melanoma in Hong Kong

4区 · 医学

ArticleOA

作者: Leung, Linda K S ; Loong, Herbert H ; Tan, S C ; Wang, Jingshu ; Aguiar-Ibáñez, Raquel ; Lee, Mary Y K ; Wong, Carlos K H ; Jen, Jason

Abstract:

Background:

Pembrolizumab has been shown to improve overall survival (OS) and progression free survival (PFS) compared to ipilimumab in patients with ipilimumab-naïve advanced melanoma; however, there are no published data on the cost-effectiveness for pembrolizumab compared to standard-of-care treatments currently used in Hong Kong for advanced melanoma.

Methods:

A partitioned-survival model based on data from a recent randomized phase 3 study (KEYNOTE-006) and meta-analysis was used to derive time in PFS, OS, and post-progression survival for pembrolizumab and chemotherapy, such as dacarbazine (DTIC), temozolomide (TMZ), and the paclitaxel-carboplatin combination (PC). A combination of clinical trial data, published data, results of meta-analysis, and melanoma registry data was used to extrapolate PFS and OS curves. The base-case time horizon for the model was 30 years with costs and health outcomes discounted at a rate of 5% per year. Individual patient level data on utilities and frequencies of adverse events were obtained from the final analysis of KEYNOTE-006 (cut-off date: 3-Dec-15) for pembrolizumab. Cost data included drug acquisition, treatment administration, adverse event management, and clinical management of advanced melanoma. The distribution of patient weight from the Hong Kong population was applied to calculate the drug costs. Analyses were performed from a payer’s perspective. The incremental cost effectiveness ratio (ICER) expressed as cost in US Dollars (USD) per quality-adjusted life years (QALYs) was the main outcome.

Results:

In base-case scenario, the ICER for pembrolizumab as a first-line treatment for advanced melanoma was USD49,232 compared to DTIC, with the ICER values lower than cost-effectiveness threshold in Hong Kong. Results comparing pembrolizumab to TMZ and to PC were similar to that when compared to DTIC. Probability sensitivity analyses showed that 99% of the simulated ICERs were below three times the Gross Domestic Product (GDP) per capita for Hong Kong (currently at $119,274//QALY threshold). In a scenario analysis comparing pembrolizumab with ipilimumab, the estimated ICER was USD8,904.

Conclusions:

Pembrolizumab is cost-effective relative to chemotherapy (DTIC, TMZ and PC), and highly-cost-effective compared to ipilimumab, for the first-line treatment of advanced melanoma in Hong Kong.

2020-07-01·Clinical drug investigation4区 · 医学

An Economic Evaluation of Pembrolizumab Versus Other Adjuvant Treatment Strategies for Resected High-Risk Stage III Melanoma in the USA

4区 · 医学

Article

作者: Bensimon, Arielle G ; Gao, Wei ; Zhou, Zheng-Yi ; Jenkins, Madeline ; Krepler, Clemens ; Signorovitch, James ; Song, Yan ; Scherrer, Emilie ; Aguiar-Ibáñez, Raquel ; Wang, Jingshu

BACKGROUND AND OBJECTIVE:

Over the past 5 years, adjuvant treatment options for surgically resected stage III melanoma have expanded with the introduction of several novel immune checkpoint inhibitors and targeted therapies. Pembrolizumab, a programmed cell death protein 1 inhibitor, received US Food and Drug Administration approval in 2019 for resected high-risk stage III melanoma based on significantly longer recurrence-free survival versus placebo. This study evaluated the cost-effectiveness of pembrolizumab versus other adjuvant treatment strategies for resected high-risk stage III melanoma from a US health system perspective.

METHODS:

A Markov cohort-level model with four states (recurrence-free, locoregional recurrence, distant metastases, death) estimated costs and quality-adjusted life-years (QALYs) for pembrolizumab versus routine observation and other adjuvant comparators: ipilimumab in the overall population; and dabrafenib + trametinib in the BRAF-mutation positive (BRAF+) subgroup. Transition probabilities starting from recurrence-free were estimated through parametric multi-state modeling based on phase 3 KEYNOTE-054 (NCT02362594) trial data for pembrolizumab and observation, and network meta-analyses for other comparators. Post-recurrence transitions were modeled based on electronic medical records data and trials in advanced/metastatic melanoma. Utilities were derived using quality-of-life data from KEYNOTE-054 and literature. Costs of treatment, adverse events, disease management, and terminal care were included.

RESULTS:

Over a lifetime, pembrolizumab, ipilimumab, and observation were associated with QALYs of 9.24, 7.09, and 5.95 and total costs of $511,290, $992,721, and $461,422, respectively (2019 US dollars). Pembrolizumab was thus dominant (less costly, more effective) versus ipilimumab, with an incremental cost-effectiveness ratio of $15,155/QALY versus observation. In the BRAF+ subgroup, pembrolizumab dominated dabrafenib + trametinib and observation, decreasing costs by $62,776 and $11,250 and increasing QALYs by 0.93 and 3.10 versus these comparators, respectively. Results were robust in deterministic and probabilistic sensitivity analyses.

CONCLUSIONS:

As adjuvant treatment for resected stage III melanoma, pembrolizumab was found to be dominant and therefore cost-effective compared with the active comparators ipilimumab and dabrafenib + trametinib. Pembrolizumab increased costs relative to observation in the overall population, with sufficient incremental benefit to be considered cost-effective based on typical willingness-to-pay thresholds.

2019-10-03·Journal of medical economics4区 · 医学

Cost-effectiveness of pembrolizumab for the adjuvant treatment of resected high-risk stage III melanoma in the United States

4区 · 医学

Article

作者: Bensimon, Arielle G. ; Gao, Wei ; Zhou, Zheng-Yi ; Jenkins, Madeline ; Krepler, Clemens ; Liu, Frank Xiaoqing ; Song, Yan ; Signorovitch, James ; Aguiar-Ibáñez, Raquel ; Wang, Jingshu

Aims: To evaluate the cost-effectiveness of adjuvant pembrolizumab relative to observation alone following complete resection of high-risk stage III melanoma with lymph node involvement, from a US health system perspective. Materials and methods: A Markov cohort model with four health states (recurrence-free, locoregional recurrence, distant metastases, and death) was developed to estimate costs, life-years, and quality-adjusted life-years (QALYs) associated with pembrolizumab vs observation over a lifetime (46-year) horizon. Using a parametric multi-state modeling approach, transition probabilities starting from recurrence-free were estimated based on patient-level data from KEYNOTE-054 (NCT02362594), a direct head-to-head phase 3 trial. Post-recurrence transition probabilities were informed by real-world retrospective data and clinical trials in advanced melanoma. Health state utilities and adverse event-related disutility were derived from KEYNOTE-054 trial data and published literature. Costs of drug acquisition and administration, adverse events, disease management, and terminal care were estimated in 2018 US dollars. Deterministic and probabilistic sensitivity analyses were conducted to assess robustness. Results: Over a lifetime horizon, adjuvant pembrolizumab and observation were associated with total QALYs of 9.24 and 5.95, total life-years of 10.54 and 7.15, and total costs of $489,820 and $440,431, respectively. The resulting incremental cost-effectiveness ratios (ICERs) for pembrolizumab vs observation were $15,009/QALY and $14,550/life-year. Across the range of input values and assumptions tested in deterministic sensitivity analyses, pembrolizumab ranged from being a dominant strategy to having an ICER of $57,449/QALY vs observation. The ICER was below a willingness-to-pay threshold of $100,000/QALY in 90.2% of probabilistic simulations. Limitations: Long-term extrapolation of outcomes was based on interim results from KEYNOTE-054, with a median follow-up of 15 months. Conclusions: Based on common willingness-to-pay benchmarks, pembrolizumab is highly cost-effective compared with observation alone for the adjuvant treatment of completely resected stage III melanoma in the US.

项与 Merck Sharp & Dohme BV 相关的新闻（医药）

2023-04-23

·医药地理

2022医保目录 | 协议期内消化道和代谢药物分析（三）

2022年医保目录中的协议期内谈判药品，西药涵盖消化道和代谢方面药物、血液和造血器官药、心血管系统用药、β-受体阻滞剂、调节血脂药、皮肤病用药、泌尿生殖系统药和性激素、除性激素和胰岛素外的全身激素制剂、全身用抗感染药、抗肿瘤药及免疫调节剂、肌肉骨骼系统药物、神经系统药物、呼吸系统药物、感觉器官药物、其他类共16种；中药涵盖内科用药、肿瘤用药、骨伤科用药、妇科用药、民族药共5个类别。2022年医保目录将从2023年3月1日起实施，本文将分析协议期内的消化道和代谢药物。数据来自于PDB药物综合数据库（pdb.pharmadl.com），CPM新药研发监测数据库（cpm.pharmadl.com）。糖尿病用药1.阿卡波糖咀嚼片：该药医保支付标准为0.465元（50mg/片），由杭州中美华东制药有限公司申报上市（2019.9.30）。从2022年阿卡波糖销售数据上看，排名前五的省份分别是广东省（14.11%）、北京市（10.92%）、辽宁省（9.95%）、山东省（8.58%）、湖北省（6.37%）。图1：阿卡波糖2022年样本医院各区域销售占比2.西格列他钠片：该药医保支付标准为2.92元（16mg/片），由成都微芯药业有限公司申报上市（2021.10.22），2022年销售额为17.97万元。图2：西格列他钠片历年销售情况3.艾塞那肽注射液：该药医保支付标准保密，限定支付范围为二甲双胍等口服降糖药或胰岛素控制效果不佳的BMI≥25的患者，最早由Eli Lilly Nederland BV引入国内（2009.5.8），但是批文已失效。随后，AstraZeneca AB也完成上市申报（2013.6.30），青海晨菲制药有限公司（2022.7.29）也通过了一致性评价。该药曾在2016年达到销售峰值4300万元，随后逐年下降，2022年销售额仅为400万元。图3：艾塞那肽注射液历年销售情况4.利拉鲁肽注射液：该药医保支付标准保密，限定支付范围为二甲双胍等口服降糖药或胰岛素控制效果不佳的BMI≥25的患者，最早由Novo Nordisk A/S引入国内（2011.3.4），杭州中美华东制药有限公司（2023.3.28）通过了一致性评价。自2018年以来，该药销售额呈现逐年上升趋势，并于2021年达到峰值4.42亿元，2022年销售额下降至3.49亿元。图4：利拉鲁肽注射液历年销售情况5.利司那肽注射液：该药医保支付标准保密，限定支付范围为二甲双胍等口服降糖药或胰岛素控制效果不佳的BMI≥25的患者，由Sanofi-aventis groupe引入国内（2018.2.7）。2020年和2021年，该药销售额达到了800万元左右，2022年销售额则锐减至61万元左右。图5：利司那肽注射液历年销售情况6.贝那鲁肽注射液：该药医保支付标准保密，限定支付范围为糖尿病，由上海仁会生物制药股份有限公司申报上市（2016.12.13）。该药自上市以来销售金额较为稳定，2022年的销售额为160万元。图6：贝那鲁肽注射液历年销售情况7.度拉糖肽注射液：该药医保支付标准保密，限定支付范围为二甲双胍等口服降糖药或胰岛素控制效果不佳的BMI≥25的患者，最早由Eli Lilly Nederland BV引入国内（2019.2.22）。该药在2021年销售额取得了质的飞跃，达到了1.19亿元，2022年销售额突破3亿元大关。图7：度拉糖肽注射液历年销售情况8.聚乙二醇洛塞那肽注射液：该药医保支付标准为110元（0.5ml：0.1mg/支）、187元（0.5ml：0.2mg/支），限定支付范围为二甲双胍等口服降糖药或胰岛素控制效果不佳的BMI≥25的患者，由江苏豪森药业集团有限公司申报上市（2019.5.5）。该药2021年销售额为3393万元，2022年为6983万元。图8：聚乙二醇洛塞那肽注射液历年销售情况9.司美格鲁肽注射液：该药医保支付标准保密，限定支付范围为成人2型糖尿病患者的血糖控制；在饮食控制和运动的基础上，接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病患者；降低伴有心血管疾病的2型糖尿病成人患者的主要心血管不良事件（心血管死亡、非致死性心肌梗死或非致死性卒中）的风险，最早由Novo Nordisk A/S引入国内（2021.4.27），2022年该药销售额为4.65亿元。图9：司美格鲁肽注射液历年销售情况10.艾托格列净片：该药医保支付标准保密，限定支付范围为二线用药，最早由Merck Sharp & Dohme BV引入国内（2020.7.29）。2021年，该药销售额仅为400万元，2022年则增长至2300万元。图10：艾托格列净片历年销售情况11.脯氨酸恒格列净片：该药医保支付标准保密，限定支付范围为成人2型糖尿病患者，由江苏恒瑞医药股份有限公司申报上市（2021.12.31）。图11：脯氨酸恒格列净片历年销售情况年度发布2023年《全球药研新动态》《中国医院市场用药格局》（2023版）2023年《数图药讯》权威发布2021年度中国医药工业百强榜单解读中国仿制药发展报告（2022版）医药行业通用报告中国医药中间体和原料药行业调研报告中国非甾体抗炎类原料药市场调研报告中国祛痰类原料药市场调研报告中国钙拮抗剂类原料药市场调研报告中国血管紧张素Ⅱ受体拮抗剂类原料药市场调研报告END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

一致性评价医药出海

2023-02-13

·药智网

赢情人节好礼！读【博药】好文即可参与

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