A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO DETERMINE THE BE OF NIRMATRELVIR FOLLOWING ORAL ADMINISTRATION OF FDC TABLETS RELATIVE TO THE PAXLOVID® COMMERCIAL TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS

Medicines that may have different names or be made in different ways but have the same effect on the body are called bioequivalent.
The purpose of this study is to learn about the bioequivalence of nirmatrelvir plus ritonavir after taking 2 different combination tablet forms by mouth. These combination tablets are compared to the tablet formulation that is already in the market. This study will be done under fasted conditions in healthy adult participants.
This study is seeking participants who are:
* Male and non-pregnant female participants aged 18 years and above.
* with a body weight of more than 50 kilograms and Body Mass Index (BMI) between 16 to 32 kilograms per meter squared.
* are healthy as confirmed by medical history, physical examination, laboratory tests.
The study will also look at the safety and tolerability of nirmatrelvir plus ritonavir combination tablet and marketed tablet formulations in healthy adult participants.
The study will consist of 4 treatments:
Treatment A: Single oral dose of nirmatrelvir plus ritonavir 150 (1 × 150)/100 milligrams marketed tablets under fasted conditions (Reference 1) Treatment B (low dose strength): Single oral dose of nirmatrelvir plus ritonavir 150/100 milligrams (2 × [75/50 milligrams]) combination tablets under fasted conditions (Test 1) Treatment C: Single oral dose of nirmatrelvir/ritonavir 300 (2 × 150)/100 milligrams marketed tablets under fasted conditions (Reference 2) Treatment D (high dose strength): Single oral dose of nirmatrelvir/ritonavir 300/100 milligrams (2 × [150/50 milligrams]) combination tablets under fasted conditions (Test 2)
All treatments will be given under fasted conditions. Fasted condition means the participants would not have had anything to eat before taking the medicines.
Around 28 participants will be enrolled in the study. Healthy participants will be tested to see if they can be in the study within 28 days before receiving the study medicine. Selected participants will be admitted to the clinical research unit (CRU) one day before receiving the study medicine and will remain in the CRU until discharge after completing all the treatment periods.
On Day 1 of each period, participants will be given a single dose of study medicine nirmatrelvir/ritonavir 300/100 mg or 150/100 mg by mouth by chance. Study medicine will be given with approximately 240 milliliters of room temperature water under fasted conditions (overnight fast of at least 10 hours and no food until 4 hours after receiving the study medicine). Blood samples will be collected at different times of the day up to 48 hours after taking the study medicine. Participants will be discharged from the CRU on Day 3 of Period 4, after all the study related procedures have been completed.
A follow-up call will be made to participants around 28 to 35 days from receiving the final dose of the study medicine. The study will look at the experiences of participants receiving the study medicine. This will help to understand if the study medicine is safe and effective.

开始日期2025-02-14

申办/合作机构

Pfizer Inc.

NCT06792214

/ Recruiting临床4期IIT

Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD/Remdesivir Effectiveness For the prEvention of loNg coviD (DEFEND) Clinical Trial

The DEFEND trial will be the world's first clinical trial to study the effectiveness of Paxlovid or Veklury in the prevention of cardiovascular post-acute sequelae of SARS-CoV-2 among hospitalized adults. Additionally, this pilot study will inform the design and conduct of a future full-scale multi-centre trial by testing the feasibility and accuracy of this study design.

开始日期2025-01-03

申办/合作机构

Mount Sinai Hospital (Canada)

[+3]

NCT05997485

/ WithdrawnN/A

A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics Among COVID-19 Patients Receiving Treatment With Nirmatrelvir/Ritonavir (PAXLOVIDTM) in Morocco.

The purpose of this study is to collect information on the:
* general information of a group of people such as their age, sex, and other facts.
* clinical information of the patients such as any other illness before having COVID 19.
In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.
This study will be conducted in Morocco. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment. The inpatients will be admitted in the hospital for other reasons than COVID-19.
This study will have about 150 patients. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.
The study will include patient information of those who:
* are confirmed to have COVID-19 infection during the study period from 01 June 2022 to 30 June 2023.
* are 18 years of age or older.
* are prescribed Nirmatrelvir and ritonavir. This study will help to inform decision-making on use of Paxlovid at the national level.

开始日期2024-03-30

申办/合作机构

Pfizer Inc.

100 项与奈玛特韦/利托那韦相关的临床结果

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100 项与奈玛特韦/利托那韦相关的转化医学

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100 项与奈玛特韦/利托那韦相关的专利（医药）

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516

项与奈玛特韦/利托那韦相关的文献（医药）

2025-09-01·Medicina de Familia-SEMERGEN

Article

作者: García-Ortiz, A ; Hernández-Arroyo, M J ; González-Rodríguez, V M ; Rodríguez-Barrueco, C ; Romero-Sanabria, M ; Corredera-Blanco, S

OBJECTIVE:

To analyze the effectiveness and potential safety concerns of Nirmatrelvir + ritonavir (NMV-r) (Paxlovid®) in adults with mild-moderate COVID-19 disease at high risk of progression.

DESIGN:

Descriptive cross-sectional observational study.

SETTING:

Castilla y León, Spain.

PARTICIPANTS:

134 patients ≥18 years old with COVID-19 at high risk of progression to severe disease, who were treated between June and September 2022 with NMV-r.

MAIN MEASUREMENTS:

The most relevant drug interactions with concomitant medication were obtained from pharmaceutical validation records. From the monitoring of hospital admissions and deaths in the 28 days following the start of treatment, information regarding the effectiveness of the treatment was obtained.

RESULTS:

57.5% were women, the average age±SD was 69.7±17.1, 68.0% received NMV-r in the first two days of the start of symptoms, 74.6% were at home, and 95.7% were vaccinated. The main risk condition for disease progression was being immunocompromised (74.5%), followed by being >65 years old, vaccinated, but with risk factors (21.2%). A total of 62.9% had relevant interactions, with an average±SD of 1.7±1.0 per patient. 2.2% required hospital admission and 3.0% died.

CONCLUSIONS:

NMV-r has been effective in preventing severe forms of COVID-19 and hospital admissions in at-risk populations with a high vaccination rate. The prevalence of potential interactions is high, however, collaboration between family physicians and pharmacists allows NMV-r to be used safely.

2025-08-01·Current Drug Safety

Paxlovid (Nirmatrelvir/Ritonavir)-Induced Tacrolimus Toxicity in Organ Transplant Recipients - A Review on Drug Interactions Involving CYP3A Enzymes

Review

作者: Al Rashid, Sulthan ; Maideen, Naina Mohamed Pakkir

Background::

Paxlovid (nirmatrelvir/ritonavir) is the first oral therapy approved by the US FDA to treat patients with mild-to-moderate COVID-19.

Objective::

Our current review focuses on clinical data related to tacrolimus toxicity induced by Paxlovid currently available.

Methods::

A number of online databases, including LitCovid, Scopus, Web of Science, Embase, EBSCO host, Google Scholar, Science Direct, and the reference lists were searched to identify articles related to Paxlovid-induced tacrolimus toxicity, using keywords, like drug interactions, Paxlovid, ritonavir, nirmatrelvir, tacrolimus, pharmacokinetic interactions, and CYP3A.

Results::

Tacrolimus is a substrate of CYP3A enzymes and ritonavir of Paxlovid has been identified as a potent inhibitor of CYP3A enzymes. Hence, Paxlovid can inhibit the CYP3A-mediated metabolism of tacrolimus, resulting in elevated plasma concentrations of tacrolimus and toxicity.

Conclusion::

A number of case reports and case series have been published to highlight the association of Paxlovid and tacrolimus toxicity in transplant recipients with COVID-19 infection. Various recommendations have been proposed to prevent and mitigate the adverse events related to the DDI of Paxlovid and tacrolimus. Transplant physicians should be aware of this DDI and collaborate with clinical pharmacists on this issue.

2025-07-01·JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION

Inside the pharmacy: A qualitative study uncovering community pharmacists' experiences with Paxlovid prescribing

Article

作者: Mott, David ; Qudah, Bonyan ; Ford, James H ; AlMahasis, Sura O

BACKGROUND:

Community pharmacists were authorized to prescribe Paxlovid to eligible patients, yet little is known about their experiences in this role. Understanding these experiences is crucial for improving patient access.

OBJECTIVES:

This study aimed to 1) describe the Paxlovid prescribing process in community pharmacies and 2) explore associated barriers and facilitators.

METHODS:

This exploratory qualitative study involved semi-structured virtual interviews with pharmacists in Wisconsin (June-September 2023). Pharmacists were identified using the Wisconsin Department of Health Services list of pharmacies offering Paxlovid and the Pharmacy Practice Enhancement and Action Research Link network. The interview guide, pre-tested with one pharmacist, was informed by the Consolidated Framework for Implementation Research (CFIR). Descriptive statistics and thematic analysis guided by the CFIR were used.

RESULTS:

Five pharmacists were interviewed, including three in leadership roles. One represented a pharmacy partnering with two health systems, while another represented a healthcare system collaborating with 15 independent pharmacies. On average, pharmacists dispensed 130 (±142) Paxlovid doses, with eligibility screening taking 5 to 45 minutes, conducted in person, by phone, or via electronic health records (EHR). The prescribing process involved two steps: 1) assessing eligibility and 2) dispensing the appropriate prescription, with slight variations based on pharmacy's EHR access. Key themes describing facilitators and barriers to Paxlovid prescribing emerged within four CFIR domains (i.e., inner setting, outer setting, individual characteristics, and process). Major barriers included limited access to patient health information and inadequate reimbursement. Facilitators included access to decision-making support tools, compatibility, and the ability to screen and counsel patients remotely.

CONCLUSIONS:

Community pharmacists are vital to expanding access to Paxlovid but struggle with limited access to patient health information and inadequate reimbursement. Ensuring EHR access and advocating for provider status will enhance patient care. Involving pharmacists in public health program design can optimize resource allocation and effectiveness.

1,470

项与奈玛特韦/利托那韦相关的新闻（医药）

2025-06-04

·echemi

7 Pharma Giants See Q1 Sales Drop Pfizer Slips to Fourth as Cancer Race Heats Up

Seven major pharmaceutical firms reported year-over-year revenue declines in Q1, with Viatris—a leading generics player—hit hardest by an 11% drop. Pfizer followed with an 8% fall, while Organon, Bristol Myers Squibb (BMS), Regeneron, Merck, and Gilead saw milder declines, ranging from 6% to 0.3%. Once again, Pfizer took center stage with a surprising twist. After reclaiming the top spot in 2024 global pharma revenue with $63.6 billion in annual sales, it slid to fourth place in Q1, generating only $13.7 billion. The fall is largely tied to plummeting sales of Paxlovid and pricing pressure on Eliquis, partly due to U.S. Medicare policy changes under the IRA Act. Still, short-term numbers may not fully reflect Pfizer’s trajectory. The company is doubling down on oncology, where growth continues across both its full-year and Q1 results. In a bold strategic move, Pfizer recently entered a blockbuster $4+ billion deal to license a PD-1/VEGF bispecific antibody from China’s 3SBio. With a non-refundable upfront payment of $1.25 billion, the deal marks the largest-ever licensing payment for a Chinese-origin innovative drug, surpassing many biotech acquisitions. This transaction underscores Pfizer’s return to aggressive business development, and highlights the intensifying global race for bispecific antibodies, a space already prioritized by Roche, Johnson & Johnson, and BMS. Merck, too, is sharpening its oncology focus. Q1 sales reached $7.2 billion, driven mainly by Keytruda, though growth is slowing. Meanwhile, Gardasil saw a steep decline of over 40%, down to $1.3 billion, due to waning demand and high inventory in China. BMS posted $11.2 billion in revenue, a 6% dip, with U.S. sales particularly affected. As Revlimid and Pomalyst face patent cliffs, BMS is under pressure to find new growth drivers, especially as nearly two-thirds of its revenue is at risk from generic erosion. So far, the performance of newer products has fallen short of expectations.

引进/卖出

2025-06-02

·同写意

辉瑞“寻宝”：谁来填补250亿美元专利悬崖？

同写意年度巨献！！7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！近日辉瑞（Pfizer）与三生制药就PD-1/VEGF双抗达成60亿美元的合作，在医药界引发广泛关注，也揭开了辉瑞新一轮战略布局的序幕。然而，对于这家年营收超600亿美元的巨头而言，真正的挑战在于未来3年内高达250亿美元销售额的产品将面临专利到期，形成巨大的“专利悬崖”。这直接导致近80亿美元的营收缺口亟待填补。手握100-150亿美元并购预算的辉瑞，将如何精准出击，寻找能带来快速增长的“猎物”？本文将深入剖析辉瑞的家底、困境与管线，并对其潜在的并购或BD目标进行更细致的展望。TONACEA01辉瑞当前营收版图增长引擎与潜在危机并存2024年，辉瑞总营收达到636亿美元。其业务结构主要分为三大块：基础护理（Primary Care）、专科护理（Specialty Care）和肿瘤（Oncology）。基础护理部分占比47%，但近三年来，这一板块营收占比逐年下滑，与去年相比，同比下降2%。与此同时，专科护理和肿瘤业务却呈现出快速增长的态势，尤其是肿瘤业务，同比增长率高达25%，成为增长的强劲引擎。从具体销售额来看，基础护理业务中，心血管药物、COVID-19相关产品、偏头痛类药物占据主导。其中，心血管药物Eliquis以73亿美元的销售额位居榜首，紧随其后的是Prevnar疫苗系列、新冠药物Paxlovid和Comirnaty，分别实现销售额64亿、57亿和53亿美元。在专科护理业务中，罕见病药物Vyndaqel系列表现抢眼，销售额达54亿美元；自免老将Xeljanz贡献11亿美元。肿瘤业务方面，乳腺癌药物Ibrance以43亿美元的销售额位居第一，前列腺癌药物Xtandi销售额为20亿美元。从增长趋势来看，基础护理业务中，除Paxlovid外，大部分产品增速放缓，专科护理业务中Vyndaqel、Octagam和Cibinqo等少数产品处于高增长阶段，其余多数产品呈现负增长。而肿瘤业务增长趋势明显，收购Seagen带来的Padcev和Adcetris两款产品分别实现了2896%和1845%的同比增长，强力支撑了肿瘤业务的高速扩张。TONACEA02“专利悬崖”压顶80亿美元的巨大挑战辉瑞未来3年将面临8个重磅产品在美国、欧洲、日本的专利集中到期。这些产品的销售额在2024年总营收中占比高达40%，累计达250亿美元。与此同时，所有正增长的产品（排除未来三年面临专利悬崖的产品）在2024年的累计营收占比仅为27%，即173亿美元，这意味着辉瑞将面临近80亿美元的营收缺口，填补这一缺口成为当务之急。目前，辉瑞现有高增长的重点产品包括Padcev、Nurtec ODT/Vydura和Adcetris。Padcev于2021年获得FDA批准，预测峰值销售额为27亿至34亿美元，如今三年过去，销售额已达16亿美元，距离峰值仍有一定距离。Nurtec ODT/Vydura分别于2020年和2022年获得FDA和EMA批准，预测峰值销售额为20亿美元。Adcetris自上市以来，凭借其在淋巴瘤治疗领域的独特优势，也取得了不俗的市场表现，其销售额持续攀升，有望成为辉瑞在肿瘤治疗领域的又一重要支柱产品。尽管这些重点产品呈现出强劲的增长势头，但与辉瑞面临的80亿美元专利悬崖空缺相比，仍显得力不从心，难以在短期内完全填补这一巨大的市场缺口。因此，仅依靠现有产品和内生增长难以跨越专利悬崖，辉瑞必须通过M&A和BD来寻求突破。TONACEA03研发管线剖析肿瘤重兵集结，内科亟待加强辉瑞的研发投入主要集中在自免、内科、肿瘤和疫苗四大领域，其中肿瘤是核心中的核心，研发投入占比高达50.9%。肿瘤管线方面，辉瑞重点聚焦乳腺癌领域，核心策略是寻找Palbociclib的替代者，重点布局PROTAC技术、CDK2和CDK4抑制剂以及HER2抑制剂，力图覆盖HER2+、ER+/HER2-及HR+/HER2-等多种亚型乳腺癌。辉瑞在大分子药物方面重仓ADC，拥有近10个不同靶点，包括Integrin beta-6、Nectin-4、HER2、Tissue Factor、CD228、B7H4、PD-L1、CEACAM5、CD30以及Mesothelin，旨在通过ADC技术拓展至膀胱癌、尿路上皮癌、宫颈癌和非小细胞肺癌等多种癌种。自免管线方面，主要火力集中在特应性皮炎和溃疡性结肠炎这两个大适应症上，多数研发项目已进入中期阶段。老产品拓展适应症的情况较少（以Ritlecitinib为主），大部分为新分子实体。靶点选择较为多样，白介素（IL）家族靶点相对较多，另有6条管线的靶点尚未披露。内科领域方面，整体管线相对薄弱。主要聚焦于MASH、心衰和肥胖等疾病。在MASH领域，辉瑞选择的靶点PNPLA3、DGAT2和ACC较为冷门；在肥胖领域，选择了GIPR和GLP-1R作为靶点，但研发进度显著落后，目前仍处于1期临床阶段。疫苗领域，辉瑞的产品主要分为细菌感染和病毒感染两大类。在病毒感染疫苗方面，与BioNTech合作开发的COVID-19 mRNA疫苗占据主导，此外还包括流感病毒、RSV等疫苗。细菌感染疫苗则相对多样，涵盖链球菌和艰难梭菌等。整体来看，肿瘤管线虽然广泛，但显得有些零散，缺乏具有基石地位的产品，近期引进三生制药的PD-1/VEGF双抗有望成为后续的支柱产品。内科管线尤其薄弱，急需通过外部引进高质量资产来强化。TONACEA04辉瑞的“猎物清单”百亿美金将砸向何方？在2025年第一季度，辉瑞透露其拥有100亿至150亿美元的预算，旨在快速填补未来三年因专利悬崖带来的营收缺口。辉瑞强调，其未来的商务拓展（BD）和并购（M&A）策略将聚焦于“增长型资产”（revenue growth accretive assets），首要考虑临床差异化，其次关注商业价值。01肿瘤领域辉瑞新获得的PD-1/VEGF双抗，其未来价值很大程度上取决于与何种疗法联用。ADC是目前的热门联用方向。竞争对手中，BioNTech的思路是将PD-1/VEGF双抗与TROP2、HER2、B7H3、HER3等一众ADC（抗体药物偶联物）联用，以实现更优的治疗效果。默克暂未公布联用计划，但已在其管线中储备了B7H3 ADC、HER3 ADC、TROP2 ADC等多种ADC，为联合用药提供了多种选择。康方生物目前主要精力放在其双抗与PD-(L)1单抗的优效性试验上，ADC联用计划披露不多。从现有临床数据看，TROP2 ADC和Nectin-4 ADC与IO疗法联用展现出较好潜力。但是考虑到TROP2 ADC赛道已相对拥挤（已有2款获批上市），辉瑞短期内再次BD一款全新TROP2 ADC的可能性或许不高，除非该分子具有极强的差异化优势。因此辉瑞的策略可能是优先评估其PD-1/VEGF双抗与自身ADC管线（如HER2 ADC, Nectin-4 ADC, B7H4 ADC等）的联用潜力。02MASH领域MASH市场巨大且远未被满足，辉瑞在该领域布局薄弱，并购优质标的可迅速形成战斗力。Madrigal Pharmaceuticals：核心资产为Rezdiffra（Resmetirom），一种口服、肝脏靶向的THR-β选择性激动剂。已于2024年初获得FDA批准，用于治疗伴有中度至晚期肝纤维化（F2/F3期）的NASH成人患者，是美国FDA批准的首个专门针对NASH的药物。自2024年Q2上市以来，销售额已迅速达到3亿美元，超过17000名患者正在用药，并已覆盖70%的顶尖处方医生群体，显示出强劲的市场渗透能力。预计峰值销售额可达35亿美元。目前Rezdiffra正积极向MASH F4C扩展，其MAESTRO-NASH OUTCOMES研究已于去年10月完成患者入组，预计试验将进行2-3年，最快可能于2028年获批F4C适应症。今年EALS大会上公布的MAESTRO-NAFLD-1研究扩展队列数据显示，药物对肝硬度等指标有积极影响。Madrigal目前市值约60亿美元，完全在辉瑞的预算射程内。产品已上市且快速放量，并购后能迅速为辉瑞贡献营收，解燃眉之急。Akero Therapeutics：核心资产为Efruxifermin（EFX），一种Fc-FGF21融合蛋白，目前正在进行三项3期临床试验，评估其治疗MASH F2/F3期和MASH F4C患者的疗效。EFX在抗肝纤维化方面展现出目前MASH在研药物中的领先效果。在针对MASHF4C的SYMMETRY研究中，第96周数据显示，50mg EFX组有39%的患者实现纤维化改善≥1个阶段且MASH没有恶化，显著优于安慰剂组的15% （p<0.01）。在针对F2/F3期纤维化患者的HARMONY研究中，F3亚组数据显示，50mg EFX组有68%的患者实现纤维化改善≥1个阶段，而安慰剂组仅为14%。从试验进度来看，efruxifermin预计最早可在2028年获批上市。Akero Therapeutics目前市值约37亿美元，近期也有寻求被收购的传闻。可作为参照的是，GSK此前以首付款12亿美元、总价20亿美元的价格收购了波士顿制药的FGF21类似物Efimosfermin（预计最早2029年上市），显示了大型药企对FGF21靶点的认可。对辉瑞而言，Akero是具有高潜力的前瞻性布局。03肥胖领域尽管辉瑞自身肥胖管线进度滞后，但该市场潜力巨大，通过并购快速入局不失为一种策略。Viking Therapeutics：其核心资产为VK2735，一种GLP-1/GIP双重激动剂，同时开发皮下注射和口服两种剂型。皮下注射版：2期临床数据显示，治疗13周时可实现14.7%的平均体重降幅，且患者在停药后4周内大多能维持减重效果，提示其具有开发为每月一次维持用药的潜力。口服版：1期临床数据显示，100mg剂量治疗4周可减重8.3%（vs 安慰剂），同样在给药后4周内可保持减重效果。口服版VK2735展现出较好的胃肠道耐受性，因副作用导致的停药率较低。目前，Viking Therapeutics的市值约为30亿美元，处于相对合理的估值区间。对于辉瑞而言，收购Viking Therapeutics不仅可以快速填补其在肥胖治疗领域的管线空白，还能借助VK2735的市场潜力，进一步拓展其在代谢疾病领域的布局。— 结语 —面对迫在眉睫的专利悬崖和激烈的市场竞争，辉瑞的百亿美金将如何投出，不仅关乎短期业绩的修复，更将深刻影响其未来十年的发展轨迹。MASH领域的成熟或后期资产（如Madrigal、Akero）因其能较快贡献营收或填补管线空白，优先级可能更高。肿瘤领域，在已有PD-1/VEGF双抗的基础上，寻找能与之高效协同的ADC或其他创新疗法，也是重要方向。而潜力巨大的肥胖市场，则是辉瑞是否愿意进行高风险高回报战略性布局的考验。未来一两年内，辉瑞在资本市场的每一次出手都将备受瞩目。这场“寻宝”之旅，最终将为辉瑞带来怎样的未来？我们拭目以待。参考资料：各公司演示材料

并购抗体药物偶联物疫苗专利到期

2025-05-28

·E药经理人

辉瑞大跌，“一哥”市值腰斩，7家美国药企迎最差一季报！MNC全员焦虑

2025年Q1，没有一家制药巨头笑的出来，即便是增速可怕的礼来。撰文| 润屿如果说，2024年Q1，制药巨头的重心还在向内“开刀”，降本增效，到了2025年Q1，其最头疼的问题，除了化解产品“青黄不接”的尴尬局面外，还有如何抵御地缘政治、监管变化、潜在关税及多重外部压力带来的长远困扰。据外媒统计，一季度，营收位列顶尖阵营的25家制药巨头里，有7家收入同比下降，值得一提的是，7家公司全部来自美国。其中下滑最厉害的，晖致第一，辉瑞第二。25家制药巨头Q1营收增速表现来源：FiercePharma美国制药企业正面临多重外部焦虑。关税，或将抬升成本，压缩利润，致使供应链重构和产能转移。默沙东预计全年将因关税产生约2亿美元增量销售成本，直接影响毛利率；强生则预计，关税会使得公司在明年面临4亿美元的利润损失。美国医疗卫生系统人事大变动和大裁员，带来诸多不确定性，尤其是新一任美国卫生与公众服务部(HHS)部长罗伯特·F·肯尼迪的上任，引发卫生健康领域变革担忧，且已开始与一些MNC暗里“较劲”。美版“国谈”落锤，涉及辉瑞/BMS血液稀释剂Eliquis，默沙东糖尿病药 Januvia，强生抗炎药物Stelara等昔日畅销药物。但谈判价格还没等到2026年正式生效，有的销售表现已明显乏力。当然，近两月以来，特朗普出其不意，又行云流水、不拘一格的“新医改”、降药价动作，放在药企的头上，形同一把达摩克里斯之剑。再一个是巨头之间永不落幕的竞争，新一代肿瘤药之争，全球畅销药“药王”之争，价格战之争……稍微乐观的药企只有礼来，但也只是暂时。7家巨头，负增长25家企业中，7家营收一季度同比下降，受打击最大的是仿制药巨头晖致，下滑11%。其次是辉瑞（-8%）、欧加隆、BMS（-6%）、再生元（-4%）、默沙东（-2%）和吉利德（-0.3%）。辉瑞，又上演了戏剧性的一幕。2024年年报季，辉瑞重夺制药业务营收第一的位置，年度总收入达636.27亿美元。而今年Q1，其营收为137.15亿美元，排位降低至第四名，前三名为强生、罗氏和默沙东。本季度营收表现一受到抗病毒药物 Paxlovid 销售额骤降影响，二是Eliquis遭遇市场压力，由于“美国市场净价下降，包括IRA Medicare D 部分重新设计导致制造商折扣增加”，Eliquis在一季度销售表现不甚理想。当然，不能拿短暂性的成绩去重估辉瑞，这家公司正集中资源去布局肿瘤领域。事实上，从业务板块来看，无论是2024年年报，还是一季报，辉瑞肿瘤业务都得以增长。而在充实肿瘤药矩阵的方式上，辉瑞似乎又恢复了早期的“大手笔”并购、BD风格。近期，辉瑞引入三生制药PD-1/VEGF双抗一事引发广泛关注，该笔交易总金额超400亿人民币，首付款更是为不可退还和不可抵扣的12.5亿美元，直接刷新了中国创新药海外授权许可首付款金额，也促成了开年至今最大的一笔BD交易，看起来比收购一家Biotech公司还豪气。放大至行业视角，继罗氏、强生、BMS未来版图里，将双抗视为重头戏后，辉瑞此举，进一步释放了全球双抗大战的火力。同样聚焦资源与精力布局肿瘤领域的，更有现任肿瘤药霸主默沙东。今年Q1，仍旧是K药支撑起了默沙东的营收大盘，一季度销售额达72.05亿美元，增速仅为个位数，明显放缓。而在另一边，默沙东的另一明星单品——HPV疫苗佳达修（ Gardasil），销售额下降至13亿美元，同比降幅超40%，主要下是由于中国地区需求下降，库存居高不下。如何应对两大单品增长困境？从目前来看，默沙东正加大投入，聚焦ADC、多抗等肿瘤药的开发上。2024年，默沙东的III期在研产品数量较2021年翻倍，BD交易投入约400亿美元。另外，值得一提的是，今年一季度，BMS总收入达112亿美元，同比下降6%，其中美国市场收入下滑最为明显。昔日两款明星药物Revlimid（来那度胺）和Pomalyst（泊马度胺），收入均在下滑。作为今年专利悬崖风险敞口最大的制药巨头，有报告预计其64%的收入将受专利损失和仿制药冲击影响，然而现有新品商业化不及预期，需尽快找到潜力大单品。推荐阅读直击JPM丨罗氏年掷百亿美元并购；辉瑞All in减肥药；强生倾向小而美交易…MNC更新2025大计！特朗普出“杀”招降药价：今晚发布，立即下降30%至80%增长者焦虑再来看25家制药巨头的正增长情况，如果看环比，似乎只有第一三共和诺华实现了增长，而看同比情况，18家药企实现不同程度的增长，增幅最大的前五家，依次为礼来，第一三共，诺和诺德，诺华和赛诺菲。其中，诺和诺德、诺华和阿斯利康增速在10%以上，而且中国市场之于这三家企业的重要性都为之凸显。礼来，更是以45%的增幅，一骑绝尘。2024年Q1，礼来营收尚且不能冲击TOP10阵营，但今年Q1，其营收达127.29亿美元，成为全球第8大药企。而礼来一季度的增速，在同期直接竞对者诺和诺德的两倍以上。这已是礼来连续第八个季度实现 20%以上的季度增长，很大程度上归因于替尔泊肽。全球范围内，替尔泊肽两个版本加起来销售额已超61亿美元，其降糖版Mounjaro增速达113%，减重版Zepbound刚获FDA批准一年多，Q1销售额就高达23.12亿美元，年内有望与降糖版平分秋色。值得一提的是，替尔泊肽减重版和降糖版于2024年先后登陆了中国市场，尽管礼来未在Q1财报中单独披露替尔泊肽的中国区销售额，但其整体中国业务同比增长20%，创下三年来最高增速纪录。但礼来的野心没有局限于单一领域。昨日，礼来收购了一家名为SiteOne的公司，核心资产为一款Nav1.8抑制剂，属于非阿片类止痛药，同机制获批药物仅有福泰的Vixotrigine（去年上市）。收购金额不大，10亿美元。礼来扩充产品的方式与别家MNC不是一个风格，有人称其擅长用“小而精”的并购合作作风，以“小米式”的路数，对各疾病领域进行密不透风的包围，花小钱办大事，“围剿”诺和诺德的同时，力求做到肿瘤、神经等细分领域的后来者居上。而正被多方“围剿”的诺和诺德，正在苦思如何突破领先者困境。诺和诺德Q1全球营收达780.87亿丹麦克朗（约合112.45亿美元），按固定汇率计算（CER）同比增长18%，然而，这实际上是自2021年第四季度以来，公司的季度销售额增长首次低于20%。GLP-1类药物在其糖尿病和减重治疗领域仍有着强劲表现，司美格鲁肽更是取缔了K药，坐上了“药王”宝座。但长期秉持“专”和“精”风格的诺和诺德，其GLP-1产品带来的想象空间，似乎难以让投资者满意。过去一年来，受市场份额被礼来抢占、价格战、关键临床试验进展不利等影响，诺和诺德的股价近乎腰斩，至今市值跌至3100亿美元左右，仅礼来的1/2。近期，替尔泊肽头对头的研究结果出炉，在减重效果上，替尔泊肽超越了司美格鲁肽，这也打击了诺和诺德方的市场信心。受股价表现等因素影响，就在本月，诺和诺德宣布Lars Fruergaard Jørgensen辞去CEO一职。此外，诺和诺德在2025年Q1财报中将全年销售额增长预期从16%-24%下调至13%-21%，低于市场预期。整体来看，业绩增长者们要么在放大优势领域的突破，要么求各疾病领域的稳健发展，但都在主动变革，抢占先机，确保不掉队。参考链接：https://www.fiercepharma.com/pharma/except-juggernaut-eli-lilly-several-us-drugmakers-saw-revenue-declines-q1一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

财报核酸药物高管变更

100 项与奈玛特韦/利托那韦相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
新型冠状病毒感染	韩国	Pfizer Inc.	2021-12-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
新冠肺炎后遗症	临床2期	瑞典	Pfizer Inc.	2023-05-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ATS2025	N/A	ADH分泌不当综合征	-	Paxlovid	製衊製膚顧願鑰壓壓鑰(遞餘顧壓觸顧鹽憲鏇願) = known side effect of Paxlovid 獵繭壓鏇齋網餘鑰繭積 (願廠繭廠遞廠齋膚衊願 ) 更多	-	2025-05-16
NCT04960202 (phase 3 randomized trial, Pubmed \| Clin Infect Dis)	临床2/3期	新型冠状病毒感染	2,113	Nirmatrelvir/Ritonavir (NMV/R) 300 mg/100 mg	網獵鏇築夢獵網淵壓顧(繭餘廠網簾鏇膚遞醖夢) = 襯醖窪網網淵鏇夢夢獵憲膚窪獵襯鹹鑰蓋獵選 (鏇艱衊鹽網鑰夢選遞壓 ) 更多	积极	2024-11-11
				Placebo	網獵鏇築夢獵網淵壓顧(繭餘廠網簾鏇膚遞醖夢) = 蓋網夢醖願醖醖網選糧憲膚窪獵襯鹹鑰蓋獵選 (鏇艱衊鹽網鑰夢選遞壓 ) 更多
NCT05898672 (CTgov)	临床1期	新型冠状病毒感染	12	Rosuvastatin (Period 1: Rosuvastatin 10 mg)	鬱窪築觸夢網襯積構簾(鏇鏇鬱鏇製憲膚獵遞衊) = 構願製廠繭壓醖製顧鹹鹹壓膚蓋壓鏇餘範蓋選 (醖襯顧遞網觸衊鹽淵壓, 46) 更多	-	2024-10-28
				Rosuvastatin+Nirmatrelvir+Ritonavir (Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg)	鬱窪築觸夢網襯積構簾(鏇鏇鬱鏇製憲膚獵遞衊) = 餘鬱衊鑰構範鏇範製壓鹹壓膚蓋壓鏇餘範蓋選 (醖襯顧遞網觸衊鹽淵壓, 48) 更多
NCT05339334 (CTgov)	临床1期	-	14	PF-07321332+Ritonavir	襯鹹製壓鏇製蓋鏇鹹壓(觸繭壓鬱鬱網鏇範窪簾) = 夢繭夢願艱鹹選襯壓簾憲顧選製襯遞鑰艱顧衊 (遞憲鬱選鏇範蓋憲餘鹹, 29) 更多	-	2024-10-08
NCT05525910 (CTgov)	临床1期	-	15	Nirmatrelvir+Ritonavir (Nirmatrelvir/Ritonavir 300(2*150)/100 mg)	廠遞鏇夢觸淵餘製襯憲(構糧構積淵積鏇鏇獵構) = 衊構獵鹹選繭鹽鹽窪窪衊範鑰憲廠齋鹽齋範選 (網蓋壓憲積艱獵繭積廠, 36) 更多	-	2024-09-19
				Nirmatrelvir+Ritonavir (Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant)	廠遞鏇夢觸淵餘製襯憲(構糧構積淵積鏇鏇獵構) = 襯蓋襯艱積糧網鹹獵觸衊範鑰憲廠齋鹽齋範選 (網蓋壓憲積艱獵繭積廠, 28) 更多
ASCO2024 人工标引	N/A	新型冠状病毒感染	182	Nirmatrelvir/ritonavir	壓積壓蓋獵膚繭願鹽壓(鬱網艱製窪壓願願繭獵) = 餘醖衊廠窪壓範網艱淵獵壓廠範蓋構簾鏇夢築 (繭齋憲蓋齋壓窪構鹽鬱 ) 更多	积极	2024-05-24
NCT04962230 (CTgov)	临床1期	-	12	PF-07321332+Ritonavir (Period1: PF-07321332 300 mg/Ritonavir 100 mg)	淵築鏇膚鏇鬱鹽觸廠築(衊膚壓顧膚簾糧網蓋網) = 選鹽範簾範製築積選觸鹽齋衊壓鹹鑰憲衊鹹遞 (蓋餘鑰遞鬱繭鏇觸選膚, 33) 更多	-	2023-10-10
				PF-07321332+Carbamazepine+Ritonavir (Period2: Carbamazepine + PF-07321332 300 mg/Ritonavir 100 mg)	淵築鏇膚鏇鬱鹽觸廠築(衊膚壓顧膚簾糧網蓋網) = 膚憲夢憲選淵簾憲鹹構鹽齋衊壓鹹鑰憲衊鹹遞 (蓋餘鑰遞鬱繭鏇觸選膚, 43) 更多
NCT05129475 (CTgov)	临床1期	-	12	PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fed)	衊壓蓋積選範醖齋積簾(積獵選憲積範鑰獵鹽襯) = 齋範積範願觸構範憲蓋襯廠觸衊願遞膚膚鹹膚 (範餘襯壓網壓顧蓋廠窪, 31) 更多	-	2023-10-05
				PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fasted)	衊壓蓋積選範醖齋積簾(積獵選憲積範鑰獵鹽襯) = 醖鬱憲窪構遞遞鹹襯衊襯廠觸衊願遞膚膚鹹膚 (範餘襯壓網壓顧蓋廠窪, 35) 更多
NCT04909853 (CTgov)	临床1期	肾功能不全 \| 慢性肾病	35	PF-07321332+ritonavir (Part 1: Normal Renal Function)	範淵鑰鹽鑰網壓憲夢鏇(網簾鑰蓋壓醖鹽簾蓋鏇) = 膚顧膚淵構夢觸鬱齋壓選襯構鹹鹹顧構製壓鹹 (鏇鬱憲鹽衊鏇鏇顧醖齋, 31) 更多	-	2023-08-02
				PF-07321332+ritonavir (Part 1: Mild Renal Impairment)	範淵鑰鹽鑰網壓憲夢鏇(網簾鑰蓋壓醖鹽簾蓋鏇) = 鏇顧簾獵齋鏇繭鑰廠憲選襯構鹹鹹顧構製壓鹹 (鏇鬱憲鹽衊鏇鏇顧醖齋, 29) 更多
NCT04962022 (CTgov)	临床1期	新型冠状病毒感染	12	PF-07321332+Ritonavir (PF-07321332 (Suspension)/Ritonavir 300/100 mg BID, Fasted)	選範鑰糧鏇齋製鹹選網(窪醖製襯鹽糧鏇範醖簾) = 構夢獵窪鏇鑰夢獵衊獵餘衊繭夢鏇艱觸衊獵衊 (餘壓積醖鑰艱鹽鬱遞廠, 17) 更多	-	2023-07-13
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