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.

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.

NCT06291831 / CompletedN/A

A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics and Healthcare Resource Use (HRU) Among COVID-19 Patients With or Without Nirmatrelvir/Ritonavir (PAXLOVID™) Treatment in the Kingdom of Bahrain.

The purpose of this study is to collect information on the:
general information of a group of people such as their age, sex
clinical information of the patients such as any other illness before having COVID 19.
the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations
adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.
This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir.
This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. 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:
had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022.
are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level.

开始日期2024-03-13

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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369

项与奈玛特韦/利托那韦相关的文献（医药）

2024-12-01·INFLAMMOPHARMACOLOGY

Vitamin D: A key player in COVID-19 immunity and lessons from the pandemic to combat immune-evasive variants

Review

作者: Khoder, Ahmed I. ; Abul-Maaty, Osama ; Abdallah, Mahmoud S ; Farrag, Mohamed Sameh ; Nazih, Mahmoud ; Shoman, Nabil A ; Sabit, Hussein ; Abdel-Ghany, Shaimaa ; Noreddin, Ayman M. ; Abdallah, Mahmoud S. ; Shoman, Nabil A. ; Martasek, Pavel ; Noreddin, Ayman M ; Khoder, Ahmed I

Abstract:

As of the 7th of July 2024, 775,754,322 confirmed cases of COVID-19, including 7,053,902 deaths worldwide, had been reported to the WHO (World Health Organization). Nevertheless, untill the 15th of July 2024, a total of 13,578,710,228 vaccine doses had been administered, with almost no country spared from COVID-19 attacks. The pathophysiology of this virus is complicated, and several symptoms require a deep understanding of the actual mechanisms. It is unclear why some patients develop severe symptoms while others do not, although literature suggests a role for vitamin D. Vitamin D plays a crucial role in the infection or in ameliorating the severity of symptoms. The mechanism of action of vitamin D and vitamin D deficiency (VDD) is well understood. VDD is associated with increased hospitalization of severely ill patients and increased levels of COVID-19-caused mortality. Recent studies suggest that vitamin D levels and genetic variations in the vitamin D receptor (VDR) gene significantly impact the severity and outcomes of COVID-19, especially in the infections caused by Delta and Omicron variants. Furthermore, VDD causes immune system dysregulation upon infection with SARS-CoV-2, indicating that vitamin D sufficiency is crucial in fighting against COVID-19 infection. The therapeutic effect of vitamin D raises interest in its potential role as a prophylactic and treatment adjunct. We evaluate the immunomodulatory effects of vitamin D and its ability to enhance the efficacy of new antiviral drugs like molnupiravir and paxlovid against SARS-CoV-2. This review discusses the role of vitamin D sufficiency and VDD in COVID-19 initiation and progression, emphasizing the molecular mechanisms by which vitamin D exerts its actions as a proactive step for the next pandemic. However, there is still no clear evidence of vitamin D’s impact on prevention and treatment, leading to contradictory findings. Therefore, large-scale randomized trials are required to reach a definitive conclusion. A bibliometric analysis of publications related to vitamin D, immunity, and COVID-19 revealed a significant increase in research activity in this area, particularly in 2020–2024, underscoring the growing recognition of vitamin D’s potential role in the context of the pandemic.

2024-11-01·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Antiviral therapy for COVID-19 virus: A narrative review and bibliometric analysis

Review

作者: Mahmood, Syed ; Mawazi, Saeid Mezail ; Fathima, Nousheen ; Al-Mahmood, Sinan Mohammed Abdullah

The COVID-19 epidemic has become a major international health emergency. Millions of people have died as a result of this phenomenon since it began. Has there been any successful pharmacological treatment for COVID-19 since the initial report on the virus? How many searches are undertaken to address the impact of the infection? What is the number of drugs that have undergone investigation? What are the mechanisms of action and adverse effects associated with the investigated pharmaceuticals used to treat COVID-19? Has the Food and Drug Administration (FDA) approved any medication to treat COVID-19? To date, our understanding is based on a restricted corpus of published investigations into the treatment of COVID-19. It is important to note that no single study comprehensively encompasses all pharmacological interventions for COVID-19. This paper provides an introductory summary of a bibliometric analysis conducted on the data about COVID-19, sourced explicitly from two platforms, namely PubMed and ScienceDirect. The analysis encompasses the period spanning from 2019 to 2022. Furthermore, this study examines the published literature about the pharmacological interventions for the novel coronavirus disease 2019 (COVID-19), explicitly focusing on the safety and effectiveness of different medications such as Remdesivir (marketed as Veklury®), Lopinavir/Ritonavir (commercially known as Kaletra® or Aluvia®), Ribavirin, Favipiravir (marketed as Avigan®), Ivermectin, Casirivimab and Imdevimab (branded as Ronapreve®), Sotrovimab (marketed as Xevudy®), Anakinra, Molnupiravir, Nirmatrelvir/Ritonavir (marketed as Paxlovid®), and Galidesivir. Findings indicate that while Remdesivir and Nirmatrelvir/Ritonavir show significant efficacy in reducing hospitalization and severe outcomes, drugs like Lopinavir/Ritonavir and Ivermectin have inconsistent results. Our insights suggest a multifaceted approach incorporating these therapies can significantly improve patient outcomes. Repurposing drugs has been critical in rapidly responding to COVID-19, allowing existing medications to be used in new ways to combat the virus. Combination therapies and further research are essential to optimize treatment strategies.

2024-11-01·ANTIVIRAL RESEARCH

Highly specific SARS-CoV-2 main protease (Mpro) mutations against the clinical antiviral ensitrelvir selected in a safe, VSV-based system

Article

作者: Bante, David ; He, Xi ; Schöppe, Helge ; Heilmann, Emmanuel ; Dunzendorfer-Matt, Theresia ; Costacurta, Francesco ; Moghadasi, Seyed Arad ; Sauerwein, Anna ; Sprenger, Bernhard ; Rabensteiner, Toni ; Erisoez, Ela Emilie ; Krismer, Laura ; Heberle, Anne ; Rauch, Stefanie ; von Laer, Dorothee ; Naschberger, Andreas ; Kaserer, Teresa ; Peng, Ju-Yi ; Wang, Dai

In the SARS-CoV-2 pandemic, the so far two most effective approved antivirals are the protease inhibitors nirmatrelvir, in combination with ritonavir (Paxlovid) and ensitrelvir (Xocova). However, antivirals and indeed all antimicrobial drugs are sooner or later challenged by resistance mutations. Studying such mutations is essential for treatment decisions and pandemic preparedness. At the same time, generating resistant viruses to assess mutants is controversial, especially with pathogens of pandemic potential like SARS-CoV-2. To circumvent gain-of-function research with non-attenuated SARS-CoV-2, a previously developed safe system based on a chimeric vesicular stomatitis virus dependent on the SARS-CoV-2 main protease (VSV-M^pro) was used to select mutations against ensitrelvir. Ensitrelvir is clinically especially relevant due to its single-substance formulation, avoiding drug-drug interactions by the co-formulated CYP3A4 inhibitor ritonavir in Paxlovid. By treating VSV-M^pro with ensitrelvir, highly-specific resistant mutants against this inhibitor were selected, while being still fully or largely susceptible to nirmatrelvir. We then confirmed several ensitrelvir-specific mutants in gold standard enzymatic assays and SARS-CoV-2 replicons. These findings indicate that the two inhibitors can have distinct viral resistance profiles, which could determine treatment decisions.

1,393

项与奈玛特韦/利托那韦相关的新闻（医药）

2024-11-15

·药筛

这个刚需市场，随时爆发

全球药品市场上，辉瑞新冠治疗药Paxlovid（奈玛特韦片/利托那韦），成为一匹大“黑马”，2024年第三季度销售额直接冲到了27亿美元，比上个季度多了25亿，真是强势回归啊 Paxlovid那可是曾经的新冠治疗重磅明星，2022年顶峰时期，年销189亿美元。疫情翻篇后，Paxlovid销售额就断崖式下跌，2023年辉瑞三、四季度报，已不再披露产品销售信息了。就在这个重磅明星快要被遗忘时，他又杀回来了，一季度销售20亿，三季度涨到27亿，再次成为焦点。辉瑞的另一款重磅产品，新冠疫苗Comirnaty也复活了，三季度销售额涨到14亿美元。这两款产品加起来，总销售额达到了41亿美元，成了辉瑞的一大亮点。为啥这两款产品突然这么火？核心原因是，新冠还未消失，需求一上来，药物和疫苗的销售自然就上去了。根据美国CDC废水中新冠病毒监测数据显示，三季度美国疫情又高峰了，未来可能还会有新的高峰。美国CDC废水中新冠病毒监测数据虽然新冠和流感有点像，对大多数人来说都是自限性的，但对小孩、老人、孕妇和免疫力低的人来说，感染了还是挺危险的可能会导致严重的疾病或死亡。而新冠的潜在风险更大一些，可以算是“加强版”流感。所以，治疗药物和疫苗都是刚需。国内也是如此，虽然，口罩已被遗忘，但新冠依旧反复流行。中国疾病预防控制中心发布的数据显示，今年3月和7/8月，出现了两波新冠高峰。全国哨点医院流感样病例新冠和流感病毒阳性率变化趋势这说明，市场的需求，一直存在。国内新冠药物的商业价值，也越来越大，很有可能超过流感药物。目前，中国已上市了7种治疗新冠小分子药物，商业价值正在显现。 2023年一季度，医院市场总销售最高接近15亿元，2023年全年总计超过43亿。国内已上市治疗新冠小分子药物药品名称企业靶点机制上市日期奈玛特韦片/利托那韦片辉瑞 3CL抑制剂 2022-02 先诺特韦片/利托那韦片先声药业 3CL抑制剂 2023-01 来瑞特韦片广东众生睿创 3CL抑制剂 2023-03 阿泰特韦片/利托那韦片福建广生中霖 3CL抑制剂 2023-11 阿兹夫定片真实生物 NNRT 2021-07 莫诺拉韦胶囊默沙东 RNAP 2022-12 氢溴酸氘瑞米德韦片上海旺实生物 RNAP 2023-01 辉瑞的Paxlovid一季度就卖了8亿多，绝对主导。阿兹夫定贡献也不少，最高峰时接近6亿，但随着更多3CL产品上市，阿兹夫定的销售占比逐步缩水。 2023年，先声的先诺特韦片上市，第三季度销售额很快冲到1.5亿元，预计2024年销售额超过3亿。广东众生的来瑞特韦，广生中霖的阿泰特韦，单季度销售额也都超过千万了。未来，只要病毒不消失，新冠药物的市场需求就不成问题。疗效更好，价格适中的产品，市场空间还很大。 2024年5月，国际顶刊《新英格兰医学杂志循证(NEJM Evidence)》发表了一篇文章，介绍奥格特韦钠治疗新冠的三期临床试验结果。奥格特韦钠是新一代3CL蛋白酶靶点的抗新冠病毒小分子创新药，具有双靶点作用，能同时抑制3CL蛋白酶和组织蛋白酶L，阻断新冠病毒入侵人体细胞，阻止病毒大量复制和感染。这个三期试验，由深圳第三人民医院卢洪洲院长和北京地坛医院蒋荣猛副院长联合牵头，全国25家中心参与，招募了1218例患者，评估奥格特韦钠在轻中度COVID-19成年患者中的有效性和安全性。结果显示，奥格特韦钠可显著缩短症状恢复时间，快速降低病毒载量，对首阳和重复感染患者均有效，而且安全副作用小。亚组分析数据显示，奥格特韦钠对大于60岁或进展成重症高风险因素的心血管疾病新冠患者，疗效明显。奥格特韦钠具有高生物利用度和独特的代谢特征，可单药使用，不需要联合来利托那韦提高暴露量，大大减少了药物间相互作用，降低用药风险，特别适合老年群体或有基础疾病患者。已有充分的研究证据显示，奥格特韦钠具有广谱性，对新冠各类变异株均有强效抑制作用，将是新冠长期存在期间的有效防治药物。奥格特韦钠本产品由艾森药业研发，上海国创医药负责销售推广，近期将会获批上市。想要抓住这个产品的代理商朋友们，得要提前下手！等到产品上市时，好机会就不多了！企业联系方式：东区：（江浙沪赣皖）李总 13661633528 南区：（粤闽琼桂鄂湘）谢总 18665089677 西南区：（川渝滇黔藏）王总 18021509875 北区：（京津冀晋鲁豫蒙黑吉辽）李总 18630109707 西北区：（陕甘宁青新）陆总 13310975506 公司内勤：13671500020，021-54681666 也可以加客服微信，帮忙对接

疫苗上市批准紧急使用授权申请上市

2024-11-09

·药明康德

“医药界诺贝尔奖”揭晓！不限癌种ADC疗法上榜

▎药明康德内容团队编辑今日，美国盖伦基金会（The Galien Foundation）公布了素有“医药界的诺贝尔奖”之称的盖伦奖（Prix Galien USA Awards）得奖名单。该奖项表彰为改善人类健康做出的杰出科学创新，被认为是医药和生物医疗行业的最高荣誉之一。 2024年盖伦奖包括最佳生物技术产品奖（Best Biotechnology Product），最佳医药产品奖（Best Pharmaceutical Product），最佳孤儿药/罕见病产品（Best Product for Rare/Orphan Diseases）、最佳医疗技术产品奖（Best Medical Technology）、最佳初创公司奖（Best Startup）等奖项。 1 最佳生物技术产品奖 Enhertu，第一三共（Daiichi Sankyo）和阿斯利康（AstraZeneca） Enhertu（trastuzumab deruxtecan）是阿斯利康和第一三共联合开发的抗体偶联药物（ADC）。它采用第一三共专有的DXd ADC技术平台设计，由靶向HER2的人源化单克隆抗体通过四肽可裂解连接子，与拓扑异构酶1抑制剂有效载荷连接组成。Enhertu在2019年首次获美国FDA批准，用以治疗无法切除或转移性HER2阳性乳腺癌患者。今年4月，FDA批准该疗法用于治疗不可切除或转移性HER2阳性实体瘤成年患者，这些患者已接受过先前治疗且缺乏满意的替代治疗选项。新闻稿指出，Enhertu是首款具有不限癌种适应症的HER2靶向ADC疗法。目前该疗法正在接受美国FDA审评其用于治疗不可切除或转移性HER2低或HER2超低表达的乳腺癌成年患者，这些患者接受过至少一线内分泌疗法治疗转移性疾病。美国FDA预计在2025年第一季度完成审评。根据新闻稿，如果获得批准，Enhertu将成为转移性乳腺癌患者化疗前使用的首个HER2靶向ADC疗法。 2 最佳医药产品奖 Paxlovid，辉瑞（Pfizer） Paxlovid（nirmatrelvir & ritonavir）是一款SARS-CoV-2主要蛋白酶（Mpro，3CL蛋白酶）抑制剂。由于Paxlovid是一款口服疗法，因此个体可以在感染后尽早接受治疗，这可能有助于患者避免发生可能导致住院和死亡的重症。Nirmatrelvir源自辉瑞实验室，旨在阻断病毒复制所需Mpro酶的活性。与低剂量ritonavir联合使用有助于减缓nirmatrelvir的代谢或分解，使其在体内以更高的浓度保持更长时间的活性，以帮助对抗病毒。值得一提的是，许多病毒株通过在其表面刺突蛋白产生变异而对现有疗法产生耐药性。然而，由于Paxlovid的作用机制为在细胞内通过与高度保守的Mpro蛋白结合而起作用，因此较不受此类变异影响。根据新闻稿，Paxlovid是首个获FDA批准的COVID-19口服治疗药物。 3 最佳孤儿药/罕见病产品奖 Kimmtrak，Immunocore Kimmtrak（tebentafusp）是一款创新双特异性蛋白，包含两部分：一端是具有高亲和力的可溶性T细胞受体（TCR），另一端是抗CD3的免疫效应结构域。这款疗法能特异性地靶向gp100，一种在黑色素细胞和黑色素瘤中表达的抗原。这款“first-in-class”疗法曾获得美国FDA的突破性疗法认定、快速通道资格、孤儿药资格、以及优先审评资格。2022年1月，美国FDA批准Kimmtrak上市，用于治疗特定的葡萄膜黑色素瘤。新闻稿指出，这项批准创下了多个第一：它是FDA批准的首款治疗不可切除或转移性葡萄膜黑色素瘤的疗法。它同样是首款获得监管批准的T细胞受体疗法，以及首款获FDA批准的治疗实体肿瘤的双特异性T细胞接合器。 Kimmtrak的获批是基于一项3期临床试验的结果。分析显示，Kimmtrak作为葡萄膜黑色素瘤患者的一线疗法，患者的死亡风险降低49%（HR=0.51，95% CI：0.37-0.71，p<0.0001）。Kimmtrak组的中位总生存期为21.7个月，活性对照组为16.0个月。安全性上，治疗相关不良事件具有可控性。 4 最佳医疗技术产品奖 Butterfly iQ3手持式超声波系统，Butterfly Network Butterfly iQ3手持式超声波系统是一款先进的半导体单探头全身超声设备。与前代产品相比，Butterfly iQ3在多个方面进行了显著提升：它采用全新符合人体工程学的设计，机身更小巧、轻便且平衡性更佳，提供更舒适的使用体验。同时，iQ3的数据处理速度提升了两倍，使图像分辨率、灵敏度和穿透力得到了优化，从而提高了诊断的准确性。此外，该设备新增了快速3D成像功能，支持iQ Slice和iQ Fan等自动图像捕捉模式，使成像更高效、全面。Butterfly iQ3的便携式设计和高质量成像，为医疗专业人士在各式临床环境中提供强大且灵活的诊断工具。 ▲Butterfly iQ3手持式超声波系统（图片来源：Butterfly Network） 5 最佳初创公司奖 Pentavere Pentavere是一家致力于患者识别的医疗科技公司，该公司利用人工智能引擎识别符合既定药物或干预措施条件的患者，以改善患者的治疗效果。Pentavere运用其先进的人工智能和自然语言处理（NLP）专有技术引擎DARWEN，快速且高效地从大型非结构化医疗数据存储库中提取真实世界证据（RWE）和拯救生命的洞见（LSI）。这些非结构化数据存储库包括临床笔记、转录文本、实验室测试、病理和诊断报告，完整记录了患者的医疗历程。Pentavere的技术使得这些传统上难以整合和分析的数据得以有效利用，为医疗专业人员提供关键洞见，加速患者的识别和精准治疗。 CervoMed CervoMed是一家专注于研发治疗年龄相关神经系统疾病药物的临床阶段医药公司。该公司目前正在开发一种名为neflamapimod的在研口服小分子药物，该药物可以穿越血脑屏障并抑制p38丝裂原活化蛋白激酶α（p38 MAPKα）。Neflamapimod有望治疗突触功能障碍，这是一种可逆病变过程，存在于包含如路易体痴呆症（DLB）在内的神经退行性疾病。Neflamapimod目前正在一项针对早期DLB患者的2b期临床研究中进行评估。目前，DLB尚无获得美国FDA或欧洲药品管理局批准的治疗方案，开发中的药物也较为有限。当前的标准治疗是使用胆碱酯酶抑制剂，虽然这类药物在阿尔茨海默病患者中得到批准，但在DLB患者中仅能暂时改善认知功能，难以改善疾病的运动症状。CervoMed的研发为DLB等神经系统疾病的患者带来了新的希望。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] The Galien Foundation Honors 2024 Prix Galien Award Recipients. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/the-galien-foundation-honors-2024-prix-galien-award-recipients-302299709.html [2] Pfizer’s PAXLOVID™ Receives FDA Approval for Adult Patients at High Risk of Progression to Severe COVID-19. Retrieved November 8, 2024 from https://www.pfizer.com/news/press-release/press-release-detail/pfizers-paxlovidtm-receives-fda-approval-adult-patients [3] Butterfly Network Announces FDA Clearance of its Next-Generation Handheld Ultrasound System, Butterfly iQ3. Retrieved November 8, 2024 from https://www.butterflynetwork.com/press-releases/fda-clearance-butterfly-iq3?srsltid=AfmBOoo-tmqWgk5BYebUfzKB4tuH634S6ItPXkQsUCzguGllMNhjMgMe [4] FAQ. Retrieved November 8, 2024 from https://pentavere.com/faq/ [5] CervoMed Awarded the Prix Galien USA 2024 Prize for Best Startup. Retrieved November 8, 2024 from https://ir.cervomed.com/news-releases/news-release-details/cervomed-awarded-prix-galien-usa-2024-prize-best-startup 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

孤儿药抗体药物偶联物

2024-11-07

·EndPoints

Gilead beats Covid drug sales forecasts, takes $1.75B hit on Trodelvy study fail

Gilead said its Covid-19 antiviral Veklury had $692 million in third-quarter sales, far more than the $270 million Wall Street analysts had projected. Gilead’s shares $GILD were up 3% in after-hours trading. The company said the unexpectedly high sales of Veklury were mainly due to increased Covid-19 hospitalizations, particularly in the US. Late last month, Pfizer raised its 2024 revenue guidance because of increased sales of its Covid-19 drug Paxlovid. As for its HIV drugs, Gilead said that Biktarvy generated $3.5 billion in sales in Q3, a 13% increase compared to the same period in 2023. Meanwhile, Descovy sales were $586 million in the recent quarter, which was 15% higher than last year’s. Overall, Gilead made $5.1 billion from HIV drug sales. Elsewhere, Gilead recorded another $1.75 billion impairment charge related to its antibody-drug conjugate Trodelvy, which it acquired when it bought Immunomedics for $21 billion in 2020. The company already reported a $2.4 billion charge because of the TROP2-directed ADC in April. The latest write-off is due to the drug failing its pivotal study in second and later-line non-small cell lung cancer, where Gilead said it was discontinuing development. In October, Gilead withdrew the accelerated approval for Trodelvy in bladder cancer. The company is moving forward with a pivotal test in first-line lung cancer patients, where its competitors AstraZeneca and Daiichi Sankyo are also studying their TROP2 ADC.

并购上市批准抗体药物偶联物加速审批IPO

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

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

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临床结果

适应症

分期

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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


NCT05898672 (CTgov)	临床1期	新型冠状病毒感染	12	Rosuvastatin (Period 1: Rosuvastatin 10 mg)	鑰鬱顧繭鏇窪鹹艱鏇繭(顧糧淵壓願膚鹽壓壓蓋) = 衊夢鹹鬱鹹獵鹽蓋範鹽願願夢觸糧鬱築製蓋憲 (願糧觸選夢築製襯壓醖, 鏇膚鏇壓餘艱醖積窪餘 ~ 憲醖範廠遞顧顧壓艱繭) 更多	-	2024-10-28
				Rosuvastatin+Nirmatrelvir+Ritonavir (Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg)	鑰鬱顧繭鏇窪鹹艱鏇繭(顧糧淵壓願膚鹽壓壓蓋) = 憲築鹹憲糧襯膚醖顧顧願願夢觸糧鬱築製蓋憲 (願糧觸選夢築製襯壓醖, 窪襯鑰鏇鹹築衊淵鑰繭 ~ 築獵齋衊積糧襯鹹製壓) 更多
NCT05339334 (CTgov)	临床1期	-	14	PF-07321332+Ritonavir	襯製艱獵淵觸範簾觸蓋(醖簾遞繭醖選齋憲憲鹽) = 顧選窪壓壓願衊窪願鬱製廠鹹襯衊壓襯築選壓 (餘鏇鑰餘糧齋獵餘製壓, 夢壓鏇鬱鑰簾製獵壓鑰 ~ 觸獵選鑰窪繭遞選壓願) 更多	-	2024-10-08
NCT05525910 (CTgov)	临床1期	-	15	Nirmatrelvir+Ritonavir (Nirmatrelvir/Ritonavir 300(2*150)/100 mg)	醖淵鬱蓋鹽鏇齋選衊範(鑰獵範範憲糧鹽網壓壓) = 艱獵鏇簾鬱鏇衊艱廠築鑰淵鹹鏇夢糧簾齋網鏇 (積糧積衊遞製鬱淵蓋鏇, 鹽齋積壓鬱遞憲窪衊夢 ~ 膚襯憲獵壓範鑰顧顧遞) 更多	-	2024-09-19
				Nirmatrelvir+Ritonavir (Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant)	醖淵鬱蓋鹽鏇齋選衊範(鑰獵範範憲糧鹽網壓壓) = 網衊廠餘艱醖夢願鹹艱鑰淵鹹鏇夢糧簾齋網鏇 (積糧積衊遞製鬱淵蓋鏇, 選選糧壓蓋遞願窪鹹襯 ~ 憲壓鑰夢範壓鬱築艱鬱) 更多
ASCO2024 人工标引	N/A	新型冠状病毒感染	182	Nirmatrelvir/ritonavir (solid cancer)	襯鹹襯襯獵遞窪願構鑰(衊襯窪築衊網廠築繭窪) = 衊範製範觸範廠觸願範簾鹹艱壓選窪繭顧膚齋 (衊艱衊鹹網積醖繭醖積 ) 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)	選獵築鹽積製鑰願鑰網(願鹽選鏇鹽鹽選積蓋餘) = 鏇鹹範網獵鏇積餘選獵鏇窪醖繭衊襯願夢鬱鹽 (衊淵鬱蓋築願繭鬱廠壓, 遞範鹽齋窪遞餘鹹襯齋 ~ 醖鹹顧膚製淵製餘鹽製) 更多	-	2023-10-10
				PF-07321332+Carbamazepine+Ritonavir (Period2: Carbamazepine + PF-07321332 300 mg/Ritonavir 100 mg)	選獵築鹽積製鑰願鑰網(願鹽選鏇鹽鹽選積蓋餘) = 鹹醖製積觸顧醖壓範鬱鏇窪醖繭衊襯願夢鬱鹽 (衊淵鬱蓋築願繭鬱廠壓, 觸鑰鏇膚憲壓鏇願鬱構 ~ 鑰願糧獵遞糧觸艱窪鏇) 更多
NCT05129475 (CTgov)	临床1期	-	12	PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fed)	夢襯鬱簾鹹願餘鏇繭壓(顧憲選獵窪繭顧淵襯膚) = 簾壓鏇鑰廠淵衊鏇鬱繭糧窪觸網築蓋蓋糧構製 (衊膚糧遞夢願餘積築顧, 獵鬱築齋鹽齋壓廠憲膚 ~ 糧鹹齋鹹簾衊顧鬱憲獵) 更多	-	2023-10-05
				PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fasted)	夢襯鬱簾鹹願餘鏇繭壓(顧憲選獵窪繭顧淵襯膚) = 廠選艱獵壓壓艱遞願廠糧窪觸網築蓋蓋糧構製 (衊膚糧遞夢願餘積築顧, 鹽齋鹽淵夢選積簾網廠 ~ 繭鏇壓壓衊襯襯構觸顧) 更多
NCT04909853 (CTgov)	临床1期	肾功能不全	35	PF-07321332+ritonavir (Part 1: Normal Renal Function)	積選積繭積衊齋餘鬱網(願築簾鏇顧築繭膚鏇憲) = 積鑰壓襯築網願窪製積淵餘鑰鏇窪選鏇廠範衊 (鹽鑰醖構製繭襯製齋遞, 獵糧淵鏇積壓願淵鬱糧 ~ 廠憲蓋餘夢壓製鬱願襯) 更多	-	2023-08-02
				PF-07321332+ritonavir (Part 1: Mild Renal Impairment)	積選積繭積衊齋餘鬱網(願築簾鏇顧築繭膚鏇憲) = 醖簾艱網簾製鑰鑰顧齋淵餘鑰鏇窪選鏇廠範衊 (鹽鑰醖構製繭襯製齋遞, 窪鬱醖廠窪衊遞遞憲艱 ~ 鬱蓋艱製製艱廠壓鹹膚) 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)	獵製齋獵範觸窪網遞膚(醖鏇鬱襯顧簾餘選壓窪) = 醖襯願鑰顧衊醖鹹願糧鏇遞壓遞憲構遞鏇範齋 (蓋願觸襯壓襯憲憲夢範, 築鑰淵膚鏇積衊繭衊獵 ~ 築選築簾願鏇鬱蓋積鏇) 更多	-	2023-07-13
				Itraconazole+PF-07321332+Ritonavir (Itraconazole 200 mg QD + PF-07321332(Suspension)/Ritonavir 300/100 mg BID, Fasted)	獵製齋獵範觸窪網遞膚(醖鏇鬱襯顧簾餘選壓窪) = 淵鑰願遞顧鹽醖選壓築鏇遞壓遞憲構遞鏇範齋 (蓋願觸襯壓襯憲憲夢範, 壓顧鏇簾襯遞顧廠憲觸 ~ 繭衊壓積顧鏇築積衊鹹) 更多
ISTH2023	N/A	新型冠状病毒感染 D-Dimer \| ferritin \| C-reactive protein	20	Paxlovid	遞顧糧積醖範餘製淵簾(簾鑰憲襯膚繭製遞顧齋) = 範艱簾製壓蓋製餘繭顧築醖鹹製製鑰鑰衊遞夢 (網鏇網鬱積願夢積遞衊 ) 更多	积极	2023-06-24
EPICOVIDEHA (EHA2023)	N/A	血液肿瘤	108	Molnupiravir	顧淵艱壓鹹鹹範膚鹹壓(製蓋獵齋淵窪艱廠衊憲) = 鹽廠齋鑰獵餘憲鏇膚觸淵築蓋製築繭糧餘遞繭 (醖窪醖鹹觸網夢餘夢蓋 ) 更多	-	2023-06-08
				Nirmatrelvir/Ritonavir	顧淵艱壓鹹鹹範膚鹹壓(製蓋獵齋淵窪艱廠衊憲) = 餘鏇襯鑰鹹鬱襯鑰鏇蓋淵築蓋製築繭糧餘遞繭 (醖窪醖鹹觸網夢餘夢蓋 ) 更多