富马酸丙酚替诺福韦(Tenofovir Alafenamide Fumarate) - 药物靶点：RT_在研适应症：病毒感染，慢性乙型肝炎，肝病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

TAF、tenofovir alafenamide、Tenofovir alafenamide fumarate (USAN/JAN)

+ [9]

靶点

RT

作用方式

抑制剂

作用机制

RT抑制剂(逆转录酶抑制剂)

治疗领域

感染消化系统疾病免疫系统疾病+ [1]

在研适应症

病毒感染慢性乙型肝炎肝病+ [1]

非在研适应症

获得性免疫缺陷综合征慢性肾病疲劳+ [2]

原研机构

Gilead Sciences, Inc.

在研机构

Gilead Sciences, Inc.Gilead Sciences Ireland UCGilead Sciences Pty Ltd.

+ [1]

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2016-11-10),

慢性乙型肝炎肝病

最高研发阶段(中国)批准上市

特殊审评特殊审批 (中国)

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结构/序列

分子式C25H33N6O9P

InChIKeyMEJAFWXKUKMUIR-FHPNUNMMSA-N

CAS号1392275-56-7

关联

275

项与富马酸丙酚替诺福韦相关的临床试验

NCT05652478

/ Recruiting临床2期IIT

A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers

Background:
People with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.
Objective:
To see how a common INSTI, dolutegravir (DTG), affects how the body uses energy. DTG will be compared with a non-INSTI drug, tenofovir alafenamide (TAF).
Eligibility:
Healthy people aged 18 to 55.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.
Participants will have 2 inpatient stays at the clinic. Each stay will be for 11 nights, with a 3-week break between.
Both DTG and TAF are gel caps swallowed once per day by mouth. Participants will take 1 drug for 8 days during each stay.
Participants will have tests to see how their body uses energy:
They will spend 23 continuous hours in a special room that measures how much oxygen they breathe in and how much carbon dioxide they breathe out. They will do this a total of 6 times.
They will have a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density.
They will lie on a table. Electrodes will be placed on their hands and feet to measure body fat and lean body mass.
They will stand still on a platform for about 30 seconds. High-resolution laser cameras will scan their bodies.

开始日期2025-06-03

申办/合作机构

National Institute of Allergy & Infectious Diseases

ChiCTR2500101438

/ SuspendedN/AIIT

The Plasma Concentration of Bictegravir/Emtricitabine/Tenofovir Alafenamide and Influencing Factors in PLWH with low-level viremia in Sichuan: A Prospective Observational Study

开始日期2025-05-10

申办/合作机构-

ChiCTR2500101733

/ SuspendedN/AIIT

A Multicenter, Prospective, Open-label, Non-inferiority Randomized Controlled Study on the Efficacy of Tenofovir Alafenamide Fumarate vs. Tenofovir Disoproxil Fumarate in Preventing Mother-to-Child Transmission of Hepatitis B Virus in Pregnant Women with High Viral Loads

开始日期2025-05-01

申办/合作机构

广州医科大学附属市八医院（广州市第八人民医院、广州市肝病医院、广州市传染病研究所）

100 项与富马酸丙酚替诺福韦相关的临床结果

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100 项与富马酸丙酚替诺福韦相关的转化医学

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100 项与富马酸丙酚替诺福韦相关的专利（医药）

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2,036

项与富马酸丙酚替诺福韦相关的文献（医药）

2025-12-31·HIV Research & Clinical Practice

Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start

Article

作者: Boffito, Marta ; Henderson, Merle ; Whitlock, Gary ; Khawaja, Akif A. ; Taylor, Graham P. ; Fidler, Sarah ; Soler-Carracedo, Alfredo ; Emerson, Michael

INTRODUCTION:

The BIC-T&T study aimed to determine the efficacy of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF) at suppressing viral load in a two-arm, open-label, multi-centre, randomised trial under a UK test-and-treat setting. This sub-study aimed to evaluate potential off-target cardiovascular impact by examining ex vivo platelet function.

METHODS:

Platelets were isolated by centrifugation of citrated blood from participants attending Chelsea and Westminster Hospital or St Mary's Hospital at Week 48 following enrolment. Platelet activation was assessed by real-time flow cytometry to examine integrin activation and granule release and platelet aggregation was evaluated by light transmission aggregometry. Statistical significance was determined by 2-way ANOVA with a Šidák's multiple comparisons post-test.

RESULTS:

An analysis of 21 participants was performed at Week 48 (96% male and 48% white; mean (range) age was 37 (23-78) years). No difference between arms was observed in ADP-, collagen- or thrombin receptor activator for peptide (TRAP)-6-evoked platelet α_IIbβ₃ integrin activation, granule release or platelet aggregation in response to any of the agonists tested. Despite differences in the demographics between treatment arms, the presence of an unboosted integrase inhibitor or boosted protease inhibitor in a test-and-treat setting did not impact platelet function.

CONCLUSIONS:

Our study provides no evidence of differences in downstream platelet responses between participants taking BIC/F/TAF compared to DRV/c/F/TAF following 48 wk of treatment. Further data are required to explore whether there are biologically significant off-target effects, including effects on platelets and other components of the cardiovascular system between these two test-and-treat regimens.

CLINICAL TRIAL NUMBER:

NCT04653194.

2025-12-31·HIV Research & Clinical Practice

Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort

Article

作者: Uriel, Alison ; Robineau, Olivier ; Watanabe, Dai ; Choy, Chiaw Yee ; Mallolas, Josep ; Marchetti, Giulia ; Thorpe, David ; Yang, Chia-Jui ; Vogelmann, Roger ; Berrevoets, Marvin ; D’Amato, Lisa ; Heinzkill, Marion ; Ramroth, Johanna ; Trottier, Benoit ; De Barra, Eoghan ; Marongiu, Andrea ; Elbirt, Daniel ; Lee, Sun Hee ; Gündüz, Alper

BACKGROUND:

BICtegravir Single Tablet Regimen (BICSTaR) is an observational cohort study evaluating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV.

OBJECTIVE:

To present final pooled 24-month outcomes for the full cohort.

METHODS:

Prospective data were pooled from TN and TE adults with HIV initiating B/F/TAF in routine clinical practice across 14 countries (data collection: 25/06/2018-29/12/2023). Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), persistence, and safety. Outcomes were also analysed in key populations.

RESULTS:

Of 2,074 (483 TN, 1,591 TE) participants included, most were male (85%), White (70%), and had ≥1 comorbidity (66%). Median (Q1, Q3) age was 45 (35, 54) years. At 24 months, 94% of TN and 96% of TE participants had HIV-1 RNA <50 copies/mL (missing = excluded analysis). These values were 88% and 86%, respectively, in a discontinuation = failure analysis. Effectiveness remained high across all key populations at 24 months. Median (Q1, Q3) CD4 count increased by 257 (127, 447) cells/µL in TN and 40 (-70, 153) cells/µL in TE participants (both p < 0.001). There was no reported treatment-emergent resistance to B/F/TAF. Persistence was high at 24 months (TN, 95%; TE, 91%). Drug-related adverse events occurred in 11% of TN and 12% of TE participants, leading to B/F/TAF discontinuation in 5%.

CONCLUSIONS:

B/F/TAF was generally well tolerated over 24 months, with high effectiveness and persistence observed among a broad range of people with HIV.

2025-10-01·TISSUE & CELL

Tetracera asiatica ﬂavonoids attenuate alcohol-induced liver injury by suppressing oxidative stress and inflammation mediated by the Keap-1/Nrf2/HO-1, NF-κB/MAPK and PERK/Nrf2 signaling pathways in alcoholic liver injury rats

Article

作者: Da, Fang-Fang ; Meng, Yao-Ting ; Chen, Yu-Feng ; Dai, Zhong-Hua ; Yuan, Zi-Wan ; Liu, Ying

Alcoholic liver disease is regarded as a leading reason for liver cirrhosis. This study aimed to investigate the protective effect of tetracera asiatica ﬂavonoids (TAF) on alcoholic liver injury (ALI) and explore the associated mechanisms. An ALI rat model was established and then divided into four groups, including ALI group, low-dose TAF (l-TAF) group, medium-dose TAF (m-TAF) group, and high-dose TAF (h-TAF) group. Levels of ALT, AST, ALB, SOD, MDA, NO, CAT, TG, TNF-α, IL-1β, Nrf2, Keap1, HO-1, NQO-1, and GSH-Px were measured in ALI rats in different groups. Pathological changes and inflammatory infiltration were examined using HE staining. Western blot was used to detect expressions of Nrf2, MAPK p38, PERK, NF-κB, ERK1/2 and anti-JNK1/2/3. The results showed that TAF protected against alcoholic liver injury in ALI rats by decreasing ALT and AST levels and inhibiting inflammatory response. TAF significantly reversed alcohol-induced increase in NO (P < 0.05), and remarkably decreased levels of TNF-α (P < 0.001) and IL-1β (P < 0.01), compared with the ALI group. TAF significantly increased the transcription of Nrf2, Keap1, HO-1, NQO-1 and GSH-Px gene (all P < 0.05) and inhibited the alcohol-induced upregulation of MAPK p38 expression (P < 0.001), p-NF-κB/NF-κB ratio (P < 0.001), p-ERK/1/2/ERK1/2 ratio (P < 0.05), and p-JNK1/2/3/JNK1/2/2 ratio (P < 0.05), compared with the ALI group (all P < 0.001). TAF obviously reversed effects of ALI modeling, and remarkably downregulated the expression of PERK and upregulated Nrf2 (all P < 0.001) compared with the ALI rats. In conclusion, TAF attenuates alcohol-induced livery injury through suppressing Keap-1/Nrf2/HO-1, NF-κB/MAPK and PERK/Nrf2 signaling pathways mediated oxidative stress and inflammation in ALI rats.

527

项与富马酸丙酚替诺福韦相关的新闻（医药）

2025-05-27

·摩熵医药

全球抗HIV药物市场动态：吉利德与GSK的市场份额与未来趋势

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近年来，艾滋病的治疗取得了显著进展，尤其是在抗HIV药物的研发方面。吉利德和GSK是艾滋病药物领域的主要玩家。吉利德作为行业的先行者，其必妥维（Biktarvy）等新一代药物，凭借高效的病毒抑制率和优越的患者依从性，迅速成为全球抗艾滋病药物市场的领军者。GSK也在不断推出多款有竞争力的产品，如多伟托和绥美凯等。此外，随着新药的推出和老款药物的逐步淘汰，抗HIV药物市场正在发生剧变。本文节选自摩熵咨询发布的《抗HIV药物——市场研究专题报告》，分析了吉利德和GSK在抗HIV药物领域的市场表现与发展趋势，探讨了创新药物的市场前景与挑战。 01吉利德抗HIV药物市场格局分析（1）深耕艾滋病治疗领域，多款重磅药物持续引领创新2001年，吉利德公司首个抗艾滋病药物 Viread（替诺福韦酯）获FDA批准上市；2003年，收购Triangle公司获得其核心产品 Emtricitabine（恩曲他滨），该产品为公司第二款抗HIV药物；吉利德后续推出一系列每日一片的组合疗法，包括首个每日一片的二联疗法 Truvada（替诺福韦酯/恩曲他滨），首个每日一片的三联疗法 Atripla（恩曲他滨/依法韦伦/替诺福韦酯）等。图片来源：摩熵咨询《抗HIV药物——市场研究专题报告》目前公司新一代HIV药物为必妥维，相比于前代药物，必妥维具有良好的HIV抑制率、良好的依从性和耐受性以及高耐药屏障。公司每半年注射一次的长效HIV疗法Lenacapavir在女性中的HIV预防用途上已显示出100%的有效性，公司未来将持续在艾滋病治疗领域引领创新。（2）新一代抗HIV药物必妥维，或成为国内首个年销售超十亿抗艾单品必妥维作为吉利德研发的新一代抗HIV药物，其病毒学抑制率高达99.8%，患者治疗期间没有发生病毒学耐药，也没有患者因肾脏、骨骼或肝脏不良事件而停药。是目前体积最小、质量最轻的单片复方制剂。根据摩熵医药销售数据库统计，2023年必妥维全球销售额为118亿美元，位列全球药品销售额第五名，该产品也占据美国艾滋病市场49%的份额。国内销售方面，自2022年纳入医保后，必妥维销售额增长迅速，2022年达4.7亿元，2023年达9.6亿元，有望成为国内首个年销售额超10亿元的抗HIV药物。数据来源：摩熵医药销售数据库其另一款产品达可挥，于2018年获批上市，用于治疗成人艾滋病毒感染及作为艾滋病毒暴露前预防。根据摩熵医药销售数据库，达可挥上市后的峰值销售额约1600万元，销售表现远不及核心产品必妥维。数据来源：摩熵医药销售数据库（3）必妥维各级医院市场分析（以哈尔滨市为例）据摩熵医药药物流向数据显示，以哈尔滨市为例，必妥维2023年各季度销售量和销售额如下图，可以看出其销售额呈现季节性变化特征，2023Q2与2023Q4为销售高峰期。数据来源：摩熵医药药物流向数据库必妥维2023年各医院（哈尔滨市为例）销售额分布如下图，可以看出，哈尔滨市第六医院的销售额达200万元，占全年总销售额的50%以上。数据来源：摩熵医药药物流向数据库必妥维2023年销售市场分布在二、三级医院，一、二季度销售市场以三级医院为主，三、四季度销售市场以二级医院为主。数据来源：摩熵医药药物流向数据库（4）受产品迭代影响，捷扶康、舒发泰等部分旧抗HIV药物销售下滑明显捷扶康于2018年获批上市，主要成分包括丙酚替诺福韦、恩曲他滨、考比司他和艾维雷韦。捷扶康在2020年纳入医保后销售额增长显著，2020年销售额约1.5亿元，2021年达到销售峰值4.4亿元，自2022年起销售出现下滑趋势，2023年销售额仅1.3亿元。数据来源：摩熵医药销售数据库随着必妥维、达可挥等抗HIV新药不断推出，公司部分旧抗HIV药物如舒发泰销售额出现明显的下滑趋势，旧产品市场需求不断减少。02GSK抗HIV药物市场格局分析（1）开发首款艾滋病药物齐多夫定，现有核心抗HIV药物超过7款GSK在艾滋病治疗领域占据行业第二的位置。1987年，GSK开发出全球首个艾滋病药物齐多夫定，目前旗下已上市核心HIV产品数量超过7款，包括卡替拉韦/Cabotegravir、多伟托/Dovato、特威凯/Tivicay、绥美凯/Triumeq、 Cabenuva等药物。多伟托由固定剂量的多替拉韦和拉米夫定组成，是一种每日一次、单一片剂的HIV治疗药物。根据摩熵医药数据库，多伟托自2021年在我国获批上市后，2021-2023年全国销售额分别为0.03、0.9、2.6亿元，呈现明显的销售增长趋势，未来有望持续扩大国内HIV药物市场份额。（2）老款抗HIV产品销售持续下滑，超/长效产品是未来重要规划绥美凯/Triumeq主要成分包括多替拉韦、阿巴卡韦和拉米夫定，于2014年获得美国FDA批准上市，适用于治疗感染HIV的成人和12岁以上的青少年；在中国，绥美凯于2017年正式上市，为中国内地首个完整单片复方的HIV治疗药物。据摩熵医药销售数据库数据显示，绥美凯、特威凯等老款产品销售额总体保持下降趋势。未来，公司将重点开发超/长效HIV产品，包括四月给药一次/长效产品、六月给药一次/超长效产品，卡替拉韦也将取代多替拉韦成为HIV治疗的基础药物。小结随着新一代抗HIV药物的不断推出，艾滋病治疗领域呈现出更加积极的发展势头。吉利德和GSK的创新药物为患者提供了更为有效、耐受性更好的治疗选择，提升了治疗的效果和患者的生活质量。同时，随着产品迭代和市场竞争的加剧，传统药物的市场份额逐步被新药所替代，未来几年的抗HIV药物市场将更加依赖于超长效和个性化治疗产品的创新。对于制药企业而言，如何在不断变化的市场中占据优势，将是决定未来成败的关键。END本文为原创文章，转载请留言获取授权抗HIV药物——市场研究专题报告下期内容预告目录一、抗HIV国产药物崛起：前沿生物、艾迪药业布局，艾博韦泰销售破亿近期将持续更新，敬请期待近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准并购

2025-05-23

·药时空

斥资1000万美元！吉利德获2款治疗性疫苗所有权

5月22日，据行业知名媒体Fierce Biotech报道，吉利德支付1000万美元以获得与Hookipa Pharma公司长期合作开发的针对乙型肝炎（HBV）和艾滋病毒（HIV）的沙粒病毒免疫疗法的全部所有权。Hookipa Pharma成立于2011年，总部位于纽约和维也纳，是一家专注于开发免疫疗法的生物技术公司。公司自主研发的沙粒病毒平台，通过“重新编程”免疫系统，帮助人体识别并清除病毒或肿瘤细胞，应用领域涵盖传染病与肿瘤治疗。图1：Hookipa Pharma的在研管线本次交易涉及的两款治疗性疫苗分别为：1、HB-400一种针对慢性HBV的沙粒病毒治疗性疫苗。GS-2829 + GS-6779是两种基于病毒载体的疫苗成分，是基于Hookipa的非复制性沙粒病毒载体（arenavirus vector）疫苗接种技术平台开发，分别使用了淋巴细胞性脉络丛脑膜炎病毒（LCMV）和水疱性口炎病毒（VSV）载体。这些载体经过改造，能够表达HBV抗原，从而激活宿主的免疫反应。图2：HB-400早在2023年，Hookipa便启动了HB-400的1a/1b期试验。在荷兰阿姆斯特丹举办的2025年欧洲肝病年会（EASL2025）上，研究人员公布了GS-2829 + GS-6779这两款治疗性疫苗正在进行的旨在评估药物安全性、耐受性和免疫原性的1a期研究（NCT05770895）结果。结果显示，单次和交替的病毒载体给药均安全且耐受良好。疫苗引发的免疫反应与剂量相关；在几名参与者（C8）中，第5和第6剂的增加进一步提高了T细胞反应的幅度。参与者对所有疫苗编码的HBV抗原产生了HBV特异性T细胞且伴随持续高幅度的抗HBsAg。2、HB-500一种针对HIV的沙粒病毒治疗性疫苗。该疫苗利用基于沙粒病毒Pichinde病毒和淋巴细胞性脑膜炎病毒的两个复制载体。这些载体递送来自HIV-1蛋白免疫原区域的HIV抗原，这些区域在HIV-1 B型变体中高度保守。免疫原之间的氨基酸序列不同，允许覆盖超过80%的循环HIV-1病毒变体。2025年1月，Hookipa宣布完成其评估HB-500治疗HIV的Ib期临床试验的招募。该试验涉及30名参与者，预计将在2025年下半年完成主要终点。根据近日签署的交易协议，将涉及Hookipa逐步结束HB-500的1期研究，而不是由吉利德接手推进。吉利德与Hookipa的合作关系可以追溯到2018年，当时该公司首次授权使用沙粒病毒免疫技术对抗HBV和HIV。2021年，吉利德决定不将由此产生的HIV免疫疗法推进到临床阶段，但在2022年重新考虑后更新了合作。当时，吉利德支付了1500万美元的预付款以及500万美元的股权投资。该原始协议的条款包括吉利德可能支付1000万美元的项目完成费，并附带另外1.625亿美元的开发里程碑付款以及高达6500万美元的商业化里程碑付款。现在，吉利德决定将这2款候选疫苗完全掌控在自己手中。根据5月22日提交给美国证券交易委员会的一份文件，吉利德将为此总共支付1000万美元，其中300万美元将在交易结束时支付，剩余的700万美元将分三阶段支付，对应技术转移计划的推进步骤。去年，吉利德在艾滋病病毒相关产品中的销售额总计达到196亿美元，其中以抗逆转录病毒药物必妥维（Biktarvy）和抗病毒药物德斯科维（Descovy）为主力产品。虽然该公司尚未将治疗性疫苗推向市场，但随着公司准备将其已获批的HIV长效预防用药Lenacapavir投入暴露前预防（PrEP）市场，这种情况似乎将在未来几周内发生变化。在HBV方面，吉利德已经在销售抗病毒药物Vemlidy，而HB-400治疗性疫苗或将为公司在该领域上再次加码，提供替代产品。今年到目前为止，Vir Biotechnology和GSK都放弃了针对该病毒的拟议“功能性治疗方法”，尽管GSK仍在开发另一种药物。值得注意的是，最近几个月，Hookipa接连传出坏消息：2月取消了与Poolbeg Pharma的合并计划，此前其还经历了艰难的2024年，其中包括在罗氏退出其KRAS突变癌症HB-700项目的合作后进行裁员30%。在这种情况下，吉利德选择购买HB-400和HB-500的所有权，可见其对于Hookipa的这两款治疗性疫苗项目的看好。参考资料：[1]Gilead pays partner Hookipa $10M to take over HBV, HIV therapeutic vaccine programs.By James Waldron.May 22, 2025 10:10am.[2]吉利德、Hookipa Pharma官网.[3]功能性治愈慢乙肝的曙光| 吉利德慢乙肝治疗性疫苗 (GS-2829 + GS-6779)正在开展临床1期试验研究. 药研途. 2025年04月25日.[4]EASL2025：Gilead治疗性乙肝疫苗GS-2829/GS-6779首次人体临床数据公布. 肝脏时间. 2025年05月19日.[5]一波不太引人注目的新型生物技术公司，计划2025年攻克HIV. 文刀有先后HIV最新动态. 2025年04月17日.识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

免疫疗法疫苗临床1期引进/卖出临床2期

2025-05-22

·FierceBiotech

Gilead pays partner Hookipa $10M to take over HBV, HIV therapeutic vaccine programs

Gilead Sciences will pay $3 million at the close of a deal with Hookipa Pharma and the remaining $7 million across a three-stage transfer plan.\n Gilead Sciences is paying $10 million for sole ownership of arenavirus immunotherapies for hepatitis B (HBV) and HIV resulting from the company’s long-running collaboration with Hookipa Pharma.The partners launched a phase 1a/1b trial of HB-400, an arenaviral therapeutic vaccine for chronic HBV back in 2023, while the biotech’s early-stage trial of HB-500, an arenaviral therapeutic vaccine for HIV, is ongoing.Now, Gilead has decided to take full control of the candidates. The pharma will pay $10 million in total for the programs, with $3 million due at the deal’s close and the remaining $7 million spread across a three-stage transfer plan, according to a May 22 Securities and Exchange Commission filing.The deal, which was signed yesterday, will involve Hookipa winding down the phase 1 study of HB-500 rather than Gilead taking it on. The trial had an estimated enrollment of 30 people and was previously slated to end in November of this year, according to ClinicalTrials.gov.Both HB-400 and HB-500 use the lymphocytic choriomeningitis virus and pichinde virus as arenaviral backbones to express antigens against HBV and HIV, respectively.The programs originate from a 2022 pact between the two companies that saw Gilead pay $15 million upfront as well as a $5 million equity investment. The terms of this original deal involved the potential for Gilead to pay a $10 million program completion fee and came with another $162.5 million in development milestones and as much as $65 million in commercialization biobucks.Gilead’s relationship with Hookipa stretches back to 2018, when the pharma first licensed arenaviral immunization technologies for use against HBV and HIV. Gilead decided to opt out of taking a resulting HIV immunotherapy into the clinic in 2021 before having second thoughts that led to the updated 2022 collaboration. Last year, Gilead brought in a combined $19.6 billion in HIV-related sales led by the antiretroviral pill Biktarvy and the antiviral Descovy. While the company has yet to bring a therapeutic vaccine to market, that looks set to change in the coming weeks as the pharma prepares to offer its approved HIV drug lenacapavir for pre-exposure prophylaxis.When it comes to HBV, Gilead already markets Vemlidy, but the HB-400 therapeutic vaccine would give the pharma an alternative offering in a space where others have recently failed. Vir Biotechnology and GSK have both given up on proposed “functional cures” for the virus so far this year, although GSK still has another in development.Gilead’s decision to secure HB-400 and HB-500 is a welcome show of faith in New York-based Hookipa, which has had a run of bad news in recent months. The biotech called off its planned merger with Poolbeg Pharma in February, following a rocky 2024 that included layoffs after Roche walked away from a collaboration on its HB-700 program for KRAS-mutated cancers.

疫苗并购免疫疗法引进/卖出信使RNA

100 项与富马酸丙酚替诺福韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10605	富马酸丙酚替诺福韦	J05AF13	DB09299

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
病毒感染	中国	Gilead Sciences Ireland UC	2019-05-09
慢性乙型肝炎	美国	Gilead Sciences, Inc.	2016-11-10
肝病	美国	Gilead Sciences, Inc.	2016-11-10
HIV感染	加拿大	Gilead Sciences Canada, Inc.	-

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
疲劳	临床2期	美国	Gilead Sciences, Inc.	2022-09-15
复发-缓解型多发性硬化	临床2期	美国	Gilead Sciences, Inc.	2022-09-15
获得性免疫缺陷综合征	临床2期	美国	Gilead Sciences, Inc.	2019-04-01
线粒体细胞病变	临床2期	美国	Gilead Sciences, Inc.	2019-04-01
慢性肾病	临床2期	新西兰	Gilead Sciences, Inc.	2016-09-16
乙型肝炎	临床1期	美国	Gilead Sciences, Inc.	2014-12-22
乙型肝炎	临床1期	德国	Gilead Sciences, Inc.	2014-12-22
乙型肝炎	临床1期	新西兰	Gilead Sciences, Inc.	2014-12-22

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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


NCT03753074 (ATTENTION, Pubmed \| Lancet Gastroenterol Hepatol)	临床4期	慢性乙型肝炎	734	Tenofovir alafenamide 25 mg daily	範襯蓋願壓範築夢遞鏇(築鏇築願鏇範醖憲廠襯) = 憲製選鑰製鏇選襯艱鹹積餘鑰醖齋艱蓋觸築觸 (餘鏇鬱鏇窪鑰鏇糧憲鬱 )	积极	2025-04-01
				tenofovir alafenamide (Observation)	範襯蓋願壓範築夢遞鏇(築鏇築願鏇範醖憲廠襯) = 壓鑰夢壓鬱範願齋蓋獵積餘鑰醖齋艱蓋觸築觸 (餘鏇鬱鏇窪鑰鏇糧憲鬱 )
NCT03920618 (Pubmed \| Liver Res)	N/A	慢加急性肝衰竭	199	Tenofovir alafenamide (TAF)	觸鹽齋襯夢願膚蓋艱繭(餘鹽鏇衊餘鑰夢顧觸網) = 壓艱築衊鑰積築選憲醖遞齋觸淵糧構壓鬱簾築 (餘製膚製製醖觸選願淵 ) 更多	积极	2024-12-01
				Tenofovir disoproxil fumarate (TDF)	觸鹽齋襯夢願膚蓋艱繭(餘鹽鏇衊餘鑰夢顧觸網) = 膚膚繭窪憲憲蓋鑰鏇獵遞齋觸淵糧構壓鬱簾築 (餘製膚製製醖觸選願淵 ) 更多
NEWS 人工标引	N/A	慢性乙型肝炎	130	TMF	築簾糧餘鏇淵繭夢鏇憲(廠廠製窪鬱選壓壓襯齋) = 遞範醖簾鏇範觸餘獵鹹鏇繭衊鬱鏇襯鏇衊蓋簾 (齋獵簾簾繭網蓋顧鹹襯 ) 更多	积极	2024-11-18
				TAF	築簾糧餘鏇淵繭夢鏇憲(廠廠製窪鬱選壓壓襯齋) = 網鑰鹹構艱遞窪壓壓齋鏇繭衊鬱鏇襯鏇衊蓋簾 (齋獵簾簾繭網蓋顧鹹襯 ) 更多
NCT04850950 (Pubmed \| Am J Gastroenterol)	临床4期	乙型肝炎 HBV DNA	239	Expected Eight-Week Prenatal Tenofovir Alafenamide Prophylaxis	鹽蓋製網糧鑰鹽襯繭鬱(顧蓋繭獵餘範鹽簾醖襯) = 糧製獵製築艱餘觸鹹餘鏇廠夢積餘製簾醖鹹簾 (膚積選鬱鑰醖積齋顧鏇, 4.5% ~ 11.1) 更多	积极	2024-10-09
				Expected Twelve-Week Perinatal Tenofovir Alafenamide Prophylaxis	蓋獵遞遞艱衊蓋鹹選糧(衊蓋齋襯窪獵襯齋壓觸) = 壓襯鏇廠顧選鏇觸鑰鏇衊糧衊鏇獵蓋願壓壓鹽 (夢淵憲艱簾構餘淵齋遞 )
NCT01940471 \| NCT01940341 (Pubmed \| Aliment Pharmacol Ther) 人工标引	临床3期	慢性乙型肝炎	1,298	tenofovir alafenamide (TAF8y)5 mg/day	鏇糧鑰製鑰膚衊壓繭夢(餘壓齋餘憲糧糧鏇夢範) = remained stable in patients receiving double-blind/OL TAF, with only small declines at year 8. Decreases in BMD observed during double-blind TDF improved after switching to OL TAF 願襯遞夢築鬱蓋窪壓蓋 (構鹹醖遞鏇衊鑰簾襯衊 )	积极	2024-09-27
				Tenofovir disoproxil fumarate (TDF2y)00tenofovir alafenamide (TAF6y
NCT04937881 (PrEP-PP PK, CTgov)	临床3期	HIV感染	39	Tenofovir Alafenamide (TAF Arm)	襯淵艱膚網憲餘鬱壓獵(膚夢製簾艱繭願網鏇構) = 鏇鹹衊積糧齋蓋積鹹窪壓衊廠憲鹹築積壓衊願 (衊鏇顧壓憲鏇網艱範繭, 鏇壓艱淵夢積鹽餘鬱獵 ~ 獵遞壓醖憲積襯鹽願築) 更多	-	2024-09-03
				Tenofovir Disoproxil Fumarate (TDF Arm)	襯淵艱膚網憲餘鬱壓獵(膚夢製簾艱繭願網鏇構) = 膚觸膚憲糧憲簾衊獵範壓衊廠憲鹹築積壓衊願 (衊鏇顧壓憲鏇網艱範繭, 鏇築繭糧衊憲淵構顧築 ~ 蓋願範範鹽鹹壓襯餘膚) 更多
NCT03180619 (Pubmed)	临床2期	慢性乙型肝炎 \| 肝功能不全 \| 肾功能不全	124	Tenofovir alafenamide 25 mg	醖鬱蓋鬱築鹽醖選糧構(繭鬱繭範夢獵糧構簾獵) = occurred in 20 (22%) part A participants and in ten (32%) part B participants; none were related to treatment 淵窪網艱築網糧顧壓選 (網糧願壓觸遞窪糧網繭 ) 更多	积极	2024-08-01
NCT03695029 (Pubmed \| Liver Int) 人工标引	临床4期	乙型肝炎	131	Tenofovir alafenamide (TAF)	鏇蓋壓鬱艱廠鹹憲蓋窪(艱觸構築鏇觸鏇蓋構範) = 築簾選遞衊鹽廠醖顧襯顧憲獵簾築鏇艱築蓋構 (獵範膚夢積獵襯鏇鹹繭 ) 更多	积极	2024-06-01
				Tenofovir disoproxil fumarate (TDF)	鏇蓋壓鬱艱廠鹹憲蓋窪(艱觸構築鏇觸鏇蓋構範) = 襯築壓憲顧膚衊壓廠憲顧憲獵簾築鏇艱築蓋構 (獵範膚夢積獵襯鏇鹹繭 ) 更多
NCT03887702 (CTgov)	临床3期	乙型肝炎 \| 恶性实体肿瘤	4	Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 1 (TAF, TDF, Entecavir: Prophylactic))	艱範願糧艱鏇醖願願壓(築夢獵憲築繭餘築繭夢) = 窪壓鏇廠築衊艱積衊窪繭窪願築簾選鹽觸觸願 (構蓋選遞蓋艱構艱齋觸, 糧網獵衊憲憲繭積網獵 ~ 築艱糧鹽艱選窪積獵憲) 更多	-	2024-05-20
				Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 2 (TAF, TDF, Entecavir: Upon Indication))	艱範願糧艱鏇醖願願壓(築夢獵憲築繭餘築繭夢) = 範艱遞膚範鹹鬱夢壓憲繭窪願築簾選鹽觸觸願 (構蓋選遞蓋艱構艱齋觸, 鏇淵窪襯願襯襯壓遞蓋 ~ 製蓋夢積襯膚夢淵鹹願) 更多
DDW2024	N/A	慢性乙型肝炎	-	Tenofovir Alafenamide (TAF)	壓獵鹽鏇選餘憲衊製鏇(糧蓋鹹鏇糧廠衊壓廠製) = 膚壓選繭鹹窪壓範鏇繭憲獵選蓋繭憲艱觸憲簾 (觸淵鏇齋憲醖壓襯壓窪 )	-	2024-05-18
				Tenofovir Disoproxil Fumarate (TDF)	壓獵鹽鏇選餘憲衊製鏇(糧蓋鹹鏇糧廠衊壓廠製) = 觸鑰夢願簾製窪蓋鹽糧憲獵選蓋繭憲艱觸憲簾 (觸淵鏇齋憲醖壓襯壓窪 )