ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.

The ALIGN study will evaluate the delivery of injectable Lenacapavir (LEN), a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP), amongst adolescents and young people (aged 15-35 years) living within the Klipfontein-Mitchell's health sub-district of Cape Town, South Africa. LEN will be offered alongside injectable Cabotegravir long-acting (CAB LA), an injectable PrEP product already approved for use in South Africa, and oral PrEP (F/TDF) modalities (including intermittent dosing where appropriate), the current standard of care (SOC) biomedical HIV prevention in South Africa. Following counselling, participants will be able to choose which PrEP product (LEN, CAB LA, or oral PrEP) to initiate, with the option to switch at any future clinical visit, and followed for 18 months. These options will be offered from two types of delivery sites, namely public health facilities and established mobile service delivery trucks, where various forms of PrEP are currently delivered as part of outreach services and ongoing research studies (FastPrEP UCT HREC nr. 713/2021 and PrEPared to Choose 567/2023).
Lenacapavir (LEN) is a novel, first-in-class, multi-stage HIV-1 capsid inhibitor with high potency and a long half-life, allowing administration by subcutaneous injection twice yearly (1). The PURPOSE 1 study, a phase 3, double-blind, randomized, controlled trial involved adolescent girls and young women in South Africa and Uganda. Purpose 1 study found that none of the participants receiving twice-yearly LEN injection acquired HIV infection (1). Purpose 2, which was conducted amongst cisgender men who have sex with men, transgender, and non-binary populations, reported two incident infections amongst 2179 LEN users. CAB LA is an alternative long-acting injectable formulation administered by intra-muscular injection every two months. CAB LA efficacy and safety was established in the HPTN 083 and HPTN 084 studies, which indicated a 66% and 88% reduction in HIV risk compared to oral PrEP users respectively. The ongoing PrEPared to Choose study, conducted by this study team, (UCT HREC 567/2023) offers CAB LA and oral PrEP products and has demonstrated the feasibility and impact of many of the PrEP choice and delivery processes put forward in this protocol. As such, this study team has extensive experience in CAB LA and oral PrEP real-world delivery.
The ALIGN study will provide one of the first real-world (outside of the clinical trial research site) evaluations of LEN delivery with the view to evaluate firstly, what implementation strategies best support LEN initiation and persistence at the level of the PrEP provider and the PrEP user, and secondly, persistence (defined as consistent, uninterrupted use as prescribed) on LEN compared to alternative injectable products and SOC oral PrEP. The proposed study will utilise a hybrid implementation study design, with co-primary implementation and clinical aims, in the form of a non-randomised, quasi-experimental trial design. Findings from this study will be used to inform the anticipated LEN rollout into public health facilities (including ANC clinics) as well as the implementation of PrEP choice service delivery in a new era of expanded biomedical HIV prevention products. The addition of LEN will build on the experiences of implementing previous long-acting PrEP products (such as injectable long-acting Cabotegravir) and will generate practical insights to inform the scale of this innovative tool while national regulatory approvals are being sought. This will include working with communities to harness their insights and answering specific questions to support effective delivery and drive uptake and effective use of injectable PrEP (LEN and CAB LA).
Study purpose:
To evaluate the delivery strategies (public health facility and community-based) and potential impact of Lenacapavir (LEN) as PrEP, on the relative persistence of up to 3700 young people (aged 15-35 years) initiating on LEN compared to an alternative injectable product (CAB LA) and oral PrEP products (standard of care).
We hypothesize that people who select injectable PrEP will be more likely to persist on PrEP when compared with people who select oral PrEP, and further that injectable LEN will show enhanced persistence compared to injectable CAB LA.
Primary study objectives:
The primary objectives of this study are to distinguish PrEP persistence patterns across different PrEP modalities (oral PrEP vs injectable CAB vs injectable LEN as PrEP) and identify successful implementation strategies that will aid the provision of PrEP choice to adolescents and young people in South Africa from two distinct delivery platforms (public health facilities and mobile services).

开始日期2026-01-29

申办/合作机构

Desmond Tutu Hiv Foundation

[+3]

NCT06819176

/ Recruiting临床1期IIT

Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy

Background:
Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Researchers want to find ways to reduce the size of HIV reservoirs in people taking ART.
Objective:
To test a drug (lenacapavir) in people with HIV who are on effective ART. Lenacapavir, also called Sunlenca, is already approved for use in people with HIV who cannot be treated with standard ART.
Eligibility:
People aged 18 to 75 years with HIV that has been suppressed for at least 3 years with ART.
Design:
Participants will have 13 clinic visits over 2 years.
Participants will be screened. They will have a physical exam with blood tests. They will maintain their ART throughout the study.
Participants will undergo leukapheresis up to 6 times. Blood will be drawn via a tube in an arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a second tube.
Two-thirds of participants will take lenacapavir in addition to their regular ART. They will receive the drug as an injection under the skin 3 times at 6-month intervals. They will also take lenacapavir as 2 pills swallowed by mouth on the first 2 days of the study.
...

开始日期2026-01-20

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT07218211

/ Recruiting临床4期IIT

INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP

The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.

开始日期2026-01-13

申办/合作机构

Duke University

[+1]

100 项与来那帕韦钠相关的临床结果

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100 项与来那帕韦钠相关的转化医学

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100 项与来那帕韦钠相关的专利（医药）

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242

项与来那帕韦钠相关的文献（医药）

2026-03-01·ANNALS OF PHARMACOTHERAPY

Lenacapavir: A Twice-Yearly Injectable for HIV Preexposure Prophylaxis

Review

作者: Koren, David E. ; Sherman, Elizabeth M. ; Chahine, Elias B.

Objective::

To review the efficacy and safety of lenacapavir for the prevention of HIV-1 infection.

Data Sources::

Clinical trials and review articles were obtained through August 2025 using search terms lenacapavir, GS-CA1, GS-6207, capsid inhibitor, preexposure prophylaxis, and PrEP.

Study Selection and Data Extraction::

All relevant articles, trials, and abstracts in the English language were included.

Data Synthesis::

Lenacapavir uses a novel mechanism for HIV prevention administered through subcutaneous injection. In a counterfactual design, lenacapavir arms demonstrated superior efficacy for prevention against a background HIV incidence rate across a variety of populations and gender identities. Adverse events commonly reported include injection-site reactions, which may include nodules, pain, or swelling at the injection site.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

The extended dosing frequency of lenacapavir may uniquely serve patients at risk of HIV acquisition who are unable or unwilling to take oral prevention medications. The mechanism of action for lenacapavir is not duplicative of other medications used in first-line antiretroviral regimens and thus may not risk resistance to regularly used classes if resistance occurs. Lenacapavir is a moderate cytochrome P450 inhibitor and thus may have interactions with other medications; however, neither renal nor hepatic dose adjustments are required.

Conclusions::

Lenacapavir provides a long-acting injectable option for people seeking a pharmacologic prevention agent against HIV-1. Despite injection-site reactions being relatively common, these did not present a barrier to treatment continuation among trial participants.

2026-03-01·INTERNATIONAL JOURNAL OF STD & AIDS

High-level multi-class transmitted antiretroviral resistance in a man with newly acquired HIV

Article

作者: Miller, Theodore R. ; Sison, Raymund ; Gruta, Cristina ; Fierer, Daniel S.

A 19 year old man was diagnosed newly acquired HIV and prescribed bictegravir/emtricitabine/tenofovir alafenamide at his initial visit for HIV care. The genotype results from that initial visit returned two weeks later, showing high-level multi-class transmitted drug resistance, including multiple resistance-associated mutations (RAM) in the integrase gene. Although he had an initial substantial decline in viremia in the first 4 weeks, it was felt that the risk of subsequent failure was too high, and his antiretroviral treatment (ART) regimen was therefore changed to daily dolutegravir and darunavir/cobicistat/emtricitabine/tenofovir alafenamide, plus injected lenacapavir. He had durable virologic suppression on this new regimen for 12 months as of his last follow-up. This case of high-level multi-class transmitted drug resistance, in the context of rapid emergence of resistance to dolutegravir where it has been used as part of a salvage regimen, suggests that assessing for RAM in the integrase gene should be added to the currently recommended resistance testing for all patients with newly acquired HIV prior to initiating ART.

2026-03-01·AIDS

Final efficacy and safety of twice-yearly subcutaneous lenacapavir in treatment-naive people with HIV

Article

作者: Gupta, Samir K. ; Scribner, Anita ; Crofoot, Gordon E. ; Sanchez, William E. ; Vanderveen, Laurie A. ; Hagins, Debbie ; Ruane, Peter J. ; McDonald, Cheryl ; Sims, James ; Berhe, Mezgebe ; Liu, Shan-Yu ; Rhee, Martin S. ; Ramgopal, Moti N. ; Dvory-Sobol, Hadas ; Benson, Paul

Objective::

To assess final efficacy (through Week [W] 132), safety, and emergent resistance with lenacapavir-based combination regimens in the CALIBRATE study.

Design::

CALIBRATE was a Phase 2, randomized, open-label study (NCT04143594).

Methods::

Treatment-naive PWH were randomized (2 : 2:2 : 1) to four treatment groups (TG): TG1 and TG2 received twice-yearly subcutaneous lenacapavir plus oral daily emtricitabine/tenofovir alafenamide (F/TAF); TG3 received oral daily lenacapavir plus F/TAF; and TG4 received oral daily bictegravir/F/TAF. At W28, TG1 switched to lenacapavir plus TAF and TG2 switched to lenacapavir plus bictegravir. At W80, TG4 completed the study and TG1–3 continued assigned treatments.

Results::

Overall, 182 participants received at least one dose of study drug (TG1–4, respectively: n = 52, n = 53, n = 52, n = 25). Virologic suppression (HIV-1 RNA <50 copies/ml) at W80 by FDA snapshot: 87, 75, 87, and 92% in TG1–4, respectively. When excluding missing data, virologic suppression at W132 across TG1–3 was 98–100%. Mean (95% CI) increase from baseline to W80 in CD4 cells/μl was consistent across TG1–4: 275 (214; 337), 262 (203; 320), 245 (174; 315), and 248 (155; 340), respectively. No serious treatment-related adverse events occurred. Two participants in TG1 and three in TG2 discontinued study drug due to adverse events. Injection-site reactions were mostly mild to moderate. LEN resistance-associated mutations emerged in four participants.

Conclusion::

Lenacapavir-containing combinations achieved and maintained high rates of virologic suppression in treatment-naive participants through W132; lenacapavir was well tolerated. These data support future development of lenacapavir-containing regimens for HIV-1 treatment.

767

项与来那帕韦钠相关的新闻（医药）

2026-02-27

·泓博医药

今日生物医药快讯-2026.02.27

本期快讯简要聚焦：临床方面，吉利德 HIV 每日一次单片复方制剂三期数据优异，Rgenta 披露口服 PMS1 抑制剂治疗亨廷顿舞蹈症潜力；公司动态涵盖 GSK 以 9.5 亿美元收购 35Pharma 布局肺高压领域，诺华扩建美放射药生产基地，诺和诺德联手 Vivtex 研发口服减重药，George Medicines 推进三联高血压药东南亚商业化；监管层面，Curanex 更新核心管线审批节点。多维热点交织，勾勒全球医药产业最新脉动。 01 临床试验 01 吉利德公布两项后期临床数据，验证其每日一次 HIV 单片复方制剂的疗效吉利德科学（Gilead）披露了两项关键 3 期临床研究（ARTISTRY-1 和 ARTISTRY-2）的最新数据，旨在评估其由整合酶抑制剂必妥维（Bictegravir）与 Lenacapavir 组成的每日一次单片复方制剂（STR）。研究结果显示，在接受该 STR 治疗的病毒抑制型 HIV-1 感染者中，其疗效与继续接受现有抗逆转录病毒疗法相当，成功达到了主要终点。这一进展标志着吉利德在简化 HIV 治疗方案、提高患者依从性方面迈出了重要一步，进一步巩固了其在抗病毒领域的领导地位。关键词：吉利德，HIV，Lenacapavir，临床 3 期 https://www.fiercepharma.com/pharma/gilead-paints-clearer-picture-bictegravir-lenacapavir-single-tablet-combos-prowess-varied 02 Rgenta Therapeutics 发布临床前数据，展示口服 PMS1 抑制剂治疗亨廷顿舞蹈症的潜力 Rgenta Therapeutics 在近期学术会议上展示了其新型候选药物 RGT-0474060 的临床前研究成果。该药物被定义为一种具有前景的口服 PMS1 抑制剂，专门用于治疗亨廷顿舞蹈症（HD）。临床前数据显示，RGT-0474060 能够通过靶向 RNA 加工机制有效调节致病基因表达，并在动物模型中观察到了良好的安全性与药代动力学特性。这一发现为针对亨廷顿舞蹈症这种高度致残的神经退行性疾病提供了全新的治疗策略和靶点选择。关键词： Rgenta，PMS1 抑制剂，亨廷顿舞蹈症，临床前研究 https://www.globenewswire.com/news-release/2026/02/25/3244536/0/en/Rgenta-Therapeutics-Presents-Preclinical-Data-Unveiling-its-New-Drug-Candidate-RGT-0474060-as-a-Promising-Oral-PMS1-Inhibitor-for-the-Treatment-of-Huntington-s-Disease.html 02 公司动态 01 GSK 耗资 9.5 亿美元收购 35Pharma，加码心血管及肺高压管线布局葛兰素史克（GSK）宣布已达成协议，以 9.5 亿美元现金预付款收购加拿大生物技术公司 35Pharma。此次交易的核心资产是一款类似于默沙东 Winrevair 的高血压药物。该候选药物主要针对激活素（Activin）信号通路，旨在治疗肺动脉高压（PAH）等严重心血管疾病。GSK 此举意在通过收购具有差异化竞争力的资产，迅速填补其在特药领域的增长需求，挑战默沙东在这一细分市场的垄断地位。关键词：GSK，35Pharma，肺动脉高压，并购 https://www.fiercebiotech.com/biotech/gsk-pays-950m-cash-canadian-biotech-and-its-winrevair-blood-pressure-drug 02 诺华扩建美国德克萨斯州放射药物生产基地，推进 230 亿美元投资计划诺华（Novartis）宣布在德克萨斯州设立新的放射性药物生产基地，作为其在美国大规模投资蓝图的一部分。此举旨在完善其全球放射配体疗法（RLT）的供应链体系，以支持其重磅产品 Pluvicto 和 Lutathera 的市场供应。随着放射药物在肿瘤治疗中的地位日益凸显，诺华正通过在美累计投入约 230 亿美元的“闪电战”式布局，确保在这一高技术壁垒领域的生产优势及市场领先地位。关键词：诺华，放射药物，Pluvicto，产能扩张 https://www.fiercepharma.com/pharma/novartis-rounds-out-radiopharmaceutical-plans-amid-broader-23b-us-investment-blitz 03 诺和诺德与 Vivtex 达成合作，致力于开发新一代口服肥胖与糖尿病药物诺和诺德（Novo Nordisk）与 Vivtex 宣布达成战略合作伙伴关系，共同开发针对肥胖和糖尿病的创新口服制剂。Vivtex 拥有独特的人体器官芯片技术平台，能够精确模拟肠道吸收过程。通过此次合作，诺和诺德希望利用该平台克服生物大分子药物口服吸收的生物学障碍，开发出疗效更强且便捷性更高的下一代代谢类药物。这对于诺和诺德维持其在减重药物市场的竞争优势具有重要战略价值。关键词：诺和诺德，Vivtex，口服减重药，技术平台 https://www.biopharmadive.com/news/vivtex-novo-nordisk-oral-obesity-drugs-biologics/812754/ 04 George Medicines 与东方药业签署协议，在东南亚商业化高血压三合一复方制剂 George Medicines 近日宣布与东方药业（Orient EuroPharma）达成独家许可协议，旨在东南亚市场推广其创新高血压三合一候选药物 GMRx2。GMRx2 将三种常用抗高血压药物以超低剂量组合，研究表明其在降低血压方面的效率显著优于标准单药或双联疗法，且副作用更低。此次合作是 George Medicines 全球商业化战略的重要一环，将有助于该疗法在心血管疾病负担沉重的东南亚地区实现快速覆盖。关键词： George Medicines，GMRx2，高血压，东南亚市场 https://www.globenewswire.com/news-release/2026/02/25/3244483/0/en/George-Medicines-advances-its-global-commercial-strategy-for-GMRx2-with-an-exclusive-licensing-agreement-with-Orient-EuroPharma-in-Southeast-Asia.html 03 监管政策 01 Curanex 提供核心监管里程碑运营更新，推进在研管线上市进程 Curanex 公司今日发布了关于其核心候选产品在主要市场监管审批进度的官方声明。报告详述了公司在与 FDA 及 EMA 等监管机构沟通中的最新进展，包括关键性临床研究的数据提交时间表以及预期的监管反馈节点。Curanex 强调，公司正致力于按计划达成这些合规目标，以确保创新疗法能够尽快获批上市。这一更新为投资者和行业观察者提供了关于该公司产品管线确定性的重要参考依据。关键词：Curanex，监管里程碑，FDA，上市审批 https://www.globenewswire.com/news-release/2026/02/25/3244564/0/en/Curanex-Provides-Operational-Update-on-Key-Regulatory-Milestones.html END 科学主导不断创新 A Small Molecule CRO/CDMO Service Provider 长按二维码关注公众号

2026-02-27

·医时周见

新版《国家基本药物目录管理办法》正式发布，瑞博生物与 Madrigal 达成 44 亿美元全球独家许可协议

近期，医疗、生物医药领域的重要事件回顾，医时周见整理如下：新版《国家基本药物目录管理办法》正式发布 2 月 11 日，国家卫生健康委等 11 部门联合印发新版《国家基本药物目录管理办法》，基药目录时隔 11 年迎来首次修订。主要修订内容：在原文件总体框架和主要内容的基础上，《国家基本药物目录管理办法》主要修订六个方面：一是增加法律政策依据。增加《基本医疗卫生与健康促进法》《药品管理法》等上位法依据，并与《国务院办公厅关于完善国家基本药物制度的意见》《国务院办公厅关于进一步做好短缺药品保供稳价工作的意见》等政策衔接。二是合理优化目录结构。将国家基本药物分为化学药品和生物制品、中药（中药饮片和中成药）等。化学药品和生物制品主要依据临床药理学分类，中成药主要依据功能分类。三是完善目录管理机制。国家基本药物供应使用与分级诊疗、药品集中采购、支付报销等政策相衔接。由国家卫生健康委按程序对更名、异名的基本药物进行归属认定。四是突出药品临床价值。明确根据疾病谱变化、药品临床应用实践、药品标准变化、药品新上市情况等，坚持中西医并重、临床首选的原则，综合考虑我国基本医疗卫生服务需求、基本医疗保障水平、药品供应保障等因素，对基本药物的品种和数量进行调整。五是规范动态调整机制。强化基本药物功能定位，坚持定期评估、动态管理，调整周期原则上不超过 3 年，必要时，可适时组织调整。六是强化监测评价。国家健全以基本药物为重点的药品使用监测和临床综合评价体系，加强评价结果分析应用，为动态优化目录和完善管理政策提供支撑。 FDA：单项关键试验将成为新药获批的“默认选项” 2 月 18 日，FDA 局长 MartinMakary 和 CBER 主任 Vinay Prasad 在《新英格兰医学杂志》上发表的最新文章，FDA 未来的新默认标准将是“仅需一项关键临床试验”即可支持新药上市申请。打破了长期以来FDA 审批新药的“黄金标准”：要求制药企业提供至少两项充分且受到良好控制的关键临床试验数据。礼来 24 亿美金收购 Orna Therapeutics 2 月 9 日，礼来宣布以 24 亿美元收购致力于开发体内工程免疫细胞的生物技术公司Orna Therapeutics。根据协议条款，礼来将收购Orna，Orna 股东将获得高达 24 亿美元的现金，包括预付款和实现某些临床开发里程碑后的后续付款。Orna 正在推进一类新的治疗方法，利用工程化的环状 RNA 与新型脂质纳米颗粒配对，使患者自己的身体产生可以治疗潜在疾病的细胞疗法。Orna 的主要项目是ORN-252，这是一种临床试验就绪的 CD19 in vivo CAR-T 疗法，旨在治疗 B 细胞驱动的自身免疫性疾病。迄今为止的实验表明，Orna 的环状 RNA 平台可以提供更持久的治疗蛋白表达，从而解锁目前 RNA 或细胞治疗平台不可行的治疗方法。吉利德公布 2025 年财报，HIV 领域贡献 207.52 亿美金吉利德 2025年全年营收 294.43 亿美元（+2%），其中产品收入 289.15 亿美元（+1%），剔除新冠产品 Veklury 影响，产品总收入同比增长 4%。HIV 领域 2025 年贡献了 207.52 亿美元的收入（+6%），占据了公司总营收的 70%以上，其中核心产品 Biktarvy 全年销售额 143.34 亿美元，同比增长 7%，Q4 单季 40 亿美元，美国治疗市占率突破 52%，预防业务高增，Descovy 全年销售额 28 亿美金，同比增长 31%，新获批的半年一次长效 HIV 预防药Yeztugo 快速放量，全年销售额 1.5 亿美金，其中 Q4 贡献了 0.96 亿美金。2026 年 HIV 指引为预期增长 6%，其中 Yeztugo 预期销售额将达到 8 亿美金。晶泰科技自动化实验室落地巴斯夫 2 月 9 日，公司宣布已成功向全球化工巨头巴斯夫（BASF）交付了配方稳定性测试自动化工作站，助力巴斯夫构建起“样品管理—测试分析—数据管理”全链路的自动化体系。此次合作是晶泰科技智能自主实验室解决方案在化工自动化领域的又一重要进展，标志着其技术实力与商业化交付能力再次获得行业顶尖企业的验证。晶泰科技凭借其大规模自主机器人实验室的国际领先性、卓越的定制化能力与跨领域迁移性，持续助力药物研发、石油化工、新能源、新材料等领域积累高精度研发数据，其行业数字化、智能化升级提供新一代基础设施。翰森制药肺癌新药阿美替尼于欧盟获批上市 2 月 20 日，公司宣布，阿美替尼单药治疗已正式获批在欧盟上市，用于：（i）具有表皮生长因子受体（EGFR）外显子 19 缺失或外显子 21（L858R）置换突变的晚期非小细胞肺癌（NSCLC）成人患者的一线治疗；（ii）晚期 EGFR T790M 突变阳性 NSCLC 成人患者的治疗。阿美替尼作为中国首个自主研发的三代 EGFR-TKI，自 2020年上市以来，已在中国内地获批五项适应症。国际化上，2025 年 6 月，阿美替尼单药治疗两项适应症在英国获批上市。2025 年 12 月，翰森制药宣布授予 Glenmark 阿美替尼多区域独家权益。金赛药业 PD-1 激动剂抗体启动类风关 2b 期临床根据丁香园数据库，2 月 13 日，金赛药业在临床试验登记网站上首次登记了 PD-1 激动剂抗体 GenSci120 治疗类风湿关节炎的 2b 期临床试验，评价 GenSci120 注射液在对至少一种改善病情抗风湿药物应答不佳的中重度活动性类风湿关节炎患者中的有效性等研究，计划入组 450 例类风湿关节炎患者，对照组包括安慰剂和阳性对照阿达木单抗。瑞博生物与 Madrigal 达成 44 亿美元全球独家许可协议，携手开发 MASH 创新 siRNA疗法 2 月 11 日，公司宣布与与全球 MASH 领域领军企业 Madrigal Pharmaceuticals 达成全球独家许可协议，双方将基于瑞博生物自主研发的肝靶向 RiboGalSTAR ™平台，联合开发六款针对代谢功能障碍相关脂肪性肝炎（MASH）的创新 siRNA 疗法。根据协议条款，瑞博生物将授予 Madrigal 多款 MASH 领域单靶点及双靶点临床前 siRNA 资产的全球独家研发、生产与商业化权利。瑞博生物将获得 6000 万美元首付款；在达成临床开发、监管审批及商业销售等一系列里程碑节点后，瑞博生物将有资格获得累计 44 亿美元包含首付款和里程碑在内的款项，同时可享受基于合作产品全球净销售额的特许权使用费。和铂医药就 CTLA-4 抗体达成授权协议及股权合作 2 月 23 日，公司宣布与 Solstice Oncology 达成授权协议及股权合作，授予对方一款临床阶段候选产品 HBM4003 在大中华区以外地区的独家开发及商业化权益。根据协议，和铂医药将获得总价值逾 1.05 亿美元的前期对价，包括现金形式的 5000 万美元首付款、500 万美元近期付款以及价值逾 5000 万美元的 Solstice Oncology 股权。此外，基于未来特定里程碑事件的达成，和铂医药还有资格进一步获得最高约 11 亿美元的开发、监管及商业里程碑付款，以及基于大中华区以外地区净销售额的分级特许权使用费。来源：公开信息资料编辑：武辰欣

2026-02-26

·药明康德

同行致远 | 从长效注射到双药方案，多款HIV疗法公布最新结果 | CROI 2026

编者按：随着抗逆转录病毒药物的广泛应用，艾滋病已从一种致命性疾病逐步转变为可长期管理的慢性疾病。然而，艾滋病病毒（HIV）感染者仍面临诸多未被满足的临床需求，尤其是对已产生耐药性或难以长期坚持复杂治疗方案的患者而言，治疗选择仍有进一步优化空间。为应对这些挑战，全球范围内已有上百个创新药研发项目持续推进，旨在不断拓展HIV感染治疗的临床边界与更多可能性。作为全球医药创新的赋能者，药明康德始终致力于提供一体化、端到端的新药研发与生产服务，助力全球合作伙伴加速包括HIV感染在内的各类感染性疾病创新疗法的研发进程，惠及更多患者。本周，第33届逆转录病毒与机会性感染会议（CROI）在美国科罗拉多州丹佛市召开，多项HIV在研疗法的最新研究进展相继公布。本文将对相关研究进行盘点，梳理HIV领域的最新动态与发展趋势。药物：Doravirine/islatravir 开发公司：默沙东（MSD）进展：三项关键3期试验达主要终点默沙东公布了三项关键3期临床试验结果，这些研究评估旗下每日一次口服双药单片复方方案doravirine/islatravir（DOR/ISL；100 mg/0.25 mg）在HIV-1成人患者中的疗效与安全性。Doravirine是由默沙东开发的一种每日一次的口服创新非核苷逆转录酶抑制剂。它通过与HIV-1的逆转录酶结合，防止病毒将RNA逆转录为DNA，从而阻断HIV-1病毒复制。它已在美国获批用于治疗未接受过抗病毒疗法的成年HIV-1感染患者。Islatravir则是默沙东研发的一种核苷类逆转录酶易位抑制剂（NRTTI）。 3期双盲临床试验MK-8591A-053在初治的HIV-1成人患者中，评估DOR/ISL与bictegravir/emtricitabine/tenofovir alafenamide（BIC/FTC/TAF；50 mg/200 mg/25 mg）三联疗法相较的疗效与安全性。结果显示，研究达到主要疗效终点，即实现病毒学抑制（HIV-1 RNA＜50拷贝/毫升）的受试者比例。在第48周时，DOR/ISL相较BIC/FTC/TAF达到非劣效性，病毒抑制率分别为91.8%和90.6%（治疗差异1.2%，95% CI：-3.7，6.2，p＜0.001）。两组治疗的安全性特征相似，并与既往研究观察结果一致。药物相关不良事件（AEs）及因药物相关不良事件导致的停药比例在两组间相近（DOR/ISL为14%，BIC/FTC/TAF为18%；因药物相关AEs停药比例分别为1.1%和2.2%）。此外，研究人员还公布了3期MK-8591A-052与MK-8591A-051试验的最新96周数据。这两项研究评估了在病毒学抑制的HIV-1患者中，由原治疗方案转换至DOR/ISL治疗后，与BIC/FTC/TAF或基线抗逆转录病毒治疗（bART）相较的疗效与安全性。两项研究均显示，DOR/ISL在第96周维持了较高水平的病毒抑制率，其安全性特征与BIC/FTC/TAF及bART相似。这些研究的48周数据支持美国FDA此前所受理DOR/ISL用于HIV-1感染成人患者的新药申请（NDA），拟用于将目前在抗病毒方案下已获得稳定病毒学抑制的成人患者转换至DOR/ISL方案治疗。FDA已将目标审评完成日期设定为2026年4月28日。药物：Bictegravir/lenacapavir 开发公司：吉利德科学（Gilead Sciences）进展：两项3期试验数据公布吉利德科学公布了3期ARTISTRY-1与ARTISTRY-2临床试验的最新数据。结果显示，将病毒学抑制的HIV感染者转换至旗下在研单片复方方案bictegravir/lenacapavir（BIC/LEN；75 mg/50 mg）治疗具有良好的疗效与安全性。 ARTISTRY-1研究结果表明，在既往接受复杂多片治疗方案并实现病毒学抑制的患者中，转换至BIC/LEN单片方案在第48周维持病毒抑制方面达到非劣效性。结果显示，BIC/LEN组中HIV-1 RNA≥50拷贝/毫升的比例为0.8%，对照组为1.1%。两组患者的CD4细胞计数均保持稳定，且未出现治疗过程中产生的耐药性。此外，转换至BIC/LEN治疗与空腹血脂指标改善相关，总胆固醇中位变化为-15 mg/dL，而继续原复杂方案治疗的患者为+2 mg/dL。 ARTISTRY-2研究则显示，在第48周时，BIC/LEN组与HIV获批疗法Biktarvy（bictegravir/emtricitabine/tenofovir alafenamide，B/F/TAF；50 mg/200 mg/25 mg）组维持病毒学抑制的比例相近，分别有1.3%与1.0%的患者出现HIV-1 RNA≥50拷贝/毫升。两组CD4细胞计数及体重指数均保持稳定。耐药性分析显示，大多数病例未检测到治疗相关耐药，仅在BIC/LEN组一名患者中发现孤立的整合酶位点替代，但未表现出表型耐药，也未检测到衣壳突变。安全性方面，两组药物相关不良事件发生率相似，分别为10.4%与12.0%。药物：VH184、VH499 开发公司：ViiV Healthcare 进展：公布1期临床研究结果 ViiV Healthcare公布其第三代整合酶链转移抑制剂（INSTI）长效制剂VH184的1期临床研究数据。结果显示，单次注射即可维持药物体内浓度长达6个月，展现出每年两次给药的潜力。体外研究进一步表明，VH184在耐药HIV株中较bictegravir具有更强活性和更优化的耐药性特征。安全性方面，该药总体耐受性良好，不良反应主要为轻度1级注射部位反应，如红斑、疼痛和结节，较少出现2级或3级反应，其安全性特征与既往研究及已获批INSTI药物相似。与此同时，ViiV Healthcare还公布了在研衣壳抑制剂VH499的1期研究数据，该药同样显示出实现超长效（ULA）半年一次给药的潜力。在正在进行的研究中，未感染HIV的成人受试者接受100 mg至1200 mg剂量范围内的单次肌内或皮下注射，结果显示两种给药方式均可在较长时间内维持稳定药物浓度。VH499整体耐受性良好，最常见的不良反应为注射部位反应，主要表现为1级或2级注射部位疼痛，多为轻至中度且持续时间较短。研究期间未报告严重不良事件，也未出现因不良事件导致的退出病例。研究人员表示，后续研究将基于当前数据进一步优化VH499的给药方案。药物：Lotivibart、cabotegravir 开发公司：ViiV Healthcare 进展：公布2b期临床研究结果 ViiV Healthcare公布其2b期EMBRACE研究的12个月期中疗效与耐受性数据。该研究评估了在接受稳定抗HIV治疗的成人患者中，每4个月给药一次的广谱中和抗体lotivibart（N6LS）联合每月一次肌内注射长效cabotegravir（CABLA）方案的治疗效果。结果显示，该联合方案在维持病毒学抑制方面表现良好，其中接受静脉注射（IV）lotivibart的患者中有94%维持病毒抑制，皮下注射（SC）组为82%，而标准治疗组为88%。在12个月期中分析中，联合治疗方案在大多数受试者中持续维持病毒学抑制，仅少数患者出现确证的病毒学失败：IV组为4%（2/50），SC组为6%（3/49），而每日口服标准治疗组为4%（1/26）。安全性方面，lotivibart总体耐受性良好，受试者对治疗的接受度较高。研究期间，关于注射部位反应困扰程度、身体影响、睡眠影响及整体可接受性的平均评分始终维持在“非常可接受”至“完全可接受”范围内。与药物相关的不良事件在IV组发生率较低（24%），低于SC组（53%）。此外，3至4级输注部位反应仅在SC组中报告（16%），IV组未出现此类事件，进一步支持该方案的可耐受性特征。图片来源：123RF 从本届CROI大会公布的多项研究可以看出，HIV治疗领域正持续向更长效、更简化的治疗模式演进。无论是双药口服方案还是长效注射药物与广谱中和抗体联合策略，研发重点均聚焦于在维持稳定病毒学控制的同时，进一步降低患者治疗负担并改善长期依从性。这些创新方向不仅体现了通过机制优化与给药方式革新推动治疗升级的趋势，也标志着HIV治疗正从“有效控制”迈向“长期高质量管理”的新阶段。当前，全球仍有百余项HIV在研管线处于临床阶段，涵盖小分子、抗体、疫苗、核酸药物、多肽及细胞治疗等多种技术类型。在这一不断演进的创新生态中，研发模式本身也在发生转变。随着药物复杂度持续提升，从早期研究到商业化生产各阶段的高效协同，正日益成为推动创新成果落地的关键基础。长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，通过独特的一体化、端到端CRDMO模式，助力突破性疗法加速研发进程。例如，药明康德的传染病平台能够为抗病毒药物和疫苗从早期研究到临床试验的全流程开发提供全面支持。平台覆盖包括HIV在内的20多种病毒的抗病毒药物和疫苗发现，并且对130多种细菌和真菌的抗菌疗法开发同样提供了广泛的支持。在全球科研与产业协作不断深化的背景下，HIV治疗模式正加速向以患者为中心、兼顾疗效稳定性与长期治疗体验优化的方向演进。随着创新生态不断成熟，推动更多创新疗法更快惠及患者，仍将是产业各方共同努力的目标。参考资料： [1] Merck Announces Late-Breaking Data from Three Phase 3 Trials Evaluating Doravirine/Islatravir (DOR/ISL), an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living with HIV-1 at CROI 2026. Retrieved February 25, 2026 from https://www.merck.com/news/merck-announces-late-breaking-data-from-three-phase-3-trials-evaluating-doravirine-islatravir-dor-isl-an-investigational-once-daily-two-drug-regimen-for-the-treatment-of-adults-living-with-hiv-1/ [2] Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy. Retrieved February 25, 2026 from https://www.businesswire.com/news/home/20260224254904/en/Gileads-Single-Tablet-Regimen-of-Bictegravir-and-Lenacapavir-Maintained-Virological-Suppression-in-People-With-HIV-Who-Switched-Antiretroviral-Therapy [3] ViiV Healthcare presents pipeline data for two investigational HIV treatment therapies with potential for twice-yearly dosing. Retrieved February 25, 2026 from https://www.businesswire.com/news/home/20260225546292/en/ViiV-Healthcare-presents-pipeline-data-for-two-investigational-HIV-treatment-therapies-with-potential-for-twice-yearly-dosing [4] ViiV Healthcare reports positive 12-month data showing investigational bNAb lotivibart (N6LS) maintains high levels of viral suppression in long-acting HIV treatment regimen. Retrieved February 25, 2026 from https://www.businesswire.com/news/home/20260225354805/en/ViiV-Healthcare-reports-positive-12-month-data-showing-investigational-bNAb-lotivibart-N6LS-maintains-high-levels-of-viral-suppression-in-long-acting-HIV-treatment-regimen 免责声明：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：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

临床3期临床结果

100 项与来那帕韦钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15673

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
HIV感染	欧盟	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	冰岛	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	列支敦士登	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	挪威	Gilead Biopharmaceutics Ireland UC	2022-08-17

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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


NCT05729568 (Pubmed \| Lancet Microbe)	临床2期	HIV感染	80	Lenacapavir+Teropavimab+Zinlirvimab	餘願廠餘淵衊網網艱網(製遞糧鑰襯積壓獵鹽衊) = 夢選鏇選壓構鹹積積製構製齋廠憲選憲積壓網 (積構積選廠構艱憲壓選 )	积极	2026-02-01
				SBR	鹽憲積憲鏇醖製遞衊憲(網齋艱觸壓繭鏇鏇範壓) = 襯壓夢鬱顧製糧網顧獵壓製觸夢鑰築衊鑰糧製 (鹹憲襯網繭願糧壓選構, 0.0 ~ 12.8) 更多
NCT05052996 (Pubmed \| Ann Intern Med)	临床2期	HIV感染	104	Islatravir + Lenacapavir	襯醖獵顧網壓淵鹹製鏇(鑰願觸鑰糧襯壓醖獵顧) = 夢餘鬱窪範積夢蓋壓衊鏇築壓廠簾衊衊鹽鑰鹹 (鹹蓋淵獵廠鹹鬱願獵膚 ) 更多	积极	2025-12-23
				Bictegravir, Emtricitabine, Tenofovir Alafenamide	觸鏇襯簾膚願選廠構選(鏇網襯選憲鏇襯範廠願) = 廠廠醖餘遞壓齋鬱膚淵願繭窪鑰鏇鏇繭鬱製憲 (糧繭膚艱構願襯衊簾簾 ) 更多
NCT04994509 \| NCT04925752 (PURPOSE 2, NEWS) 人工标引	临床3期	HIV感染	-	lenacapavir (每年两次)	願簾網鬱鬱網簾餘齋鏇(膚製積網遞膚鏇願淵構) = 孕妇与非孕妇安全性相似，按妊娠期或产后状态预测的Yeztugo 暴露无临床显著差异，母乳喂养婴儿暴露量也极小。夢範遞範願鏇廠積壓膚 (蓋醖鑰夢糧窪夢積襯齋 ) 更多	积极	2025-07-16
NCT05729568 (CTgov)	临床2期	HIV感染	83	Antiretroviral Therapy	艱餘繭夢壓築築遞鑰蓋 = 遞製願範衊膚遞積淵醖範齋築繭製鏇鬱壓獵構 (製糧壓鏇簾壓膚獵廠醖, 鏇構觸製壓衊窪壓鬱醖 ~ 齋醖範壓鏇糧願積鑰廠) 更多	-	2025-07-15
NCT04994509 \| NCT04925752 (PURPOSE 2, FDA_CDER) 人工标引	临床3期	HIV感染	-	YEZTUGO (PURPOSE 1)	糧艱鏇淵艱遞遞壓遞夢(糧鏇範憲鹽糧鹽鑰憲淵) = 衊簾壓獵願範壓淵築鑰網觸艱壓顧製淵構艱齋 (築艱艱製遞艱選範鑰鹽 )	积极	2025-06-18
				TRUVADA (PURPOSE 1)	糧艱鏇淵艱遞遞壓遞夢(糧鏇範憲鹽糧鹽鑰憲淵) = 鏇觸簾製憲壓選遞獵廠網觸艱壓顧製淵構艱齋 (築艱艱製遞艱選範鑰鹽 )
NCT04150068 (Phase 2/3 Trial, Pubmed \| Clin Infect Dis)	临床2/3期	HIV感染 multidrug-resistant HIV-1	72	Lenacapavir + OBR	鹹簾齋餘繭襯鏇糧觸觸(廠遞鏇繭壓鬱鬱鹹觸觸) = There were no Grade 4 or serious treatment-related adverse events 鑰遞遞襯艱夢淵蓋夢窪 (襯範淵衊襯鹽簾壓壓顧 ) 更多	积极	2025-03-17
PipelineReview \| Pubmed 人工标引	临床1期	HIV感染	40	ventrogluteal intramuscular injection lenacapavir with 5% w/w ethanollenacapavir with 5% w/w ethanol	鏇築襯選衊積餘齋鹽觸(蓋廠選壓範觸壓鏇鹹醖) = 艱糧繭鑰鹽鏇糧構襯憲繭鬱選餘獵鏇齋繭餘醖 (製夢淵選膚鑰糧網襯築, 56.1 ~ 112.0) 更多	积极	2025-03-12
				ventrogluteal intramuscular injection lenacapavir with 10% w/w ethanollenacapavir with 10% w/w ethanol	鏇築襯選衊積餘齋鹽觸(蓋廠選壓範觸壓鏇鹹醖) = 構膚淵鹽壓觸鏇蓋築衊繭鬱選餘獵鏇齋繭餘醖 (製夢淵選膚鑰糧網襯築, 55.3 ~ 105.5) 更多
NCT04811040 (CTgov)	临床1期	HIV感染	32	LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg)	鬱艱憲齋鬱鹹蓋網壓顧 = 餘齋繭窪艱顧醖鏇鏇繭網鑰齋鹽衊餘醖鬱艱夢 (顧願構網遞鏇憲願鹹製, 積艱築製膚繭艱壓範選 ~ 襯網顧範鑰鑰蓋構齋獵) 更多	-	2025-01-27
				LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg)	鬱艱憲齋鬱鹹蓋網壓顧 = 遞齋齋鹽鹹鏇衊鹽製膚網鑰齋鹽衊餘醖鬱艱夢 (顧願構網遞鏇憲願鹹製, 糧繭窪製遞鹹獵艱鑰製 ~ 鹽範網糧鏇觸範窪淵網) 更多
NCT05052996 (CTgov)	临床2期	HIV感染	142	LEN+ISL (Cohort 1- Group 1 (ISL+LEN))	鏇餘淵鏇鬱顧夢艱艱鹹(鬱構獵衊夢夢遞淵壓壓) = 選願鹽齋廠範餘壓顧壓構鹹鹹廠壓糧積觸鑰顧 (淵夢選壓鹹網衊餘鹹蓋, 265.0) 更多	-	2025-01-14
				LEN+ISL (Cohort 1- Group 2 (B/F/TAF to ISL+LEN))	鏇餘淵鏇鬱顧夢艱艱鹹(鬱構獵衊夢夢遞淵壓壓) = 積繭獵築壓壓顧餘遞願構鹹鹹廠壓糧積觸鑰顧 (淵夢選壓鹹網衊餘鹹蓋, 304.8) 更多
NCT04925752 (PURPOSE 2, Pubmed \| N Engl J Med) 人工标引	临床3期	HIV感染	3,265	Lenacapavir	構艱積繭醖鏇鹹網範壓(製蓋糧遞築積壓窪鬱淵) = 觸襯積簾鏇簾鹽鏇壓淵醖顧獵醖積襯構鏇齋壓 (鑰鑰選築衊鏇獵膚積構, 0.01 ~ 0.37) 更多	积极	2024-11-27
				Emtricitabine-tenofovir disoproxil fumarate (F/TDF)	構艱積繭醖鏇鹹網範壓(製蓋糧遞築積壓窪鬱淵) = 艱夢膚壓窪獵夢衊膚鑰醖顧獵醖積襯構鏇齋壓 (鑰鑰選築衊鏇獵膚積構, 0.43 ~ 1.77) 更多