Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma During Anti-Lymphoma Treatment: A Multicenter Prospective Non-Randomized Controlled Study

The goal of this clinical trial is to evaluate the efficacy and safety of different antiretroviral therapy (ART) strategies in adults with AIDS-related lymphoma (ARL) receiving anti-lymphoma treatment. The main questions it aims to answer are:
Does long-acting injectable ART, including albuvirtide (ABT) or long-acting cabotegravir/rilpivirine (CAB/RPV), improve virological suppression compared with oral ART during anti-lymphoma treatment? Do different ART strategies differ in immune recovery, virological failure, low-level viremia, and safety in patients with ARL?
Researchers will compare three treatment strategies-oral ART alone, oral ART plus long-acting albuvirtide (ABT), and long-acting cabotegravir/rilpivirine (CAB/RPV)-to determine whether long-acting injectable ART provides better virological control and comparable safety during lymphoma treatment.
Participants will:
Receive one of three ART strategies according to their clinical condition and treatment preference while receiving standard anti-lymphoma therapy.
Attend scheduled study visits at baseline and Weeks 4, 8, 12, 24, 36, and 48. Undergo plasma HIV-1 RNA testing, CD4+ T-cell count measurement, laboratory assessments, and safety evaluations throughout the 48-week follow-up period.
Be monitored for virological suppression, immune recovery, adverse events, and lymphoma-related clinical outcomes.

开始日期2026-05-26

申办/合作机构

上海大众卫生投资有限公司

ChiCTR2600119477

/ SuspendedN/AIIT

Efficacy, Influencing Factors, and Changes in Cardiovascular Disease Risk Associated with the Use of Albuvirtide (ABT) to Promote Immune Reconstitution in Treated HIV-1-Infected Patients with Immunological Non-responder

开始日期2026-02-01

申办/合作机构-

ChiCTR2600119426

/ SuspendedN/AIIT

A clinical study of pegylated interferon alfa-2b combined with Albuvirtide (ABT) for functional cure in HIV-1 infection

开始日期2025-10-09

申办/合作机构-

100 项与艾博韦泰相关的临床结果

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100 项与艾博韦泰相关的转化医学

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100 项与艾博韦泰相关的专利（医药）

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项与艾博韦泰相关的文献（医药）

2026-07-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Efficacy and safety of albuvirtide intensification for low-level viremia in people with HIV-1: A retrospective pilot study

Article

作者: Xie, Tingting ; Li, Ping ; Zhang, Chuantiao ; Cao, Yang ; Liu, Yuantao ; Qian, Shu

BACKGROUND:

Low-level HIV-1 viremia (LLV) predicts virologic failure and remains a therapeutic challenge, particularly in cases where drug resistance restricts available oral treatment options. This study evaluated the efficacy and safety of intensification with the long-acting fusion inhibitor albuvirtide (ABT) in persons with HIV(PWH) experiencing LLV.

METHODS:

We conducted a retrospective, single-arm pilot study involving adults living with HIV-1 with confirmed plasma HIV-1 RNA (50-200 copies/mL) despite receiving stable antiretroviral therapy for >24 weeks. ABT was administered as a 12-week induction (320 mg daily for 3 days, then weekly) followed by a 16-week maintenance phase (weekly or every 4 weeks) combined with the background regimen. Primary endpoints were the rates of achieving an undetectable viral load (<50 copies/mL) and longitudinal T-cell subset changes.

RESULTS:

Of 27 enrolled participants, 77.8% (21/27) achieved viral suppression at Week 12. By Week 28, the rate of undetectable viral load rose to 85.2% (23/27). Linear mixed-effects models showed significant immune reconstitution: CD4⁺T-cell counts increased by 123.52 cells/µL at Week 28 (P< 0.001), And CD8⁺T-cell counts remained stable (P = 0.619). The CD4/CD8 ratio improved significantly (coefficient = 0.16, P < 0.001). No serious adverse events or toxicity-related discontinuations occurred.

CONCLUSION:

Albuvirtide intensification represents a safe and well-tolerated strategy with the potential to achieve undetectable viral loads in PWH experiencing LLV. The regimen induced a favorable immune profile characterized by selective CD4⁺T recovery. It supporting ABT as a valuable strategy for managing complex LLV cases.

2026-07-01·INTERNATIONAL JOURNAL OF STD & AIDS

Albuvirtide-based regimens for advanced- stage HIV and Talaromyces marneffei co-infection: A longitudinal case series

Article

作者: Li, Shengyi ; Nong, Wenjun ; Yu, Xiaoshu ; Lu, Yansi ; Song, Cong ; Ma, Fuyan ; Tan, Lianlian ; Ma, Qinge ; Zhou, Changjing ; He, Jingjing ; Zou, Jun ; Lu, Pingxuan

Objective:

Talaromyces marneffei (TM) represents a major opportunistic infection among People living with HIV (PLWH) in Southeast Asia and southern China. This study aimed to evaluate the efficacy and safety of Albuvirtide (ABT, currently licensed only in China)-based antiretroviral regimens during the advanced stage of infection in this understudied population.

Methods:

We conducted a longitudinal case series from June 2022 to March 2024 at two hospitals in Guangxi, China. The study included treatment-naive HIV/TM co-infected patients who initiated ABT-based antiretroviral therapy combined with oral background regimens (predominantly dolutegravir/lamivudine or bictegravir/emtricitabine/tenofovir alafenamide). Analyses and findings evaluated after 6 weeks of treatment included changes in HIV viral load, CD4 + T-cell count, and CD4/CD8 ratio. Data were analyzed using Wilcoxon signed-rank and McNemar’s tests.

Results:

A total of 52 patients were included. Excluding one patient lost to follow-up, the 6-week survival rate was 98.0% (50/51), with a single mortality attributed to advanced disease. In the 50 patients analyzed, the median viral load decreased rapidly from 274,500 (IQR: 52,775-794,874) to 119.5 (IQR: 40-464.5) copies/mL (P < 0.001). The median CD4 + T-cell count increased significantly from 14.0 (IQR: 5.0-32.0) to 83.5 (IQR: 35.0-127.75) cells/μL (P < 0.001). The CD4/CD8 ratio showed an improving trend (0.065 to 0.100, P = 0.058). No severe adverse events related to the study drugs were observed.

Conclusion:

Findings from this small case series suggest that ABT-based regimens demonstrated a favorable safety profile and achieved rapid viral suppression during the critical advanced stage of HIV/TM co-infection. These findings suggest that adding parenteral ABT to oral background regimens provides a feasible and intensified treatment strategy to stabilize critically ill patients, particularly those with potential gastrointestinal dysfunction.

2026-01-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Safety, pharmacokinetics, and efficacy of albuvirtide administered by intravenous bolus every 4 weeks in combination with oral dolutegravir in virologically suppressed adults living with HIV: A 24-week study

Article

作者: Fu, Yanhua ; Xie, Xiaoxin ; Yang, Xiaoyan ; Song, Yebing ; Guo, Lei ; Song, Chunli ; Gan, Lin ; Long, Hai ; Sun, Fangfang

BACKGROUND:

Albuvirtide (ABT), China's first domestically developed long-acting HIV-1 fusion inhibitor, shows significant potential for simplifying antiretroviral therapy when used in combination with dolutegravir (DTG).

METHODS:

This single-center, open-label, single-arm pilot study enrolled nine virologically suppressed people living with HIV. Participants received ABT 640 mg via intravenous bolus every 4 weeks plus a daily oral dose of DTG 50 mg for 24 weeks. The primary endpoints were the virologic failure rate and pharmacokinetic (PK) interactions.

RESULTS:

All nine participants completed the 24-week study with no virologic failures. A statistically significant increase in CD4+ T cell count was observed (median change +66 cells/µl, P = 0.045). The PK profile was favorable, with the steady-state ABT trough concentrations being approximately 27-fold the required inhibitory concentration, and no clinically significant PK interactions were noted. Treatment-emergent adverse events were mild to moderate, most commonly laboratory abnormalities and transient cardiac events, with no discontinuations due to AEs.

CONCLUSION:

In this small-sample, open-label study, the combination of 4-weekly ABT with daily DTG demonstrated excellent short-term efficacy, a favorable safety profile, and desirable pharmacokinetic properties over 24 weeks. These preliminary findings support further investigation of this novel long-acting regimen in larger, controlled clinical trials.

317

项与艾博韦泰相关的新闻（医药）

2026-09-03

·新浪财经

前沿生物(688221)2026年半年报点评：双靶小核酸深度布局营收结构持续优化

前沿生物中期业绩公告：公司上半年实现总营业收入3.13 亿元，同比增长434.27%；利润总额达到1.49 亿元，同比扭亏为盈。扣非归母净利润1.28 亿元，经营活动现金流净额1.81 亿元由负转正，盈利质量较高。　　业绩高增长主要系2026 年2 月公司与GSK 达成两款小核酸管线全球独家授权合作，本期确认授权许可收入2.77 亿元，该笔收入直接拉动营收规模扩张并推动业绩扭亏，同时大幅优化了公司经营性现金流，为后续研发投入提供充足资金支撑。　　与GSK 达成两款小核酸管线全球独家授权，双靶小核酸布局全面。公司构建小核酸递送与双靶点分子设计两大核心技术能力，自主开发ACORDE 肝外递送技术，已在肌肉、脂肪、心脏等组织完成概念验证。　　公司与GSK 达成两款小核酸全球独家授权，首付款加里程碑合计超10 亿美元，完成创新成果的国际化输出。其中一款小核酸FB7013 进入I 期临床。　　公司小核酸管线重点布局心血管-肾脏-代谢综合征（CKM）等临床需求广阔的疾病领域。研发端选择具备病理协同调控效应的靶点组合，推动管线从传统单靶点小核酸药物向双靶点小核酸药物迭代升级。在双靶点小核酸药物布局方面，公司已形成覆盖代谢、心血管、肾脏等领域的差异化产品矩阵，核心在研产品包括：　　针对ASCVD 的FB7023 （ PCSK9/Lp(a) ）、针对MASH 的FB7033（HSD17B13/CIDEB）、针对肾病的FB7013 和FB7011，以及其他疾病领域的早研产品。　　公司三线布局，持续构筑自身核心竞争优势。2026 年上半年，公司围绕“长效抗HIV 药物+新技术小核酸药物+高端仿制药”核心战略。艾可宁稳定贡献营收底盘，FB3002 已获批上市，FB4001 处于技术审评阶段。公司以小核酸为核心主线、以抗病毒为基础支撑、以高端仿制药为稳健补充，持续构筑自身核心竞争优势。　　投资建议：前沿生物商业化稳步推进，并在前沿赛道双靶小核酸领域广泛布局。　　我们预计2026-2028 年公司营业收入分别为4.18/2.81/3.35 亿元，同比增速为239%/-32.8%/19.1%；归母净利润分别为0.25/-0.99/-0.88 亿元；EPS 分别为0.07/-0.26/-0.24 元；PS 分别是15/23/19 倍。考虑到小核酸药物赛道目前正处于快速发展的阶段，我们看好公司小核酸药物的前瞻布局。维持“推荐”评级。　　风险提示：候选药物研发不及预期的风险；相关技术迭代的风险；商业化不及预期的风险；核心人才流失的风险。

2026-09-02

·江宁科学园

企业汇 | 前沿生物荣获“新质企业金牛奖”

近日，由中国证券报主办的2026科技创新与产业高质量发展大会成功举办，园区企业前沿生物药业（南京）股份有限公司（以下简称“前沿生物”）凭借在创新药领域持续的技术突破、硬核研发实力与产业成长潜力，荣膺“新质企业金牛奖”（生物医药）。大会以“科创引领・链动新质”为主题，聚焦新质生产力培育、科创产业升级等关键议题，是国内资本市场链接硬科技实体产业的产业盛会。金牛奖是国内资本市场公信力与影响力兼具的标杆评选，新质企业金牛奖作为面向硬科技上市公司推出的专项荣誉，跳出单一短期财务指标评价逻辑，重点考察企业原始创新能力、核心技术壁垒、科研成果转化水平以及赛道长期战略价值，筛选深耕关键技术攻关、具备产业引领潜力的科创标杆企业。本次获评，代表资本市场、行业专家对前沿生物研发模式、管线布局、商业化成效与产业使命的综合权威认可。创新药是生物医药领域发展新质生产力的核心载体，原始创新是行业发展的底层驱动力。前沿生物搭建覆盖药物早期发现、临床开发、产业化落地的完整创新链条，立足国内重大未被满足的临床治疗需求，同时通过技术授权、管线合作等多元路径推进国际化布局，以小核酸、多肽为代表的生物医药硬科技，助力国内创新药产业能级升级。研发层面，前沿生物将小核酸创新药作为核心发展主线，公司聚焦心血管‑肾脏‑代谢综合征（CKM）赛道，搭建覆盖 MASH、降血脂、IgA肾病等适应症的产品矩阵，3款双靶点候选药物稳步推进关键性研究，单靶点产品FB7013已经获批临床并顺利开展Ⅰ期入组随访；部分管线研究成果亮相EASL 2026、OCC 2026等国际顶级学术会议，收获全球专家广泛关注与积极评价。在底层技术能力建设上，前沿生物同步构建ACORDE肝外递送技术平台，以及双靶点单分子设计技术，打造ACORDE递送平台+双靶点单分子设计双重核心技术壁垒。ACORDE肝外递送技术已完成肌肉、脂肪、心脏等多组织概念验证，有望破解小核酸药物靶向组织受限的行业痛点；依托自主双靶点单分子设计技术能力，可同步沉默双重致病靶点，实现通路协同增效。依托小核酸技术硬实力，前沿生物达成与跨国药企的全球授权合作，实现中国原创技术的国际化价值验证。商业化层面，该公司多元化矩阵稳步落地。核心产品艾可宁®持续拓宽基层与院外终端覆盖，深挖门诊序贯治疗市场；缬康韦®完成全国各省挂网，市场规模稳步扩大；小沿易贴® 采用自营加招商模式拓展商业化网络；CDMO产业化服务持续接单，镇痛管线新品近期斩获药品注册证书，为未来增长储备新动能，商业化体系多点开花，不断夯实企业经营基本盘。立足新发展阶段，前沿生物将以本次获奖为全新起点，依托资本市场赋能，持续释放自主创新势能，把技术优势转化为临床价值与产业价值，深度践行科创企业使命，书写创新驱动高质量发展的新篇章。来源：前沿生物编辑：郭芳、江大庆审核：王远龙发布：张海洋 THE END ✦ 苏南国家自主创新示范区核心区 ✦ 国家创新型特色园区 ✦ 国家创新人才培养示范基地 ✦ 国家火炬(江宁)生物医药特色产业基地 ✦ 江苏省知识产权示范园区 ✦ 江苏省留学人员创业园 ✦ 江苏省众创社区长按二维码关注我们~

2026-09-02

·前沿生物药业

前沿生物荣获 “新质企业金牛奖”｜硬科技赋能新质发展，创新药实力获资本市场权威认可

点击上方蓝字关注我们近日，由中国证券报主办的2026科技创新与产业高质量发展大会在江苏常州隆重举办。前沿生物药业（南京）股份有限公司（688221.SH）凭借在创新药领域持续的技术突破、硬核研发实力与产业成长潜力，荣膺新质企业金牛奖。公司董事、首席技术官陆荣健博士代表企业出席本次大会，并登台领取该项重磅荣誉。大会以“科创引领・链动新质”为主题，聚焦新质生产力培育、科创产业升级等关键议题，是国内资本市场链接硬科技实体产业的产业盛会。金牛奖是国内资本市场公信力与影响力兼具的标杆评选，新质企业金牛奖作为面向硬科技上市公司推出的专项荣誉，跳出单一短期财务指标评价逻辑，重点考察企业原始创新能力、核心技术壁垒、科研成果转化水平以及赛道长期战略价值，筛选深耕关键技术攻关、具备产业引领潜力的科创标杆企业。本次获评，代表资本市场、行业专家对前沿生物研发模式、管线布局、商业化成效与产业使命的综合权威认可。创新药是生物医药领域发展新质生产力的核心载体，原始创新是行业发展的底层驱动力。前沿生物搭建覆盖药物早期发现、临床开发、产业化落地的完整创新链条，立足国内重大未被满足的临床治疗需求，同时通过技术授权、管线合作等多元路径推进国际化布局，以小核酸、多肽为代表的生物医药硬科技，助力国内创新药产业能级升级。研发层面，前沿生物将小核酸创新药作为核心发展主线，公司聚焦心血管‑肾脏‑代谢综合征（CKM）赛道，搭建覆盖 MASH、降血脂、IgA肾病等适应症的产品矩阵，3款双靶点候选药物稳步推进关键性研究，单靶点产品FB7013已经获批临床并顺利开展Ⅰ期入组随访；部分管线研究成果亮相EASL 2026、OCC 2026等国际顶级学术会议，收获全球专家广泛关注与积极评价。在底层技术能力建设上，前沿生物同步构建ACORDE肝外递送技术平台，以及双靶点单分子设计技术，打造ACORDE递送平台+双靶点单分子设计双重核心技术壁垒。ACORDE肝外递送技术已完成肌肉、脂肪、心脏等多组织概念验证，有望破解小核酸药物靶向组织受限的行业痛点；依托自主双靶点单分子设计技术能力，可同步沉默双重致病靶点，实现通路协同增效。依托小核酸技术硬实力，公司达成与跨国药企的全球授权合作，实现中国原创技术的国际化价值验证。商业化层面，公司多元化矩阵稳步落地。2026 年上半年，公司营业总收入31,329.62万元，同比激增434.27%；取得归母净利润14,893万元。核心产品艾可宁®持续拓宽基层与院外终端覆盖，深挖门诊序贯治疗市场；缬康韦®完成全国各省挂网，市场规模稳步扩大；小沿易贴® 采用自营加招商模式拓展商业化网络；CDMO产业化服务持续接单，镇痛管线新品近期斩获药品注册证书，为未来增长储备新动能，商业化体系多点开花，不断夯实企业经营基本盘。立足新发展阶段，前沿生物将以本次获奖为全新起点，依托资本市场赋能，持续释放自主创新势能，把技术优势转化为临床价值与产业价值，深度践行科创企业使命，书写创新驱动高质量发展的新篇章。

100 项与艾博韦泰相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D13020	-	J05A	DB15166

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
HIV感染	中国	前沿生物药业（南京）股份有限公司	2018-05-23

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
获得性免疫缺陷综合征	临床3期	中国	重庆前沿生物技术有限公司	2014-02-19

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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


Pubmed \| Int J Infect Dis	N/A	HIV感染	9	Dolutegravir 50 mg + Dolutegravir 50 mg	範範選簾醖構簾獵蓋壓(選糧積積願壓獵鬱窪壓) = Treatment-emergent adverse events were mild to moderate, most commonly laboratory abnormalities and transient cardiac events, with no discontinuations due to AEs 觸窪構觸觸顧艱築鏇選 (網淵憲壓餘願觸願選構 )	积极	2026-01-01
NEWS 人工标引	N/A	HIV感染	-	艾可宁	壓醖餘築糧觸蓋顧觸廠(製選餘獵選淵糧構積糧) = 受试者接受基于艾可宁®的强化方案治疗12周后，可以明显改善CD4+T淋巴细胞计数，较对照组具有显著的优效性。選鹽鏇憲遞觸鬱衊獵簾 (鏇繭憲淵簾選構遞鑰醖 ) 更多	积极	2024-07-29
				对照组
Company_Website 人工标引	N/A	HIV感染	10	艾博韦泰+多替拉韦	憲艱齋構簾餘餘壓膚獵(顧積衊憲淵範築壓餘遞) = None 選襯壓選餘醖鏇鹽選簾 (簾齋膚壓鏇淵獵築廠鏇 ) 更多	积极	2024-06-28
NCT02369965 (TALENT, NEWS) 人工标引	临床3期	HIV感染	418	Lopinavir/Ritonavir+艾可宁	膚觸選鏇簾鹹鬱膚憲製(鹹網艱鬱廠艱顧築鑰顧) = 選願鹹簾範選衊鹽簾憲觸獵壓衊衊築蓋餘壓鏇 (顧艱蓋窪鹽製齋鏇憲齋 )	非劣	2022-06-13
				Lopinavir/Ritonavir+NRTI	膚觸選鏇簾鹹鬱膚憲製(鹹網艱鬱廠艱顧築鑰顧) = 膚窪憲鹹鑰積範糧衊獵觸獵壓衊衊築蓋餘壓鏇 (顧艱蓋窪鹽製齋鏇憲齋 )