Evaluating Persistence of Switching From Oral RPV/FTC/TAF to Long- Acting Injectable CAB+RPV in a Cohort of Virologically-suppressed PLWH: a Real-life Study

People living with HIV (PLWH) need to take antiretroviral therapy (ART) long-life. The development of new and more effective ART regimens has increased viral suppression and improved the recovery of immune function, leading to an extension of the lifespan of PLWH. However, antiretroviral drugs have short- and long-term side effects. In fact, ART has recently been reported as one of the significant factors associated with metabolic syndromes (obesity, liver disease, and factor). This insidious progression of long-term metabolic complications has become a new challenge for our clinics. Therefore, optimizing ART in the context of viral suppression is mandatory. In recent years, thanks to the availability of more potent drugs with a high genetic barrier, simplification strategies have been explored with various regimens containing fewer drugs for PLWH who are virologically suppressed on a standard three-drug regimen. Based on international guidelines, following the results of clinical trials, two-drug regimens are now recommended as pro-active switch strategies within preventive strategies to reduce morbidity in PLWH. Following the results of the ATALS-2M, FLAIR, and SOLAR studies, the long-acting parenteral regimen containing cabotegravir and rilpivirine (CAB+RPV), administered every 2 months, has been included in the guidelines as a pro-active switch strategy for maintaining virological suppression. Cabotegravir, a new integrase inhibitor (INI), has demonstrated high efficacy, excellent tolerability, and safety, with a higher-than-average genetic barrier.
Rilpivirine is a non-nucloside reverse transcriptase inhibitor (NNRTI) with potent virological efficacy and a favorable safety profile compared to other NNRTIs. This type of strategy has several primary advantages: improve adherence, especially in complex PLWH, easier to integrate into daily activities, less likely to generate stigma and/or discrimination.
Furthermore, intramuscular administration, bypassing intestinal metabolism, potentially reduces the severity of drug-drug interactions. In light of the growing attention to the metabolic impact of various antiretroviral therapy regimens and their associated adverse events, it is crucial to examine the tolerability of this injectable regimen as a medium- and long-term switching strategy. The results of the Phase 3 studies are based on populations with a short exposure to antiretroviral drugs, which may not be generalized to PLWH with a long history of ART, who represent the majority of patients in clinical practice in high-income countries. This study aims, in a clinical practice setting, to evaluate the cumulative probability of treatment discontinuation (TD) at 48 weeks in PLWH switching to the injectable LA CAB + RPV (LAI CAB + RPV) regimen from an oral regimen with rilpivirine/emtricitabine/tenofovir alafenamide fumarate (RPV + FTC + TAF).

开始日期2026-06-01

申办/合作机构-

NCT07727642

/ RecruitingN/AIIT

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

NCT07370649

/ RecruitingN/AIIT

Long-Acting Cabotegravir And Rilipivirine In People Living With HIV-1 Subtype A6. A Multicentre Real-world, Retrospective Matched Case Study

This study evaluates the real-world effectiveness and safety of a long-acting injectable HIV treatment consisting of cabotegravir and rilpivirine in people living with HIV-1. The focus is on individuals with HIV-1 subtype A6, which is common in Eastern Europe and among people who acquired HIV in that region, and on comparison with individuals with subtype B and those with an unknown subtype.
Although long-acting cabotegravir and rilpivirine are widely used and effective, limited real-world data are available on how well this treatment works in people with HIV-1 subtype A6. This is important because subtype A6 has been suggested as a potential risk factor for treatment failure, but current evidence is inconclusive.
The study uses existing medical records from treatment centers in Poland, Germany, and the Czech Republic. It includes adults with HIV who have received at least one injection of long-acting cabotegravir and rilpivirine and follows their clinical outcomes for up to 24 months. Researchers will assess viral suppression, treatment persistence, adherence to injection schedules, and reasons for treatment discontinuation.
The results of this study will help clinicians better understand whether HIV-1 subtype A6 affects treatment outcomes and whether knowing a patient's HIV subtype is important when deciding to switch to long-acting injectable therapy. The findings may support safer and more effective use of this treatment in diverse patient populations.

开始日期2026-05-12

申办/合作机构

ViiV Healthcare Ltd.

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100 项与卡博特韦/利匹韦林相关的专利（医药）

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项与卡博特韦/利匹韦林相关的文献（医药）

2026-03-01·Contemporary Clinical Trials

Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa

Article

BACKGROUND:

Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults.

METHODS:

LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12- < 20 years in Kenya/South Africa/Uganda/Zimbabwe. Randomisation was 1:1 to LAI CAB/RPV given once every 8 weeks (after optional oral lead-in) or daily oral TLD. The primary outcome is viral rebound (two consecutive viral loads ≥50 copies/mL by 96-weeks). Viral loads are measured every 24 weeks. The trial employs the Smooth Away From the Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event rate in the control arm. Secondary outcomes include confirmed viral load ≥200 copies/mL by 96-weeks, HIV resistance, safety, patient-reported outcomes and cost-effectiveness. LAI participants return to oral ART at confirmed viral load ≥200 copies/mL; LAI participants who become pregnant are given the choice to continue on LAI or to switch back to daily oral ART, with optional pharmacokinetic sampling during pregnancy and post-partum in both groups. Enrolment of 476 AHIV completed in April 2024. Results will be reported in 2026.

CONCLUSION:

LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing.

TRIAL REGISTRATION:

This trial has been registered with ClinicalTrials.gov (NCT05154747).

2022-08-03·Expert review of anti-infective therapy

Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV

Review

作者: Namvar, Ali ; Heidary, Mohsen ; Ghahramanpour, Hossein ; Soleimani, Faezeh ; Taki, Elahe ; Asadi, Arezoo

INTRODUCTION:

The development of long-acting (LA) drugs has changed the management of common medical conditions for human replication immunodeficiency virus (HIV). Cabenuva (cabotegravir/Rilpivirine) is the first LA antiretroviral injectable drug composed of nano-formulation of cabotegravir (CAB) and rilpivirine (RPV).

AREAS COVERED:

In this review article, we aim to have a brief overview of results of major clinical trials that administrated Cabotegravir/Rilpivirine for patients considering the efficacy and safety profiles. Moreover, we discuss about CAB and RPV chemical structure, mechanism of action, ‎activity against drug-sensitive and -resistant HIV, and pharmacodynamics/pharmacokinetics properties.

EXPERT OPINION:

Based on the results of the ATLAS and FLAIR trials, Cabotegravir/Rilpivirine regimen once-monthly has shown equal effectivity to oral combination antiretroviral therapy (cART) in maintaining HIV-1 suppression in patients. Furthermore, ATLAS-2 M study revealed the non-inferiority of Cabotegravir/Rilpivirine regimen every 8 weeks compared to every 4 weeks. The injectable LA ART reduces the number of treatment intake as well as increases adherence, especially in patients with HIV-related stigma. Administration of extended-release agents probably minimize the risk of treatment-related toxicity and resistance related to sub-optimal adherence to oral ART, so Cabotegravir/Rilpivirine can be suggested as a suitable alternative for HIV infection control in current era.

2022-08-01·AIDS (London, England)

Cabotegravir–rilpivirine treatment initiation in a nonvirologically suppressed patient

Article

作者: Laura Armas-Kolostroubis ; Steven K. Barnett ; Michael Sension ; David J. Riedel

Currently, there is a single option for a complete parenteral HIV antiretroviral therapy (ART) regimen.Cabotegravir rilpivirine is a complete HIV ART regimen combining an extended-release injectable integrase strand inhibitor (INSTI) solution (cabotegravir) with an extended-release injectable nonnucleoside reverse transcriptase inhibitor (NNRTI) solution (rilpivirine), which allows for once-amonth dosing.We describe a patient who had failed four different traditional oral HIV ART regimens and had no ART resistance who was initiated on a once-monthly injection of cabotegravir-rilpivirine to circumvent poor pill adherence and gastrointestinal concerns.

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项与卡博特韦/利匹韦林相关的新闻（医药）

2026-10-06

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基因测序与药物研发每日资讯 · 2026-10-07

基因测序与药物研发每日资讯当日资讯摘要基因测序：水稻：全生命周期时空细胞图谱登 Cell——119 种细胞类型、133 个亚型，第一次把细胞身份与它在植株里的位置对上[1] 药物研发 · 基因与细胞治疗：EGFR 20 插入肺癌：伏美替尼一线未达终点——盲态评审 PFS 11.0 对 9.5 个月，次要终点仍显获益[6] 监管获批 · 投资并购：软骨发育不全：口服 infigratinib 获优先审评——年化身高速度改善 2.10 cm/年，PDUFA 定在 2027 年 2 月[14] 一、🧬 基因测序（4 条） 1. 水稻：全生命周期时空细胞图谱登 Cell 2026-10-06 · Cell · 崖州湾国家实验室 / 华大生命科学研究院崖州湾国家实验室联合华大生命科学研究院、华中农业大学等十二家机构，用华大智造时空组学 Stereo-seq、DNBelab C 系列单细胞核 RNA 测序与 DNBSEQ-T7 平台，以粳稻中花 11 为材料构建出覆盖 10 类器官组织、61 个发育阶段的水稻全生命周期三维时空细胞图谱，成果 10 月 6 日在线发表于 Cell[1]。其中空间转录组覆盖 43 个关键发育阶段，单核 RNA 测序覆盖 47 个，共注释出 119 种细胞类型与 133 个细胞亚型。过去研究细胞常常丢掉它们在植株里的原始位置，只能知道水稻有哪些基因，说不清基因具体在哪里发挥作用。这份图谱显示，看似浑然一体的胚乳内部存在精细的空间分工：靠近背部富集碳水化合物代谢与淀粉合成相关基因，靠近腹部则偏向储藏蛋白合成；突变实验进一步证实，相关基因改变会影响淀粉与蛋白在背腹两侧的积累格局。 2. 小鼠胚胎：空间三维基因组技术问世 2026-10-06 · Developmental Cell · 中国科学院遗传与发育生物学研究所中国科学院遗传与发育生物学研究所李响团队 10 月 6 日在 Developmental Cell 发表空间三维基因组学技术 SpaceA，把微流控空间条形码与无连接酶的接触检测策略结合，在组织切片原位高置信解析远距离染色质互作[2]。团队对 9 个小鼠胚胎切片、覆盖 E11.5 至 E14.5 四个发育时期开展测序，产出约 4 TB 高深度数据。单细胞三维基因组技术此前无法保留细胞在组织中的空间位置；已有的空间三维方案多基于连接反应的 Hi-C，更容易抓到 10 Mb 以内的近距离互作。SpaceA 换用无连接路线后远距离互作检出明显增多，据此发现 A/B 区室在 E12.5–E13.5 剧烈转变并与转录组剧变同步，还首次看到胚胎肝脏里 10–40 Mb 中距离互作增强、40 Mb 以上远距离互作减弱的独特组装方式。 3. 杜氏肌营养不良：长读长破解复杂倒位 2026-10-05 · npj Genomic Medicine · 国际研究团队部分杜氏肌营养不良病例因复杂结构变异，常规基因检测一直查不出病因。研究团队对 4 名常规检测阴性的先证者同时做了长读长测序与 RNA 测序，在所有人中都找到此前未报道的、破坏 DMD 基因座的大范围倒位，跨度 4 到 80 Mbp 不等，断点全部经 Sanger 测序验证，其中三个为母系遗传[3]。其中一名先证者的数据尤其能说明参考基因组的价值：改用 T2T-CHM13 完整参考基因组比对后，GRCh38 下出现的假阳性被消除，RNA 测序还检出一个致病的 DMD-PRRG1 融合转录本。研究认为，以 T2T-CHM13 为底的长读长测序，是解决这类复杂致病结构变异的有力手段，也让这批长期查不出病因的家庭有了明确答案。 4. 视网膜色素变性：IDUA 基因型被锁定 2026-10-06 · The American Journal of Human Genetics · Greenwood 遗传中心 Greenwood 遗传中心牵头、二十余家机构参与的国际研究，在 12 个家系的 14 名视网膜色素变性患者中发现，他们两个拷贝的 IDUA 基因都携带变异；而 IDUA 通常对应的是黏多糖贮积症 I 型这类罕见代谢病。论文 10 月 6 日发表于《美国人类遗传学杂志》[4][5]。引人注意的是，其中不少人年事已高却没有 MPS I 典型的心脏、骨骼与严重肢体受累表现。团队用自建的功能平台验证，部分变异仍保留极少量酶活性，这或可解释为何病变集中在视网膜。研究者建议，在评估遗传性视网膜病时把 IDUA 纳入检测范围，即便患者没有 MPS I 的典型特征，也不要在检出变异后就停下功能验证。二、💊 药物研发 · 基因与细胞治疗（5 条） 5. EGFR 20 插入肺癌：伏美替尼一线未达终点 2026-10-06 · 企业通稿 / SEC 8-K · ArriVent / 艾力斯 ArriVent 与艾力斯 10 月 6 日公布 III 期 FURVENT 结果：伏美替尼一线治疗 EGFR 20 号外显子插入突变的非鳞非小细胞肺癌，盲态独立中心评审的 PFS 主要终点未达标[6]。240 mg 组中位 PFS 11.0 个月，化疗对照 9.5 个月，HR 0.75（95% CI 0.55–1.02，P=0.0654），确认客观缓解率 60% 对 33%。研究者评估的 PFS（11.1 对 7.1 个月，HR 0.61）与缓解率等次要终点仍显示临床获益，总生存虽不成熟但呈改善趋势，安全性与此前研究一致、未出现新信号。伏美替尼是已在国内获批并纳入医保的第三代 EGFR 靶向药，艾力斯表示将与 ArriVent 共同评估完整数据集后再定后续开发路径[7]。按盲态评审，240 mg 组中位 PFS 比化疗长了 1.5 个月，统计上仍未跨过门槛，这也就是本条与"彻底失败"之间的距离。 6. [进展更新]威尔逊病：体内先导编辑完成首例给药 2026-10-05 · 企业通稿 · Prime Medicine Prime Medicine 10 月 5 日宣布，全球 I/II 期试验中首例患者已完成 PM577a 给药。这是该公司体内先导编辑疗法首次进入人体，也是其肝脏管线的第一个临床项目；此前 7 月 1 日该项目刚获临床批件[8]。PM577a 以脂质纳米颗粒包裹、单次静脉输注，靶向 ATP7B 基因的 p.H1069Q 突变，FDA 同期授予 PM577 罕见儿科疾病认定。试验为开放标签、全球多中心，入组至少携带一个 H1069Q 等位基因且在当前标准治疗下病情稳定的成人及青少年，先入成人并按剂量递增。终点为安全性、耐受性与初步疗效，疗效指标包括铜-64 PET 测定的铜外排、血清铜蓝蛋白、非铜蓝蛋白结合铜与 24 小时尿铜，以及能否停用基线治疗[9]。初步数据预计 2027 年读出。 7. 多发性骨髓瘤：体内 CAR-T 缓解难持久 2026-10-06 · Nature Medicine · 国际研究团队 Nature Medicine 10 月 6 日在线发表的一项延长随访显示，4 例接受体内 BCMA CAR-T 治疗的复发难治多发性骨髓瘤患者，缓解持续时间有限[10]。体内 CAR-T 不经过体外制备，而是把工程化指令直接递送进人体，让患者自身 T 细胞获得靶向受体，理论上可省下单采、清淋与数周的制造周期。样本只有 4 例，结论边界很窄，却正落在体内 CAR-T 领域最关键的那个问题上：绕开体外制造，能否拿到与常规产品同样深、同样久的缓解。BCMA 已是骨髓瘤里被反复验证的靶点，双抗与 CAR-T 都能打出高缓解率，但缓解能维持多久始终没有答案。这次随访说明，递送环节的简化并不自动换来持久性。 8. HIV：长效注射可用于未抑制者 2026-10-06 · 企业通稿 / 媒体报道 · ViiV Healthcare GSK 旗下 ViiV Healthcare 10 月 6 日宣布，IIIb 期 CROWN 研究达到主要终点：入组时仍可检测到病毒的 HIV-1 感染者，直接使用每年给药六次的长效 Cabenuva（卡博替拉韦＋利匹韦林），六个月时的病毒抑制率优于每日口服抗逆转录病毒方案[11]。研究在 8 个国家 85 个中心入组约 326 名成人与青少年。目前 Cabenuva 在美国等市场仅获批用于已在稳定治疗下达到病毒抑制的患者，本次结果指向把适用人群前推到起始治疗阶段，补上 LATITUDE 研究留下的证据缺口——入组者需无整合酶抑制剂与非核苷类反转录酶抑制剂耐药证据[12]。ViiV 表示在病毒可检测人群中的使用仍属研究性质，将把数据提交监管机构。 9. 同种异体 CAR-T：Caribou 双项目终止 2026-10-06 · SEC 8-K · Caribou Biosciences Caribou Biosciences 10 月 6 日披露，董事会已启动战略替代方案评估，可能涉及合并、收购或其他交易；同时计划停止 vispa-cel 与 CB-011 两款同种异体 CAR-T 的进一步开发并大幅裁员，裁员预计四季度基本完成[13]。截至 6 月 30 日，公司持有现金及有价证券 1.138 亿美元。首席执行官 Rachel Haurwitz 表示，这一决定与产品潜力无关，而是同种异体 CAR-T 的融资环境已难以支撑项目推进。vispa-cel 已做好关键试验准备，III 期设计也与 FDA 达成一致，是首个在临床上带 PD-1 敲除的同种异体 CD19 CAR-T。行业里"现货型"能否同时兼顾深度、持久与成本，这道考题仍在等待答案。对已经排队的患者而言，一款关键试验就绪的产品被叫停，损失的不只是一家公司的时间。三、📋 监管获批 · 投资并购（5 条） 10. 软骨发育不全：口服 infigratinib 获优先审评 2026-10-06 · 企业通稿 / 媒体报道 · BridgeBio Pharma BridgeBio 10 月 6 日宣布，FDA 已受理口服 infigratinib 治疗儿童软骨发育不全的新药申请并授予优先审评，PDUFA 目标日期为 2027 年 2 月 4 日[14]。关键 III 期 PROPEL 3 达到主要终点：第 52 周年化身高速度较安慰剂改善 2.10 cm/年，P<0.0001，身高 Z 评分这一关键次要终点同样达标。在 8 岁以下儿童的预设探索性分析中，该药成为首个在随机对照试验里显著改善身体比例的方案，臂展 Z 评分提高 0.37 个标准差；52 周治疗未出现与研究药物相关的停药或严重不良事件，睡眠呼吸暂停与中耳炎也呈改善趋势[15]。软骨发育不全由 FGFR3 激活变异引起，在美国与欧盟影响约 5.5 万人，现有获批疗法都是需要注射的 CNP 类似药。公司计划四季度向 EMA 递交上市申请。 11. [进展更新]细胞治疗耗材：Repligen 完成收购 2026-10-06 · SEC 8-K · Repligen / BioLife Solutions Repligen 10 月 6 日宣布已完成对 BioLife Solutions 的收购；交易方案此前于 8 月 5 日披露，本次为交割落地。BioLife 股东每股获得 11.25 美元现金加 0.1442 股 Repligen 普通股，零股以现金替代[16]。Repligen 将在三季度财报电话会上说明交易对 2026 年财务展望的影响。 BioLife 的核心资产是以 CryoStor 为代表的生物保存介质产品组合，已支持 18 款获批商业化疗法，以及美国多数企业申办的细胞治疗临床试验。合并后 BioLife 可借 Repligen 的全球渠道（含亚太）扩张，Repligen 则补上细胞治疗流程中高毛利、可重复的耗材业务，把工具链从上游延伸到冻存环节。对细胞治疗企业来说，这类耗材一旦嵌入工艺就很难替换，切换成本极高，正是这类收购愿意付溢价的原因。 12. 免疫学管线：Spyre 3.5 亿美元增发 2026-10-05 · 企业通稿 · Spyre Therapeutics Spyre Therapeutics 10 月 5 日公布增发定价，以每股 85 美元发行 4,117,648 股普通股，预计募资约 3.5 亿美元；承销商另有 30 天内追加约 5,250 万美元的超额配售选择权，交割预计在 10 月 7 日前后[17]。Jefferies、TD Cowen、Leerink Partners 与 Stifel 担任联席簿记管理人。募资将投向胃肠、风湿与皮肤科三大方向的临床与生产，包括为 III 期做准备，以及把 SPY072 推进到化脓性汗腺炎的后期开发。这家临床阶段公司主打更长持久性、更简用药体验的新一代免疫学疗法，在一个尚未有产品收入的阶段一次性铺足后期临床所需资金，反映的是把多个项目同时推向关键试验的节奏。增发落地后现金跑道明显拉长，短期融资压力随之下降。 13. 罕见病 RNA：万份长读长样本供 AI 建模 2026-10-06 · 企业通稿 · PacBio / TychoBio PacBio 与 AI 药物发现公司 TychoBio 10 月 6 日宣布合作：TychoBio 将用 PacBio HiFi 与 Kinnex 长读长 RNA 测序，为超过 10,000 份样本生成全长度转录本数据，用于训练 RNA 疗法设计模型[18]。首批聚焦空间位阻反义寡核苷酸，随后计划扩展到 siRNA 等其他 RNA 靶向药物。与只衡量目标位点结合不同，TychoBio 会在多种细胞类型中测试候选药物，用测序刻画整个转录组的变化，把"设计—效应—非预期改变"连成训练数据，让模型预测有效性、作用持续时间与潜在脱靶。长读长的价值正在于能看到完整 isoform 与剪接变化，这恰是短读长最容易丢失的一层信息。对 PacBio 而言，这也延续了把 HiFi 数据卖给 AI 药物发现公司的路线。 14. [进展更新]肺癌双抗：阿斯利康 20 亿美元入股交割 2026-10-05 · SEC 6-K / 媒体报道 · 阿斯利康 / Summit Therapeutics 阿斯利康 10 月 5 日宣布，已完成对 Summit Therapeutics 的 20 亿美元股权投资；交易 9 月 28 日首次披露，本次为交割落地[19]。资金用于加速 PD-1/VEGF 双抗依沃西单抗与抗体偶联药的联用开发，双方已就 sonesitatug vedotin 联用签署临床合作协议。阿斯利康以约 108,955 股优先股入股，按 1:1000 转股，折合普通股 18.36 美元[20]。阿斯利康与第一三共另与 Summit 达成合作，评估 Datroway 联合依沃西单抗在肺癌、乳腺癌等瘤种的表现。依沃西单抗的美国 BLA 已于 1 月受理，PDUFA 目标日期为 11 月 14 日。对康方生物来说，合作方拿到的是现金与一张 ADC 联用网络；对阿斯利康来说，这是在 PD-1/VEGF 双抗赛道提前锁定位置。三笔协议叠加，等于把这款双抗直接接进了自己的 ADC 版图。趋势点评今天四条测序进展有一条共同主线：测序正从"看得见"走向"定得准"。水稻图谱第一次把细胞类型与它在植株中的位置绑在一起；SpaceA 把空间分辨率从转录组推进到三维基因组；DMD 那批查不出病因的病例靠长读长与完整参考基因组找回答案。工具层每进一步，临床上就少几个"查不出来"。两条结果值得对照。伏美替尼一线 III 期在盲态评审下差一口气，研究者评估与缓解率却是正的，终点选择正成为胜负手；体内 BCMA CAR-T 延长随访提醒，简化流程不等于延长缓解。另一边，长效 HIV 注射把适用人群往前推，体内先导编辑首次进入人体。今天的资金流向很清楚：一端押注罕见病与儿童用药，软骨发育不全口服疗法拿到优先审评；另一端补基础设施与现金，细胞治疗耗材完成整合，两笔大额股权融资落定。大药厂不只在买分子，也在买把分子送进去、造出来的能力。关于 NextSeq 亦镁诺 NextSeq 亦镁诺（上海亦镁诺生物科技有限公司）专注组学数据分析与AI建模，携手美国合作伙伴 AmpSeq（实验室位于 Maryland、Boston 及 Connecticut），为科研机构与药企提供从快速测序到生信分析的端到端服务。在分析端，我们支持定制化生信Pipeline开发，并将AI建模能力拓展至肿瘤新抗原预测、mRNA/siRNA设计等药物开发场景；在CGT领域，具备面向长期安全性评估的NGS检测与解读能力。AmpSeq美国实验室同步提供Nanopore及NGS快速测序和交付服务，以灵活方案覆盖从深度分析到快速交付的多样化需求。如需了解，欢迎在公众号留言，或访问 nextseq.cn / ampseq.com。资料来源 📎 本文全部参考文献已汇总，点击底部「阅读原文」一键查看。 [1] 亿欧数据 — 首个水稻版「清明上河图」出炉登 Cell，华大智造助力绘制（2026-10-06）｜论文报道：研究团队构成、Stereo-seq 与 snRNA-seq 覆盖阶段数、细胞类型与亚型数、胚乳背腹空间分工。 https://data.iyiou.com/intelligence/details/21c289e07f37b3db781d419d9af7ca39 [2] 中国科学院遗传与发育生物学研究所 — 李响团队开发高级染色质结构的空间组学技术 SpaceA（2026-10-06）｜机构通稿：SpaceA 技术路线、胚胎切片样本数与发育时期、约 4 TB 数据量、肝脏区室互作新发现。 https://www.genetics.cas.cn/dtxw/kyjz/202610/t20261006_8289372.html [3] 生物通 — 长读长测序结合 RNA 测序揭示杜氏肌营养不良中复杂致病性结构变异（2026-10-05）｜论文报道：4 名先证者、4–80 Mbp 倒位、T2T-CHM13 比对消除假阳性、DMD-PRRG1 融合转录本。 https://www.ebiotrade.com/newsf/2026-10/202610050002106332.htm [4] Medical Xpress — Unexpected link identified between rare metabolic disease gene and inherited blindness（2026-10-06）｜论文报道：14 例患者 12 个家系、IDUA 双等位基因变异、残留酶活性解释视网膜局限表型。 https://medicalxpress.com/news/2026-10-unexpected-link-rare-metabolic-disease.html [5] American Journal of Human Genetics — Hypomorphic IDUA genotypes are associated with retinitis pigmentosa（2026）｜论文原文：期刊、DOI 与题干作者信息。 https://doi.org/10.1016/j.ajhg.2026.09.008 [6] ArriVent BioPharma 8-K — Phase 3 FURVENT Trial Update（2026-10-06）｜监管披露文件：BICR 与研究者评估的中位 PFS、HR 与 p 值、确认 ORR、≥3 级不良事件比例。 https://www.stocktitan.net/sec-filings/AVBP/8-k-arri-vent-bio-pharma-inc-reports-material-event-36613dd8ce66.html [7] Allist Pharmaceuticals — Announces Program Update from the Phase 3 FURVENT Trial（2026-10-06）｜企业通稿：艾力斯对完整数据集评估与后续开发路径的表态。 https://www.allist.com.cn/en/newsd/102/1058.html [8] Prime Medicine — First Patient Dosed in Global Phase 1/2 Trial of PM577a for H1069Q-Mutated Wilson Disease（2026-10-05）｜企业通稿：首例给药、罕见儿科疾病认定、试验设计与疗效指标、NCT07748403。 https://investors.primemedicine.com/news-releases/news-release-details/prime-medicine-announces-first-patient-dosed-global-phase-12 [9] Stock Titan — Prime Medicine announces first patient dosed in global Phase 1/2 clinical trial（2026-10-05）｜企业通稿转载：入组人群、R778L 后续候选、初步数据读出时间。 https://www.stocktitan.net/news/PRME/prime-medicine-announces-first-patient-dosed-in-global-phase-1-2-35ryx0sscadc.html [10] Developments Today — In Vivo BCMA CAR-T Shows Limited Durability in Myeloma Follow-Up（2026-10-06）｜论文报道：Nature Medicine 延长随访、4 例复发难治骨髓瘤、缓解持续时间有限。 https://developmentstoday.com/health/in-vivo-bcma-car-t-limited-durability-myeloma-follow-up [11] Clinical Trials Arena — ViiV Healthcare's Cabenuva beats daily oral ART in Phase IIIb trial（2026-10-06）｜媒体报道：CROWN 主要终点、326 名受试者、8 国 85 个中心、NCT06694805。 https://www.clinicaltrialsarena.com/news/viiv-healthcares-cabenuva-beats-daily-oral-art-in-phase-iiib-trial/ [12] ViiV Healthcare — CROWN 研究达到主要终点（2026-10-06）｜企业通稿：现行获批人群范围、研究性质定位与监管提交计划。 https://www.finanznachrichten.de/nachrichten-2026-10/69767367-viiv-healthcare-s-long-acting-hiv-treatment-cabenuva-cabotegravir-rilpivirine-meets-primary-endpoint-of-superior-viral-suppression-vs-daily-oral-004.htm [13] Caribou Biosciences 8-K — Caribou Biosciences to Evaluate Strategic Alternatives（2026-10-06）｜监管披露文件：战略替代方案、vispa-cel 与 CB-011 终止、裁员安排、6 月 30 日现金余额。 https://www.sec.gov/Archives/edgar/data/1619856/000119312526415559/d235175dex991.htm [14] BridgeBio Pharma — FDA Acceptance and Priority Review of NDA for Oral Infigratinib（2026-10-06）｜企业通稿：PDUFA 日期、PROPEL 3 主要与关键次要终点、EMA 递交计划。 https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-Oral-Infigratinib-for-Children-with-Achondroplasia/default.aspx [15] RTTNews — FDA Accepts BridgeBio's Infigratinib NDA For Priority Review（2026-10-06）｜媒体报道：年化身高速度 +2.10 cm/年、身体比例与臂展改善、安全性。 https://www.rttnews.com/3696883/fda-accepts-bridgebio-s-infigratinib-nda-for-priority-review.aspx [16] Repligen Corporation 8-K — Repligen Completes Acquisition of BioLife Solutions（2026-10-06）｜监管披露文件：交割对价、CryoStor 覆盖 18 款商业疗法、业务互补表述。 https://www.sec.gov/Archives/edgar/data/730272/000119312526415015/d240327dex991.htm [17] Spyre Therapeutics — Pricing of $350.0 Million Public Offering（2026-10-05）｜企业通稿：发行股数与价格、募资总额、超额配售选择权、交割时间与募资用途。 https://www.biopharmawatch.com/news/SYRE/spyre-therapeutics-350-million-public-offering [18] PacBio — PacBio and TychoBio Collaborate to Train AI Models for Rare Disease RNA Therapeutics（2026-10-06）｜企业通稿：10,000+ 样本、HiFi 与 Kinnex 长读长 RNA 测序、SBO 到 siRNA 的扩展计划。 https://www.pacb.com/press_releases/pacbio-and-tychobio-collaborate-to-train-ai-models-for-rare-disease-rna-therapeutics/ [19] AstraZeneca PLC 6-K — AstraZeneca completes equity investment in Summit（2026-10-05）｜监管披露文件：20 亿美元股权投资交割、与 ADC 联用开发安排。 https://www.sec.gov/Archives/edgar/data/901832/000165495426008783/a6290x.htm [20] RTTNews — Summit Therapeutics Secures $2B Strategic Investment From AstraZeneca（2026-10-05）｜媒体报道：108,955 股优先股、1:1000 转股比、18.36 美元折算价、PDUFA 11 月 14 日。 https://www.rttnews.com/3696463/summit-therapeutics-secures-2b-strategic-investment-from-astrazeneca.aspx 关注 NextSeq亦镁诺，每日获取基因测序与药物研发最新资讯。

2026-10-06

·Business Wire

ViiV Healthcare’s long-acting HIV treatment Cabenuva (cabotegravir + rilpivirine) meets primary endpoint of superior viral suppression vs. daily oral therapy in people with viremia

LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced the phase IIIb CROWN study met its primary endpoint, demonstrating that at six months, long-acting Cabenuva (cabotegravir + rilpivirine [CAB + RPV LA]) achieved superior rates of viral suppression compared with standard-of-care oral antiretroviral therapy (ART) in adults and adolescents living with HIV-1 who had detectable virus when they entered the study. Findings build on the LATITUDE study, which demonstrated that CAB + RPV LA was superior to daily oral therapy in maintaining viral suppression among people with HIV who had achieved viral suppression on oral ART but had a history of adherence challenges. CROWN addresses a remaining evidence gap by evaluating direct initiation of the regimen in people who still had detectable virus at study entry and had no evidence of resistance to INSTIs (integrase inhibitors) or NNRTIs (non-nucleoside reverse transcriptase inhibitors). Use of CAB + RPV LA in people with detectable viremia is investigational and has not been approved by regulatory authorities. Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: "People living with HIV who experience challenges achieving or maintaining viral suppression with daily oral therapy continue to face significant barriers to optimising care. The CROWN study was designed to address this important evidence gap. These findings add to the growing body of data around long-acting treatment with cabotegravir plus rilpivirine, and provide important insights into the potential role of this approach for treatment-experienced people living with HIV." CROWN is an international, randomised, open-label study designed to evaluate whether people living with HIV-1 who have detectable virus despite a history of daily oral ART can directly initiate CAB + RPV LA, administered six times a year, and achieve viral suppression. The study enrolled approximately 326 participants, including adults and adolescents, across eight countries at 85 study sites. CAB + RPV LA is currently approved in the US and other markets under the brand name Cabenuva and Vocabria + Rekambys in the EU and Japan for the treatment of HIV-1 infection in adults and adolescents who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Full results are planned for presentation at an upcoming scientific meeting. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Johnson & Johnson. Rilpivirine tablets are approved in the US and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information here. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 with GSK (LSE: GSK) and Shionogi as current shareholders. The company is dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. ViiV Healthcare’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025, and GSK’s Q2 Results for 2026. Registered in England & Wales: GSK plc ViiV Healthcare Limited No. 3888792 No. 06876960 Registered Office: 79 New Oxford Street ViiV Healthcare Limited London GSK Medicines Research Centre WC1A 1DG Gunnels Wood Road, Stevenage United Kingdom SG1 2NY

临床3期临床结果上市批准

2026-10-06

·Firstwordpharma

GSK's long-acting Cabenuva scores win in unsuppressed HIV

GSK said Tuesday that Cabenuva (cabotegravir/rilpivirine) delivered superior viral suppression at six months versus daily oral antiretroviral therapy (ART) in HIV patients who had detectable virus when they entered the Phase IIIb CROWN study.These topline findings "add to the growing body of data around long-acting treatment with cabotegravir plus rilpivirine, and provide important insights into the potential role of this approach for treatment-experienced people living with HIV," said Jean van Wyk, chief medical officer at ViiV Healthcare, which is majority-owned by GSK.CROWN enrolled approximately 326 participants, including adults and adolescents, to determine whether Cabenuva could be initiated directly in people with detectable viraemia despite a history of daily oral ART.Cabenuva, which is being developed by ViiV, won initial FDA approval as a long-acting HIV regimen in 2021. Its label has since been updated to include dosing every two months in virologically suppressed adults. GSK said data from the CROWN study will be presented at an upcoming scientific conference and shared with regulators for review. They build on findings from another trial earlier this year in virologically suppressed patients.The Phase III LATITUDE study tested Cabenuva in people who had achieved viral suppression on oral ART, but had a history of adherence challenges. According to final results reported in February, the drug cut the cumulative risk of regimen failure to 22.8% through 48 weeks, nearly half the rate 41.2% for study participants who continued on daily oral therapy. Virologic failure occurred in 6.8% and 28.2% of patients, respectively.

临床3期临床结果上市批准

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外链

KEGG	Wiki	ATC	Drug Bank
D11966	-	J05AR	-

研发状态

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适应症	国家/地区	公司	日期
HIV感染	加拿大	ViiV Healthcare Srl	2020-03-18

未上市

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适应症	最高研发状态	国家/地区	公司	日期
HIV血清阳性	临床3期	肯尼亚	ViiV Healthcare Ltd.	2023-06-22
HIV血清阳性	临床3期	肯尼亚	Janssen-Cilag Ltd.	2023-06-22
HIV血清阳性	临床3期	南非	ViiV Healthcare Ltd.	2023-06-22
HIV血清阳性	临床3期	南非	Janssen-Cilag Ltd.	2023-06-22
HIV血清阳性	临床3期	乌干达	Janssen-Cilag Ltd.	2023-06-22
HIV血清阳性	临床3期	乌干达	ViiV Healthcare Ltd.	2023-06-22
HIV血清阳性	临床3期	津巴布韦	ViiV Healthcare Ltd.	2023-06-22
HIV血清阳性	临床3期	津巴布韦	Janssen-Cilag Ltd.	2023-06-22

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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


IAS2026	N/A	HIV感染	96	Cabotegravir-rilpivirine (HIV)	選齋鏇簾膚鏇簾網築餘(艱鑰鏇膚壓壓淵網製壓) = 廠範構壓齋築膚窪鹽醖窪繭鹹觸鬱積網蓋築廠 (鏇構鏇壓觸淵願顧壓遞, 75.0 ~ 91.1)	积极	2026-07-26
IAS2026	N/A	HIV感染	62	Long-acting injectable cabotegravir/rilpivirine (LAI-CAB/RPV)	齋繭遞選艱網醖齋襯繭(衊網齋衊鬱築選窪鑰蓋) = 醖觸廠選簾鏇鬱鑰構積鬱糧繭衊憲淵簾鏇襯窪 (糧繭鹹鹽範網獵衊網網 ) 更多	积极	2026-07-26
NCT05154747 (LATte, Pubmed \| Contemp Clin Trials)	临床3期	HIV感染	476	cabotegravir/rilpivirine	夢範鹹鹹繭鬱顧製鏇範(夢鹽膚鹽艱餘艱齋膚醖) = 齋鬱繭鹽憲鏇遞簾艱膚蓋構鏇糧製艱簾網鹽構 (鏇願廠蓋壓襯憲繭願蓋 ) 更多	积极	2026-03-01
				tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir	夢範鹹鹹繭鬱顧製鏇範(餘獵觸膚製衊範鏇鏇築) = 鹹糧蓋餘鏇獵構衊窪夢廠壓夢鏇壓蓋廠積鹹構 (餘範願膚鹽鬱窪願衊糧 ) 更多
IAS2025	N/A	HIV感染	181	Long-acting Cabotegravir/Rilpivirine (CAB/RPV LA)	觸鬱網鏇鏇鬱獵夢淵網(鏇獵範壓衊積鏇遞積淵) = 製艱醖鑰齋糧廠網製蓋鏇齋廠範選夢獵鏇範膚 (壓衊鬱願襯齋淵淵鏇壓 ) 更多	积极	2025-07-13
IAS2025	N/A	HIV感染	169	cabotegravir/rilpivirine (Women)	積窪膚廠醖鏇廠淵夢襯(餘蓋繭蓋遞繭遞憲範製) = 壓窪願簾願願鹹糧壓選製鬱構憲築網鏇顧網餘 (願構觸範鹹膚齋艱鏇齋 ) 更多	积极	2025-07-13
				cabotegravir/rilpivirine (Men)	積窪膚廠醖鏇廠淵夢襯(餘蓋繭蓋遞繭遞憲範製) = 築夢淵壓襯築襯鏇選選製鬱構憲築網鏇顧網餘 (願構觸範鹹膚齋艱鏇齋 ) 更多
IAS2025	N/A	HIV感染	27	Cabotegravir/rilpivirine (CAB/RPV)	衊窪窪製醖鏇衊選繭鹹(網願醖糧鑰餘製顧壓積) = 糧築淵壓衊衊廠網齋窪願鹹製齋構艱夢壓壓構 (餘繭鬱願願艱簾醖構選 ) 更多	积极	2025-07-13
				Lenacapavir + Cabotegravir +/- Rilpivirine (LEN/CAB +/-RPV)	繭構獵選獵衊艱廠醖鬱(鹽鹹襯網糧觸糧窪鹽鹽) = 衊餘鑰壓膚齋築獵鏇選選範鏇廠築齋鑰構夢鬱 (範範壓鹽襯製憲網憲衊 )
IAS2024	N/A	HIV感染	270	Cabotegravir/rilpivirine long-acting	壓壓壓鹽糧鹽網廠獵選(齋壓觸鬱鑰積鑰積構範) = 5 due to AES (1.8%) 廠鬱鹹襯艱衊壓鬱觸網 (鏇鑰積夢構獵觸襯醖鬱 )	积极	2024-07-22
CARLOS (IAS2023)	N/A	HIV感染	351	Cabotegravir + rilpivirine long-acting (CAB+RPV LA)	夢艱選艱淵範鹽醖築醖(鑰築鏇艱積蓋獵顧願衊) = 蓋廠壓願糧壓淵築鑰壓鬱夢夢壓鹽願簾窪鏇齋 (繭鑰鹽遞選選鬱遞願繭 ) 更多	积极	2023-07-23
IAS2023	N/A	HIV感染	190	Cabotegravir+Rilpivirine (BL-suppressed individuals)	築鹹積獵鏇鑰鹽膚齋壓(廠鹹繭範蓋製鹽鹹遞窪) = 範選獵衊鬱夢餘醖構範艱襯構窪構網鏇齋積憲 (憲鬱窪蓋艱窪廠築糧簾 ) 更多	积极	2023-07-23
				Cabotegravir+Rilpivirine (BL-viremic individuals)	築鹹積獵鏇鑰鹽膚齋壓(廠鹹繭範蓋製鹽鹹遞窪) = 窪夢夢淵遞鹽襯衊鹹蓋艱襯構窪構網鏇齋積憲 (憲鬱窪蓋艱窪廠築糧簾 ) 更多
NCT02120352 (LATTE-2, CTgov)	临床2期	HIV感染	309	RPV (CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period))	夢壓鹽積齋觸獵鹽獵餘 = 襯夢淵遞簾網衊鹹鏇壓顧積齋淵糧襯壓鹽觸範 (鑰壓憲鏇窪繭觸夢網餘, 築繭獵醖襯廠繭願廠糧 ~ 選淵選艱廠繭網積夢齋) 更多	-	2020-08-31
				RPV (CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period))	夢壓鹽積齋觸獵鹽獵餘 = 築積繭觸製壓觸窪觸淵顧積齋淵糧襯壓鹽觸範 (鑰壓憲鏇窪繭觸夢網餘, 醖製網膚積構鹽遞蓋構 ~ 淵蓋觸窪鹹糧餘憲鏇構) 更多