The goal of this study is to learn what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time. Researchers want to learn if DOR and ISL are in breast milk.

开始日期2025-09-26

申办/合作机构

Merck Sharp & Dohme LLC

NCT06719570

/ Completed临床1期

An Open-Label Study to Evaluate the Effect of a High-Fat Meal on the Pharmacokinetics of Doravirine/Islatravir (100 mg/0.25 mg) Fixed-dose Combination Tablet and to Compare the Pharmacokinetics of Doravirine/Islatravir to Doravirine and Islatravir Single Entities in Healthy Adult Participants

The purpose of this study is to learn what happens to MK-8591A in a person's body over time. Researchers will compare what happens to MK-8591A in the body when it is given with and without food.

开始日期2024-01-23

申办/合作机构

Merck Sharp & Dohme LLC

NCT05766501

/ Active, not recruiting临床3期

A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

开始日期2023-03-17

申办/合作机构

Merck Sharp & Dohme LLC

100 项与多拉韦林/伊拉曲韦相关的临床结果

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100 项与多拉韦林/伊拉曲韦相关的转化医学

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100 项与多拉韦林/伊拉曲韦相关的专利（医药）

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项与多拉韦林/伊拉曲韦相关的文献（医药）

2026-07-01·Lancet HIV

Fixed-dose daily doravirine (100 mg) with islatravir (0·25 mg) versus bictegravir, emtricitabine, and tenofovir alafenamide for initial HIV-1 therapy: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial

Article

作者: Diamond, Tracy L ; Fox, Michelle C ; Avihingsanon, Anchalee ; Vesnesky, Mary ; Sinclair, Gary ; Paredes, Roger ; Klopfer, Stephanie O ; Gatanaga, Hiroyuki ; Pisculli, Mary L ; Rockstroh, Jürgen K ; Bettacchi, Christopher ; Kassim, Sheetal ; Crabtree Ramírez, Brenda ; Molina, Jean-Michel ; Stamm, Luisa M ; Mugo, Nelly ; Xu, Yayun

BACKGROUND:

Doravirine and islatravir is a two-drug regimen being investigated for the treatment of HIV-1. This study evaluated efficacy and safety of once daily doravirine and islatravir versus bictegravir, emtricitabine, and tenofovir alafenamide in adults with HIV-1 who were treatment-naive.

METHODS:

MK-8591A-053 is a phase 3, randomised, double-blind, active-controlled, non-inferiority study being done at 116 research, community, and hospital-based clinics across 20 countries. Adults aged at least 18 years with HIV-1 RNA of 500 copies per mL or more never previously treated for HIV-1 were randomly assigned (1:1), stratified by screening HIV-1 RNA viral load and CD4-cell count, to received either doravirine (100 mg) and islatravir (0·25 mg) or bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) orally once daily. The primary endpoint was percentage of participants with HIV-1 RNA less than 50 copies per mL at week 48 (FDA snapshot; prespecified non-inferiority margin -10%). Participants who received at least one dose of study intervention were analysed for safety. This trial is ongoing and is registered with ClinicalTrials.govNCT05705349.

FINDINGS:

We screened 756 participants for eligibility between March 8, 2023, and Oct 11, 2024. 269 participants were treated with doravirine-islatravir and 267 with bictegravir-emtricitabine-tenofovir. The last study visit for this analysis occurred on Oct 13, 2025. Median age was 32 years (IQR 26-40), 134 (25%) participants were assigned female at birth, 225 (42%) were White, 92 (17%) had CD4 counts less than 200 cells per μL, 197 (37%) had an HIV-1 RNA greater than 100 000 copies per mL, and 314 (59%) had pre-existing resistance-associated mutations. At week 48, doravirine-islatravir was non-inferior to bictegravir-emtricitabine-tenofovir: 247 (91·8%) of 269 versus 242 (90·6%) of 267 had HIV-1 RNA less than 50 copies per mL (estimated difference 1·2%, 95% CI -3·7 to 6·2). Mean increase in CD4 count was 218 cells per μL in the doravirine-islatravir group and 226 cells per μL in the bictegravir-emtricitabine-tenofovir group (estimated difference -6·8, 95% CI -35·8 to 22·2). Two participants in the doravirine-islatravir group and one in the bictegravir-emtricitabine-tenofovir group with pretreatment HIV-1 RNA greater than 1 million copies per mL and CD4 counts less than 200 cells per μL acquired treatment-emergent mutations. Phenotypic analysis revealed resistance to doravirine in two participants treated with doravirine-islatravir. 38 (14%) of 269 participants in the doravirine-islatravir group and 48 (18%) of 267 in the bictegravir-emtricitabine-tenofovir group had treatment-related adverse events: the most common were increased weight (7, 3%), headache (6, 2%), and dizziness (5, 2%) in the doravirine-islatravir group and increased weight (9, 3%), headache (9, 3%), and decreased estimated glomerular filtration rate (8, 3%) in the bictegravir-emtricitabine-tenofovir group.

INTERPRETATION:

Doravirine (100 mg) and islatravir (0·25 mg) is a two-drug, once daily regimen with efficacy and safety similar to bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) for initial treatment of HIV-1, which could provide an option for treatment without an integrase strand transfer inhibitor.

FUNDING:

Merck Sharp & Dohme, a subsidiary of Merck & Co.

2026-02-01·LANCET

Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial

Article

作者: Su, Feng-Hsiu ; Colson, Amy E ; Ramgopal, Moti N ; Mills, Anthony M ; Johnson, Margaret ; Katner, Harold P ; Crofoot, Gordon ; Lahoulou, Rima ; Diamond, Tracy L ; Barninger, Erika ; Fox, Michelle C ; Bettacchi, Christopher ; Osiyemi, Olayemi O ; Klopfer, Stephanie O ; Eves, Karen ; Xu, Yayun ; Stamm, Luisa M ; Hinestrosa, Federico ; Gatanaga, Hiroyuki

BACKGROUND:

The combination of doravirine and islatravir is under investigation as a fixed-dose, single-tablet regimen for the treatment of HIV-1. We aimed to assess the efficacy and safety of switching to doravirine (100 mg) and islatravir (0·25 mg) from bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV-1.

METHODS:

This phase 3, randomised, controlled, double-blind, non-inferiority trial was conducted at 49 research, community, and hospital-based clinics in six countries: Australia, Chile, Israel, Japan, the UK, and the USA. Adults aged 18 years or older with HIV-1, who were virologically suppressed (with a viral load of HIV-1 RNA <50 copies per mL) for at least 3 consecutive months on bictegravir, emtricitabine, and tenofovir alafenamide and had no history of treatment failure or known resistance to doravirine, were eligible for the study. Participants were randomly assigned, in a 2:1 ratio according to a computer-generated randomisation schedule with a block size of three, to switch to oral doravirine (100 mg) and islatravir (0·25 mg) or to continue bictegravir, emtricitabine, and tenofovir alafenamide, once daily. Participants, investigators, study staff, and sponsor personnel were masked to study treatment; sponsor personnel directly involved in this analysis were unmasked at week 48. The primary endpoint, which was assessed in all randomly assigned participants who received at least one dose of study treatment, was the percentage of participants with a viral load of 50 copies per mL or higher at week 48 according to the US Food and Drug Administration snapshot approach; non-inferiority would be concluded if the upper bound of the multiplicity-adjusted 95% CI for the treatment difference was less than 4%. The trial is registered at ClinicalTrials.gov, NCT05630755, and is ongoing but closed to enrolment.

FINDINGS:

Between Feb 17 and Nov 17, 2023, 585 individuals were screened, of whom 514 were randomly assigned and 513 treated: 342 participants were switched to doravirine (100 mg) and islatravir (0·25 mg) and 171 continued bictegravir, emtricitabine, and tenofovir alafenamide. The median age of the 513 participants was 47 years (IQR 37-58), 403 (79%) were assigned male and 110 (21%) were assigned female at birth, 158 (31%) were Black or African American, and 117 (23%) were Hispanic, Latino, or Latina. At week 48, doravirine and islatravir showed non-inferiority to bictegravir, emtricitabine, and tenofovir alafenamide (viral load ≥50 copies per mL in five [1·5%] of 342 vs one [0·6%] of 171 participants) with a treatment difference of 0·9% (multiplicity-adjusted 95% CI -1·9 to 2·9). The rates of adverse events (74·6% [255 of 342 participants] vs 71·3% [122 of 171 participants]; difference 3·2 [95% CI -4·7 to 11·6]), treatment-related adverse events (10·2% [35] vs 9·4% [16]; 0·9 [-5·1 to 6·0]), serious adverse events (4·4% [15] vs 6·4% [11]; -2·0 [-7·1 to 1·9]), and discontinuations due to adverse events (2·9% [ten] vs 1·8% [three]; 1·2 [-2·3 to 3·9]) were similar in the doravirine and islatravir group and the bictegravir, emtricitabine, and tenofovir alafenamide group, and no deaths were reported.

INTERPRETATION:

The combination of doravirine (100 mg) and islatravir (0·25 mg) has similar efficacy and safety profiles to bictegravir, emtricitabine, and tenofovir alafenamide, and could provide a two-drug, once daily, oral single-tablet option without an integrase strand-transfer inhibitor for adults who are virologically suppressed and want to switch to a different ART regimen.

FUNDING:

Merck Sharp & Dohme, a subsidiary of Merck & Co.

2026-02-01·LANCET

Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, randomised, open-label, non-inferiority trial

Article

作者: Grandhi, Anjana ; Jackson, Beth ; Kim, Jason ; Mngqibisa, Rosie ; Bloch, Mark ; Diamond, Tracy L ; Tebas, Pablo ; Braun, Dominique L ; Fuszard, Monica ; Orkin, Chloe ; Fox, Michelle C ; Kumar, Princy ; Eves, Karen ; Walmsley, Sharon ; Klopfer, Stephanie O ; Carr, Andrew ; Stamm, Luisa M ; Velez, Juan Diego ; Yokomaku, Yoshiyuki

BACKGROUND:

Doravirine and islatravir is an investigational, once-daily, single-tablet regimen containing two potent antiretrovirals with complementary mechanisms of action and resistance profiles. We aimed to evaluate the efficacy and safety of switching from stable, oral antiretroviral therapy (ART) to the fixed combination of doravirine (100 mg) and islatravir (0·25 mg) in virologically suppressed adults living with HIV-1.

METHODS:

This phase 3, randomised, active-controlled, open-label, non-inferiority trial was conducted at 53 research, community, and hospital-based clinics in eight countries: Australia, Canada, Colombia, Japan, South Africa, Switzerland, the UK, and the USA. Adults (aged ≥18 years) with a viral load of fewer than 50 copies of HIV-1 RNA per mL on any oral, two-drug or three-drug ART regimen for at least 3 months, with no history of treatment failure, known resistance to doravirine, or active hepatitis B infection, were randomly assigned (2:1) according to a computer-generated randomisation schedule (block size three) to receive oral doravirine (100 mg) and islatravir (0·25 mg) once daily or to continue baseline ART for 48 weeks. Randomisation was stratified by the anchor antiretroviral drug class (integrase strand-transfer inhibitor [INSTI], non-nucleoside reverse transcriptase inhibitor, or protease inhibitor) in the baseline regimen. The primary endpoint (assessed in all treated participants) was the percentage of participants with a viral load of 50 copies per mL or higher at week 48 (analysed according to the US Food and Drug Administration snapshot approach); non-inferiority would be concluded if the upper bound of the multiplicity-adjusted 95% CI for the treatment difference was less than 4%. The safety analysis population included all randomly assigned participants who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov, NCT05631093, and is ongoing but closed to enrolment.

FINDINGS:

Between Feb 20 and Oct 24, 2023, 614 individuals were screened for eligibility, of whom 553 were randomly assigned to receive doravirine and islatravir (n=368) or baseline ART (n=185). 551 participants received at least one dose of allocated medication: 366 in the doravirine and islatravir group and 185 in the baseline ART group. Of these 551 participants, 332 (60%) were assigned male and 219 (40%) were assigned female at birth, and the median age was 51 years (IQR 41-59); 250 (45%) identified as Black or African American and 80 (15%) identified as Hispanic, Latino, or Latina. Doravirine and islatravir showed non-inferiority at week 48, with viral loads of 50 copies per mL or higher in five (1·4%) of 366 participants versus nine (4·9%) of 185 participants on baseline ART (difference -3·6% [multiplicity-adjusted 95% CI -7·8 to -0·8]). Treatment-related adverse events were more common with doravirine and islatravir (44 [12·0%] of 366 participants) than with baseline ART (nine [4·9%] of 185 participants; difference 7·2 [95% CI 2·2 to 11·6]). Rates were similar in the doravirine and islatravir group and the baseline ART group for any adverse event (79·5% [291 of 366 participants] vs 83·8% [155 of 185 participants]; difference -4·3 [-10·7 to 2·8]), serious adverse events (6·3% [23] vs 4·9% [nine]; 1·4 [-3·2 to 5·2]), and discontinuation due to adverse events (0·5% [two] vs 2·2% [four]; -1·6 [-4·9 to 0·2]). One death occurred (in the baseline ART group) and was not considered treatment-related. No participants discontinued treatment as a result of protocol-specified declines in CD4 cell or total lymphocyte counts.

INTERPRETATION:

Doravirine and islatravir is efficacious and well tolerated and would represent the first non-INSTI-based, two-drug regimen for HIV-1 treatment. With increasing concern over the potential development of widespread INSTI resistance, this once-daily, oral, single-tablet regimen could be a potential option for people living with HIV-1 requiring a change to their antiretroviral regimen. The safety and efficacy findings support the ongoing development of islatravir, a drug with long-acting potential.

FUNDING:

Merck Sharp & Dohme, a subsidiary of Merck & Co.

160

项与多拉韦林/伊拉曲韦相关的新闻（医药）

2026-08-10

·珐成浩鑫

【P村情报】一周生物 “药” 闻（2026.8.3-8.7）

NEWS（8.3-8.7） //// 【P村情报】是珐成浩鑫诚意推出的资讯板块。我们汇总生物医药行业一周的重要新闻，帮助各位看官梳理热点、把握趋势，了解行业最新动向。 8/3 ■ 全球首个，罗氏眼科IL-6单抗拟纳入优先审评 CDE网站显示，罗氏的伐米奇拜单抗（vamikibart）拟纳入优先审评，用于治疗葡萄膜炎性黄斑水肿（UME）。伐米奇拜单抗是罗氏自Sesen Bio（已被Carisma Therapeutics收购）引进的一款IL-6单抗，具有较长的玻璃体内滞留时间和较快的系统性清除速度。该药物结合、阻断IL-6信号的活性是托珠单抗的1000倍。 ■ 诺华重磅核药再获批准诺华宣布Pluvicto（镥[177Lu]特昔维匹肽）的新适应症获得FDA批准，用于前列腺特异性膜抗原阳性（PSMA+）转移性雄激素途径调节-未敏感型（mAPMN/S）前列腺癌（以前称为激素敏感性前列腺癌）患者。至此，Pluvicto目前可用于所有阶段的PSMA+转移性前列腺癌患者，适用人群几乎翻倍。 ■ 中国生物制药BCL-2抑制剂申报上市CDE网站显示，中国生物制药旗下公司正大天晴的TQB3909地基上市申请，用于治疗既往经过至少包含BTK抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞性淋巴瘤（CLL/SLL）。TQB3909是正大天晴自主研发的一款高效、口服生物利用度高的选择性BCL-2抑制剂，于2021年进入临床阶段。BCL-2家族蛋白可以通过阻止线粒体外膜通透化（MOMP）从而抑制肿瘤细胞凋亡，其过表达与癌症的耐药性的形成密切相关。通过抑制BCL-2与促凋亡蛋白（如BAK）的结合，抑制BCL-2依赖性肿瘤的生长，从而发挥抗肿瘤的作用。 8/4 ■ 20.93亿美元，康宁杰瑞FIC新药授权出海康宁杰瑞宣布其全资子公司江苏康宁杰瑞与Pathos AI就康宁杰瑞自主研发的同类首创（First-in-class, FIC）新药TROP2/HER3双特异性抗体偶联药物（ADC）JSKN016达成授权许可协议。JSKN016是康宁杰瑞利用单域抗体、双抗及糖基定点偶联平台自主研发的靶向TROP2/HER3双抗ADC。该药物通过糖基定点偶联获得DAR4的均一结构，实现高稳定性与低脱靶毒性。在作用机制上一方面可以精准结合肿瘤细胞表面受体，阻断致癌信号通路；另一方面定点释放拓扑异构酶Ⅰ抑制剂，高效杀伤肿瘤。JSKN016已在多种实体瘤中展现出良好的抗肿瘤活性和安全性，目前已开展JSKN016单药和联合疗法治疗肺癌、乳腺癌等的多项Ⅱ期临床研究，治疗三阴性乳腺癌的Ⅲ期临床研究正在进行中。■ 14mg口服司美格鲁肽在华获批新适应症诺和诺德在发布上半年业绩时披露了司美格鲁肽口服片剂的三项重要进展。基于ESSENCE研究，已在美国递交25mg司美格鲁肽口服片剂（Wegovy pill）用于治疗代谢障碍相关脂肪性肝炎（MASH）的上市申请，预计在2027年一季度迎来审批决定。此前，2.4mg司美格鲁肽注射液（Wegovy）于2025年8月基于ESSENCE研究获得FDA批准MASH适应症。在ESSENCE研究中，2.4mg司美格鲁肽注射液组和安慰剂组实现肝纤维化改善且脂肪性肝炎没有恶化的患者比例分别为36.8%和22.4%（P<0.001），实现脂肪性肝炎得到缓解且肝纤维化没有恶化的患者比例分别为62.9%和34.3%（P<0.001）。该注射液已在中国申报MASH适应症。已向FDA递交25mg司美格鲁肽口服片剂（Ozempic pill）用于治疗2型糖尿病的上市申请，预计在今年四季度迎来审批决定。 ■ 全球首个埃博拉病毒mRNA疫苗启动临床试验 Moderna宣布其针对布本迪布焦埃博拉病毒（Bundibugyo ebolavirus，BDBV）的mRNA疫苗mRNA-1469已在加拿大启动I期临床试验，首批受试者已完成接种。目前，已有疫苗主要针对扎伊尔埃博拉病毒（Zaire ebolavirus），但尚无获批疫苗可预防BDBV引起的埃博拉病毒病。mRNA-1469是全球首个进入临床阶段的埃博拉mRNA疫苗。 8/5 ■ 武田FIC新药在美国获批上市武田宣布奥普雷顿（oveporexton，英文商品名：Orzeyful，中文商品名：奥泽悦）获得FDA批准用于治疗1型发作性睡病。该药物已于今年7月在国内获批上市，是全球首个获批的食欲素2型受体（OX2R）激动剂。奥普雷顿可选择性地刺激OX2R以恢复其信号传导，并改善因食欲素缺乏而导致的1型发作性睡病。 ■ 默沙东HIV-1新药在华申报上市 CDE网站显示，默沙东的多拉韦林伊拉曲韦片（doravirine/islatravir，英文商品名：Idvynso）在华申报上市。根据优先审评进度，本次申报的适应症为：作为治疗成人HIV-1感染的完整双药治疗方案，适用于正接受稳定抗逆转录病毒治疗方案达到病毒学抑制（HIV-1 RNA<50拷贝/ml）、无抗病毒治疗失败史且无已知与多拉韦林耐药相关突变的患者，替代其当前的抗逆转录病毒治疗方案。 ■ 石药与阿斯利康成立合资公司石药集团发布公告，已与阿斯利康签署协议，双方共同设立合资公司，于石家庄高新区建设新一代生物制剂生产基地，标志双方合作从管线授权研发延伸至全球化生产制造领域。根据股权安排，石药集团持股51%，阿斯利康持股49%，双方共同参与合资企业运营管理。新合资公司将整合双方优势资源：依托石药AI驱动的GMP智能制造体系、生物药工程建设与生产运营能力，叠加阿斯利康全球质量管控与供应链管理经验，面向全球市场开展约定生物制剂产品的生产与供应，后续将视业务发展拓展产品范围。本次合资落地，是跨国药企与国内大型制药企业深度绑定制造端的代表性事件。此前双方已在小分子、长效多肽、siRNA小核酸等多个创新管线开展研发合作，多次兑现研发里程碑付款，本次落地生产基地，实现 “研发+制造”全链条协同。 8/6 ■ FDA批准首款mRNA流感疫苗上市 Moderna宣布，美国FDA已批准其mRNA流感疫苗mFLUSIVA（mRNA-1010）上市，用于50岁及以上成年人预防季节性流感。至此，mFLUSIVA成为Moderna全球第五款获批产品，也是其第四款在美国获批的产品，同时也是美国首款获批的mRNA流感疫苗。Moderna预计，该产品将于未来数周在美国部分零售渠道上市。 ■ 结直肠癌领域首个！恒瑞HER2 ADC获批新适应症国家药监局（NMPA）官网显示，恒瑞医药的瑞康曲妥珠单抗（SHR-A1811）获批新适应症，用于经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的HER2阳性结直肠癌成人患者。该药物是第一款获批用于治疗结直肠癌的ADC药物。瑞康曲妥珠单抗是恒瑞医药自主研发的一款HER2ADC，可通过与HER2表达的肿瘤细胞结合并内吞，在肿瘤细胞溶酶体内通过蛋白酶剪切释放毒素，诱导细胞周期阻滞，从而诱导肿瘤细胞凋亡。其释放的毒素具有高透膜性，可发挥旁观者杀伤效应，进一步提高抗肿瘤疗效。 ■ 药捷安康首款创新药获批上市国家药监局（NMPA）官网显示，药捷安康的核心产品替恩戈替尼片获批上市，用于治疗既往至少接受过一种系统性治疗和FGFR抑制剂治疗的晚期、转移性或不可手术切除的胆管癌成人患者。该药物是药捷安康旗下首款获批上市的创新药。替恩戈替尼是一款药捷安康自主研发的创新多靶点小分子激酶抑制剂，通过靶向肿瘤细胞和改善肿瘤微环境发挥抗肿瘤作用。 ■ 恒瑞医药JAK1抑制剂获批新适应症国家药监局（NMPA）官网显示，恒瑞医药的艾玛昔替尼获批上市，适应于对非甾体抗炎药（NSAID）应答不佳或不耐受且存在客观炎症征象（表现为C反应蛋白[CRP]升高和/或磁共振成像[MRI]异常）的活动性放射学阴性中轴型脊柱关节炎成人患者。 ■ 首个替尔泊肽仿制药在国内申报上市CDE官网显示，翰宇药业在国内递交替尔泊肽注射液的上市申请。该产品已在美国申报上市。替尔泊肽是礼来公司研发的GLP-1R/GIPR双靶点激动剂，在全球减重及降糖药物市场中占据重要地位，全球尚无仿制药产品上市。根据礼来2026年H1财报数据，替尔泊肽上半年全球销售额合计约277亿美元，继续登顶“药王”。 8/7 ■ 中因科技眼科基因疗法拟纳入优先审评 CDE网站显示，中因科技的眼科基因治疗药物ZVS101e注射液拟纳入优先审评，用于治疗携带CYP4V2双等位基因突变的结晶样视网膜变性（Bietti Crystalline Corneoretinal Dystrophy，BCD）。ZVS101e是北京大学第三医院与中因科技合作开发的基因增强疗法，通过重组腺相关病毒向BCD患者递送具有功能的CYP4V2基因拷贝。编辑及审定：市场部 · 欢迎点击上方图片内容，一键直达

2026-08-10

·穗维卓生物

【每周药闻】不容错过的生物医药动态！（2026.8.3-8.9）

8.3-8.9 欢迎关注穗维卓生物【每周药闻】！追踪前沿动态，洞察产业风向，每周一篇，与您共读生物医药的时代命题。 8.3 英矽智能/衡泰生物帕金森病口服1类新药获批临床英矽智能（Insilico Medicine）宣布，公司与衡泰生物（Hygtia Therapeutics）共同开发的创新口服NLRP3抑制剂ISM8969/HT-001已获得中国国家药品监督管理局（NMPA）临床试验批件，拟用于帕金森病治疗。针对这类恶性肿瘤，再鼎医药在研新药获FDA孤儿药资格再鼎医药宣布，美国FDA已授予zocilurtatug pelitecan（zoci，前称ZL-1310）孤儿药资格，用于治疗神经内分泌癌。Zoci是一款靶向Delta样配体3（DLL3）的抗体偶联药物（ADC）。 80 亿美元！核药领域再现并购大单 Curium 和 Lantheus Holdings, Inc. 已达成最终协议，Lantheus 将与 Curium US 的全资子公司合并。根据最终协议条款，Curium US 将以每股 102.50 美元的现金收购 Lantheus 所有已发行股份。此外，股东还可能通过与 Lantheus 前列腺癌、神经病学和 Definity 产品线 2030 年前的销售里程碑挂钩的或有价值权，获得每股最高 12 美元的额外收益。罗氏：眼科新药拟纳入优先审评 CDE 官网显示，罗氏的伐米奇拜单抗注射液（vamikibart）拟纳入优先审评品种，用于治疗葡萄膜炎性黄斑水肿（UME）。 8.4 正大天晴1类抗肿瘤新药申报上市并被纳入优先审评正大天晴宣布自主研发的1类新药TQB3909片上市许可申请（NDA），正式获得中国国家药品监督管理局药品审评中心（CDE）受理，用于治疗既往经过至少包含BTK抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)。7月13日，TQB3909被纳入优先审评，标志着该创新药上市进程进一步加速。超20亿美元！康宁杰瑞就双抗ADC新药达成国际授权合作康宁杰瑞宣布与Pathos公司就康宁杰瑞自主研发的新药TROP2/HER3双特异性抗体偶联药物（ADC）JSKN016达成授权许可协议。根据许可协议，康宁杰瑞授予Pathos在全球（不包括中国内地、香港、澳门及台湾地区）研究、开发、制造及商业化JSKN016的独家许可。康宁杰瑞保留JSKN016在中国内地、香港、澳门及台湾地区的开发、制造及商业化的完整专有权利。诺诚健华联合疗法获纳入突破性治疗品种，针对这类淋巴瘤诺诚健华宣布，奥布替尼与mesutoclax（ICP-248）联合方案获中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入突破性治疗品种，用于治疗既往至少接受过一种治疗的边缘区淋巴瘤（MZL）患者。 8.5 石药集团/康宁杰瑞乳腺癌联合疗法申报上市石药集团宣布，其附属公司石药集团上海津曼特生物与康宁杰瑞合作开发的安尼妥单抗（KN026）联合石药集团自主研发的注射用多西他赛（白蛋白结合型）（HB1801）的新药上市申请已获中国国家药品监督管理局（NMPA）受理，并纳入优先审评审批。本次申请适应症为安尼妥单抗联合多西他赛（白蛋白结合型）±卡铂新辅助治疗早期或局部晚期HER2阳性成人乳腺癌。默沙东抗艾滋病口服新药在中国申报上市中国国家药监局药品审评中心（CDE）官网公示显示，默沙东（MSD）申报的多拉韦林伊拉曲韦片（doravirine/islatravir，DOR/ISL）上市申请已获得受理。根据CDE官网，该产品此前已经被纳入优先审评，拟定适应症为：作为治疗成人HIV-1感染的完整双药治疗方案，适用于正接受稳定抗逆转录病毒治疗方案达到病毒学抑制（HIV-1 RNA<50拷贝/ml）、无抗病毒治疗失败史且无已知与多拉韦林耐药相关突变的患者，替代其当前的抗逆转录病毒治疗方案。石药集团宣布与阿斯利康在中国成立合资公司石药集团宣布，其与阿斯利康已就成立合资公司签署合资合同，在中国石家庄建设新一代生物制剂生产基地，以进一步深化战略合作。根据公告，该合资公司旨在结合石药集团以人工智能驱动的良好生产规范 (GMP) 体系、药品生产建设及运营能力，以及阿斯利康在全球质量标准及供应链管理的专业优势，致力于向全球患者提供高质量药品。 8.6 海思科1类新药获批临床，拟治疗偏头痛中国国家药监局药品审评中心（CDE）官网近日公示显示，海思科申报的1类新药HSK51155片获得临床试验默示许可，拟用于偏头痛的治疗。恒瑞医药：HER2 ADC 重磅新适应症获批，针对结直肠癌 NMPA 官网显示，恒瑞 HER2 ADC「瑞康曲妥珠单抗」获批一项新适应症，用于治疗经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的 HER2 阳性结直肠癌成人患者（受理号：CXSS2600018）。中国生物制药：针对疼痛，又一款新药获批上市中国生物制药发布公告，其子公司泰德制药的国家 5.1 类新药第二代氟比洛芬贴剂（商品名：泽普思）已获得药监局批准上市，用于下列疾病及症状的镇痛、消炎：骨关节炎、肩周炎、肌腱及腱鞘炎、腱鞘周围炎、肱骨外上髁炎（网球肘）、肌肉痛、外伤所致肿胀、疼痛。 8.7 赛诺菲：长效 RSV 单抗新适应症申报上市 CDE 官网公示，赛诺菲尼塞韦单抗注射液一项新适应症上市申请获得受理，注册分类为 3.1 类。根据公开信息和临床试验进展，Insight 数据库推测本次申报适应症为预防以下婴幼儿呼吸道合胞病毒（RSV）引起的下呼吸道感染：即将进入或在第二个 RSV 感染季期间出生的新生儿和婴儿。礼邦医药：首个创新药申报上市 CDE 官网公示，礼邦医药1类新药AP301 胶囊申报上市。值得一提的是，这是礼邦医药旗下首款申报上市的创新药。 1.9亿！药明系再出手创胜集团医药有限公司于2026年8月6日宣布，旗下全资附属公司杭州奕安济世生物药业与药明生物全资附属公司杭州明德生物医药技术订立资产购买协议，拟以人民币1.9亿元出售CDMO资产。编辑及审定：市场部关于穗维卓生物上海穂维卓生物科技有限公司（简称"穂维卓生物"），是专注制药与医美领域的高科技制造企业，为客户商业化生产提供专业在线配液系统解决方案。公司以技术创新为核心，深耕在线配液系统研发、设计与制造，产品融合自动化控制、流体工程与洁净工艺，可实现缓冲液自动切换、全程闭环控制，支持集成或独立运行，高效省空间、稳定可靠。产品严格契合制药行业GMP规范，有效提升生产效率、降低污染风险，保障药品质量稳定；同时依托核心技术优势，拓展至医美领域，满足医美制剂精准、高效、安全的配液需求，助力医美生产标准全面升级。联系我们 15821024259（王经理） 13817019275（程经理）

2026-08-10

·洁维生物

【医周速览】快速复盘行业一周“药”闻（2026.8.3-8.9）

🗓️ 8.3-8.9 欢迎关注洁维生物【医周速览】！将一周的行业热点浓缩成篇，为您梳理脉络，解读趋势。希望这个栏目能成为您了解行业动态的高效充电站，与您共创专业价值。 8.3 英矽智能/衡泰生物帕金森病口服1类新药获批临床英矽智能（Insilico Medicine）宣布，公司与衡泰生物（Hygtia Therapeutics）共同开发的创新口服NLRP3抑制剂ISM8969/HT-001已获得中国国家药品监督管理局（NMPA）临床试验批件，拟用于帕金森病治疗。针对这类恶性肿瘤，再鼎医药在研新药获FDA孤儿药资格再鼎医药宣布，美国FDA已授予zocilurtatug pelitecan（zoci，前称ZL-1310）孤儿药资格，用于治疗神经内分泌癌。Zoci是一款靶向Delta样配体3（DLL3）的抗体偶联药物（ADC）。 80 亿美元！核药领域再现并购大单 Curium 和 Lantheus Holdings, Inc. 已达成最终协议，Lantheus 将与 Curium US 的全资子公司合并。根据最终协议条款，Curium US 将以每股 102.50 美元的现金收购 Lantheus 所有已发行股份。此外，股东还可能通过与 Lantheus 前列腺癌、神经病学和 Definity 产品线 2030 年前的销售里程碑挂钩的或有价值权，获得每股最高 12 美元的额外收益。罗氏：眼科新药拟纳入优先审评 CDE 官网显示，罗氏的伐米奇拜单抗注射液（vamikibart）拟纳入优先审评品种，用于治疗葡萄膜炎性黄斑水肿（UME）。 8.4 正大天晴1类抗肿瘤新药申报上市并被纳入优先审评正大天晴宣布自主研发的1类新药TQB3909片上市许可申请（NDA），正式获得中国国家药品监督管理局药品审评中心（CDE）受理，用于治疗既往经过至少包含BTK抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)。7月13日，TQB3909被纳入优先审评，标志着该创新药上市进程进一步加速。超20亿美元！康宁杰瑞就双抗ADC新药达成国际授权合作康宁杰瑞宣布与Pathos公司就康宁杰瑞自主研发的新药TROP2/HER3双特异性抗体偶联药物（ADC）JSKN016达成授权许可协议。根据许可协议，康宁杰瑞授予Pathos在全球（不包括中国内地、香港、澳门及台湾地区）研究、开发、制造及商业化JSKN016的独家许可。康宁杰瑞保留JSKN016在中国内地、香港、澳门及台湾地区的开发、制造及商业化的完整专有权利。诺诚健华联合疗法获纳入突破性治疗品种，针对这类淋巴瘤诺诚健华宣布，奥布替尼与mesutoclax（ICP-248）联合方案获中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入突破性治疗品种，用于治疗既往至少接受过一种治疗的边缘区淋巴瘤（MZL）患者。 8.5 石药集团/康宁杰瑞乳腺癌联合疗法申报上市石药集团宣布，其附属公司石药集团上海津曼特生物与康宁杰瑞合作开发的安尼妥单抗（KN026）联合石药集团自主研发的注射用多西他赛（白蛋白结合型）（HB1801）的新药上市申请已获中国国家药品监督管理局（NMPA）受理，并纳入优先审评审批。本次申请适应症为安尼妥单抗联合多西他赛（白蛋白结合型）±卡铂新辅助治疗早期或局部晚期HER2阳性成人乳腺癌。默沙东抗艾滋病口服新药在中国申报上市中国国家药监局药品审评中心（CDE）官网公示显示，默沙东（MSD）申报的多拉韦林伊拉曲韦片（doravirine/islatravir，DOR/ISL）上市申请已获得受理。根据CDE官网，该产品此前已经被纳入优先审评，拟定适应症为：作为治疗成人HIV-1感染的完整双药治疗方案，适用于正接受稳定抗逆转录病毒治疗方案达到病毒学抑制（HIV-1 RNA<50拷贝/ml）、无抗病毒治疗失败史且无已知与多拉韦林耐药相关突变的患者，替代其当前的抗逆转录病毒治疗方案。石药集团宣布与阿斯利康在中国成立合资公司石药集团宣布，其与阿斯利康已就成立合资公司签署合资合同，在中国石家庄建设新一代生物制剂生产基地，以进一步深化战略合作。根据公告，该合资公司旨在结合石药集团以人工智能驱动的良好生产规范 (GMP) 体系、药品生产建设及运营能力，以及阿斯利康在全球质量标准及供应链管理的专业优势，致力于向全球患者提供高质量药品。 8.6 海思科1类新药获批临床，拟治疗偏头痛中国国家药监局药品审评中心（CDE）官网近日公示显示，海思科申报的1类新药HSK51155片获得临床试验默示许可，拟用于偏头痛的治疗。恒瑞医药：HER2 ADC 重磅新适应症获批，针对结直肠癌 NMPA 官网显示，恒瑞 HER2 ADC「瑞康曲妥珠单抗」获批一项新适应症，用于治疗经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的 HER2 阳性结直肠癌成人患者（受理号：CXSS2600018）。中国生物制药：针对疼痛，又一款新药获批上市中国生物制药发布公告，其子公司泰德制药的国家 5.1 类新药第二代氟比洛芬贴剂（商品名：泽普思）已获得药监局批准上市，用于下列疾病及症状的镇痛、消炎：骨关节炎、肩周炎、肌腱及腱鞘炎、腱鞘周围炎、肱骨外上髁炎（网球肘）、肌肉痛、外伤所致肿胀、疼痛。 8.7 赛诺菲：长效 RSV 单抗新适应症申报上市 CDE 官网公示，赛诺菲尼塞韦单抗注射液一项新适应症上市申请获得受理，注册分类为 3.1 类。根据公开信息和临床试验进展，Insight 数据库推测本次申报适应症为预防以下婴幼儿呼吸道合胞病毒（RSV）引起的下呼吸道感染：即将进入或在第二个 RSV 感染季期间出生的新生儿和婴儿。礼邦医药：首个创新药申报上市 8 月 7 日，CDE 官网公示，礼邦医药1类新药AP301 胶囊申报上市。值得一提的是，这是礼邦医药旗下首款申报上市的创新药。 1.9亿！药明系再出手创胜集团医药有限公司于2026年8月6日宣布，旗下全资附属公司杭州奕安济世生物药业与药明生物全资附属公司杭州明德生物医药技术订立资产购买协议，拟以人民币1.9亿元出售CDMO资产。编辑及审定：市场部

100 项与多拉韦林/伊拉曲韦相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
HIV感染	日本	MSD KK (Tokyo)	2026-03-06

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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


NCT05630755 \| NCT05631093 \| NCT05766501 (Pubmed \| J Infect Dis)	临床3期	HIV感染	1,227	Doravirine/Islatravir (100/0.25 mg)	蓋餘鏇鬱鏇獵齋範衊願(繭壓夢鏇衊築窪餘齋艱) = 鬱鑰築積製齋願廠窪築糧簾憲觸餘齋選憲夢簾 (齋憲顧鬱範選築襯遞窪 )	积极	2026-05-29
NCT05705349 (MK-8591A-053, Pubmed \| Lancet HIV) 人工标引	临床3期	HIV感染一线	536	doravirine-islatravir	壓蓋繭餘壓醖齋鹽膚遞(鏇蓋襯醖鏇糧餘夢繭鹽) = 製夢鏇襯構餘鹹鏇簾製衊壓鏇艱顧鹽廠蓋齋遞 (鏇艱夢網膚憲夢襯鏇網 ) 更多	非劣	2026-02-25
				bictegravir-emtricitabine-tenofovir	壓蓋繭餘壓醖齋鹽膚遞(鏇蓋襯醖鏇糧餘夢繭鹽) = 鹹醖築顧醖糧顧鑰遞窪衊壓鏇艱顧鹽廠蓋齋遞 (鏇艱夢網膚憲夢襯鏇網 ) 更多
NCT05631093 (MK-8591A-051, Pubmed \| Lancet \| BusinessWire) 人工标引	临床3期	HIV感染	551	doravirine-islatravir	範顧膚憲淵糧選獵憲選(製鹽餘膚鹽襯廠衊鹹糧) = 壓餘膚鑰積構醖選糧夢鑰窪衊蓋願壓廠鬱壓艱 (衊遞壓鑰膚艱鏇鑰願壓 ) 达到更多	非劣	2026-02-07
				ART	範顧膚憲淵糧選獵憲選(製鹽餘膚鹽襯廠衊鹹糧) = 廠網艱獵範鬱繭壓淵簾鑰窪衊蓋願壓廠鬱壓艱 (衊遞壓鑰膚艱鏇鑰願壓 ) 达到更多
NCT05630755 (MK-8591A-052, Pubmed \| Lancet \| BusinessWire) 人工标引	临床3期	HIV感染	513	doravirine-islatravir	鑰壓構觸積築糧簾願顧(膚範繭鬱艱顧遞獵壓積) = 齋齋願窪顧繭齋襯窪夢繭廠築顧餘憲艱憲壓獵 (鑰觸繭鹹夢製壓襯簾積 ) 达到更多	非劣	2026-02-01
				Bictegravir/Emtricitabine/Tenofovir Alafenamide	鑰壓構觸積築糧簾願顧(膚範繭鬱艱顧遞獵壓積) = 餘憲艱憲遞遞夢鏇糧淵繭廠築顧餘憲艱憲壓獵 (鑰觸繭鹹夢製壓襯簾積 ) 达到更多
NCT05631093 (MK-8591A-051, CTgov)	临床3期	HIV感染	553	DOR+Islatravir (Doravirine/Islatravir (DOR/ISL))	構繭構鹹願膚築鬱鹹夢 = 繭鏇鏇齋願廠鹹齋範築廠餘衊夢網選膚淵鏇獵 (製願繭鑰鑰簾襯顧選鬱, 夢選築鹽範網艱遞願簾 ~ 餘壓積鏇範觸積廠夢鏇) 更多	-	2025-11-21
				DOR (Baseline ART + DOR/ISL)	構繭構鹹願膚築鬱鹹夢 = 製鏇繭窪鹹艱願鹽夢築廠餘衊夢網選膚淵鏇獵 (製願繭鑰鑰簾襯顧選鬱, 淵糧構淵襯蓋製積顧網 ~ 夢範鹽夢獵壓築鹹網範) 更多
NCT05630755 (MK-8591A-052, CTgov)	临床3期	HIV感染	514	Placebo to BIC/FTC/TAF+DOR/ISL (DOR/ISL and Placebo to BIC/FTC/TAF)	網積範膚壓廠糧願積餘 = 齋積鏇顧構襯壓鏇餘糧繭獵鬱願蓋廠壓艱鬱廠 (夢網餘憲築憲鏇網鹽壓, 鑰選製繭選遞範獵壓範 ~ 積鑰積觸顧壓鹹餘鏇繭) 更多	-	2025-11-18
				Placebo to DOR/ISL+BIC/FTC/TAF (BIC/FTC/TAF and Placebo to DOR/ISL)	網積範膚壓廠糧願積餘 = 願襯構繭構夢鬱夢鏇衊繭獵鬱願蓋廠壓艱鬱廠 (夢網餘憲築憲鏇網鹽壓, 獵鹽網膚齋糧獵憲顧網 ~ 製壓醖艱繭製鏇廠蓋網) 更多
NCT05630755 (MK-8591A-052, Company_Website)	临床3期	HIV感染	513	placebo+Doravirine+Islatravir-MK8591A	憲網繭憲醖鬱鏇選顧膚(網範顧夢衊鑰艱壓夢構) = 繭糧蓋鏇廠衊齋壓鬱糧獵鑰襯願膚淵膚顧願選 (網願膚膚範範壓簾醖顧 ) 更多	积极	2025-10-15
				placebo+Bictegravir+Tenofovir alafenamide+Emtricitabine	憲網繭憲醖鬱鏇選顧膚(網範顧夢衊鑰艱壓夢構) = 膚齋觸製壓構觸繭製網獵鑰襯願膚淵膚顧願選 (網願膚膚範範壓簾醖顧 ) 更多
NCT04233879 (Pubmed \| Clin Infect Dis)	临床3期	HIV感染	597	Doravirine/islatravir (100/0.75 mg)	憲範鬱顧壓願願遞選壓(製餘鏇鑰鬱顧積獵艱壓) = AEs leading to discontinuations were higher with doravirine/islatravir (8.7%, 3.7%) due to protocol-specified criteria requiring discontinuation for decreased CD4 and lymphocyte counts 製製廠鬱積鹹壓鬱餘築 (窪繭繭繭範夢鹹鑰壓鑰 ) 更多	-	2025-09-16
				Bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg)
NCT04223778 (8591A-017 \| MK-8591A-017, CTgov)	临床3期	HIV感染	672	DOR/ISL (Group 1: Doravirine/Islatravir (DOR/ISL))	遞構鑰鑰醖築窪鏇憲遞 = 廠構選鹹顧淵窪選選繭選艱齋糧鏇糧願廠獵蓋 (艱憲積鹹製窪蓋鹹網網, 齋獵餘夢膚衊壓膚餘築 ~ 築憲鏇廠構衊鹹鬱網壓) 更多	-	2022-09-19
				ART+DOR/ISL (Group 2: Baseline Antiretroviral Therapy (ART))	遞構鑰鑰醖築窪鏇憲遞 = 糧範醖衊鑰鹹醖獵糧夢選艱齋糧鏇糧願廠獵蓋 (艱憲積鹹製窪蓋鹹網網, 蓋衊範遞選襯鏇艱鬱顧 ~ 網網淵鹽繭壓蓋蓋製淵) 更多