Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.

开始日期2025-12-15

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT05652478

/ Recruiting临床2期IIT

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

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

开始日期2025-09-29

申办/合作机构

National Institute of Allergy & Infectious Diseases

CTR20253373

/ RecruitingN/A

多替拉韦钠片在健康受试者中的生物等效性试验

本研究以成都倍特药业股份有限公司生产的多替拉韦钠片（50mg（以多替拉韦计））为受试制剂，以原研ViiV Healthcare B.V.持证，Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)生产的多替拉韦钠片（50mg（以多替拉韦计））（商品名：特威凯®）为参比制剂，评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。

开始日期2025-09-12

申办/合作机构

成都倍特药业股份有限公司

100 项与多替拉韦钠相关的临床结果

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100 项与多替拉韦钠相关的转化医学

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100 项与多替拉韦钠相关的专利（医药）

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3,466

项与多替拉韦钠相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Treatment persistence among treatment-experienced people with HIV switching to integrase strand transfer inhibitor–based antiretroviral regimens

Article

作者: Chen, Megan ; de Boer, Melanie ; Trom, Cassidy ; Chuo, Ching-Yi ; Christoph, Mary J. ; Zachry, Woodie

AIMS:

Low rates of persistence are associated with poor outcomes in people with HIV (PWH). This retrospective cohort study assessed treatment persistence as measured by time to treatment switch in treatment-experienced (TE) PWH initiating integrase strand transfer inhibitor (INSTI)-based regimens.

METHODS:

United States prescription claims and medical history data from the IQVIA Longitudinal Access and Adjudication Dataset between January 1, 2018, and August 31, 2023, were analyzed. TE PWH with ≥1 prescription claim for initiation of an INSTI-based antiretroviral regimen during the index period (January 1, 2020, to December 31, 2022) were included. Descriptive analyses of demographic and comorbidity variables were performed, stratified by regimen. Kaplan-Meier analysis was used to evaluate time to subsequent treatment switch in the overall population and among PWH aged ≥50 years, those receiving Medicare, and those with mental health conditions or substance use disorders.

RESULTS:

Overall, 29,348 TE PWH were included. The majority of INSTI-based regimen initiations were for bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (61%; n = 17,917), followed by dolutegravir/lamivudine (27.4%; n = 8034) and cabotegravir + rilpivirine (7.4%; n = 2186). A subsequent switch occurred in 3341 (11.4%) PWH. Risk factors for switch included female sex, Medicare/Medicaid coverage, and higher Charlson Comorbidity Index scores. B/F/TAF was associated with the fewest subsequent switches (9.2%; n = 1656) and was significantly less likely than any other regimen to lead to a subsequent switch, either in the overall population or in the three at-risk subgroups.

LIMITATIONS:

No data are available to determine the underlying reasons for initial treatment choice or subsequent treatment switch.

CONCLUSIONS:

This study provides evidence for greater treatment persistence with B/F/TAF versus other INSTI-based regimens. Unlike prior studies that focused on treatment-naïve individuals, this analysis uniquely evaluates persistence among treatment-experienced PWH initiating newer INSTI-based regimens.

2025-12-31·Global Health Action

Low-level viremia in people with HIV in Ethiopia is associated with subsequent lack of viral suppression and attrition from care

Article

作者: Abdissa, Alemseged ; Björkman, Per ; Abdulahi, Ilili Jemal ; Reepalu, Anton ; Elvstam, Olof ; Medstrand, Patrik

BACKGROUND:

Low-level viremia during antiretroviral therapy (ART) has been associated with inferior outcomes, but knowledge on the impact of low-level viremia in the current era of dolutegravir-based ART in low-income countries is limited.

OBJECTIVE:

To investigate whether low-level viremia predicts virologic non-suppression and attrition from care in people with HIV receiving ART in Ethiopia.

METHODS:

We included people receiving ART at public health facilities in an urban area in central Ethiopia and categorized persons with ≥1 available viral load 2019-2020 as having either suppression (<150 copies/mL) or low-level viremia (151-1,000 copies/mL); people with >1,000 copies/mL were excluded. We used multivariable logistic regression adjusted for age, sex, ART regimen, type of health facility, and duration of ART to analyze the associations between viremia category and incidence of unsuppressed viral load (>1,000 copies/mL) and attrition from care (death or loss to follow-up) during 3 years of follow-up.

RESULTS:

Among 12,165 participants, the median age was 44 years, 64.2% were female, and 89.1% received tenofovir/lamivudine/dolutegravir. Of the study population, 11,959 (98.3%) had suppression and 206 (1.7%) had low-level viremia. Over 3 years of follow-up, 2.2% of participants with suppression and 11.3% with low-level viremia had unsuppressed viral load. Low-level viremia was associated with both unsuppressed viremia (adjusted odds ratio [aOR], 3.7; 95% confidence interval [CI], 2.2-6.2) and attrition (aOR, 3.4; 95% CI, 1.7-6.6).

CONCLUSION:

Among Ethiopian people with HIV receiving ART, low-level viremia predicted subsequent virologic non-suppression and attrition from care, supporting current recommendations for heightened attention to low-level viremia in ART recipients.

2025-12-31·ANNALS OF MEDICINE

24-month outcomes after switching to Dolutegravir/Lamivudine in people living with HIV and HBcAb positivity at the Beijing Ditan Hospital in China

Article

作者: Zhao, Hongxin ; Biao, Ruojia ; Liu, Ying ; Chen, Jing ; Fu, Jiantao

BACKGROUND:

Dolutegravir/lamivudine (DTG/3TC) is a recommended therapy regimen for hepatitis B surface antigen (HBsAg)-negative people living with HIV (PLWH) who have achieved HIV virological suppression or are treatment-naïve. However, this may overlook the impact of occult hepatitis B infection on HIV suppression, which mainly present as hepatitis B core antibody (HBcAb) positive but HBsAg negative. We aim to assess the effect of HBcAb positivity on HIV suppression among PLWH who had switched to DTG/3TC.

METHODS:

A retrospective study was conducted including 127 HBcAb-positive and 474 HBcAb-negative PLWH (all were HBsAg negative) who had switched to DTG/3TC at the Beijing Ditan Hospital in China. HIV-RNA suppression was compared pre-switch (not baseline), at switch, and at 12&24 months post-switch, across three categories: (1) target not detected (TND); (2) HIV RNA < 40 cp/mL; (3) blip. Virological suppression included TND and HIV RNA < 40 cp/mL. Epidemiological (gender, age) and clinical data (CD4 count, HIV viral load, etc.) were extracted from the hospital information system. A p-value < 0.05 was considered statistically significant.

RESULT:

HBcAb-positive PLWH were older at DTG/3TC switch (median age: 41 vs. 36 years old, p < 0.001) and had lower nadir CD4 counts (median nadir CD4 counts: 255 vs. 295, p = 0.011). No difference in TND and HIV RNA < 40 cp/mL was present in the two groups at the switch (HBcAb-positive and -negative: 86.6% vs. 88.8%, 12.6% vs. 10.5%, p = 0.789). Similar HBcAb-positive compared with -negative PLWH resulted in TND at 12&24 months post-switch: 91.4% vs. 91% (p = 0.522) and 88.4% vs. 92.7% (p = 0.249), respectively. Consistent result was observed in HIV RNA < 40 cp/mL.

CONCLUSION:

In the 24-month follow-up after switching to DTG/3TC, HBcAb positivity was not significantly associated with HIV virological suppression.

261

项与多替拉韦钠相关的新闻（医药）

2025-09-16

·EndPoints

Exclusive: Fred Hutch duo's startup launches with $10M to build AI generative genomics models

If scientists run enough variations of a lab experiment, perhaps AI models could, someday, predict the results of future versions of that study. A new Seattle-based startup called Synthesize Bio believes it may be able to achieve that sooner than later, starting with gene-expression studies. Synthesize has already generated some promising results in predicting these types of lab experiments, according to a preprint published Tuesday. Synthesize will officially launch on Wednesday, its co-CEOs , Jeff Leek and Robert Bradley, exclusively told Endpoints News, as it releases its AI model, called GEM-1. The 15-employee biotech was founded in 2023 and raised a previously undisclosed $10 million seed round in October 2023, led by Madrona Ventures. Other investors include Sahsen Ventures, AI2 Incubator, Inner Loop Capital, and MD Venture Investments. Leek and Bradley came up with the idea behind Synthesize in the hallways of the Fred Hutchinson Cancer Center. Leek is the cancer center’s chief data officer, and Bradley is the scientific director of a translational data science research center. They wanted to see if biotech could follow a similar trajectory in building large AI models, similar to how companies like OpenAI and Anthropic grew large language models trained on nearly all of the internet’s data. “We felt like this is an idea where we believe it can transform how scientists go about their work,” Bradley said in an interview. The Fred Hutch duo built a model called GEM-1 over the last two years. The model is trained on tons of different gene-expression experiments that they curated and annotated from public datasets. Synthesize is already at work on the next-generation version of the model called GEM-2. “This is the worst version of the GEM model you will ever see,” Leek said. “It’s only going to get better over time.” Gene-expression experiments and single-cell studies have been a hot space within the AI bio field. Large organizations, like the Chan Zuckerberg Initiative and the Arc Institute , are championing moonshot projects that view these types of experiments as key building blocks in eventually making models of virtual cells. Virtual cells could allow more experiments traditionally done in the lab to be accurately simulated by computers. Other startups, like Noetik , Tahoe Therapeutics , and Xaira Therapeutics , are also taking their own twists on building large or rich datasets using some of these experiments. Synthesize believes its model can tackle a wider range of gene-expression experiments than the rest. To test that belief, they looked at how GEM-1’s predictions compared to real-world results. They set a cut-off date of mid-2024, training their model on experimental data in public databases before that date, and then using new experiments added after that date as tests. Overall, Synthesize’s team found GEM-1 “yielded accuracy comparable to the best-possible performance estimated by comparing the results of matched lab experiments,” according to the preprint. The preprint also found that about 95% of these new experiments were similar to those in GEM-1’s training data, meaning the model had already seen experiments that studied similar types of cells or similar perturbations. GEM-1’s predictions varied in accuracy. The model nailed the effect on gene expression of certain molecules, like the hair-loss drug finasteride and an alpha blocker called doxazosin. But predictions for other compounds were less than 50% accurate, like the HIV treatment dolutegravir or cancer drug afatinib, according to the preprint. An area of active research is working on confidence intervals, which could give users a sense of the quality of a prediction. Bradley said that’s something the broader AI field is also working on, as it’s an important problem. That could be critical in telling the finasteride and afatinib predictions apart. “Our goal is not to replace experiments,” Bradley said. “Our goal is to have a seamless blend of wet-lab work and AI experimentation. Experiments are critical. They’re always going to be the gold standard.” Instead, GEM-1 could allow scientists on finite budgets to consider more data for experiments they may not have the time or resources to run. It could also enable scientists to get a sense of results on experiments that are impossible or impractical today, Bradley said. For instance, the model could help predict a drug’s activity in tissue where you can’t take a patient’s biopsy, he said. Leek said there are blind spots, where GEM-1’s performance is wanting. That’s why they are eager to release the model openly, including free access on its website , to gain a sense of how researchers use it and its real-world performance.

2025-09-11

·漫游药化

全球最畅销的十款小分子药物！

小分子药物已过时？显然没有！随着抗体、基因疗法、细胞疗法等新兴药物模式的兴起，小分子药物一度被认为即将过时，事实上，小分子药物仍有其不可替代性，相对生物制剂来说，小分子在生产制造、运输、患者依从性、可用靶点范围、免疫原性等方面仍具有明显优势。在全球范围内的上市药物中，小分子药物的占比仍然高达近90%。而在2023年前三季度FDA批准的40个新药中，也有21个小分子。下面就让我们一起盘点小分子药物中的优等生，看看在销售榜单中的top 10都有哪些明星分子。根据Arizona大学Jon Njardarson课题组的统计，2022年前十大销售额的小分子药物总计销售超966亿美元，治疗领域涵盖病毒感染、心血管、肿瘤等。从公司来看，辉瑞不愧为小分子药物开发先驱，共有4款药物入围前十，其次是BMS，有阿哌沙班、来那度胺两款小分子药进入前十，合计贡献217亿美元营收。表1, 2022销售额 top 10小分子药物 01 奈玛特韦（Paxlovid，Nirmatrelvir）由辉瑞研发的一款3CL蛋白酶抑制剂，可以抑制3CL蛋白酶的作用，从而阻止新冠病毒后续的一系列复制活动。在临床试验中，Paxlovid可将新冠肺炎非住院患者的住院或死亡率降低89%。该药于2021年12月成为首款获得FDA紧急批准的新冠口服药，上市第一年，销售额便达到了189亿美元，一举超越阿哌沙班成为最畅销小分子药物。奈玛特韦是在先前开发的针对非典（SARS）的特效药PF-00835231基础上改造得来，辉瑞的研究人员发现，PF-00835231与SARS-CoV的结合位点，同样存在于新冠病原SARS-CoV-2，这意味着PF-00835231也许对新冠病毒同样有效，经测试证明确实如此，但静脉注射剂型太过繁琐，辉瑞便对PF-00835231进行结构优化并引入三氟乙酰胺基团，提高了生物利用度，使其可通过口服吸收。图1，由SARS特效药改造得到SARS-CoV-2特效药Paxlovid 02 阿哌沙班（Eliquis，apixaban）由BMS和辉瑞公司联合研发的一种新型凝血因子Xa（Factor Xa）抑制剂，分别于2011和2012年在欧洲和美国上市，用于患者术后静脉血栓栓塞症（VTE）预防及房颤患者脑卒中预防。虽然专利还未到期（2026年），但2022年销售额同比2021年仍降低了约30%，为117亿美元。阿哌沙班由BMS经过高通量筛选优化得到，对人FXa的Ki 0.08 nM，对 FXa 的选择性比其他人凝血蛋白酶高 30000 倍以上。与维生素K拮抗剂华法林等相比，阿哌沙班具有疗效更好，安全性更高的特点。图2, 阿哌沙班的结构优化过程 03 必妥维（Biktarvy）由吉利德科学公司研发，于2018年获FDA批准上市的用于治疗HIV的三合一复方新药，含有比克替拉韦（bictegravir）50mg/恩曲他滨（emtricitabine）200mg/丙酚替诺福韦（tenofovir alafenamide）25mg，bictegravir是HIV-1整合酶抑制剂，emtricitabine和tenofovir alafenamide都是核苷类似物，用作逆转录酶抑制剂。2020/2021/2022年的销售额分别为72.59亿、86.24亿、103亿美元，放量十分迅速。恩曲他滨和丙酚替诺福韦在2003和2015年就已经上市，只有比克替拉韦为Biktarvy复方新药中的NME成分，其化学结构与多替拉韦（Dolutegravir， GSK开发的HIV药物）类似，同为整合酶抑制剂，但Biktarvy安全性更佳。图3, Bictegravir（BIC）和Dolutegravir（DTG） 04 来那度胺（Revlimid, Lenalidomide）来那度胺由新基制药开发，是老药新用的经典案例，前身是臭名昭著的“反应停“沙利度胺。上世纪90年代，科学家发现沙利度胺有抗癌疗效，对其进行分子改造后得到来那度胺，后者于2005年获批上市，用于治疗多发性骨髓瘤（MM）、骨髓瘤增生异常综合征（MDS）等疾病。该药2020/2021/2022年的销售额分别为121亿、129亿、100亿美元，2023年进一步降至61亿美元，但上市至今累计销售额已达1050亿美元。图4, 沙利度胺与来那度胺后来，经过更广泛的研究，科学家发现来那度胺是通过分子胶水的机制诱导E3连接酶Cereblon (CRBN) 降解靶蛋白来发挥治疗作用，由此开发出了一项全新的小分子药物技术—蛋白水解靶向嵌合体（PROTAC），其能够弥补传统小分子药物难以靶向不可成药靶点的缺陷，诱导致病蛋白的降解。 05 恩格列净（Jardiance, Empagliflozin）由勃林格殷格翰公司研发的钠-葡萄糖协同转运蛋白-2 (SGLT2)抑制剂，于2014年8月获FDA批准上市，用于控制2型糖尿病成人患者的血糖和降低患者的心血管风险。SGLT2主要在肾脏表达，负责从肾小管腔重吸收过滤后的葡萄糖和钠，当SGLT2被抑制后，肾脏对葡萄糖和钠的重吸收都会减少，降低体内血糖浓度。该药2020/2021/2022年销售额为41.08亿、58.29亿、82.15亿美元。图5, 恩格列净作用机制 06 伊布替尼（Imbruvica，Ibrutinib）该药于2013年在美国上市，是全球首个BTK共价抑制剂，用于治疗套细胞淋巴瘤（MCL）、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）和华氏巨球蛋白血症（WM）等血液肿瘤。然而，伊布替尼作为一代抑制剂，对BTK选择性不够好，存在脱靶效应，并可能抑制其他具有相同保守的Cys残基的激酶从而导致过敏和腹泻等不良反应。图6, 已上市的BTK抑制剂结构该药2020/2021/2022年销售额为94.42亿、97.77亿、83亿美元，核心专利将于2026年到期，但由于泽布替尼和其他后来者的强力竞争，伊布替尼的市场急剧下滑，2023年销售额仅为36亿美元。而2022年刚获FDA批准的泽布替尼，2023年销售额已达到13亿美元。 07 多替拉韦（Tivicay，Dolutegravir）由GSK和ViiV Healthcare共同研发，与bictegravir一样，是HIV整合酶抑制剂，阻断HIV病毒DNA整合来限制HIV的复制，于2013年8月获FDA批准上市。多替拉韦还是GSK其他三款HIV产品——Triumeq(多替拉韦/阿巴卡韦/拉米夫定)、Juluca(多替拉韦/利匹韦林）和Dovato（多替拉韦/拉米夫定)的成分之一，该药2022年销售额达到了81亿美元。在dolutegravir之前，已经有raltegravir、elvitegravir等整合酶抑制剂上市，对整合酶药物结合口袋的构效关系研究也已经比较清楚，于是盐野义和GSK的研究人员在总结前期发表的分子结构基础上引入氧原子设计了化合物5，以增强化何物对整合酶的结合能力，之后又对生物利用度、半衰期和突变体结合活性进行了优化，得到了dolutegravir，半衰期为6 h，生物利用度达到了34%。图7, Dolutegravir（3）结构优化历程 08 Trikafta (Elexacaftor, Tezacaftor, Ivacaftor) 由福泰制药研发，于2019年10月获FDA批准上市，用于治疗6岁及以上囊性纤维化跨膜电导调节蛋白（CFTR）的基因至少有一个F508del突变或其它有效突变的囊性纤维化（cystic fibrosis, CF）患者。 Trikafta由三个小分子复方组成，他们同时结合致病的CFTR突变蛋白，彼此之间有协同作用，elexacaftor是新一代CFTR蛋白校正剂，帮助恢复携带F508del突变的CFTR蛋白的功能；tezacaftor帮助组装和运输CFTR蛋白至细胞表面来增强它的功能，ivacaftor则通过增加位于细胞表面CFTR通道的开放率（门控通道），提高CFTR蛋白的活性，增加氯化物的转运。三种分子联合应用能增加CFTR蛋白的数量并增强蛋白的功能。图8，Trikafta含有的三个小分子结构及其作用机制囊性纤维化是一种遗传性疾病，由CFTR的基因突变引起，在美国有3万多名囊性纤维化患者，全世界约有7万名患者。Trikafta则是福泰制药的当家产品，该药在2020/2021/2022/2023年销售额分别为39亿、57亿、76亿、89亿美元，年均增长率达32%，在2023年更是贡献了福泰全年总营收的90%。 09 利伐沙班（Xarelto，Rivaroxaban）利伐沙班由拜耳制药开发，为首个上市的Factor Xa抑制剂（分别于2008和2011年在欧洲和美国获批），它通过抑制因子Xa可以中断凝血瀑布的内源性和外源性途径，抑制凝血酶的产生和血栓形成。 Bayer于1998年便启动了直接抑制FXa小分子抗凝药物研发项目，经过高通量筛选20万化合物后得到了一个IC50为70 nM、选择性抑制FXa体外酶活的苗头化合物，并对其进行结构优化以提升抑制活性和口服生物利用度，最终优化得到含有吡咯烷酮结构的利伐沙班，IC50为0.7 nM，口服生物利用度接近60%。图9，利伐沙班抗凝血机制 10 恩杂鲁胺（Xtandi, Enzalutamide）由美国Medivation公司研发，是一款成功的me-better的非甾体雄激素受体（androgen receptor，AR）抑制剂，于2012年获FDA批准上市，用于治疗去势性前列腺癌和转移性激素敏感性前列腺癌。最初的药化工作是由UCLA大学的Jung和Memorial Sloan-Kattering癌症中心的Sawyers合作进行, Jung等以药物尼鲁米特和雄激素激动剂RU59063为出发点, 试图优化得到AR拮抗剂，最终从合成的200多个化合物中优选出恩杂鲁胺。图10 恩杂鲁胺及其先导化合物结构恩杂鲁胺2020/2021/2022年销售额51亿、56.36、62亿，销售额仍处于稳定爬坡中。 Ref： Wong PC, Pinto DJ, Zhang D. Preclinical discovery of apixaban, a direct and orally bioavailable factor Xa inhibitor. J Thromb Thrombolysis. 2011 May;31(4):478-92. Owen DR, Allerton CMN, Zhu Y. An oral SARS-CoV-2 Mpro inhibitor clinical candidate for the treatment of COVID-19. Science. 2021 Dec 24;374(6575):1586-1593. Liu J, Chen C, Wang D, Zhang J, Zhang T. Emerging small-molecule inhibitors of the Bruton's tyrosine kinase (BTK): Current development. Eur J Med Chem. 2021 May 5;217:113329. Perzborn, E., Roehrig, S., Straub, A.et al. The discovery and development of rivaroxaban, an oral, direct factor Xa inhibitor. Nat Rev Drug Discov 10, 61–75 (2011). https://www.xareltohcp.com/ Fiedorczuk K, Chen J. Molecular structures reveal synergistic rescue of Δ508 CFTR by Trikafta modulators. Science. 2022 Oct 21;378(6617):284-290. Yoshiyuki Taoda, Shuichi Sugiyama & Takahiro Seki. (2023) New designs for HIV-1 integrase inhibitors: a patent review (2018-present). Expert Opinion on Therapeutic Patents 33:1, pages 51-66. 作者：betaloc

上市批准细胞疗法基因疗法紧急使用授权

2025-09-04

·国家药品监督管理局

2025年09月04日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2401901腹膜透析液（乳酸盐-G1.5%）上海长征富民金山制药有限公司国药准字H202581772025年09月03日2CYHB2401902腹膜透析液(乳酸盐-G2.5%)上海长征富民金山制药有限公司国药准字H202581782025年09月03日3CYHB2401906氯化钠注射液河北天成药业股份有限公司————2025年09月02日4CYHB2401921氯化钾注射液石药银湖制药有限公司————2025年09月02日5CYHB2450320注射用泮托拉唑钠马鞍山丰原制药有限公司————2025年09月03日6CYHB2450450注射用盐酸地尔硫䓬石药集团欧意药业有限公司————2025年09月03日7CYHB2501275注射用盐酸头孢吡肟广州白云山天心制药股份有限公司————2025年09月02日8CYHB2501276注射用盐酸头孢吡肟广州白云山天心制药股份有限公司————2025年09月02日9CYHB2501278盐酸肾上腺素注射液遂成药业股份有限公司————2025年09月02日10CYHB2501301别嘌醇片上海信谊万象药业股份有限公司————2025年09月02日11CYSB2300198甲型H1N1流感病毒裂解疫苗上海生物制品研究所有限责任公司————2025年09月03日12CYSB2400181冻干乙型脑炎灭活疫苗(Vero细胞)辽宁成大生物股份有限公司————2025年09月03日13CYSB2400331注射用瑞替普酶爱德药业（北京）有限公司————2025年09月03日14CYZB2501116清热八味胶囊内蒙古奥特奇蒙药股份有限公司金山蒙药厂————2025年09月02日15CYZB2501298胎盘片湖南一格制药有限公司————2025年09月02日16CYZB2501368白脉软膏甘肃奇正藏药有限公司————2025年09月02日17CYZB2501717乌鸡白凤丸西安自力制药科技有限公司————2025年09月01日18CYZB2501718乌鸡白凤丸西安自力制药科技有限公司————2025年09月01日19CYZB2501737治伤胶囊德泰汉方（陕西）药业有限公司————2025年09月01日20JTH2500121羟考酮氮氧化物萌蒂（中国）制药有限公司————2025年09月02日21JTH2500124拉坦前列素齐鲁制药有限公司————2025年09月02日22JYHB2500216达格列净片西普拉（中国）医药有限公司————2025年09月03日23JYHB2500289巴瑞替尼片礼来苏州制药有限公司————2025年09月02日24JYHB2500290巴瑞替尼片礼来苏州制药有限公司————2025年09月02日25JYHZ2500078阿达帕林凝胶科医国际贸易（上海）有限公司国药准字HJ201600222025年09月03日26JYHZ2500094达罗他胺片拜耳医药保健有限公司国药准字HJ202100102025年09月03日27JYHZ2500096多替拉韦钠片葛兰素史克（中国）投资有限公司国药准字HJ201506832025年09月03日28JYSB2500022达雷妥尤单抗注射液（皮下注射）强生制药有限公司————2025年09月03日29JYSB2500135塔奎妥单抗注射液强生制药有限公司————2025年09月03日30JYSB2500136塔奎妥单抗注射液强生制药有限公司————2025年09月03日31JYSB2500139司美格鲁肽注射液诺和诺德（中国）制药有限公司————2025年09月03日32JYSB2500140司美格鲁肽注射液诺和诺德（中国）制药有限公司————2025年09月03日33JYSB2500141司美格鲁肽注射液诺和诺德（中国）制药有限公司————2025年09月03日34JYSB2500142司美格鲁肽注射液诺和诺德（中国）制药有限公司————2025年09月03日35JYSB2500143司美格鲁肽注射液诺和诺德（中国）制药有限公司————2025年09月03日36JYSB2500144格菲妥单抗注射液罗氏（中国）投资有限公司————2025年09月03日

疫苗申请上市

100 项与多替拉韦钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10113	多替拉韦钠	J05AX12	DB08930

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	美国	ViiV Healthcare Co.	2013-08-12

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
肺结核	临床3期	巴西	ViiV Healthcare Ltd.	2025-09-18
结核	临床3期	巴西	ViiV Healthcare Ltd.	2025-09-18
怀孕	临床3期	南非	ViiV Healthcare Ltd.	2017-03-14
怀孕	临床3期	乌干达	ViiV Healthcare Ltd.	2017-03-14
潜伏性结核	临床2期	美国	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	博茨瓦纳	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	海地	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	马拉维	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	南非	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	泰国	ViiV Healthcare Ltd.	2021-02-27

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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


GS-US-380-1844，ALLIANCE (Pubmed)	-	HIV感染	2,622	多替拉韦+恩曲他滨+丙酚替诺福韦	構齋繭製獵夢簾糧鑰醖(鹹夢鑰襯築廠範遞醖鹽) = 糧窪獵醖網窪鬱襯窪鏇繭鑰鹹齋願衊繭齋願蓋 (廠鹽獵蓋鬱壓簾繭膚淵 ) 更多	积极	2024-11-18
				多替拉韦	構齋繭製獵夢簾糧鑰醖(鹹夢鑰襯築廠範遞醖鹽) = 構膚憲壓鬱網齋構衊淵繭鑰鹹齋願衊繭齋願蓋 (廠鹽獵蓋鬱壓簾繭膚淵 ) 更多
NCT03048422 (IMPAACT 2010 (VESTED), Pubmed \| J Acquir Immune Defic Syndr)	临床3期	bone mineral density \| creatinine clearance	-	Dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF)	製窪壓鏇齋網製構廠積(顧積衊顧鬱繭衊鬱鹹網) = 壓鹹襯築遞鹹構襯獵簾觸遞廠網鹽鹹鑰願淵壓 (選糧鹽網糧襯構淵襯鹹 )	积极	2024-10-01
				Dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF)	製窪壓鏇齋網製構廠積(顧積衊顧鬱繭衊鬱鹹網) = 獵簾餘簾蓋網築鏇鬱襯觸遞廠網鹽鹹鑰願淵壓 (選糧鹽網糧襯構淵襯鹹 )
NCT03017872 (D2EFT, Pubmed)	临床4期	HIV感染二线 HIV RNA load	828	ritonavir-boosted darunavir plus two NRTIs	膚範壓艱遞獵鬱顧選顧(醖艱選衊淵膚襯憲膚膚) = 構獵憲選襯艱觸鹹積憲鏇鑰壓衊夢鹹蓋膚顧構 (觸觸簾觸製襯構遞觸顧 )	积极	2024-07-01
				ritonavir-boosted darunavir plus dolutegravir	膚範壓艱遞獵鬱顧選顧(醖艱選衊淵膚襯憲膚膚) = 壓簾鏇獵糧選簾憲鑰築鏇鑰壓衊夢鹹蓋膚顧構 (觸觸簾觸製襯構遞觸顧 )
NCT04857892 (CTgov)	临床1期	HIV感染	41	GSK3640254+DTG (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)	獵艱築製獵糧製夢願淵(醖獵鏇鬱簾顧鑰顧網糧) = 衊顧廠簾網蓋網蓋膚積遞製鹽築衊糧積壓壓艱 (觸鑰艱膚鹽網醖淵襯蓋, 46.8) 更多	-	2024-03-12
				GSK3640254+DTG (Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))	獵艱築製獵糧製夢願淵(醖獵鏇鬱簾顧鑰顧網糧) = 壓夢醖壓憲鏇觸廠製顧遞製鹽築衊糧積壓壓艱 (觸鑰艱膚鹽網醖淵襯蓋, 36.6) 更多
NCT01837277 (IDEA, CTgov)	临床2/3期	获得性免疫缺陷综合征	186	Dolutegravir 50 mg (Dolutegravir)	繭遞壓窪齋選窪鑰鏇鏇 = 衊餘衊簾鹽範齋顧壓構顧鏇淵衊鑰憲遞廠簾淵 (醖繭壓鹹窪鏇襯選齋網, 構鏇遞顧遞淵糧蓋顧鏇 ~ 鑰齋願襯鑰網衊餘鑰製) 更多	-	2023-12-14
				Efavirenz (Efavirenz)	繭遞壓窪齋選窪鑰鏇鏇 = 遞積獵廠遞顧壓積顧齋顧鏇淵衊鑰憲遞廠簾淵 (醖繭壓鹹窪鏇襯選齋網, 艱廠製壓夢壓築憲製鬱 ~ 蓋鹹築膚願構鹹膚壓鏇) 更多
NCT02777229 (NAMSAL-ANRS-12313, Pubmed \| Open Forum Infect Dis)	临床3期	HIV感染一线	613	Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)	齋糧觸獵網衊選窪構鹽(鑰獵齋簾鹽襯繭鹽夢構) = 範壓艱簾齋膚餘夢廠選淵壓壓糧襯淵觸餘衊願 (簾艱鏇鑰衊鏇鏇鏇鹽繭 ) 更多	积极	2023-12-01
				Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)	齋糧觸獵網衊選窪構鹽(鑰獵齋簾鹽襯繭鹽夢構) = 糧繭鑰鑰網壓觸遞齋獵淵壓壓糧襯淵觸餘衊願 (簾艱鏇鑰衊鏇鏇鏇鹽繭 ) 更多
NCT02777229 (NAMSAL ANRS 12313, Pubmed \| J Acquir Immune Defic Syndr)	临床3期	HIV感染一线	613	Dolutegravir 50 mg (DTG)	選獵糧鏇築糧壓窪積鬱(積獵廠齋選鑰觸餘窪鹽) = 選製糧構廠製積醖艱積繭鏇遞齋觸選顧選鏇構 (願繭鹹範網鑰鹹餘襯築 ) 更多	积极	2023-11-01
				Low-dose Efavirenz (EFV400)	選獵糧鏇築糧壓窪積鬱(積獵廠齋選鑰觸餘窪鹽) = 蓋築獵願鹽廠選顧憲鹹繭鏇遞齋觸選顧選鏇構 (願繭鹹範網鑰鹹餘襯築 ) 更多
NCT02777229 (NAMSAL ANRS 12313, Pubmed)	临床3期	一线	613	Dolutegravir 50 mg (DTG)	憲膚鹹齋願艱艱製繭齋(製艱糧範糧膚襯製壓蓋) = decreased from 7.2 to 3.0 齋齋觸簾憲願築遞襯鏇 (顧遞構齋積蓋廠顧鹽廠 ) 更多	积极	2023-11-01
				Low-dose efavirenz (EFV400)
NCT03851588 (RADIANT-TB, CTgov)	临床2期	结核 \| HIV感染	108	Dolutegravir 50 mg (Supplementary Dose)	積簾醖構餘憲齋選鑰壓 = 遞製糧繭夢壓淵鬱積顧簾築蓋夢膚艱膚鑰鹽觸 (鹽獵鬱鑰壓淵艱鏇憲蓋, 鑰觸繭衊鏇範網選蓋獵 ~ 範遞獵獵顧餘鏇夢觸壓) 更多	-	2023-09-18
				Placebo (Placebo Dose)	積簾醖構餘憲齋選鑰壓 = 構構襯鹹願糧鹹範衊鏇簾築蓋夢膚艱膚鑰鹽觸 (鹽獵鬱鑰壓淵艱鏇憲蓋, 選繭膚夢積壓憲鑰鹽襯 ~ 遞鹽築餘觸憲壓積鬱糧) 更多
NCT03224338 (Phase 2 Study, Pubmed \| Clin Infect Dis)	临床2期	HIV感染一线	30	Dolutegravir plus 2 NRTIs	鑰膚繭繭鏇遞壓鹽淵艱(遞簾淵鬱淵鏇繭衊膚繭) = One participant discontinued due to central nervous system symptoms 繭鏇淵遞網製廠鏇築願 (製鏇積艱餘鬱醖壓夢憲 ) 更多	积极	2023-09-11