Developing technologies to help measure and provide tools to support medication-taking behaviors (medication adherence) is an important step to ending the human immunodeficiency virus (HIV) epidemic. TruTag Technologies has pioneered the use of a microparticle system that can be incorporated into the coating of medications may help users both identify the medication they are taking and record adherence events. By using a standard smartphone camera, shining light on TruTag-coated medications automatically identifies them to an onboard smartphone app which then indirectly records the adherence event. This study evaluates the real-world usability and feasibility of operating this system among people living with HIV (PLWH).

开始日期2024-09-15

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

NCT05719441 / Recruiting临床2期IIT

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether:
* Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe.
* Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks compared to participants who receive placebo plus ART.
* Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.

开始日期2024-08-19

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT06337032 / Not yet recruiting临床4期

An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.
The primary objectives of this study are as follows:
* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.
* To evaluate the safety of the study drug(s) in participants with HIV-1.

开始日期2024-08-01

申办/合作机构

Gilead Sciences, Inc.

100 项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的临床结果

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100 项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的转化医学

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100 项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的专利（医药）

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项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的文献（医药）

2024-01-01·Heliyon

Comparison of the efficacy of combined budesonide and fexofenadine versus combined fluticasone propionate and fexofenadine on the expression of class-4 semaphorins and their receptors in the peripheral blood cells of patients with allergic rhinitis

Article

作者: Rezaei Varmaziar, Fatemeh ; Salari, Farhad ; Rezaiemanesh, Alireza ; Gorgin Karaji, Ali ; Falahi, Sara ; Feizollahi, Parisa ; Asadi, Gelayol ; Rajabinejad, Misagh ; Faryadi, Elham

Background:

Allergic rhinitis (AR) is a common immunoglobulin (Ig) E-mediated disease. This study aimed to evaluate the gene expression levels of class 4 semaphorins and their receptors in AR patients before and after treatment with budesonide and fexofenadine (B/F) compared to fluticasone propionate and fexofenadine (FP/F).

Methods:

In this study, 29 AR patients (age 34.4 ± 1.2 years, 18 men and 11 women) were treated with B/F, and 24 AR patients (age 32.8 ± 1.9 years, 15 men and 9 women) were treated with FP/F for one month. Before and after treatment, peripheral blood samples were taken from patients. The expression levels of SEMA4A, SEMA4C, SEMA4D, Plexin-B2, and Plexin-D1 genes were measured using the qPCR method. In addition, the serum levels of IgE were measured using an enzyme-linked immunosorbent assay (ELISA).

Results:

The expression levels of SEMA4A (P = 0.011), 4C (P = 0.017), Plexin-B2 (P = 0.0005), and Plexin-D1 (P = 0.008) remarkably increased in AR patients treated with B/F. Our results show a significant reduction in the gene expression levels of SEMA4A (P = 0.002), 4C (P = 0.014), 4D (P = 0.003), Plexin-B2 (P = 0.033), and Plexin-D1 (P = 0.035) after treatment with FP/F. The serum levels of IgE increased in FP/F treated group (P = 0.017) and conversely decreased in the treated group with B/F (P = 0.019). Moreover, the percentages of eosinophils were reduced in both FP/F and B/F groups (P = 0.015 and P = 0.0001, respectively).

Conclusion:

In conclusion, concomitant use of fexofenadine and fluticasone propionate reduced SEMA4A, 4C, 4D, Plexin-B2, and Plexin-D1, while the SEMA4A, 4C, Plexin-B2, and Plexin-D1 gene expression levels were increased in the patient group treated with B/F.

2024-01-01·AIDS (London, England)

A study of the pharmacokinetics, safety, and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed pregnant women with HIV

Article

作者: Shang, Justin ; Avihingsanon, Anchalee ; Marathe, Dhananjay D. ; Hindman, Jason T. ; Arora, Priyanka ; Davis, Maggie ; Xiao, Deqing ; Girish, Sandhya ; Zhang, Haeyoung ; Lin, Ludwig ; Palaparthy, Ramesh

Objective::

The objective of this study was to assess the pharmacokinetics, safety, and efficacy and confirm the dose of once-daily bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; B/F/TAF) during pregnancy.

Design::

An open-label, multicenter, single-arm, phase 1b study (NCT03960645) was conducted in 33 virologically suppressed pregnant women with HIV-1.

Methods::

Participants received B/F/TAF (50/200/25 mg) from the second or third trimester through ∼16 weeks postpartum. Steady-state maternal plasma pharmacokinetic samples were collected at the second and third trimesters and 6 and 12 weeks postpartum for BIC, FTC, and TAF. Neonates (n = 29) were followed from birth to 4–8 weeks with sparse washout pharmacokinetic sampling for BIC and TAF. The proportion of participants with HIV-1 RNA less than 50 copies/ml at delivery (missing = excluded) was evaluated.

Results::

Mean areas under the concentration–time curve over the dosing interval (AUCtau) for BIC, FTC, and TAF were lower during pregnancy versus postpartum but were closer to AUCtau values for nonpregnant adults with HIV reported in other studies. Geometric least-squares mean ratios for BIC, FTC, and TAF AUCtau during pregnancy versus postpartum ranged from 41 to 45%, 64 to 69% and 57 to 78%, respectively. Mean BIC trough concentrations during pregnancy were more than 6.5-fold greater than the protein-adjusted 95% effective concentration. In neonates, the median BIC half-life was 43 h. Virologic suppression was maintained in all adult participants throughout the study, with no virologic failure or treatment-emergent resistance to HIV-1, no discontinuations because of adverse events, and no perinatal transmission.

Conclusion::

Exposures to BIC, FTC, and TAF were lower during pregnancy than postpartum. However, mean BIC trough concentrations were maintained at levels indicative of efficacious exposure, and FTC/TAF data were concordant with published literature in this population. Pharmacokinetic and safety data, combined with maintenance of robust virologic suppression, suggest that once-daily B/F/TAF without dose adjustment is appropriate during pregnancy.

2023-11-20·Chinese medical journal

Efficacy and safety profiles of dolutegravir plus lamivudine vs. bictegravir/emtricitabine/tenofovir alafenamide in therapy-naïve adults with HIV-1

Article

作者: Wang, Yanhao ; Deng, Yiming ; Xu, Ruhong ; Wei, Yinghua ; He, Lixia ; Li, Jin ; Zhong, Huijun ; Wen, Li

Abstract:

Background::

Dual regimen dolutegravir (DTG) plus lamivudine (3TC) has demonstrated non-inferior efficacy compared to DTG-based three-drug regimens (3DRs), yet directly comparative data regarding the efficacy and safety of DTG + 3TC and bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for therapy-naïve people with human immunodeficiency virus (HIV)-1 (PWH) are still limited. We aimed to assess the antiviral potency and safety profiles of DTG + 3TC vs. B/F/TAF based on antiretroviral therapy (ART)-naïve PWH in China.

Methods::

This retrospective multicenter study enrolled PWH initiating ART with DTG + 3TC or B/F/TAF from 2020 to 2022 in Guangdong and Guangxi. We analyzed response rates based on target not detected (TND) status using intention-to-treat (ITT) analysis. Subgroups were formed based on baseline viral load (VL) (<100,000 vs. ≥100,000 copies/mL) and CD4+ cell count (<200 vs. ≥200 cell/µL). Median time to TND VL was assessed by Kaplan–Meier method. We also measured changes from baseline in CD4+ cell counts, CD4/CD8 ratio, lipid parameters, weight, creatinine (Cr), estimated glomerular filtration rate (eGFR), and drug-related adverse effects (DRAEs).

Results::

We enrolled 280 participants, including 137 (48.9%) on DTG + 3TC and 143 (51.1%) on B/F/TAF. At week 48, 96.4% (132/137) on DTG+3TC and 100% (143/143) on B/F/TAF achieved TND (P = 0.064). At week 12, TND responses were higher with B/F/TAF (78.3% [112/143]) than DTG+3TC (30.7% [42/137]) (P <0.001). This trend held across subgroups. B/F/TAF achieved TND faster (12 weeks) than DTG+3TC (24 weeks) (P <0.001). No differences were seen in CD4+ cell count and CD4/CD8 ratio, except in the high-VL subgroup, where B/F/TAF showed better recovery. DRAEs were significantly lower with B/F/TAF (4.9% [7/143]) than with DTG + 3TC (13.1% [18/137]) (P = 0.016). Lipid parameters, body weight, and Cr increased in both groups over 48 weeks, with DTG+3TC showing a more favorable effect on triglycerides, high-density lipoprotein (HDL) cholesterol, and weight gain.

Conclusions::

In this real-life study, B/F/TAF led to a faster viral decline and fewer DRAEs compared to DTG+3TC. No significant difference was observed in the TND rate at week 48, regardless of baseline VL and CD4+ cell count. CD4+ recovery was superior for B/F/TAF in participants with high VL. The DTG + 3TC regimen had less impact on metabolic changes than B/F/TAF.

210

项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的新闻（医药）

2024-08-23

·E药经理人

礼来“杀疯”，辉瑞乏力，全球TOP20畅销药格局大变！百济、传奇有望跻身？

上市第几年能看出一款新药有重磅炸弹潜力？全球TOP20畅销药放量节奏是什么？Evaluate Pharma的统计数据给出了答案。撰文| Erin 一款新药何时、如何才能展现出成为全球TOP20畅销药的潜力？ Evaluate Pharma在近期的一份报告中给出了统计学答案：那些在2014年之后上市、2023年被列入全球最畅销的20款重磅炸弹药物的平均水平是，上市第一年就卖到2亿美元，3年达成“10亿美元重磅炸弹”的成就。有意思的是，如果按照这两个指标，“药王”K药、“网红”DS8201才只是“中等生”水平，诺和诺德的司美格鲁肽、吉利德的必妥维是“优等生”，而礼来的Mounjaro，上市首个完整年度仅糖尿病适应证就突破50亿美元，是货真价实的“学霸”。而如果拆解2014年之后上市的全球百余款重磅炸弹药物，及其背后的药企，他们呈现出了不同的商业节奏，以及差异化明显的自研及外部并购能力：礼来、AZ培育出的重磅炸弹药物最多，辉瑞最少；强生、吉利德彰显出强悍的临床开发能力；BMS、辉瑞并购眼光待提升。不过，一切的选择都是为了更好地“赚钱”，谁是下一个超级重磅炸弹？下一个超级重磅炸弹来自哪家药企？结合Evaluate Pharma此份报告，以及2024年上半年全球十大畅销药物，能够得出一定答案。沿此逻辑，目前备受关注的三款登陆美国市场的国产新药，泽布替尼，西达基奥仑赛和呋喹替尼，在未来有进入全球TOP20畅销药榜单的潜力吗？何时能够进入？ 2024年H1全球TOP10畅销药（仅统计2014年之后上市的新药） TOP20格局变天一款新药上市第一年卖多少钱才能成为全球TOP20畅销药潜力股？ Evaluate Pharma在这份报告中给出了答案：第一年销售额能否卖出2亿美元，是跻身TOP20的第一大门槛。那上市多少年，销售额才能突破10亿、50亿、100亿美元？以2014年之后上市、2023年最畅销的20款重磅炸弹药物的放量路线为参考。平均来讲，这20款畅销药成为10亿美元重磅炸弹用时3年，其中15款已经成功突破50亿美元分水岭的超级重磅炸弹，它们平均花费了5.5年的时间，而有5款百亿美元最畅销药物，突破这一大关，它们平均花了6.6年时间。全球TOP20畅销药销售情况及预期光看时间的数据可能并不具象，如果从具体产品的放量曲线来看，会发现，其实如今的“药王”K药，和备受行业看好的DS8201只是代表平均水平的“中等生”。 E药经理人根据默沙东的财报统计，K药于2014年首次在美国获批上市，2016年（上市第三年）才突破10亿美元关卡，成为重磅炸弹，2018年（上市第五年）突破50亿美元、2020年（上市第七年）突破100亿美元。如今全球最畅销的ADC药物DS8201，在2019年12月首次在美获批HER2阳性乳腺癌，但其一开始的放量并不迅速，一直到2022年获批成为首个获批用于HER2低表达乳腺癌亚型的疗法，销售额才实现翻倍突破10亿美元。 TOP20畅销药中真正的“优等生”，是什么样子的？在上市第二年，甚至是首年，就能突破10亿美元的销售额。礼来的GIPR/GLP-1R双靶点激动剂替尔泊肽就是一款十年难遇的“优等生”，其降糖版Mounjaro于2022年5月首次获得FDA批准用于2型糖尿病，上市半年多的时间就卖出了4.83亿美元的销售额，到了2023年，其获批上市的第一个完整销售年度，仅凭糖尿病适应证就实现销售额翻十倍，达51.63亿美元。Mounjaro在2024年放量更为迅速，上半年就实现收入48.97亿美元。值得一提的是，替尔泊肽在2023年年底还获批了减重版本Zepbound，该产品在今年上半年也实现了17.61亿美元的销售额，两个版本加起来总收入超66亿，增速远超诺和诺德司美格鲁肽的放量速度。替尔泊肽属于业内10年难得一见的现象级产品。不过，除此之外，也有一些畅销药能在上市第二年突破10亿美元，典型如诺和诺德的司美格鲁肽、艾伯维的利生奇珠单抗、BMS的O药、吉利德的必妥维、福泰的Trikafta和罗氏的Ocrevus。每一个进入TOP20畅销药榜单的产品，其实都是跨国药企一场精心谋划的战局，更是一切具备划时代意义的药研成果，能够带来的极致价值体现。上市首年/第二年就突破10亿美元大关的O药、替尔泊肽，一个是全球首款PD-1，一个头顶首个双靶点GLP-1光环；K药的快速放量，既是在非小细胞肺癌上打败O药的战利品，又得益于默沙东为其打造40余项适应证、多个大适应证金标准的坚固城墙；DS8201两个关键放量节点，也是头对头击败“前辈”T-DM1，并开创HER2低表达乳腺癌治疗时代。一个有意思的事实是，目前备受关注的三款登陆美国市场的国产新药，按照Evaluate的分析标准，未来都有进入TOP20畅销药榜单的潜力。其中，百济神州的泽布替尼，在其上市的第四个完整年度（2023年）率先冲进10亿美元俱乐部；2023年年底上市的和黄医药呋喹替尼，今年上半年就取得1.3亿美元销售额；传奇合作伙伴强生预计，2022年获批的国产CAR-T西达基奥仑赛，2024年有望突破10亿美元。推荐阅读 * 罗氏跌出前五，辉瑞、诺华滑至末位，BMS、GSK“消失”，诺和诺德、礼来登顶，2030年全球制药TOP10格局大洗牌！ * 当罗氏沉寂、AZ迸发，礼来超越强生，TOP20药企交出Big Pharma成长选规模or选创新的答案！内部自研与外部引进平分天下根据Evaluate Pharma统计，全球范围内在2014年之后获批上市、2023年达到10亿美元销售额门槛的药物来自186家制药企业，其中105家药企通过内部研发（自临床前开始研发）打造，81家药企的产品来自外部引进（临床阶段引入）。在这186家制药企业中，礼来和AZ是诞生重磅炸弹药物最多的两家公司，都有13款重磅炸弹。其中，礼来是内部研发重磅炸弹最多的公司，有8款自研；AZ则是外部引进最多的公司，有8款外部引进。然而，两家跨国药企的市值却相差悬殊，伴随替尔泊肽的半年销售额的披露，礼来的市值也再度回到最高峰9068.68亿美元；AZ的市值2663.07亿，不足礼来的三分之一。事实上，礼来偏爱自研的风格早已被业界公认，礼来市值增长的两大支点替尔泊肽和donanemab其实都来自内部自研。不过，这种风格到近两年似乎发生了明显转换。临床阶段管线一直鲜少出现在礼来的“狩猎”范围内，去年以来，礼来却屡屡布局临床阶段的收购：去年24亿美元收购的Dice Therapeutic，19亿美元收购的Versanis，两家公司的核心管线都在临床II期；今年7月初，礼来再次宣布以32亿美元收购炎症性肠病（IBD）疗法公司Morphic，该公司的主要管线口服整合素疗法MORF-057也在II期临床。虽然从结果来看，阿斯利康的重磅炸弹产品多数来自外部引进，但其实最近几年阿斯利康似乎已经将目光瞄准到了临床前/早期临床管线上，并呈现出为已经布局的领域补齐的特征。2021年，阿斯利康完成了斥资390亿美元对罕见病巨头亚力兄制药的并购交易。从而获得C5补体抑制剂Soliris、Ultomiris，以及多款关键临床阶段的罕见病药物。之后，阿斯利康又在罕见病领域收购了临床阶段的公司Amolyt Pharma和临床前阶段的基因疗法公司LogicBio Therapeutics。此外，在与第一三共合作HER2 ADC DS8201和HER3 ADC HER3-DXd取得一定进展后，阿斯利康将目光瞄准到了中国，与康诺亚达成Claudin 18.2靶向ADC CMG901的合作，该项目正在早期临床阶段。阿斯利康与中国Biotech安锐生物、祐森健恒、诚益生物的合作也都在临床前/早期临床阶段。除此之外，强生和吉利德的自研重磅炸弹产品比例也占据高位，都有7款；相反，BMS则是自研重磅炸弹最少的跨国药企，仅有2款。当然，强生和吉利德的表现或许与行业对其“并购狂魔”的印象相悖，但实际上Evaluate Pharma的分析指标是将从临床前阶段购入的管线就计算为内部研发，如此也能看出这两家跨国药企的BD/并购眼光、临床开发能力都可圈可点。以强生的古塞奇尤单抗（Guselkumab）为例，该药物是杨森利用合作方MorphoSys的独家技术开发出的第一个抗体药物。古塞奇尤单抗在今年上半年卖出了17.14亿美元，同比增长27.3%，是强生增速最快的产品之一。吉利德最重磅的HIV药物必妥维(Biktarvy)，其实是比克替拉韦、恩曲他滨和替诺福韦艾拉酚胺的组合，其中，恩曲他滨就来自吉利德在2002年收购的Triangle公司。如今，Biktarvy已经是全球HIV领域最畅销药物之一，Q2销售额32亿美元，同比增长8%。 BMS成为自研重磅炸弹最少的跨国药企背后其实折射出，其并购选择的失利。从产品角度来讲，5年前，BMS斥资740亿美元天价并购新基，成为BMS迈入全球抗肿瘤霸主地位的重要一步。然而，由新基带来的来那度胺不过几年时间就面临专利断崖，后续泊马度胺、CAR-T等产品也并未实现快速放量，致使这笔收购在2022年之后就不再能给BMS的排名带来提振作用。而BMS如今销售额最高的产品O药，则来自2009年以240亿美元并购的Medarex。Evaluate Pharma预计，到2027年，O药销售额能达到130亿美元。而重磅炸弹最少的辉瑞，则呈现出内部自研和外部引进的困境。总结来看，无论是思路转变的礼来、AZ，还是临床开发实力强悍的强生、吉利德，抑或是急于寻找新增长点的BMS，手握大笔金钱的跨国药企似乎都在“买买买”。不过，逻辑已经转变，此前野蛮的规模主导型已经走向利润主导，左手“快准狠”砍掉低价值研发管线，右手加紧在新兴生物技术赛道“抢车位”，最终的目的是寻找那些回报更高、增长更快的药物。据不完全统计，2024年上半年，全球营收TOP10的跨国药企共计砍掉了上百个项目，从肿瘤、自免到代谢、罕见病，横跨临床前到临床III期。资料来源：Evaluate Pharma报告Billion Dollar Blueprint: The Journey to Blockbuster Status 一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

财报上市批准申请上市

2024-08-12

·GBIHealth

Y24Q2财报速读：吉利德保持增长，高价买断强生seladelpar；传奇生物稳定发展，CEO对地缘政治压力持乐观态度

近日，多家药企陆续公布了2024年第二季度财务业绩。吉利德本季度保持增长，支柱业务优势驱动，高价买断强生seladelpar特许权使用费权利。传奇生物第二季度稳定发展，CEO回应地缘政治问题，表示以最大限度提高股东价值。 3.2亿美元买断强生seladelpar特许权使用费权利吉利德科学近日公布2024年第二季度（2024Q2）财务业绩，并举行了财报电话会。该公司透露，已向强生子公司杨森支付3.2亿美元，以买断后者seladelpar的全球销售额特许权使用费。吉利德首席财务官Andrew Dickinson表示，吉利德已开始完全拥有该药物，其在美国提交的上市申请PDUFA截止日期是8月14日。Seladelpar是一款PPARδ激动剂，由吉利德于今年2月以43亿美元收购CymaBay Therapeutics（纳斯达克代码：CBAY）获得。基于III期ASSURE研究数据，Seladelpar已向美国FDA提交用于治疗原发性胆汁性胆管炎（PBC）的上市申请。这笔3.2亿美元的付款取消了此前杨森与CymaBay签署的协议中，基于未来销售额收取8%特许权使用费的权利。PBC既往一直被认为是一种罕见的肝脏疾病，在美国约13万人患有此病，主要是40岁以上的女性。这种疾病可能导致肝功能逐渐受损，影响生活质量，并可能与肝脏相关死亡风险增加有关。财报显示，吉利德2024年第二季度全球收入同比增长5%，由艾滋病、肝病和肿瘤学业务推动。艾滋病产品占吉利德总收入的47亿美元，总体同比增长3%。其中，必妥维（比克替拉韦，恩曲他滨，丙酚替诺福韦）是该公司最畅销的品牌，2024年第二季度销售额为32亿美元，同比增长8%。面对地缘政治压力CEO充满信心传奇生物（纳斯达克代码：LEGN）近日公布了2024年第二季度财务业绩，其首席执行官黄颖回应了公司可能成为美国《生物安全法案》目标的传言和相关问题。今年6月，美国众议院“中国问题特别委员会”要求美国联邦调查局调查金斯瑞生物科技（股票代码：01548）及其子公司（包括传奇生物）的背景，以确定其对美国的国家安全是否构成潜在威胁。投资者向黄颖博士提问，包括传奇生物的立场和针对这一消息采取的措施，黄博士表示相信传奇生物将能够规避该法案的影响，该公司已经仔细评估了该法案草案，并一直在与华盛顿特区的某些利益相关者接触，包括委员会和众议院议长办公室。目前，黄博士不认为传奇生物会受到任何直接影响，并且不太担心公司会成为生物安全法案的目标。据报道，上个月传奇生物开始考虑收购要约，并聘请Centerview Partners为任何潜在交易提供支持，但黄博士就该事件提供的细节较少。黄博士转而强调了传奇生物取得的积极成就，包括继续与全球合作伙伴杨森合作开发CAR-T细胞疗法西达基奥仑赛，特别是将适应证扩展到二线治疗多发性骨髓瘤（MM），同时正在进行一线治疗试验。黄博士指出，公司正在考虑各种选择，以最大限度地提高股东价值；而且“我们坚信，我们面前还有很大的增长空间；对于当前实现西达基奥仑赛全部潜力的长期战略，我们充满信心”，这也许在暗示公司保持独立地位的可能性仍然很大。 2024年第二季度，西达基奥仑赛的净销售额达到约1.86亿美元，同比增长18.5%。美国FDA和欧盟4月份批准西达基奥仑赛用于治疗二线多发性骨髓瘤，随后英国药品和健康产品管理局（MHRA）和加拿大卫生部在第二季度批准了相同的适应证。该药物的市场需求日益增长，传奇生物和强生目前面临的关键挑战应该是提高产能。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报并购临床3期

2024-08-09

·FiercePharma

Gilead looks to 'redefine' HIV PrEP market with 2025 launch of long-acting Sunlenca

Gilead Sciences looks to launch Sunlenca in the pre-exposure prophylaxis market as a long-acting option in 2025. With Gilead Sciences' stated focus to grow in oncology, the company's recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. But, with a unique pre-exposure prophylaxis (PrEP) offering for HIV that could “redefine” the market, the drugmaker is touting lofty ambitions there, too.After scoring an FDA approval for Sunlenca (lenacapavir) to treat multidrug-resistant HIV, Gilead launched the drug at end of 2022. The drug's every-six-month dosing schedule has yet to show its full potential given that it must still be paired with other daily drugs to form a complete regimen. The indication isn’t exactly a major sales driver, as Sunlenca's approved patient population represents just 2% of adults with HIV.That approval was just “the beginning of the rest of this journey,” Gilead's vice president of clinical development Jared Baeten, M.D., Ph.D., said in an interview at the time. Now, the company is looking to another milestone late next year with the planned commercial launch of Sunlenca as a long-acting PrEP med, CEO Daniel O'Day said on Gilead's second-quarter earnings call. In June, Sunlenca achieved an “unprecedented” phase 3 win as a PrEP med with 100% efficacy in a study of cisgender women. In the trial, no infections were reported among more than 2,000 women who took Sunlenca.The next hurdle for the drug is an ongoing study in different populations including cisgender gay men, transgender women and men and nonbinary people. A big difference in the two study populations is varying levels of PrEP awareness and compliance, Gilead's chief commercial officer Johanna Mercier noted on the company's conference call.PrEP for HIV is “not a typical market,” Mercier said. Patients essentially aren’t sick or unwell, making compliance on a daily oral pill all the more challenging.“We have to think completely differently about what lenacapavir could offer all of these people and really make a dent in this HIV epidemic,” Mercier said.The company is positioning the drug as the first long-acting PrEP option with a twice-yearly dosing schedule. Already, Gilead has kept a hold in the PrEP market with its Truvada follow-on therapy Descovy, but Sunlenca offers a chance to “redefine the PrEP market as a whole,” Mercier said.GSK was the first to launch a long-acting PrEP drug, but Gilead’s option so far takes the cake on time between doses. GSK’s Apretude can be administered up to every two months, and the British drugmaker is looking to keep up with four- and six-month options that are in development. GSK has said it expects to launch those options later this decade. Meanwhile, during the second quarter, Gilead's HIV business made up the bulk of its revenue haul with $4.7 billion in quarterly sales. On the treatment side, Gilead's leading HIV drug Biktarvy contributed $3.2 billion during the period. The medicine holds more than 49% of the U.S. HIV treatment market, a 3% increase from last year and the 24th consequence quarter of market-share gains.Elsewhere, on the oncology front, Gilead is leaning on Trodelvy's status as a standard of care in second-line metastatic triple-negative breast cancer after the antibody-drug conjugate suffered clinical setbacks in non-small cell lung cancer and bladder cancer. The drugmaker hopes to move the needle in earlier lines of triple-negative breast cancer therapy in an ongoing phase 3. If successful, the trial could support global filings. Gilead “continues to assess” the path ahead in the other cancer areas, O’Day said.All told, Gilead’s total sales output in the second quarter increased 5% to $7 billion, with growth contribution across the company's offerings in HIV, liver disease and oncology.

临床3期上市批准临床结果

100 项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J05AR	-

研发状态

批准上市

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适应症	国家/地区	公司	日期
HIV感染	美国	Gilead Sciences, Inc.	2018-02-07

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
乙型肝炎	临床3期	-	Gilead Sciences, Inc.	2018-05-07

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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


NCT04416906 (Pubmed) 人工标引	临床3期	HIV感染一线	100	Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)	積鑰鏇壓窪廠獵築淵廠(簾醖廠簾淵繭鹹蓋觸廠) = 齋築鬱構艱願襯蓋網鏇鬱獵鬱鑰衊網廠構鬱製 (選獵膚齋鑰醖齋繭衊選 ) 更多	积极	2024-07-24
Studies 1489 and 1490 (Pubmed \| AIDS)	临床3期	-	519	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)	製憲壓淵艱襯壓齋壓願(築顧繭製衊窪憲膚鹽窪) = Two participants discontinued B/F/TAF due to treatment-related AEs 顧襯壓鹹觸製窪艱鑰鬱 (鏇網構積鹹衊鏇顧蓋鏇 ) 更多	积极	2024-06-01
Studies 1489 and 1490 (Pubmed \| AIDS)	临床3期	-	519	Dolutegravir/F/TAF		积极	2024-06-01
NCT06177574 (Pubmed)	临床4期	HIV感染一线	208	Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)	觸觸襯蓋築網築觸繭餘(淵顧鹹簾鏇製齋廠範範) = 膚夢襯艱憲窪餘衊窪夢簾選鹽獵齋糧憲廠艱積 (窪鬱願糧夢製醖觸構淵 ) 更多	-	2024-04-02
NCT03547908 (ALLIANCE, Corporate Publications) 人工标引	临床3期	乙型肝炎 \| 合并感染 \| HIV感染	243	Biktarvy	鏇壓糧淵鬱鹽繭餘齋鹹(壓夢鬱簾襯鹽鬱廠壓範) = upper respiratory tract infection (19.8% vs. 14.8%), COVID-19 (38% vs. 36.1%), pyrexia (12.4% vs. 13.1%), ALT increase (8.3% vs. 12.3%), and nasopharyngitis (12.4% vs. 6.6%). 淵製艱齋衊繭獵選糧齋 (鹹糧鹽範廠遞艱遞築鹹 )	积极	2024-03-06
NCT03547908 (ALLIANCE, Corporate Publications) 人工标引	临床3期	乙型肝炎 \| 合并感染 \| HIV感染	243	dolutegravir+emtricitabine+tenofovir disoproxil fumarate		积极	2024-03-06
NCT04734652 (INSIGHT, BusinessWire) 人工标引	临床2期	结核 \| 合并感染 \| HIV感染	-	Biktarvy	窪餘艱築窪願醖齋製鬱(觸觸憲蓋憲觸鏇觸夢鏇) = 鬱鹽齋構艱構築顧網夢艱鹹鏇醖窪襯淵齋艱醖 (觸製糧廠願觸膚艱簾顧 )	积极	2024-03-06
NCT04734652 (INSIGHT, BusinessWire) 人工标引	临床2期	结核 \| 合并感染 \| HIV感染	-	dolutegravir+lamivudine+tenofovir disoproxil fumarate	窪餘艱築窪願醖齋製鬱(觸觸憲蓋憲觸鏇觸夢鏇) = 簾艱願鹹網艱淵構觸願艱鹹鏇醖窪襯淵齋艱醖 (觸製糧廠願觸膚艱簾顧 )	积极	2024-03-06
NCT04538040 (CTgov)	临床4期	HIV感染	20	Doravirine+Bictegravir/emtricitabine/tenofovir alafenamide	選築選鹽齋齋餘積構鹹(廠夢築淵餘積衊衊觸願) = 蓋願遞鑰積壓選廠蓋夢憲鹽糧範鏇選築鹽積齋 (淵膚獵選衊選糧衊糧糧, 顧選廠範選網淵構構築 ~ 顧鹹壓窪壓膚廠鹹築糧) 更多	-	2024-03-05
Rainbow study (Pubmed \| Int J Antimicrob Agents)	临床4期	HIV感染 HIV-RNA	30	BIC/FTC/TAF	鹽範蓋齋遞齋廠鑰觸醖(襯齋夢遞獵齋齋衊鏇醖) = Two participants developed IRIS 醖鑰範膚觸艱廠築遞鬱 (鏇餘醖構膚齋選膚築觸 ) 更多	积极	2024-01-01
NCT03797014 (BEST-HBV, CTgov)	临床4期	乙型肝炎 \| 合并感染 \| HIV感染	28	B/F/TAF	壓襯構範窪鹽膚築顧範(淵遞壓壓壓獵鑰廠艱積) = 鏇遞製鏇製壓觸構憲衊獵簾夢鹹網積觸構簾窪 (夢艱積構艱夢醖鹹製築, 顧襯窪鹹壓鬱憲鑰製鬱 ~ 糧鏇艱衊艱願獵廠網鹽) 更多	-	2023-07-18
NCT04860505 (CTgov)	临床4期	性传播疾病	20	Doxycycline+Biktarvy	膚網簾願選鏇網範壓窪(壓艱襯築觸蓋鹽鬱鑰蓋) = 鑰襯願鹹築簾選積淵觸鬱窪餘觸觸範憲繭鹹網 (願廠獵網網淵鏇構選製, 壓鹽鹽膚鬱選夢築餘廠 ~ 壓淵糧壓遞鹹觸淵觸膚) 更多	-	2023-05-23
NCT03547908 (ALLIANCE, CTgov)	临床3期	乙型肝炎 \| HIV感染	244	Placebo to match DTG+B/F/TAF	網膚艱遞顧廠製艱選齋(顧膚鏇範鹽鏇鬱鏇夢膚) = 遞願遞鏇齋衊構壓範鏇積壓選繭憲簾襯壓廠願 (窪鹽鹹齋遞襯壓鹽憲鏇, 鹽膚簾壓齋夢選繭繭範 ~ 範鑰窪壓齋淵遞鏇繭製) 更多	-	2023-03-15