This is a pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply and were between the ages of 18 and 50 years at the time of screening

开始日期2023-07-12

申办/合作机构

SCYNEXIS, Inc.

CTR20223058

/ Suspended临床3期

一项在念珠菌血症和/或侵袭性念珠菌病患者中比较两项治疗方案（静脉注射棘白菌素后口服Ibrexafungerp 和静脉注射棘白菌素后口服氟康唑）的III 期、多中心、前瞻性、随机、双盲研究（MARIO）

主要研究目的：在念珠菌血症和/或侵袭性念珠菌病患者中，评估IV 棘白菌素后口服Ibrexafungerp 第30 天的全因死亡率（All Cause Moritality, ACM）非劣效于IV 棘白菌素后口服氟康唑的治疗方案；关键次要研究目的：在念珠菌血症和/或侵袭性念珠菌病患者中，评估IV 棘白菌素后口服Ibrexafungerp 第14 天的总体应答率（经数据审查委员会 [Data Review Committee, DRC] 判定的临床、影像学和真菌学方面的综合应答）非劣效于IV 棘白菌素后口服氟康唑的治疗方案；其他次要目的：根据第30天和抗真菌治疗结束时的总体应答、临床应答、真菌学应答、无复发、患者存活且真菌学清除指标来评估有效性；评估IV棘白菌素后口服Ibrexafungerp治疗的安全性；评估Ibrexafungerp的药代动力学（PK）特征。

开始日期2023-03-18

申办/合作机构

SCYNEXIS, Inc.

[+1]

ISRCTN51111674

/ Recruiting临床1期

A phase I, open-label, single-centre study to evaluate the absorption, distribution, metabolism and excretion (ADME) of oral [14C]-ibrexafungerp in healthy male subjects after repeat dosing

开始日期2022-12-15

申办/合作机构-

100 项与枸橼酸艾瑞芬净相关的临床结果

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100 项与枸橼酸艾瑞芬净相关的转化医学

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100 项与枸橼酸艾瑞芬净相关的专利（医药）

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140

项与枸橼酸艾瑞芬净相关的文献（医药）

2025-08-11·Future Microbiology

Clinical impact of fluconazole-resistant Candida parapsilosis: a narrative review.

Review

作者: Bassetti, Matteo ; Vena, Antonio ; Giacobbe, Daniele Roberto ; Bartalucci, Claudia

Fluconazole resistance in Candida parapsilosis is an increasing global concern, with resistance rates varying widely and reaching up to 80% in some regions. This trend has led to hospital outbreaks, primarily driven by mutations in the ERG11 gene, especially the Y132F substitution. The clinical relevance of fluconazole resistance remains controversial, as studies have yielded conflicting results regarding its impact on mortality. While some studies described an increased mortality associated with resistant strains, others reported no significant difference. Treatment options are limited: echinocandins and liposomal amphotericin B (L-AmB) are commonly used alternatives, but their use is challenged by intrinsic and emerging echinocandin resistance and L-AmB toxicity and cost. These limitations emphasize the need for robust antifungal stewardship and the development of new therapies. Novel agents such as rezafungin, fosmanogepix, and ibrexafungerp have shown promising activity against fluconazole-resistant C. parapsilosis, though further clinical studies are needed to confirm their efficacy. This narrative review aims to summarize current evidence on the epidemiology, clinical implications, and therapeutic approaches for fluconazole-resistant C. parapsilosis infections.

2025-08-03·Expert Review of Anti-Infective Therapy

The future of non-invasive azole antifungal treatment options for the management of vulvovaginal candidiasis

Review

作者: Quindós, Guillermo ; Eraso, Elena ; Marcos-Arias, Cristina ; Sevillano, Elena ; Schneider, José ; Jauregizar, Nerea ; Miranda-Cadena, Katherine

INTRODUCTION:

High worldwide prevalence and significant morbidity of vulvovaginal candidiasis (VVC) requires better therapeutic approaches to improve quality of life of affected women. Although treatment of acute episodes is often straightforward, complicated and recurrent vulvovaginal candidiasis (RVVC) presents medical challenges.

AREA COVERED:

This review focuses on therapy of VVC particularly by topical antifungals , especially imidazoles, compared to oral treatment with fluconazole, itraconazole, ibrexafungerp, or oteseconazole. Candidiasis by non-Candida albicans, VVC in pregnant women and RVVC are complex challenges . Current treatment, alternatives, and roles played by topical azoles in VVC are highlighted.

EXPERT OPINION:

VVC requires personalized treatment considering whether the woman is pregnant or not, concomitant treatments, clinical presentations (acute or recurrent) and the Candida species involved. Although therapeutic tools are increasing, the usefulness of topical drugs, such as clotrimazole and miconazole, is very relevant. In addition, we it is also necessary to expand the therapeutic tools with new antifungals and formulations, and repurposing current drugs against fluconazole-resistant species of Candida.

2025-08-01·AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY

A phase 3, multicenter, randomized, placebo-controlled trial of monthly oral ibrexafungerp to reduce the incidence of recurrent vulvovaginal candidiasis

Article

作者: Angulo, David A ; Nyirjesy, Paul ; Azie, Nkechi E ; Sobel, Ryan ; Goje, Oluwatosin ; Sobel, Jack D

BACKGROUND:

Recurrent vulvovaginal candidiasis develops in 5% to 9% of people assigned female at birth and has a serious impact on quality of life. Oral ibrexafungerp is a first-in-class, nonazole, triterpenoid antifungal approved in the United States for the treatment of postmenarchal females with acute vulvovaginal candidiasis and for the reduction in the incidence of recurrent vulvovaginal candidiasis.

OBJECTIVE:

This phase 3 study (CANDLE) describes the efficacy and safety of monthly oral ibrexafungerp vs placebo for reducing the incidence of recurrent vulvovaginal candidiasis.

STUDY DESIGN:

Participants with a history of recurrent vulvovaginal candidiasis experiencing an acute infection episode (confirmed by positive potassium hydroxide test) received 3 doses of oral fluconazole (150 mg once-daily every 3 days). Those who had culture-confirmed vulvovaginal candidiasis from the screening sample achieved substantial resolution of signs and symptoms (composite Vulvovaginal Signs and Symptoms score≤2) following fluconazole treatment and continued to meet all study eligibility criteria, entered a maintenance phase. In the maintenance phase, eligible participants were randomized (1:1) to oral ibrexafungerp (300 mg twice-daily for 1 day) or placebo, which was repeated once every 4 weeks for a total of 6 treatments (until week 20). Efficacy was assessed by the percentage of participants with no mycologically proven recurrence and the percentage of participants with clinical success (a participant with a Test-of-Cure [week 24] evaluation and no recurrence; mycologically proven, presumed, or suspected) by Test-of-Cure (4 weeks after last study drug dose). Safety and tolerability assessments included incidence of adverse events and treatment discontinuations. Participants were further assessed for recurrence during a 12-week follow-up phase.

RESULTS:

In the intent-to-treat population, 70.8% (n=92/130) of participants who received ibrexafungerp and 58.5% (n=76/130) who received placebo had no mycologically proven recurrence by Test-of-Cure (relative risk, 1.22; 95% confidence interval, 1.032, 1.430; P=0.019). The proportion of participants who achieved clinical success by Test-of-Cure was 65.4% (n=85/130) with ibrexafungerp and 53.1% (n=69/130) with placebo (relative risk, 1.24; 95% confidence interval, 1.034, 1.486; P=0.020). The benefit of ibrexafungerp over placebo was sustained over the 4 months following last study drug dose for both the no mycologically proven recurrence (65.4% [n=85/130] vs 53.8% [n=70/130]; relative risk, 1.22; 95% confidence interval, 1.021, 1.456; P=0.029) and clinical success (57.7% [n=75/130] vs 46.2% [n=60/130]; relative risk, 1.26; 95% confidence interval, 1.017, 1.555; P=0.034) endpoints. Overall, 64.6% (n=84/130) of participants who received ibrexafungerp and 58.5% (n=76/130) of participants who received placebo experienced ≥1 treatment-emergent adverse event. Treatment-related adverse events occurred in 14.6% (n=19/130) of participants in the ibrexafungerp group and 6.9% (n=9/130) of participants in the placebo group. No adverse events in the ibrexafungerp group led to treatment or study discontinuation. The most common adverse events reported in both the ibrexafungerp and placebo groups were headache, bacterial vaginosis, and diarrhea; these events were mostly mild in severity.

CONCLUSION:

Once-monthly oral ibrexafungerp was effective and well-tolerated in participants with recurrent vulvovaginal candidiasis.

181

项与枸橼酸艾瑞芬净相关的新闻（医药）

2025-09-04

·GlobeNewswire-Health Care

SCYNEXIS Announces Multiple Presentations Highlighting Data from its Second-Generation Fungerp, SCY-247, at the 12th Congress on Trends in Medical Mycology (TIMM-12)

Oral presentation will feature data demonstrating SCY-247 in vitro activity against C. auris strains, including isolates with mutations commonly associated with echinocandin-resistanceAdditional poster presentations highlight SCY-247’s broad spectrum of antifungal activity, against Candida species, including multidrug- and pandrug-resistant C. auris and Aspergillus speciesCompany anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3 2025 JERSEY CITY, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced multiple upcoming presentations highlighting data on the Company’s second-generation fungerp drug candidate, SCY-247, at the upcoming 12th Congress on Trends in Medical Mycology (TIMM-12), which is scheduled to take place from September 19th to 22nd, 2025, in Bilbao, Spain. “Our six presentations at this year’s TIMM-12 Congress highlight the significant potential of SCY-247 to combat difficult, resistant Candida infections, including C. auris,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “We are developing SCY-247 to specifically address one of the most serious and challenging issues in infectious disease, and the data from these presentations provide highly encouraging evidence that SCY-247 has the potential to address these difficult-to-treat and life-threatening fungal infections. Later this quarter, we anticipate reporting results from our Phase 1 SAD/MAD trial of SCY-247, which represents an important next step in further advancing this exciting program.” SCY-247 data presentations at TIMM-12: TitleSCY-247, a Novel Second-Generation IV/Oral Triterpenoid Antifungal, Demonstrates In vitro Activity against C. auris, including the majority of FKS1 mutants Session:Oral Presentation, S15.5S Session Date:Saturday, September 20, 2025 Presentation Start Time17:25 Central European Time (CET) (10 minutes) Presenting AuthorEelco Meijer, MD, PhDAffiliations: Canisius-wilhelmina Hospital (CWZ)/Dicoon, Radboudumc-CWZ Center of Expertise for Mycology Summary:Candida auris is a public health concern causing large and persistent outbreaks in healthcare institutions, globally. High incidence of resistance to approved antifungals necessitates investigation of novel drugs for future patient care. Here, we performed antifungal susceptibility testing on the investigational compound SCY-247 and other antifungals, including echinocandins anidulafungin and micafungin against 65 unique FKS1 resistant C. auris isolates representing clades I, II, III, IV, and V. Overall, in comparison to the echinocandins, SCY-247 consistently demonstrated lower MICs for C. auris in isolates with commonly found FKS1 resistance mutations. TitleThree Months of SCY-247 EUCAST MIC Testing: Uniform Activity Against Candida Species and No Cross-Resistance to Echinocandins Poster #P052 Session DateSunday, 21 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorKarin Meinike Jørgensen PhDAffiliations: Statens Serum Institut SummaryWe present the first three months of EUCAST SCY-247 MICs compared to anidulafungin and micafungin MICs of 293 Candida isolates. SCY-247 displayed uniform activity against all Candida species included, with no indication of cross-resistance to the echinocandins. TitleIn vitro efficacy of second-generation triterpenoid antifungal, SCY-247 against multidrug- and pandrug-resistant Candida auris Poster #P053 Session DateSaturday, 20 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorVishnu Chaturvedi, PhDAffiliations: New York Medical College, Valhalla, New York Summary:Candida auris is a newly recognized global health threat by the CDC and WHO. In the USA, the New York –New Jersey metropolitan area remains a hotbed for multidrug- and pandrug-resistant C. auris strains. 300 C. auris isolates, mostly from New York area, were tested against SCY-247 and 10 other antifungal agents. SCY-247 demonstrated potent activity against C. auris including pandrug-resistant isolates. TitleThe Novel Second-Generation IV/Oral Triterpenoid SCY-247 Maintains In vitro and In vivo Activity against Resistant Candida glabrata Poster #P423 Session DateSaturday, 20 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorNathan Wiederhold, PhDAffiliations: University of Texas Health Science Center at San Antonio SummaryCandida glabrata is a major cause of invasive candidiasis and is considered a high priority pathogen by the WHO. In vitro susceptibility testing was performed against 29 echinocandin-resistant clinical strains of C. glabrata. SCY-247 maintained in vitro activity against echinocandin-resistant C. glabrata and also demonstrated in vivo efficacy in an invasive candidiasis mice model caused by an echinocandin- and fluconazole-resistant C. glabrata strain. TitleEfficacy of once or twice daily oral SCY-247, a second-generation triterpenoid antifungal, in a murine model of Candida auris infection Poster #P426 ThemeNew antifungal agents Session DateSunday, 21 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorMahmoud Ghannoum, PhDAffiliations: Case Western Reserve University and University Hospitals Cleveland Medical Center SummaryCandida auris is a multidrug resistant fungus exhibiting a 200% increase in incidence in the U.S from 2019 to 2023. The objective was to assess the activity of 7 days of once or twice daily oral SCY-247 treatment in lowering kidney fungal burden in a mouse model of C. auris infection. SCY-247 demonstrated in vivo efficacy against invasive C. auris candidiasis. Significant reductions in fungal burden were observed in the kidneys of mice treated with SCY-247 in a dose dependent fashion with similar activity observed between QD and BID doses. TitleIn vitro activity of SCY-247 and comparators against clinical isolates of Aspergillus spp. and Lomentospora prolificans Poster #P427 ThemeNew Antifungal Agents Session DateSaturday, 20 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorAnastasiia HrynzovskaAffiliations: Mycology Reference Laboratory, National Centre for Mycology, Bogomolets National Medical University SummaryThe aim of this study is to investigate the in vitro activity of SCY-247 against cryptic Aspergillus species and Lomentospora prolificans isolated from clinical samples. A total of 54 clinical isolates were analyzed including cryptic species of Aspergillus (n=48) and Lomentospora prolificans (n=6). SCY-247 activity was compared to 3 marketed antifungals. SCY-247 exhibited low MECs against cryptic Aspergillus species and moderately high MECs against L.prolificans. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in clinical, pre-clinical and discovery phases, including the compound SCY-247. For more information, visit www.scynexis.com. Forward-Looking Statements Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: Company anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3, 2025. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. CONTACT:Investor RelationsIrina KofflerLifeSci AdvisorsTel: 917-734-7387ikoffler@lifesciadvisors.com

临床1期上市批准临床结果

2025-08-18

·思齐俱乐部

国内外大批药企做研发管线“断舍离”！

来源：制药网近日，海创药业宣布：拟暂停募投项目"创新药研发项目"HP501子项目后续的研发推进。HP501是海创药业自主研发的小分子化学创新药，为尿酸盐阴离子转运体1(UrateAnionTransporter1，URAT1)抑制剂。截至今年6月30日，该项目已投入募集资金8111.25万元。对于按下“暂停键”的原因，海创药业解释称，国内已有药企针对URAT1靶点的产品获批上市，并有多项围绕该靶点的Ⅲ期临床研究正在进行。故公司预计，未来URAT1靶点的竞争将较为激烈。公司评估后决定不再将资金投入至HP501项目中。实际上，近期以来，药企研发管线叫停的消息屡见不鲜。除了国内药企以外，一些国际大型药企如阿斯利康、GSK、默沙东等也在积极做“减法”。例如阿斯利康7月29日在上半年财报中披露，将终止AZD5851(GPC3CAR-T)、AZD6422(CLDN18.2CAR-T)和NT-125(TCR-T)的I期临床开发，以及zibotentan+dapagliflozin用于肝硬化、Ultomiris(瑞利珠单抗)用于狼疮性肾炎的II期临床开发。此次终止原因是细胞治疗领域存在研发周期长、制造流程繁琐、成本难控、标准化水平低等问题，公司经权衡后决定重新分配资源，集中投入更具可行性与回报潜力的细胞治疗项目。肝硬化适应症终止可能与临床数据未达预期或战略调整有关，公司更聚焦肿瘤和心血管领域的核心管线。 GSK 7月30日发布2025年H1财报，终止项目中包含两项III期临床，具体包括： TIGIT单抗belrestotug用于非小细胞肺癌和ibrexafungerp用于侵入性念珠菌感染的III期临床。今年5月13日，由于GALAXIESLung-201研究未达成主要终点，GSK决定终止belrestotug开发项目并终止与iTeos的合作。此前，葛兰素史克(GSK)向iTeos公司支付6.25亿美元预付款，获得belrestotug的权益。在该药物|期临床试验失败后，这家生物技术公司原本计划逐步停止运营，但最终于本月早些时候接受了ConcentraBiosciences的收购要约。同时，葛兰素史克(GSK)已终止代号为GSK3437949的佐剂重组蛋白疟疾疫苗II期研发项目。这一决定是基于制药部门近期宣布将重点转向第二代多阶段疟疾疫苗的战略调整。此外，抗生素sanfetrinem的口服前药sanfetrinemcilexetil也已从公司1I期研发管线中移除。罗氏7月24日发布2025年上半年业绩报告，同步更新了研发管线进展。报告显示，2025年上半年，罗氏共削减7个临床项目，其中备受关注的TIGIT单抗RG6058(tiragolumab)仅剩的两项III期临床均被终止。自2022年起，该产品III期研究就不顺利：2024年，其在转移性非鳞状非小细胞肺癌II/III期研究中，无法与对照组拉开疗效差距；同年，该产品联合PD-L1抗体治疗局部复发性或转移性非小细胞肺癌的III期临床也未达到总生存期(OS)主要终点。2025年，其联合Tecentriq用于一线治疗不可切除的III期非小细胞肺癌，以及联合Tecentriq和Avastin用于一线治疗肝细胞癌的两项III期临床，均未达到无进展生存期(PFS)主要终点。诺华7月17日公布第二季度财报，宣布停止Ianalumab在化脓性汗腺炎(一种导致皮肤摩擦区域形成疼痛肿块的疾病)适应症上的开发，因Ianalumab未能达到诺华预设的疗效阈值，。默沙东也在近日公布2025第二季业绩，同时提到多个II期和III期临床管线被终止，其中包括MK-1308(CTLA-4单抗)针对非小细胞肺癌的II期研究、MK-1022(HER3-ADC)针对非小细胞肺癌的III期研究，以及MK-7902(仑伐替尼)针对食管癌的III期研究。此外，赛诺菲、强生等也有在近期宣布终止一些在研项目，原因包括药物上市前景黯淡、疗效不足等。业内认为，药企研发管线的叫停潮，揭示了新药研发领域的高风险与不确定性。这既是市场竞争激烈化、研发回报预期改变的结果，也反映出药企对研发资源的重新审视与合理配置。在这场研发管线的“断舍离”中，药企需要更加审慎地选择研发方向，聚焦真正具有临床价值与市场潜力的项目。只有这样，才能在激烈的市场竞争中，提高研发成功率，为患者带来更多有效的创新药物，实现可持续发展。免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。 8月27-29日敬请期待第十届「MMC医学市场年会」点击阅读原文了解更多

财报临床3期疫苗并购临床1期

2025-08-05

·药研网

2025多家跨国药企财报PPT分享

2025年上半年，强生、罗氏、阿斯利康、诺华等跨国药企陆续公布业绩。药研网后台回复“2025药企财报”填写后可获取多家跨国药企2025 Q2&H1财报资料包强生强生2025年上半年业绩：营收达456.36亿美元，同比增长4.1%；其中2025年Q2总销售额达237亿美元，同比增长5.8%。业务亮点方面，创新药板块成为主要增长引擎，特别是肿瘤业务表现突出，上半年收入119.90亿美元，同比大幅增长21.1% 基于良好的业绩表现，强生上调全年业绩指引，预计全年运营营收将在932-936亿美元之间，增长区间为2.5%至5%；CFO称有能力进行更多并购强生股价今年迄今表现优于行业平均水平。年初至今累计上涨17.6%。图片来源：Zacks Investment Research 罗氏 2025H1，罗氏上半年总销售额达到309亿瑞士法郎(按最新汇率约为389.81亿美元），增长7%, 延续稳定增长态势。其中，制药业务收入239.85亿瑞士法郎，同比增长10%，多个核心产品继续保持强劲增长势头。中国区收入17.02亿瑞士法郎，同比增长9%。与此同时，罗氏在管线方面也进行了大规模更新，正式将TIGIT抗体tiragolumab从管线中全面移除，包括此前用于非小细胞肺癌和肝癌的两项三期临床试验，宣告TIGIT项目彻底终结。罗氏正式放弃TIGIT疗法对于2025年全年展望，罗氏预计集团销售额将在中个位数区间（CER）增长。阿斯利康 2025年H1和Q2财报：总收入为280.45亿美元，同比增长11%（按CER计算）; 核心EPS达4.66美元，同比增长17%，强劲的增长势头持续，阿斯利康宣布下一阶段的增长计划，将在2030年前向美国投资500亿美元，用于扩大药物制造与研发产能,助力阿斯利康其实现到2030年营收达800亿美元的目标(其中一半来自美国市场)。关税阴影下，阿斯利康500亿押注美国默沙东因中国HPV疫苗销售（Gardasil）锐减默沙东上半年总营收313.35亿美元，同比下降2%。默沙东制药业务收入276.88亿美元，同比下降3%。其中，因HPV疫苗销售（Gardasil）锐减，中国区收入同比下滑70%至10.75亿美元，占据默沙东全球制药业务3.9%的份额。 Keytruda 销售额仍增长 7%；保持全年销售目标 643–653 亿美元不变。默沙东全球裁员6000人！诺华 2025 Q2&H1财报显示:上半年销售额为272.87亿美元，同比增长12%，核心营业收入115亿元，同比增长21%，中国区收入22亿美元，同比增长 8%。展望2025年，诺华预计整体业绩将实现高个位数增长。葛兰素史克（GSK） 2025 H1公布：营收155.02亿英镑（约206.4亿美元,按最新汇率）同比增长5%。核心药品业务表现亮眼，核心EPS增长约15%，HIV与肿瘤业务上表现强劲; GSK在第二季度调整部分管线，先后终止了TIGIT单抗belrestotug在非小细胞肺癌（NSCLC）中的开发，以及抗真菌药ibrexafungerp的III期研究。GSK交出上半年“成绩单”：营收破200亿，终止TIGIT单抗等III期项目 GSK仍维持全年营收增长3%至5%的预期。赛诺菲 2025 Q2&H1财报显示：上半年总营收198.89亿欧元（约214.00亿美元，按最新汇率），销售增长10.1%（CER），其中Q2九种新上市药品和疫苗的销售额增长了47.3%。基于上半年强劲的销售业绩，该公司将2025年的销售预期调整至先前预期的上限,实现高个位数百分比增长（CER）。艾伯维 2025年H1财报：总营收约287.66亿美元，同比增长7.4%，主要得益于自身免疫领域领军药物Skyrizi (78.48亿美元,+65.8%)和Rinvoq(37.46亿美元,+48.5%)的推动。肿瘤学和神经科学领域也呈现稳健增长和战略扩张。艾伯维上调2025年全年盈利预期。药研网后台回复“2025药企财报”填写后可获取多家跨国药企2025 Q2&H1财报资料包文章参考：强生、罗氏、阿斯利康、诺华等多家跨国药企官网公告 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 港股创新药走出至暗时刻 2 License-out潮来袭：谁是下一个出海爆款? 3 高盛发声：中国创新药价值重估时代来临

财报疫苗临床3期并购

100 项与枸橼酸艾瑞芬净相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11544	-	J02AX	DB12471

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
外阴阴道念珠菌病	美国	SCYNEXIS, Inc.	2021-06-01

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
耳念珠菌感染	临床3期	美国	SCYNEXIS, Inc.	2017-11-15
耳念珠菌感染	临床3期	印度	SCYNEXIS, Inc.	2017-11-15
耳念珠菌感染	临床3期	巴基斯坦	SCYNEXIS, Inc.	2017-11-15
耳念珠菌感染	临床3期	南非	SCYNEXIS, Inc.	2017-11-15
念珠菌血症	临床3期	美国	SCYNEXIS, Inc.	2017-11-15
念珠菌血症	临床3期	印度	SCYNEXIS, Inc.	2017-11-15
念珠菌血症	临床3期	巴基斯坦	SCYNEXIS, Inc.	2017-11-15
念珠菌血症	临床3期	南非	SCYNEXIS, Inc.	2017-11-15
变应性支气管肺曲霉菌病	临床3期	美国	SCYNEXIS, Inc.	2017-04-01
变应性支气管肺曲霉菌病	临床3期	奥地利	SCYNEXIS, Inc.	2017-04-01

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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


NCT06954493 (CTgov)	临床1期	外阴阴道念珠菌病	5	Ibrexafungerp	窪夢顧齋窪願餘觸網壓(窪鏇衊選齋觸膚製襯鑰) = 窪糧築餘廠鑰選鏇網築襯餘選淵顧糧衊憲齋遞 (範範簾鏇壓憲窪簾遞齋, 範網顧簾願廠積壓壓憲 ~ 鬱淵蓋觸衊鏇醖壓窪鹹) 更多	-	2025-08-08
NCT03059992 (FURI, CTgov)	临床3期	外阴阴道念珠菌病 \| 球孢子菌病 \| 组织胞浆菌病 ... 更多	233	Ibrexafungerp	鑰製繭鏇蓋獵艱築蓋築(簾艱衊夢製蓋積鹹觸窪) = 觸顧願獵獵膚觸襯廠鹽廠鏇廠廠憲廠簾壓齋製 (鏇構網簾醖範觸鬱遞窪, 膚糧憲選繭窪糧夢廠襯 ~ 廠窪壓鏇夢繭醖鑰選襯) 更多	-	2024-11-20
CTR20220918 (Pubmed \| Infection) 人工标引	临床3期	外阴阴道念珠菌病	360	IbrexafungerpIbrexafungerp 300 mg	網觸夢選願遞膚網齋鹽(艱簾鏇遞積衊醖積窪鹹) = 襯鬱鏇遞糧選艱製鏇繭範積觸觸襯廠選齋網餘 (鑰廠艱選蓋築蓋製艱餘 ) 更多	积极	2024-10-01
				Placebo	網觸夢選願遞膚網齋鹽(艱簾鏇遞積衊醖積窪鹹) = 簾憲觸願願衊獵憲鑰膚範積觸觸襯廠選齋網餘 (鑰廠艱選蓋築蓋製艱餘 ) 更多
NCT03672292 (SCYNERGIA, CTgov)	临床2期	侵袭性肺曲霉菌病	22	Voriconazole+SCY-078 (SCY-078 Plus Voriconazole)	蓋壓鹽窪觸獵夢醖築窪 = 簾觸鏇衊鏇醖壓糧構鑰憲醖選窪糧願廠蓋構製 (鹹壓獵觸鏇範獵積網糧, 遞獵膚築衊簾淵積鹽襯 ~ 廠網鏇糧鹽構夢鹽鑰蓋) 更多	-	2024-08-09
				Oral Placebo Tablets+Voriconazole (Voriconazole Mono-therapy)	蓋壓鹽窪觸獵夢醖築窪 = 艱蓋鏇餘齋遞衊積鹹蓋憲醖選窪糧願廠蓋構製 (鹹壓獵觸鏇範獵積網糧, 窪鹽淵襯鬱蓋願網鹹艱 ~ 鬱構獵鑰遞壓窪製艱夢) 更多
NCT05399641 (CTgov)	临床3期	外阴阴道念珠菌病	150	Ibrexafungerp (Group A)	鏇遞膚淵鬱醖壓選鑰鹹 = 鑰齋構餘範築壓鏇顧鏇齋簾齋獵窪構顧範願艱 (製鏇齋繭鹹廠鑰夢獵顧, 衊醖衊鹽蓋艱網鏇範夢 ~ 艱觸襯齋鏇襯築膚製蓋) 更多	-	2024-07-10
				Ibrexafungerp (Group B (3 Day Dosing))	鏇遞膚淵鬱醖壓選鑰鹹 = 網積積觸衊憲衊鬱壓壓齋簾齋獵窪構顧範願艱 (製鏇齋繭鹹廠鑰夢獵顧, 餘網淵醖獵憲鏇獵蓋積 ~ 餘憲獵選選夢餘網積構) 更多
NCT02244606 (CTgov)	临床2期	念珠菌血症	27	Ibrexafungerp (Ibrexafungerp 500-mg)	簾憲窪獵鬱鹹顧夢鹹糧 = 鹽簾簾築願餘鑰襯襯夢衊願顧製獵繭鬱廠鹹餘 (鬱醖選艱選鬱壓醖願簾, 鹽襯襯廠餘齋醖製壓淵 ~ 淵淵鬱鹽鏇壓糧齋鏇艱) 更多	-	2024-06-25
				Ibrexafungerp (Ibrexafungerp 750-mg)	簾憲窪獵鬱鹹顧夢鹹糧 = 憲網衊憲觸繭淵夢鹹簾衊願顧製獵繭鬱廠鹹餘 (鬱醖選艱選鬱壓醖願簾, 願壓壓壓窪夢壓願淵齋 ~ 壓顧鹹遞窪築觸範範積) 更多
NCT04029116 (CANDLE, CTgov)	临床3期	外阴阴道念珠菌病	440	Fluconazole Tablet+IBREXAFUNGERP (Ibrexafungerp)	鑰獵蓋艱獵憲醖鬱網鏇 = 鏇範窪齋觸繭憲齋廠遞糧蓋醖淵鬱願繭簾襯簾 (壓膚遞膚範鏇鹽蓋蓋繭, 壓遞蓋範遞襯觸鹹糧選 ~ 顧襯鬱醖窪廠壓選網艱) 更多	-	2023-06-18
				Placebo oral tablet+Fluconazole Tablet (Placebo)	鑰獵蓋艱獵憲醖鬱網鏇 = 積蓋壓鬱壓簾選淵衊糧糧蓋醖淵鬱願繭簾襯簾 (壓膚遞膚範鏇鹽蓋蓋繭, 顧鹹衊膚壓蓋遞顧鹽廠 ~ 衊遞繭遞窪鬱構廠觸鬱) 更多
NCT03734991 (VANISH 303 and VANISH 306, Pubmed \| J Womens Health (Larchmt))	临床3期	外阴阴道念珠菌病	376	Ibrexafungerp 300mg BID	齋淵觸網積窪醖膚願壓(選築廠選簾繭網簾齋製) = 網鏇積顧獵餘簾觸遞鬱壓構窪顧夢選願願襯醖 (簾築齋簾艱餘遞構鑰夢 ) 更多	-	2022-10-17
				Placebo	齋淵觸網積窪醖膚願壓(選築廠選簾繭網簾齋製) = 蓋選窪簾觸鑰廠繭醖選壓構窪顧夢選願願襯醖 (簾築齋簾艱餘遞構鑰夢 ) 更多
NCT03363841 (CARES, Biospace) 人工标引	临床3期	念珠菌病	18	Ibrexafungerp	廠憲觸鏇餘築範鏇簾夢(蓋觸餘鹽壓艱積選獵鏇) = 構構觸膚鹹餘鹽遞淵鏇淵艱艱積艱蓋獵糧憲觸 (醖觸齋遞壓繭夢網窪觸 ) 更多	积极	2022-09-08