An Exploratory Phase 1b, Multicenter, Randomized, Open-Label Study to Investigate the Impact of the Administration of Intravenous VH3810109 With or Without Oral Fostemsavir in Combination With Integrase Inhibitor-Based Antiretroviral Therapy on the Viral Reservoir in Adults Living With HIV-1

This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and treatment-experienced adults currently taking a standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2).

开始日期2025-07-10

申办/合作机构

ViiV Healthcare Ltd.

NCT05996471

/ Active, not recruiting临床2期

A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV

The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV. VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).

开始日期2023-08-17

申办/合作机构

ViiV Healthcare Ltd.

NCT05291520

/ Completed临床1期

A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults

An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

开始日期2022-02-23

申办/合作机构

ViiV Healthcare Ltd.

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项与 Iotivibart 相关的文献（医药）

2025-09-03·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results

Article

作者: Donatti, Christina ; Gandhi, Yash ; Warwick-Sanders, Michael ; Wannamaker, Paul ; D’Agostino, Riccardo ; Losos, Jan ; Brown, Kathryn ; Wilches, Viviana ; Ghita, Gabriela L. ; Leone, Peter A.

ABSTRACT:

The CD4-binding site antibody VH3810109 (N6LS) demonstrated broad and potent neutralization activity in vitro and robust antiviral activity in people with HIV-1. We report safety, tolerability, pharmacokinetics, and anti-drug antibody (ADA) incidence for subcutaneous (SC) and intravenous (IV) N6LS. Safety and pharmacokinetics of a single dose of VH3810109 (also known as GSK3810109), administered either subcutaneously (SC) with rHuPH20 or intravenously (IV) [SPAN]) was an open-label, three-part, phase 1 study evaluating single-dose N6LS in adults without HIV (part 1, 20 mg/kg SC + recombinant human hyaluronidase PH20 [rHuPH20] 2,000 U/mL; part 2, 60 mg/kg IV; part 3, 3,000 mg SC + rHuPH20 2,000 U/mL). Over 24 weeks, adverse events (AEs), injection site reactions (ISRs), pharmacokinetics, and ADAs were monitored. Twenty-four participants (8/part) were enrolled and received a single N6LS dose. Overall AE incidence between SC doses was similar and higher compared with IV, driven by ISRs. No ISRs were reported for IV N6LS; for SC, 15/16 participants reported ISRs, and 17/32 events were grade 3 (all injection site erythema). All ISRs resolved without sequelae or treatment. All participants rated local reactions and pain as acceptable. No serious AEs or deaths occurred. Pharmacokinetics were as expected for a broadly neutralizing antibody; median terminal half-life ranged from 43 to 47 days. No ADAs were observed after IV N6LS (0/8); 5/16 participants had treatment-emergent ADAs after SC N6LS; however, a clear impact on pharmacokinetics was observed in only one participant. N6LS administered IV or SC + rHuPH20 had a favorable safety profile and was well tolerated. Results support the ongoing development of N6LS 3,000 mg SC + rHuPH20 and 60 mg/kg IV into phase 2b.

CLINICAL TRIALS:

Registered at ClinicalTrials.gov ( NCT05291520 ).

2025-07-01·Lancet HIV

Safety and pharmacokinetics of N6LS, a broadly neutralising monoclonal antibody for HIV: a phase 1, open-label, dose-escalation study in healthy adults

Article

BACKGROUND:

Broadly neutralising antibodies (bNAbs) have shown promise as both prevention and treatment strategies against HIV-1. The clinical effectiveness of bNAbs depends on enhancing their neutralisation breadth and extending their serum half-lives. In this study, we aimed to assess the safety, tolerability, pharmacokinetic profile, and neutralisation activity in serum of N6LS, a HIV-1 bNAb.

METHODS:

In this first-in-human, dose-escalation, open-label, phase 1 trial, healthy adult participants (aged 18-50 years) who were HIV-1 negative were recruited to the National Institutes of Health Clinical Center (Bethesda, MD, USA). Three groups received one intravenous administration of N6LS at 5 mg/kg (n=3), 20 mg/kg (n=3), or 40 mg/kg (n=3); one group received one subcutaneous administration of 5 mg/kg N6LS (n=3); two groups received three administrations of either 5 mg/kg subcutaneous (n=5) or 20 mg/kg intravenous (n=5) N6LS every 12 weeks; and two groups received one subcutaneous administration of either 5 mg/kg (n=5) or 20 mg/kg (n=5) N6LS with ENHANZE drug product (EDP), recombinant human hyaluronidase PH20. The primary objectives were the safety and tolerability of N6LS with and without EDP. All participants who received N6LS were included in the primary safety analyses. This trial is registered at ClinicalTrials.gov, NCT03538626, and is complete.

FINDINGS:

Between June 18, 2018, and April 11, 2022, we enrolled 33 healthy adults (19 female individuals and 14 male individuals). One participant did not receive N6LS and one participant was lost to follow-up after 8 weeks. N6LS had an encouraging safety profile similar to other HIV-1 bNAbs, with no serious adverse events. Local reactogenicity was observed after administration of N6LS, with the most common symptom being mild to moderate injection site pain or tenderness in subcutaneous groups, reported in six of eight participants. All ten participants who received N6LS with EDP had mild to severe injection site erythema, which, despite being graded as severe in size, was generally not noticed by participants or deemed bothersome, and resolved without intervention. Systemic reactogenicity was mild in all groups. N6LS had an overall mean serum half-life of 48·6 days and retained its broad and potent neutralisation characteristics in serum. EDP administration increased N6LS bioavailability. No functional anti-drug antibodies to N6LS were detected following administration.

INTERPRETATION:

N6LS showed a promising safety and pharmacokinetics profile while retaining its potent neutralisation characteristics in serum, making it a promising candidate for inclusion in HIV-1 prevention and therapeutic combination strategies. The addition of EDP can enable safe subcutaneous administration of higher doses and larger volumes of N6LS, supporting additional methods for prophylactic and therapeutic bNAb administration.

FUNDING:

US National Institute of Allergy and Infectious Diseases Intramural Research Program, National Institutes of Health.

2023-12-31·mAbs

Improved pharmacokinetics of HIV-neutralizing VRC01-class antibodies achieved by reduction of net positive charge on variable domain

Article

作者: Zhang, Baoshan ; Yang, Eun Sung ; Kwong, Peter D. ; Lin, Bob C. ; Lusso, Paolo ; Pegu, Amarendra ; McKee, Krisha ; Louder, Mark K. ; Mascola, John R. ; Bender, Michael F. ; Liu, Qingbo ; Asokan, Mangaiarkarasi ; Rawi, Reda ; Shen, Chen-Hsiang ; Liu, Tracy ; Doria-Rose, Nicole A. ; Schaub, Andrew J. ; Reveiz, Mateo ; Kwon, Young D.

The amino-acid composition of the immunoglobulin variable region has been observed to impact antibody pharmacokinetics (PK). Here, we sought to improve the PK of the broad HIV-1-neutralizing VRC01-class antibodies, VRC07-523LS and N6LS, by reducing the net positive charge in their variable domains. We used a structure-guided approach to generate a panel of antibody variants incorporating select Arg or Lys substituted to Asp, Gln, Glu, or Ser. The engineered variants exhibited reduced affinity to heparin, reduced polyreactivity, and improved PK in human FcRn-transgenic mice. One variant, VRC07-523LS.v34, with three charge substitutions, had an observed in vivo half-life and an estimated human half-life of 10.8 and 60 days, respectively (versus 5.4 and 38 days for VRC07-523LS) and retained functionality, neutralizing 92% of a 208-strain panel at a geometric mean IC₈₀ <1 µg/mL. Another variant, N6LS.C49, with two charge substitutions, had an observed in vivo half-life and an estimated human half-life of 14.5 and 80 days (versus 9.0 and 44 days for N6LS) and neutralized ~80% of 208 strains at a geometric mean IC₈₀ <1 µg/mL. Since Arg and Lys residues are prevalent in human antibodies, we propose substitution of select Arg or Lys with Asp, Gln, Glu, or Ser in the framework region as a general means to improve PK of therapeutic antibodies.

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2025-11-26

·今日头条

不用终身吃药了？HIV新药来那帕韦获批，每年2针就能稳住免疫功能

在当前全球公共卫生舞台上，HIV感染的现状仍然严峻，防控与治疗的每一步都牵动着亿万生命的未来。2025年最新数据显示，中国HIV感染者总数已突破138万，新增病例在青年学生和老年人中呈现双峰增长，反映出病毒传播路径和防控重点的深刻变化。背后隐藏的，不仅是病毒的“隐形威胁”，更是科学技术在抗击疫情中不断突破的证据。首先，从疫情发展趋势来看，青年群体中的感染人数已上升到3500，比去年增长了16.7%，而60岁以上老年感染者比例更是达到了25%。这类“老龄化”趋势，暴露出病毒感染面日益广泛，同时也提醒我们，预防策略不能再局限于传统的年轻人和高危人群，老年人的防护意识亟需加强。更重要的是，这一趋势对药物研发和公共卫生规划提出了新的挑战：如何确保老年人服药的便利性和安全性，以及跨年龄段的疗效保障。在药物研发方面，2025年有两个令人振奋的突破。国产长效融合抑制剂“艾可宁+”完成了III期临床试验，病毒载量达到检测限以下的比例高达92%，且只需每月一次注射，极大简化了患者的用药难度。这款即将上市的药物，不仅代表着国产药物在抗HIV领域的自主创新实力，也为“用药依从性”提供了技术保障。更值得关注的是，国际上由美国NIH开发的广谱中和抗体“N6-LS”，结合来那帕韦，成功清除了动物模型中的潜伏病毒库，首次实现了HIV“功能性治愈”的可能。这一成果，或许将在未来推动HIV治疗从控制转向根治。关于治疗方案，目前全球首个获批上市的衣壳抑制剂——来那帕韦，也成为抗疫“明星”。它每年只需两次皮下注射，极大提升了患者的生活质量。根据中国和国外的研究，来那帕韦可将感染风险降低96%以上（女性为100%），在预防和耐药性治疗中展现出巨大潜力。而在定价方面，预计2027年前在国内上市时，会通过医保谈判争取更实惠的价格，让更多患者受益。国内外研发格局也在发生深刻变化。虽然国际巨头如强生、GSK和赛诺菲在疫苗领域投入巨大，但疫苗研发仍屡屡受挫，总投入超过千亿人民币，而国产药企如艾迪、真实生物、前沿生物都在积极布局。国产“艾可宁+”的即将商业化，标志着中国在自主创新、突破国际封锁方面迈出了坚实一步。而国际科研方面，NIH的联合疗法显示了功能性治愈的希望，为未来的抗病毒策略提供了全新思路。然而，值得强调的是，虽然新药和新技术令人欣喜，但HIV依然不是“治愈性”药物。来那帕韦和其他抗病毒药物一样，必须配合整体治疗方案，不能孤立使用。同时，血液、性传播和母婴传播仍然是病毒传播的主要途径，这就意味着科学预防优于任何药物：安全性行为、定期检测、孕妇筛查全部是有效的防线。价格和耐药性的问题，也时刻提醒我们前线的战斗还未结束。吉利德的财报显示，来那帕韦在欧美市场的实际支付价在标价的60-70%之间，预计中国医保谈判后，将会带来更低的价格，减轻患者的经济压力。而最新数据显示，我国HIV耐药率已达5.8%，较2020年上升了2.3个百分点。这是药物使用中不可避免的问题，也促使科研界不断寻求新药、新机制，以应对病毒的“变脸”。最后，国家对于HIV的重视驶入“快车道”。从2025年起，将检测纳入基本公共卫生服务，二级以上医院全面提供检测，预计检测覆盖率达到85%以上。这一系列措施旨在“早发现、早治疗、早预防”，筑起全民免疫的钢铁长城。总结来看，2025年的HIV防控战场，既是科技的突破点，也是公共政策的强化点。国产药物“艾可宁+”的临床成功，将开启中国自主创新的新时代；NIH的“清除潜伏病毒库”的研究，为根治带来曙光；而国家层面的防控策略，则为全民健康提供坚实保障。这一切，正是未来抗HIV战斗的“战略蓝图”。在病毒与科技的赛跑中，只有不断推陈出新，才能让生命的希望更加明亮。减轻病毒的阴影，真正让“生命之光”照耀每一个角落，才是我们共同的追求。

2025-05-23

·医学新视点

《柳叶刀》子刊：新药有望安全、长效防治艾滋病，半衰期近49天

艾滋病，即获得性免疫缺陷综合征（AIDS），其病原体为人类免疫缺陷病毒（HIV）。现行抗逆转录病毒治疗药物的联合应用可有效抑制艾滋病进程并显著延长患者寿命，但由于HIV-1潜伏库的存在，艾滋病迄今尚无法治愈。近年发现，抗HIV广谱中和抗体（bNAb）可有效降低HIV-1病毒载量并减缓疾病进展，可能是控制HIV/AIDS的有效策略，为研发艾滋病疫苗和治愈策略带来了曙光。在《柳叶刀》子刊The Lancet HIV发表的一项1期临床试验中，来自美国国立卫生研究院（NIH）临床中心等团队评估了N6LS（新型bNAb）在健康成人中的安全性、耐受性及药代动力学特征。研究结果显示，N6LS单次或多次静脉及皮下给药后均表现出良好的安全性，血清半衰期长达48.6天，且保留了对HIV-1的广谱中和活性，是未来预防或治疗HIV的具有前景的潜在后续药物。截图来源：The Lancet HIV这是N6LS的首次人体、剂量递增、开放标签的1期试验，纳入18~50岁、HIV-1阴性的健康成人33例（1例未接受N6LS治疗、1例治疗8周后失访），探索不同给药途径（静脉或皮下）、不同剂量N6LS（5~40 mg/kg）及联合重组人透明质酸酶PH20（ENHANZE，EDP）对人体的影响，具体治疗如下：单次静脉注射，N6LS 5 mg/kg（3例）、N6LS 20 mg/kg（3例）或N6LS 40 mg/kg（3例）；单次皮下给药，N6LS 5 mg/kg（3例）；多次皮下给药，N6LS 5 mg/kg（5例），或静脉注射，N6LS 20 mg/kg（5例），每12周给药3次；单次皮下给药，N6LS 5 mg/kg（5例）或N6LS 20 mg/kg（5例），联合重组人透明质酸酶PH20；研究结果显示，与其他抗HIV-1的bNAb相似，N6LS展示出了良好的安全性特征，无一例患者发生严重安全性事件。N6LS用药后常见的局部不良反应为皮下注射部位轻中度疼痛或压痛；接受N6LS联合重组人透明质酸酶PH20的参与者均出现注射部位红斑（轻度至重度），但无需干预即可自行缓解。药代动力学分析表明，N6LS平均血清半衰期为48.6天。此外，联合重组人透明质酸酶PH20用药，可提高N6LS的生物利用度。给药后未检测到针对N6LS的功能性抗药抗体。该研究验证了N6LS在人体内的安全性和药代动力学特征，表明N6LS是预防和治疗HIV的具有前景的候选药物。N6LS与重组人透明质酸酶PH20联合用药，有望实现N6LS更高剂量的皮下安全给药，为未来HIV预防或治疗方案提供了新思路。点击文末“阅读原文/Read more”，即可访问The Lancet HIV官网阅读完整论文。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1] Richard L Wu, Katherine V Houser, Martin R Gaudinski, et al. Safety and pharmacokinetics of N6LS, a broadly neutralising monoclonal antibody for HIV: a phase 1, open-label, dose-escalation study in healthy adults. Published May 20, 2025. The Lancet·HIV. DOI: 10.1016/S2352-3018(25)00041-4.免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

临床1期临床结果疫苗

2025-05-06

·PRNewswire

HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG FIRST QUARTER 2025 RESULTS

Announcing New $250M Share Repurchase Total Revenue Increased 35% YOY to $265 million and Royalty Revenue Increased 39% YOY to $168 million Net Income Increased 54% YOY to $118 million; Adjusted EBITDA Increased 40% YOY to $162 million; GAAP Diluted EPS Increased 55% YOY to $0.93; non-GAAP Diluted EPS Increased 41% YOY to $1.111 Raising 2025 Financial Guidance Ranges for Total Revenue to $1,200 - $1,280 million, Representing YOY Growth of 18% - 26%, Adjusted EBITDA to $790 - $840 million, Representing YOY Growth of 25% - 33% and non-GAAP Diluted EPS to $5.30 - $5.70, Representing YOY Growth of 25% - 35%1 SAN DIEGO, May 6, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the first quarter ended March 31, 2025, provided an update on its recent corporate activities and raised its 2025 financial guidance. "2025 is off to a strong start with our current three blockbuster brands, Darzalex SC, Phesgo and VYVGART Hytrulo, continuing to demonstrate strong growth in their currently approved indications. Our four recently launched products, Ocrevus Zunovo in U.S. and Europe, Tecentriq Hybreza in U.S. and Europe, Opdivo Qvantig in U.S. and Rybrevant SC in Europe are just beginning their contributions as our partners focus on gaining and expanding coverage and reimbursement. This broadened portfolio is resulting in an unprecedented set of 11 additional growth catalysts that have happened recently or are expected to happen in the coming months. These opportunities include multiple new European and U.S. product approvals, multiple new indication approvals and multiple key reimbursement milestones supporting access for an even greater number of patients, all creating new near and longer-term growth opportunity. As a result of this momentum, I am pleased to announce we are increasing our full year 2025 financial guidance ranges and a new $250 million share buyback," said Dr. Helen Torley, president and chief executive officer, of Halozyme. "In addition, our long-term growth prospects have never been better with additional growth opportunities projected to result from our pipeline, where two products, BMS' nivolumab plus relatlimab SC and Takeda's 20% immune globulin SC, continue in Phase 3 and where ViiV and Acumen announced development progress and data in the quarter. I am also pleased to announce that we have signed our first HVAI development agreement with a current ENHANZE partner and that a different ENHANZE partner is now moving our SVAI into clinical testing," concluded Dr. Torley. First Quarter and Recent Corporate Highlights: On May 6, Halozyme announced a second $250 million share repurchase under the $750 million approved program from February 2024. In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the U.S. District Court in New Jersey alleging that Merck is using Halozyme's patented MDASE™ subcutaneous drug delivery technology to develop Subcutaneous ("SC") Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck's infringement of Halozyme's MDASE™ intellectual property. In March 2025, Halozyme completed the first $250 million Accelerated Share Repurchase of its common stock under the $750 million approved program from February 2024. First Quarter and Recent Partner Highlights: In April 2025, Roche received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") recommending an update to the European Union ("EU") label for Phesgo® for human epidermal growth factor receptor 2 ("HER2")-positive breast cancer. Administration of Phesgo® outside of a clinical setting (such as in a person's home) by a healthcare professional will be possible, once safely established in a clinical setting. In April 2025, argenx received a positive opinion from the CHMP recommending European Commission approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE® for SC injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy ("CIDP") after prior treatment with corticosteroids or immunoglobulins. In April 2025, argenx received U.S. Food and Drug Administration ("FDA") approval of VYVGART® Hytrulo prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with CIDP. In April 2025, Janssen received European Commission marketing authorization of the SC formulation of RYBREVANT® (amivantamab) with ENHANZE®, in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") with epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 L858R substitution mutations. Additionally, RYBREVANT® (amivantamab) is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. This represents the 10th partner product with ENHANZE® to be commercialized. In April 2025, Janssen received European Commission approval for an indication extension of DARZALEX® SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma regardless of transplant eligibility. In March 2025, Bristol Myers Squibb received a positive CHMP opinion recommending approval of Opdivo® (nivolumab) with ENHANZE® across multiple solid tumor indications. In March 2025, Acumen announced top-line results from a Phase 1 study of sabirnetug (ACU193) with ENHANZE® comparing the pharmacokinetics between SC and intravenous administrations in healthy volunteers that demonstrated weekly SC administration of sabirnetug was well-tolerated with systematic exposure supporting further clinical development. In March 2025, ViiV announced results from a Phase 2b study demonstrated N6LS administered every four months SC with ENHANZE® in combination with cabotegravir successfully maintained viral suppression in adults living with HIV who were already stable on treatment. In March 2025, Takeda announced Health Canada expanded the marketing authorization for HYQVIA® to include CIDP as a maintenance therapy after stabilization with intravenous immunoglobulin to prevent relapse of neuromuscular disability and impairment in adults. First Quarter 2025 Financial Highlights: Revenue was $264.9 million, compared to $195.9 million in the first quarter of 2024. The 35% year-over-year increase was primarily driven by royalty revenue growth and an increase in sales of bulk rHuPH20. Revenue for the quarter included $168.2 million in royalties, an increase of 39% compared to $120.6 million in the first quarter of 2024, primarily attributable to increases in revenue of VYVGART® Hytrulo, DARZALEX® SC, and Phesgo®. Cost of sales was $48.4 million, compared to $28.3 million in the first quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales. Amortization of intangibles expense remained flat at $17.8 million, compared to the first quarter of 2024. Research and development expense was $14.8 million, compared to $19.1 million in the first quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE® related to the development of our new high-yield rHuPH20 manufacturing process. Selling, general and administrative expense was $42.4 million, compared to $35.1 million in the first quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees and compensation expense. Operating income was $141.5 million, compared to $95.5 million in the first quarter of 2024. Net income was $118.1 million, compared to $76.8 million in the first quarter of 2024. EBITDA and Adjusted EBITDA were $162.0 million, compared to $115.7 million in the first quarter of 2024.1 GAAP diluted earnings per share was $0.93, compared to $0.60 in the first quarter of 2024. Non-GAAP diluted earnings per share was $1.11, compared to $0.79 in the first quarter of 2024.1 Cash, cash equivalents and marketable securities were $747.9 million on March 31, 2025, compared to $596.1 million on December 31, 2024. The increase was primarily a result of cash generated from operations. Financial Outlook for 2025 The Company is raising its financial guidance for 2025. Note that the guidance reflects tariffs that are currently implemented. For the full year 2025, the Company expects: Total revenue of $1,200 million to $1,280 million, representing growth of 18% to 26% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of $750 million to $785 million, representing growth of 31% to 37% over 2024. Adjusted EBITDA of $790 million to $840 million, representing growth of 25% to 33% over 2024. Non-GAAP diluted earnings per share of $5.30 to $5.70, representing growth of 25% to 35% over 2024. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2025 today, Tuesday, May 6, 2025, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges and transaction costs for business combinations. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides non-GAAP financial measures that it believes will be achieved; however, it cannot accurately predict all of the components of the adjusted calculations and the U.S. GAAP measures may be materially different than the non-GAAP measures. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's expected financial outlook for 2025) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share and potential share repurchases under its share repurchase program. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and the expected expiration date of our ENHANZE® patent in Europe. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations (including potential HVAI and SVAI collaborations) and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected delays in the execution of the Company's share repurchase program, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, uncertainties in tariffs and trade policies, unexpected adverse events or patient outcomes and competitive conditions. In addition, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] Footnotes: 1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end. SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床2期	美国	Halozyme Therapeutics, Inc.	2021-06-22
HIV感染	临床2期	美国	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	美国	National Institute of Allergy & Infectious Diseases	2021-06-22
HIV感染	临床2期	阿根廷	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	巴西	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	加拿大	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	墨西哥	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	秘鲁	ViiV Healthcare Ltd.	2021-06-22

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05291520 (SPAN, CTgov)	临床1期	HIV感染	24	VH3810109+rHuPH20 (Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC])	餘鏇製獵襯膚鹹淵衊鹽 = 築網積糧艱遞膚顧鑰壓願蓋夢淵範憲淵淵顧鑰 (鏇製夢積壓糧觸觸齋衊, 膚選廠簾艱餘鏇膚憲夢 ~ 醖夢窪蓋襯鹽衊鑰構鹽) 更多	-	2024-09-19
				VH3810109+rHuPH20 (Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC])	餘鏇製獵襯膚鹹淵衊鹽 = 衊獵鏇鹹鹹築壓遞範廠願蓋夢淵範憲淵淵顧鑰 (鏇製夢積壓糧觸觸齋衊, 構遞膚製艱壓繭糧淵鹹 ~ 觸鬱艱鏇鏇願願醖範鹽) 更多
NCT04871113 (BANNER, CTgov)	临床2期	HIV感染	62	GSK3810109A (Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV))	淵鏇淵蓋選獵獵膚衊鏇(襯願獵夢積衊襯積積鹹) = 齋鑰廠廠鏇齋餘淵襯齋鑰顧廠鹽襯鬱壓襯淵蓋 (蓋淵鏇憲築鹹糧繭餘鹹, 齋範蓋繭夢繭襯鹹鏇顧 ~ 範壓鹽醖顧壓鏇遞衊範) 更多	-	2023-11-18
				GSK3810109A (Part 1: GSK3810109A 280 mg IV)	淵鏇淵蓋選獵獵膚衊鏇(襯願獵夢積衊襯積積鹹) = 蓋鹹憲築鹽鏇廠鹹觸獵鑰顧廠鹽襯鬱壓襯淵蓋 (蓋淵鏇憲築鹹糧繭餘鹹, 糧觸顧餘鹹淵觸壓膚糧 ~ 簾齋觸糧蓋廠選遞齋範) 更多
NCT03538626 (VRC 609, CTgov)	临床1期	HIV感染	33	VRC-HIVMAB091-00-AB (Group 1: N6LS (5 mg/kg IV) Single Dose)	製衊鹽廠膚網膚願鬱鏇 = 製顧範繭衊膚鹽繭糧鏇鹽積構衊網夢願膚繭觸 (鏇襯鬱築艱遞鏇淵衊築, 鏇齋遞築廠網廠鑰獵遞 ~ 製鹽鏇鏇範齋製夢廠窪) 更多	-	2023-09-21
				VRC-HIVMAB091-00-AB (Group 2: N6LS (5 mg/kg SC) Single Dose)	製衊鹽廠膚網膚願鬱鏇 = 醖憲醖鹽簾築選齋壓糧鹽積構衊網夢願膚繭觸 (鏇襯鬱築艱遞鏇淵衊築, 廠壓簾遞齋鏇鏇衊鏇鑰 ~ 選膚鏇艱觸觸膚艱夢鹽) 更多