A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants

In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab subcutaneously (SC), also known as under the skin.
In this study, researchers want to learn more about new ways of delivering litifilimab SC using either an autoinjector (AI) or an on-body injector (OBI):
Both devices are designed to deliver litifilimab in an automatic way, especially helping patients who may not be able to use their hands very well, or who may be afraid of needles. While the AI is handheld, the OBI device works by being placed on the skin and can help deliver the highest amount of litifilimab through a single injection. The main objective of this study is to learn how the body processes litifilimab after using the AI device or the OBI device, as compared to using the PFS method.
The main questions researchers want to answer are:
* What is the highest amount of litifilimab found in the blood after dosing? How much total litifilimab is found in the blood throughout the study? Researchers will also learn more about: Any medical problems the participants have during the study
* Any injection site pain or reactions the participants may have. Any skin reactions to the OBI device
* Any changes in the participants' overall health after receiving litifilimab.
This study will be done as follows:
* Participants will be screened to check if they can join the study. The screening period will be up to 4 weeks, after which selected participants will check into their study research center.
* Participants will be randomly assigned to be in Part 1 or Part 2 of the study:
* Part 1: Participants will receive SC injection(s) of litifilimab through either the AI device or through PFS.
* Part 2: Participants will receive SC injection(s) of litifilimab through the OBI device or through PFS.
* Participants will remain at their study research center for the first 8 days. After that, there will be a follow-up period for 17 weeks during which participants return to the center a total of 6 times.
Each participant will be in the study for about 22 weeks.

开始日期2025-01-02

申办/合作机构

Biogen, Inc.

NCT06044337

/ Enrolling by invitation临床3期

A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.
The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.
The main objective of the study is to learn more about the long-term safety of litifilimab.
The main question researchers want to answer is:
- How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are unwanted health problems that may or may not be caused by the study drug.
Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).
Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab.
The study will be done as follows:
* The last visit of parent study 230LE301 will be the first visit of study 230LE305.
* All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug.
* Globally, the treatment period will last up to 104 weeks, or 2 years. For participants in the United States, the treatment period may last up to 260 weeks, or 5 years
* There will be a follow-up safety period that lasts up to 24 weeks.
* Globally, participants will have up to 27 study visits during the treatment period. In the US, participants will have up to 66 study visits.
* Globally, the total study duration for participants will be up to 128 weeks. In the US, the total study duration will be up to 284 weeks .

开始日期2023-10-03

申办/合作机构

Biogen, Inc.

NCT05531565

/ Recruiting临床2/3期

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).
The main questions researchers want to answer are:
* How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?
* How many participants have their skin disease activity go down by at least 70% as measured by CLASI?
Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.
The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:
* After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.
* Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.
* The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.
* During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.
* After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.
* The total study duration for participants will be up to 80 weeks.

开始日期2022-09-13

申办/合作机构

Biogen, Inc.

100 项与利替非利单抗相关的临床结果

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100 项与利替非利单抗相关的专利（医药）

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项与利替非利单抗相关的文献（医药）

2026-01-01·The Journal of clinical and aesthetic dermatology

What's New in Cutaneous Lupus Erythematosus: Guidelines, Biologics, and Beyond.

Review

作者: Childs, Beth A ; Merola, Joseph F

OBJECTIVE:

We aim to review current treatment strategies for cutaneous lupus erythematosus (CLE) and highlight emerging therapies, evolving outcome measures, and practical considerations that may inform future management of this clinically heterogeneous disease.

METHODS:

We conducted a narrative review of the literature using PubMed to identify relevant clinical trials, observational studies, and mechanistic investigations related to CLE treatment. Emphasis was placed on studies published within the past 15 years. Expert opinion from dermatology and rheumatology was incorporated to contextualize evolving therapies and their application in clinical practice.

RESULTS:

Current management of CLE follows a stepwise framework, with antimalarials and immunosuppressants forming the foundation of systemic therapy. However, many patients experience refractory disease, especially in chronic or hypertrophic subtypes. Advances in the understanding of CLE pathogenesis have led to the development of targeted biologics and small molecule agents that modulate Type I interferon signaling, B- and T-cell activation, and inflammatory cytokine pathways. Novel tools such as Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) and the Investigator Global Assessment for Cutaneous Lupus (CLA-IGA-R) are being validated to standardize disease assessment, while RNA tape sampling and real-world electronic health record (EHR)-based algorithms are enhancing research precision. Emerging therapies, such as belimumab, anifrolumab, litifilimab, deucravacitinib, and enpatoran, demonstrate promise in both clinical trials and real-world settings.

LIMITATIONS:

As a narrative review, this study is limited by the lack of systematic inclusion criteria and formal quality assessment of individual studies.

CONCLUSION:

Ongoing therapeutic innovation, guided by mechanistic insights and strengthened by the development of standardized outcome measures, is transforming the CLE landscape and advancing the goal of precision-based, durable disease control.

2025-12-01·Arthritis & Rheumatology

Pharmacodynamic Effects of Litifilimab in Lupus in a Randomized, Placebo‐Controlled Phase 2 Study: Rapid and Sustained Reductions in Type I Interferon‐Associated Gene Expression and Cytokines

Article

作者: Furie, Richard ; Milliman, Eric ; Franchimont, Nathalie ; Ferber, Kyle ; Werth, Victoria P. ; Barbey, Catherine ; Lahoud, Youmna ; Zoghbi, Jad ; Brown, Roland

Objective:

The pharmacodynamic effects of litifilimab on type I interferon (IFN) response and correlations with clinical outcomes were investigated in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).

Methods:

Participants from part A (SLE) or part B (CLE with or without SLE) of the randomized phase 2 LILAC trial who received litifilimab (at 50 mg, 150 mg, or 450 mg) or a placebo were included. IFN gene signature (IFNGS) scores were assessed from whole‐blood samples using a 22‐gene panel in 120 and 131 participants (parts A and B, respectively). IFNα and other IFN‐regulated cytokine concentrations were measured in serum in 112 and 131 participants (parts A and B, respectively).

Results:

Most participants were IFNGS‐high at baseline (79–91%), and no baseline IFNGS‐low participant results were reported. In IFNGS‐high participants, litifilimab induced rapid, significant (nominal P < 0.05), and sustained reductions in IFNGS scores and IFNα concentrations versus a placebo for litifilimab at 450 mg in part A and for litifilimab at 150 mg and 450 mg in part B. In part A, IFNα reductions with litifilimab were correlated with clinical response measures. In part B, dose‐response relationships for IFNGS score and IFNα concentration were observed, similar to those for disease activity measured with the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI‐A) score.

Conclusion:

Administration of litifilimab resulted in reductions in both IFNGS scores and IFNα concentrations, pharmacodynamic effects that correlated with clinical responses. These findings support the mechanism of action of litifilimab and its continued evaluation in larger studies of patients with SLE or CLE.image

2025-07-01·CPT-Pharmacometrics & Systems Pharmacology

An Integrative Mechanistic Model of Type 1 IFN‐Mediated Inflammation in Systemic Lupus Erythematosus

Article

作者: Volkova, Alina ; Tettamanti, Florencia ; Ugolkov, Yaroslav ; Kimko, Holly ; Sokolov, Victor ; Tang, Weifeng ; Peskov, Kirill ; Verma, Meghna

ABSTRACT:

Type I interferon (IFN1) pathway–targeting therapies represent a highly promising class of remedies for the treatment of systemic lupus erythematosus. However, the overall clinical benefit of these compounds is afflicted by marked variability. In this study, we developed a quantitative systems pharmacology model of type I IFN‐mediated inflammation and applied it for an indirect comparison of anifrolumab, sifalimumab, daxdilimab, and litifilimab pharmacodynamic response, represented in the model by the change in IFN1 gene signature (IFNGS). The model consists of 20 ordinary differential equations and 68 parameters, among which four systemic parameters (including one random effect) were estimated using patient‐level data from Phase IIb anifrolumab clinical trial. Within‐target and within‐pathway validation was performed using study‐level pharmacokinetics, IFNα, and/or IFNGS data from five anifrolumab, four sifalimumab, one daxdilimab, and one litifilimab trials. The model successfully captured overall trends in IFNGS at clinically relevant doses of these compounds and discriminated IFNGS response between patients with low (< 2.75) and high (≥ 2.75) baseline IFNGS. Overprediction of treatment benefit was observed for the low range of anifrolumab doses (100–150 mg every 4 weeks). In contrast, IFNGS response under 150 mg of daxdilimab was underpredicted, despite the accurate description of plasmacytoid dendritic cells and IFNα biomarkers. Results of the global sensitivity analysis revealed baseline IFNGS, IFNα, and IFNα fraction as key factors affecting treatment benefit the most. In terms of maximum IFNGS reduction, anifrolumab showed superior potential compared to sifalimumab, daxdilimab, and litifilimab (ΔIFNGS~25%), which was further enhanced in patients with high baseline IFNGS or IFNα (ΔIFNGS~50%–60%).

项与利替非利单抗相关的新闻（医药）

2026-02-24

·科学研读社

系统性红斑狼疮治疗的新纪元：从免疫抑制到免疫稳态重建

一场与复杂性的持久战系统性红斑狼疮（SLE）是一种经典的、高度异质性的自身免疫性疾病。它像一个狡猾的对手，临床表现千变万化，从轻微的皮疹、关节痛到致命的肾炎、神经精神症状，不一而足。过去数十年，SLE的治疗主要依赖于糖皮质激素和广谱免疫抑制剂，这些药物虽能控制病情，却伴随着显著的毒副作用，严重影响患者的生活质量和长期预后。然而，随着对SLE发病机制的深入理解，我们正迎来一个治疗模式的根本性转变。SLE的治疗已不再满足于“压制”免疫系统，而是致力于“精准打击”致病通路，并最终走向“修复”免疫系统的最终目标。 SLE的高度异质性——治疗与研发的核心挑战 SLE的复杂性是其治疗和药物研发的最大障碍。临床异质性：患者之间受累器官、疾病严重程度和病程波动差异巨大，使得“一刀切”的治疗策略难以奏效。病理异质性： SLE并非单一疾病，而是由多种致病通路（如I型干扰素通路、B细胞活化通路、中性粒细胞胞外诱捕网NETosis等）交织而成的综合征。这意味着，针对单一通路的药物可能只对特定亚群有效。这种异质性直接导致了过去许多大型III期临床试验的失败。失败的原因包括：对照组因标准治疗（如高剂量激素）而反应率过高、未能筛选出最可能受益的生物标志物阳性人群、以及缺乏能全面反映疾病改善的评估工具。图1：系统性红斑狼疮发病机制总览从传统免疫抑制到精准靶向治疗尽管挑战重重，SLE的治疗在过去十年取得了里程碑式的突破。 1. B细胞靶向治疗：从失败到成功B细胞及其产生的自身抗体是SLE的核心驱动因素。利妥昔单抗（Rituximab）：作为首个B细胞清除剂，其在大型RCT中未能达到主要终点，一度让领域陷入低谷。但事后分析表明，这可能是由于组织内B细胞清除不彻底所致。奥妥珠单抗（Obinutuzumab）：新一代抗CD20单抗，凭借更强的B细胞清除能力，在狼疮肾炎（LN）的NOBILITY和REGENCY III期试验中均取得成功，显著提高了完全肾脏缓解率。贝利尤单抗（Belimumab）：全球首个获批用于SLE的生物制剂，通过抑制B细胞活化因子（BAFF），有效降低了疾病活动度、减少了激素用量，并延缓了器官损伤。其在LN中的BLISS-LN研究也证实了长期肾脏获益。泰它西普（Telitacicept）：一种新型融合蛋白，可同时抑制BAFF和APRIL，为B细胞靶向治疗提供了新选择。 2. I型干扰素（IFN-I）通路：点亮“干扰素签名”约50-90%的SLE患者存在IFN-I通路过度活化（即“干扰素签名”）。阿尼夫鲁单抗（Anifrolumab）：通过阻断IFN-I共用的受体（IFNAR），成为第二个获批的SLE生物制剂。它在皮肤和关节症状方面效果显著，有趣的是，其疗效似乎不受基线干扰素签名水平高低的影响，拓宽了适用人群。 3. 细胞内信号通路抑制剂：多点开花靶向细胞内的关键信号分子，可以同时抑制多条炎症通路。JAK/STAT通路：巴瑞替尼（Baricitinib）和乌帕替尼（Upadacitinib）等JAK抑制剂在II期试验中显示出对皮肤和关节病变的改善作用，目前正在进行III期验证。 BTK抑制剂：奥布替尼（Orelabrutinib）等药物通过抑制B细胞受体信号，在LN中展现出降低蛋白尿和自身抗体的潜力。钙调磷酸酶抑制剂：伏环孢素（Voclosporin）作为一种新型、药代动力学更优的药物，已获批用于LN，通过稳定足细胞骨架和抑制T细胞活化，有效诱导肾脏缓解。迈向治愈：免疫稳态的重建如果说精准靶向是“治标”，那么恢复免疫系统的自我平衡（免疫稳态）则是“治本”，代表着SLE治疗的终极梦想。 1. 调节性T细胞（Treg）SLE患者普遍存在Treg细胞数量减少和功能受损。低剂量白介素-2（IL-2LD）疗法旨在选择性扩增和激活Treg细胞，已在多项小型研究中显示出改善疾病活动度、减少激素用量的潜力。虽然一些工程化IL-2变体（muteins）的IIb期试验因未达主要终点而终止，但该策略的理论基础依然坚实。 2. CAR-T细胞疗法：重置免疫系统嵌合抗原受体T细胞（CAR-T）疗法最初用于血液肿瘤，如今在SLE领域实现了突破。通过靶向CD19阳性的B细胞，CAR-T疗法在十余例难治性SLE患者中实现了长期、无药缓解。其机制被认为是通过深度清除致病性B细胞，从而“重置”了紊乱的免疫系统。这一突破性进展，首次让人们看到了“功能性治愈”SLE的曙光。 3. 其他前沿探索血浆细胞清除：靶向CD38（如达雷妥尤单抗）或BCMA的疗法，旨在清除产生自身抗体的长寿浆细胞。FcRn 抑制剂：如尼泊利尤单抗（Nipocalimab），通过阻断新生儿Fc受体，加速致病性自身抗体的降解。浆细胞样树突状细胞（pDC）：作为I型干扰素的主要来源，靶向pDC表面标志物（如BDCA2）的抗体（如Litifilimab）正在临床开发中。图2：系统性红斑狼疮的治疗方案总览未来的挑战与机遇尽管前景光明，SLE治疗仍面临重大挑战：精准分层：如何利用可靠的生物标志物（如干扰素签名、特定自身抗体谱）将患者精准分入最合适的治疗路径，是提高药物成功率的关键。治疗降级（De-escalation）：如何在疾病得到良好控制后，安全地减少甚至停用药物（尤其是激素），以最小化长期毒性，是临床实践中的核心难题。中枢神经系统狼疮（NPSLE）：针对这一严重且难以治疗的并发症，目前仍缺乏有效的特异性疗法。结语：希望与复杂性并存系统性红斑狼疮的治疗正处在一个激动人心的转折点。从过去有限的、充满毒性的选择，到如今日益丰富的精准靶向武器库，再到未来有望实现免疫系统“重置”的疗法，科学界为患者带来的希望前所未有。然而，SLE固有的复杂性和异质性提醒我们，通往“治愈”之路依然漫长。未来的成功将依赖于更深入的疾病分型、更智能的临床试验设计、以及对免疫稳态重建机制的持续探索。虽然障碍依然存在，但“持久缓解甚至治愈的希望正在上升”。这场与复杂性的持久战，正迎来属于患者的胜利曙光。往期精选文章：治愈自身免疫性疾病的开发竞赛自身免疫性疾病药物靶点的开发趋势 CAR-T疗法用于缓解自身免疫性疾病

临床3期临床结果免疫疗法

2026-02-11

·谈医说药

2026年02月11日药品临床试验默示许可

序号受理号药品名称申请人名称适应症注册分类 1 CXSL2501018 HL08 华兰生物工程股份有限公司;华兰基因工程有限公司拟用于肥胖患者的体重控制。 1 2 JXSB2600012 PF-08046054 (注射用冻干粉针) Pfizer Inc. 本品适用于治疗既往接受过含铂化疗、接受或未接受过程序性死亡受体-1（PD-1）或程序性死亡配体1抑制剂（PD-L1）治疗的局部晚期不可切除或转移性非小细胞肺癌成年患者，这些患者经过市售的或经验证的方法检测确定其肿瘤表达PD-L1表达≥1%。 1 3 JXHB2500174 LOU064片 Novartis Pharma AG 中重度化脓性汗腺炎 1 4 JXHB2500173 LOU064片 Novartis Pharma AG 中重度化脓性汗腺炎 1 5 CXHL2501351 GEN-725片河南真实生物科技有限公司 GEN-725与PD-1单抗联合用于治疗晚期实体瘤 2.4 6 CXHL2501350 GEN-725片河南真实生物科技有限公司 GEN-725与PD-1单抗联合用于治疗晚期实体瘤 2.4 7 CXHL2501343 注射用西罗莫司（白蛋白结合型）石药集团中奇制药技术（石家庄）有限公司注射用西罗莫司（白蛋白结合型）联合SYS6023用于治疗不可切除的局部晚期或转移性乳腺癌。 2.4 8 CXSL2501062 托莱西单抗注射液信达生物制药（苏州）有限公司单药用于治疗非家族性高胆固醇血症和混合型血脂异常的成人患者。治疗用生物制品:2.2类 9 CXSL2501052 阿得贝利单抗注射液上海盛迪医药有限公司;苏州盛迪亚生物医药有限公司阿得贝利单抗联合化疗用于可切除的局部进展期胃癌或胃食管结合部癌 2.2 10 CXSL2501060 信迪利单抗注射液信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 11 CXSL2501057 贝伐珠单抗注射液信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 12 CXSL2501055 SYS6023 石药集团巨石生物制药有限公司 SYS6023联合用药用于治疗不可切除的局部晚期或转移性乳腺癌。 1 13 CXSL2501054 MRG006A 乐普生物科技股份有限公司本品联合免疫检查点抑制剂、靶向治疗药物用于晚期肝癌患者的治疗 1 14 CXSL2501063 IMM0306 宜明昂科生物医药技术（上海）股份有限公司 IgG4相关性疾病（IgG4-RD） 1 15 CXSL2501061 IBI310 信达生物医药科技（杭州）有限公司;信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 16 CXHB2500326 HRS-1893片山东盛迪医药有限公司 1.拟用于治疗肥厚型心肌病以及心肌肥厚导致的心力衰竭；2.拟用于治疗射血分数保留的心力衰竭。 1 17 CXHL2501348 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 18 CXHL2501347 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 19 CXHL2501346 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 20 CXSL2501053 DXC006 杭州多禧生物科技有限公司小细胞肺癌 1 21 CXHL2501337 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 22 CXHL2501336 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 23 CXHL2501335 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 24 CXHL2501334 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 25 CXHL2501333 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 26 JXSB2500147 Litifilimab (BIIB059) Biogen Idec Research Limited 用于治疗正在接受非生物制剂标准疗法的成人活动期系统性红斑狼疮（SLE ）。有或无全身表现且抗疟药治疗反应不佳和/或不耐受的活动性亚急性皮肤型红斑狼疮（SCLE）和/或慢性皮肤型红斑狼疮（CCLE）。 1 27 CXHB2500325 CG2001 北京辰光医药科技有限公司;辰光（天津）制药有限公司本品用于男性雄激素性脱发患者的治疗。化学药品 28 JXHL2500387 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 29 JXHL2500386 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 30 JXHL2500385 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 31 JXHL2500384 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 32 JXHL2500383 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 33 JXHL2500382 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 34 JXHL2500381 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 35 JXHL2500380 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 36 JXHL2500377 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 37 JXHL2500376 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 38 JXHL2500375 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 39 JXHL2500374 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 40 CXSL2600068 BG-A3004注射液广州百济神州生物制药有限公司免疫介导性皮肤病 1 41 CXSL2501000 R01注射液杭州纽安津生物科技有限公司根治术后具高危复发风险的恶性实体瘤患者，主要包括胰腺癌、食管癌、肝细胞癌、胆道恶性肿瘤、胃癌以及结直肠癌等。 1 42 CXSL2501002 GKL-006注射液北京基因启明生物科技有限公司中重度银屑病 1 43 CXSL2500998 流感病毒裂解疫苗（高剂量）成大生物（本溪）有限公司;辽宁成大生物股份有限公司接种本疫苗后，可刺激机体产生抗流感病毒的免疫力。用于预防疫苗相关型别的流感病毒引起的流行性感冒。 3.2 44 CXSL2501188 OVV-01注射液上海荣瑞医药科技有限公司 OVV-01注射液静脉及瘤内给药联合治疗晚期实体瘤 1 45 CXSL2501187 OVV-01注射液（静脉）上海荣瑞医药科技有限公司 OVV-01注射液静脉及瘤内给药联合治疗晚期实体瘤 1 46 CXSB2500226 U16注射液上海优卡迪智造生命科技有限公司;上海优卡迪生物医药科技有限公司复发或难治性非霍奇金淋巴瘤治疗用生物制品

2026-02-11

·药事纵横

渤健业绩：总营收99亿美元，净利润12.9亿美元

近日，生物技术公司渤健（Biogen）发布了2025年第四季度及全年财务业绩。在过去的一年中，渤健在首席执行官Christopher A. Viehbacher的带领下，展现出在业务转型与财务纪律之间的有效平衡。2025年全年总收入达到98.91亿美元，较2024年的96.76亿美元增长2%。更为重要的是，非GAAP稀释后每股收益（EPS）达到15.28美元，超出了公司此前设定的14.50至15.00美元的指引区间上限，而GAAP稀释后每股收益为8.79美元。这一业绩的核心驱动力来自于新一代“增长产品”的强劲表现，它们成功抵消了多发性硬化症（MS）传统产品收入下滑的影响，标志着公司的战略转型正取得实质性进展。 Viehbacher先生评论道：“我们2025年的业绩反映了我们对强执行力与财务纪律的持续关注，这得益于来自LEQEMBI、SKYCLARYS、ZURZUVAE和QALSODY的近10亿美元收入，我们研发管线的进展，以及我们MS业务板块的韧性。” 一、全年与第四季度业绩概览：增长产品成为中流砥柱从全年来看，渤健的总收入实现了小幅增长。然而，其内部结构变化更为关键：增长产品（包括SKYCLARYS、QALSODY、ZURZUVAE、VUMERITY、SPINRAZA以及来自LEQEMBI合作的50%份额）全年收入同比显著增长19%。这一增长有效地抵消了（不包括VUMERITY的）MS产品收入同比下降带来的影响，凸显了公司产品组合迭代的成功。第四季度的业绩则更清晰地反映了转型期的挑战与亮点。当季总收入为22.79亿美元，同比下降7%。其中，产品净收入为16.67亿美元，同比下降9%。GAAP稀释后每股收益为-0.33美元，而2024年同期为1.83美元，这主要是由于当季计入了约2.22亿美元的收购在研研发（IPR&D）、预付款和里程碑费用，以及约1.31亿美元的诉讼相关费用。更能反映核心业务表现的非GAAP稀释后每股收益为1.99美元，尽管低于去年同期的3.44美元，但若剔除上述一次性项目的影响，公司的盈利能力依然稳健。二、各业务板块表现：冰火两重天，增长动能明确1. 多发性硬化症（MS）产品：传统业务预期内收缩 MS产品作为公司的传统基石业务，收入下滑在预期之内。第四季度收入为9.17亿美元，同比下降14%；全年收入为40.39亿美元，同比下降7%。具体来看：富马酸盐产品（TECFIDERA和VUMERITY）：第四季度收入为2.93亿美元。其中，VUMERITY表现出韧性，第四季度收入同比增长3%。干扰素产品（AVONEX和PLEGRIDY）：第四季度收入为2.26亿美元。 TYSABRI：第四季度收入为3.98亿美元。这部分业务的收缩主要源于市场竞争和产品生命周期规律，其收入缺口正由增长产品快速填补。2. 罕见病产品：增长引擎，表现亮眼罕见病业务是2025年最大的亮点，全年收入21.54亿美元，同比增长8%。 SKYCLARYS（用于弗里德赖希共济失调）：全年收入达5.21亿美元，增长迅猛。第四季度美国收入约为8900万美元，由需求增长驱动。2025年全球接受治疗的患者数量增长了约30%，显示出强大的市场渗透力。 SPINRAZA（用于脊髓性肌萎缩症）：全年收入为15.47亿美元，同比下降2%。第四季度收入为3.56亿美元，同比下降15%，这主要受美国以外地区发货时间安排的影响。 QALSODY（用于ALS）：全年收入为8690万美元，随着其在欧盟上市，贡献度逐步提升。3. 新一代增长产品与合作收入：未来支柱 LEQEMBI（阿尔茨海默病治疗药物）：作为最受关注的增长驱动力，其第四季度全球市场销售额约为1.34亿美元，同比增长54%。其中美国市场销售额约为7800万美元。2025年，渤健从LEQEMBI合作中获得的收入为1.78亿美元，同比激增197%。该药全年贡献已近10亿美元，其皮下制剂（IQLIK）的上市申请已获FDA优先审评，PDUFA日期为2026年5月24日，有望进一步提升用药便利性和市场潜力。 ZURZUVAE（用于产后抑郁）：显示出强大的持续需求增长，第四季度收入约6600万美元。抗CD20疗法项目收入（主要来自OCREVUS等产品的特许权使用费和合作收入）：保持稳定增长，第四季度收入5.21亿美元，同比增长12%；全年收入18.61亿美元，同比增长6%。4. 生物类似药与其他产品生物类似药收入为7.29亿美元，同比下降8%。其他产品收入（主要包括ZURZUVAE）为1.97亿美元，同比增长139%。三、财务健康状况与运营效率：现金流充沛，费用管控得当渤健在2025年保持了强劲的财务实力。现金流：全年经营活动产生的净现金流为22.05亿美元。资本支出为1.54亿美元，自由现金流（经营现金流减去资本支出）高达20.51亿美元，为公司投资创新和回报股东提供了坚实基础。资产负债表：截至2025年12月31日，公司拥有现金及现金等价物约42亿美元，总债务约为63亿美元，净债务约为20亿美元，财务状况稳健。费用管理：公司通过“Fit for Growth”计划持续优化成本结构。全年非GAAP研发费用为17.31亿美元，同比下降7%；非GAAP销售、一般及行政（SG&A）费用为24.21亿美元，同比微降3%。这体现了管理层在支持产品上市推广的同时，对运营效率的重视。四、研发管线进展：未来可期渤健的研发管线在2025年取得了多项重要进展，为长期增长积蓄能量： litifilimab：用于皮肤红斑狼疮（CLE）获得FDA突破性疗法认定；针对系统性红斑狼疮（SLE）的两项三期研究预计将在2026年第四季度读出数据。 SPINRAZA高剂量方案：已在日本和欧盟获批，美国FDA的审评决定日期为2026年4月3日。 BTK降解剂（BIIB145）：针对自身免疫性疾病的1期研究已在健康志愿者中启动。公司预计未来四年内，其研发管线中还有另外10项可能支持注册的研究将陆续读出数据，形成了一个密集的、具有潜在驱动力的数据流。五、 2026年展望：稳健预期下的持续投资基于当前业务发展，渤健对2026年给出了务实且充满信心的指引。公司预计2026年全年非GAAP稀释后每股收益将在15.25美元至16.25美元之间，与2025年的高水平基本持平或略有增长。同时，公司预计2026年总收入将出现中个位数百分比的同比下降。这主要反映了MS产品（不包括VUMERITY）收入进一步下降的预期，而增长产品的收入增加将部分抵消这一影响。这一指引清晰地表明，公司正处于新旧动能转换的关键时期，管理层对短期收入波动有清醒认识，但对其核心盈利能力和长期增长前景保持信心。六、总结与战略展望综上所述，渤健的2025年财报描绘了一幅战略转型初见成效的图景。其核心特征在于：创新增长产品（如LEQEMBI, SKYCLARYS, ZURZUVAE）正以强大的势头接棒传统MS产品，成为公司业绩的新支柱。尽管第四季度因一次性投入出现GAAP亏损，但全年的非GAAP盈利超预期，以及充沛的自由现金流，均证明了公司基本面的健康和运营管理的有效性。展望未来，渤健的战略路径非常清晰。短期来看，公司将专注于最大化新上市产品的商业潜力，并积极推进关键后期管线的研发进度。中长期而言，那10项即将陆续读出数据的注册性研究，构成了公司未来增长潜力的坚实基础。正如Viehbacher所言，渤健正在构建一个“多年期的注册数据流”，这有望为患者带来有意义的创新，并为股东创造长期价值。在稳健的财务纪律护航下，渤健正稳步穿越转型期，迈向一个由创新驱动的新增长阶段。相关阅读：默沙东公布2025年业绩，总营收增长1%，K药大卖317亿美元艾伯韦2025年业绩：营收增长9%至612亿美元，利生奇珠单抗大卖176亿美元快速觉醒的巨人：阿斯利康2025年总营收增长8%达587亿美元诺和诺德2025年财报：司美格鲁肽虽大卖345亿美元，但依旧无缘药王辉瑞2025年成绩单：营收同比下降2% 诺华2025年销售额增长8%达545.32亿美元，诺欣妥77.5亿美元安进2025年营收增长10%达368亿美元，礼来2025年成绩单：营收大涨45%至652亿美元，替尔泊肽大卖365亿美元赛诺菲公布2025年业绩，全年营收增长9.9%至436亿欧元，Dupixent大卖157亿欧元罗氏公布2025年的业绩，销售额增长7%达615亿瑞郎 GSK：总营收327亿英镑，同比增长4% BMS公布2025年业绩：阿哌沙班依然坚挺，销售额达144亿美元强生2025年业绩稳健增长，总营收942亿美元，药品营收604亿美元立即扫码加入药事纵横交流群

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适应症	最高研发状态	国家/地区	公司	日期
盘状红斑狼疮	临床3期	美国	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	中国	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	日本	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	阿根廷	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	比利时	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	巴西	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	保加利亚	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	加拿大	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	智利	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	哥伦比亚	Biogen Idec Research Ltd.	2024-02-21

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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


NCT02847598 (LILAC \| LILAC study, CTgov)	临床2期	皮肤红斑狼疮 \| 系统性红斑狼疮 \| 盘状红斑狼疮	264	Placebo (Part A: Placebo)	醖憲範構築遞簾築襯蓋(夢繭襯觸淵衊繭願構憲) = 蓋獵襯窪糧艱願艱襯艱繭鑰繭製艱鑰壓簾齋憲 (積膚夢窪積壓鏇遞鏇廠, 10.3) 更多	-	2023-05-15
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	醖憲範構築遞簾築襯蓋(夢繭襯觸淵衊繭願構憲) = 憲淵衊窪網積鑰觸鏇衊繭鑰繭製艱鑰壓簾齋憲 (積膚夢窪積壓鏇遞鏇廠, 8.7) 更多
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	临床2期	系统性红斑狼疮 BDCA2	132	Litifilimab 450 mg	憲鹹製淵襯顧築壓衊蓋(餘鹽糧築蓋選願壓衊構): P-Value = 0.04 更多	积极	2022-09-08
				Placebo
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	临床2期	皮肤红斑狼疮	132	Litifilimab 50 mg	獵繭鬱廠鹽窪願餘鹹醖(積鹽廠構憲艱艱觸鬱醖) = Litifilimab was associated with one case of herpes zoster infection 壓積製鹽糧鑰餘獵淵範 (鏇艱願觸網鏇衊壓構繭 ) 更多	积极	2022-07-28
				Litifilimab 150 mg
NCT02847598 (LILAC study, EULAR2022)	临床2期	皮肤红斑狼疮 BDCA2	-	BIIB059	觸製製艱築鏇製夢壓構(衊窪獵構膚顧觸襯鬱醖) = 膚選範築糧鏇齋鹽蓋簾廠艱憲壓選積艱築鏇觸 (構糧廠製鏇範鹹願願顧 ) 更多	积极	2022-06-01
NCT02847598 (LILAC, EULAR2022)	临床2期	系统性红斑狼疮 anti-nuclear antibodies \| anti-double-stranded DNA antibodies	-	BIIB059 450 mg	廠繭糧選顧鹽鏇衊壓蓋(願憲遞築繭簾壓選衊製) = 選鑰觸餘繭膚膚鬱範積製艱願衊窪齋簾製憲蓋 (窪壓齋窪淵顧醖鑰鬱糧 ) 更多	积极	2022-06-01
				Placebo	廠繭糧選顧鹽鏇衊壓蓋(願憲遞築繭簾壓選衊製) = 選淵蓋簾淵餘簾積憲廠製艱願衊窪齋簾製憲蓋 (窪壓齋窪淵顧醖鑰鬱糧 ) 更多
NCT02847598 (LILAC, ACR2020) 人工标引	临床2期	系统性红斑狼疮	120	BIIB059	窪築糧鬱簾遞膚繭衊齋(艱夢醖鬱製鬱艱鬱簾鹽) = 獵廠網鑰憲蓋鏇齋餘鏇鑰範簾壓範網鹹衊鬱獵 (齋憲壓簾淵願糧艱窪廠, 1.2) 更多	积极	2020-11-07
				Placebo	窪築糧鬱簾遞膚繭衊齋(艱夢醖鬱製鬱艱鬱簾鹽) = 選齋鹽構獵醖齋憲積網鑰範簾壓範網鹹衊鬱獵 (齋憲壓簾淵願糧艱窪廠, 1.3) 更多
NCT02847598 (LILAC, EULAR2020)	临床2期	皮肤红斑狼疮	132	BIIB059 50 mg	選窪艱蓋遞簾齋網願襯(醖餘範壓鏇衊廠齋壓鬱) = 62 (62.6%) 80 (60.6%) 獵積顧鏇鹽顧衊膚繭壓 (夢網鹽願觸製顧積獵衊 ) 更多	积极	2020-06-03
				BIIB059 150 mg
NCT02847598 (Pubmed \| J Pharmacokinet Pharmacodyn)	临床2期	皮肤红斑狼疮	264	BIIB059	糧淵獵網齋獵餘積襯襯(積構醖繭鹹憲衊顧遞網) = 淵憲獵鏇獵艱鬱構遞憲繭構憲膚淵壓夢築鹹鑰 (憲製憲餘構壓範積艱鹹 ) 更多	-	2020-06-01
NCT02106897 (Pubmed \| J Clin Invest) 人工标引	临床1期	湿疹 \| 系统性红斑狼疮	54	BIIB059	夢選獵觸淵網獵鑰鬱繭(廠願淵襯鑰簾膚夢獵觸) = 鬱鏇醖顧遞鹽鹽製選獵艱憲獵襯獵願餘窪鑰廠 (鬱築艱積衊積齋壓構衊 ) 更多	积极	2019-03-01
				Placebo	夢選獵觸淵網獵鑰鬱繭(廠願淵襯鑰簾膚夢獵觸) = 鬱願築夢糧選積遞積醖艱憲獵襯獵願餘窪鑰廠 (鬱築艱積衊積齋壓構衊 ) 更多
NCT02106897 (EULAR2018)	临床1期	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	齋衊積積夢餘鹽糧選築(範鑰齋餘窪選襯襯憲築) = 衊繭範選淵積鏇蓋膚壓鏇網鹽鹽鹹顧鏇顧膚窪 (網鑰鬱衊夢網廠顧構淵 ) 更多	-	2018-06-13
				BIIB059 20, 50 or 150 mg SC	範獵選願襯淵顧製壓鏇(顧醖餘獵襯衊鑰築繭遞) = 簾願鹽網衊積觸觸鑰壓廠艱積簾鹹醖襯獵餘製 (網構鑰膚範選鹹網鑰鹹 ) 更多