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.

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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 ; Franchimont, Nathalie ; Milliman, Eric ; 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%).

115

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2026-04-01

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同类资产被买爆，超低估A股创新药

上方「瞪羚社」即刻关注并加入社群近日，一笔金额巨大的融资震惊了创新药行业。3月23日，华深智药海外公司Earendil Labs完成了多轮融资，融资总额达7.87亿美元，创下了2026年开年Biotech融资的纪录，投资方包括赛诺菲、高瓴资本和辉瑞共同设立Biotech Development Fund以及多家海外知名机构。另外有投行人士消息指出，华深智药计划在香港募资5亿美元，发行前估值可能在50亿美金，已经超越了港股AI智药龙头（英矽智能、晶泰科技）。华深智药凭什么？最核心大概率是和赛诺菲的深度绑定。2025年4月Earendil Labs把两款TL1A双抗HXN-1002、HXN-1003授权给赛诺菲（1.25亿美元首付+17.2亿美元里程碑），2026年1月与赛诺菲达成战略合作（1.25亿美元首付&近期付款+25.6亿美元），涵盖多款双抗的开发，覆盖IBD、COPD和AD等领域。（华深智药自免管线）可以看到，两笔合作IBD领域资产占了合作的主导位置。其中，TL1A双抗的价值，国内市场还尚未充分意识到，前瞻性布局的Biotech（如科兴制药）估值拔升空间将会非常大。01TL1A资产实力——夯爆了TL1A是一个奇迹靶点，它承载了多家MNC迭代现有炎症性结肠病（IBD）疗法的期待。视角放到全球，默沙东108亿美元收购Prometheus、Teva和赛诺菲15亿美金的Co-co、罗氏71亿美元收购Telavant等BD或M&A屡屡刷新行业纪录。回望国内，前有明济生物与艾伯维的合作（1.5亿美元首付+15.6亿美元里程碑），后有华深智药与赛诺菲的Deal，还有先声药业和BI的Deal。TL1A为什么会成为IBD的经典/基底大靶点？TL1A在肠黏膜固有层巨噬细胞、树突状细胞和内皮细胞中高表达，受TLR4、FcγR等刺激后迅速上调，经DR3激活MAPK/NF-κB通路，放大TNF-α、IL-1β、IL-6等促炎信号；同时，它还与IL-12/IL-18协同促进Th1反应、与IL-23/IL-1β协同增强Th17分化，并通过TGF-β1/Smad3诱导上皮-间质转化，推动胶原沉积、肠壁增厚及纤维性狭窄。这代表TL1A天然同时覆盖“抗炎”和“抗纤维化”两个维度，是IBD领域治疗开发的重要上游靶点。目前从已有临床数据来看，TL1A的疗效潜力在所有生物制剂甚至口服小分子药物上都算是顶尖水平。以UC的诱导期数据看，Teva/赛诺菲Duvakitug的900mg组以经安慰剂组调整后27.3%缓解率名列前茅（当然各试验入组人群基线、安慰剂组差异较大，并非直接可比）。从Duvakitug最新更新的44周维持治疗UC数据进一步看到了TL1A的优势，低剂量（450mg）组缓解率为47%，高剂量（900mg）组为58%，高剂量组数据较诱导期的48%提升了约10个百分点，超出了海外机构预期。更值得注意的是，目前IBD主流药物如IL-23、整合素、TNF-α以抗炎为核心，而30-40%的IBD患者最终面临肠道狭窄/纤维化。而TL1A能够同时抗炎和抗纤维化，这是显著的差异化优势。另外，TL1A抗体在临床表现出的安全谱“非常干净”，对高风险人群（老年、合并症多、JAK禁忌）的价值突出。2026H2，TL1A靶点将迎来重要的验证性时刻，默沙东Tulisokibart将公布溃疡性结肠炎（UC）适应症的III期数据。02海外TL1A资产都起飞了尽管TL1A临床进度较快的资产基本上都在MNC手中，但并不妨碍聚焦于新一代TL1A管线开发的Biotech受到资金追捧。比较典型的Biotech例子便是Spyre Therapeutics（市值已接近40亿美元），其开发战略围绕IL-23、α4β7和TL1A开发长效生物制剂。这里主要关注TL1A抗体SPY002，其血清半衰期约75天，是现有临床进度最快的TL1A 抗体（afimkibart 18 天、duvakitug 约 20 天）的三倍以上。另一点在于，SPY002有望以更低剂量实现更高靶点饱和度，体外试验显示：低浓度条件下 SPY002对TF-1细胞凋亡的抑制效果优于三款竞品。强生IL-23单抗Guselkumab和TNF-α单抗组成的复方注射剂JNJ-4804在UC治疗2a期数据非常强劲，将过往任何一种单药的临床应答率和临床缓解率绝对值提升至少35%的水平，并且同时在安全性、依从性实现了“1+1＞2”的效果，这直接推高了卖方对IL-23单抗Guselkumab销售峰值，峰值有望达到120-150亿美元。多提一嘴，TNF-α与TL1A同属TNF超家族，相比TNF-α这种全身性炎症的“开关”，TL1A具有更强的组织特异性（肠道黏膜），开发出来的药物具备更针对的疗效和更低的安全性风险。JNJ-4804的数据，也让市场看到TL1A双抗巨大价值。Spyre Therapeutics受到海外资金追捧的巨大叙事在于，其本身me-better——长效、高亲和力的开发策略已然有一定竞争力，但真正让市场认为想象力巨大的，还是和上述强生JNJ-4804策略一样：采取复方制剂开发实现叠Buff达到Best in class的效果。Spyre开发了不同的制剂组合，包括：SPY-120靶向TL1A/α4β7、SPY-130靶向IL-23/α4β7、SPY-230靶向TL1A/IL-23。双抗、复方制剂才是王炸。03科兴制药：TL1A双抗大思路和显著低估我们认为科兴制药是在IBD领域TL1A双抗赛道最有想法的Biotech，2025年公司出海转型初具成果，已经实现扭亏为赢，同时创新管线布局极具特色，目前60亿出头的市值或许存在显著低估的可能性。1）全球FIC的TL1A/LIGHT双抗，极具差异化前面其实提到TL1A除了抗炎之外，真正的差异化王炸是抗纤维化，科兴制药的GB24，在TL1A基础上加入LIGHT，除了是全球首创外，还补强LIGHT介导的炎症与纤维化，尤其是进一步加强了TL1A抗纤维化能力，与现有TL1A/α4β7、TL1A/IL-23抗炎组合差异化，相比其他组合GB24不仅可覆盖前期炎症阶段，亦可防控中后期纤维化恶化，覆盖IBD全病程。GB24临床前动物模型数据显示：抑制溃疡和纤维化效果显著，可改善肠道功能和细微结构，且具备抗炎+抗纤维化双重作用。另外科兴制药的TL1A抗体GB20采用创新型的分子结构，PCC分子体外活性为竞品的10倍，差异化表位、免疫原性低、安全性高。2）科兴出海飞轮，已经形成2025年科兴制药实现归母净利润1.6亿元，同比2024年有大幅度的增长。市场最关注的出海战略层面，2024年预计实现海外业务收入超2.21亿元，2025年上半年收入1.88 亿（同比增长26.87%），得益于白蛋白紫杉醇在欧盟持续放量。2025年上半年财报提到，目前公司引进产品已在70余个国家/地区提交了约150项注册申请，其中白蛋白紫杉醇、英夫利西、贝伐珠单抗等产品在欧盟（27国）、英国、挪威、冰岛等国家/地区获批上市。（科兴制药部分出海获批产品）另外，随着过去不具备竞争力项目的终止研发和不再投入，管理的一系列改善动作（大力度控费提升运营效率），可以看到2025年虽然收入未有同比增加，但利润已经开始逐步放出来，未来出海业务的利润将逐步体现。3）一大批优质管线在路上科兴制药的创新管线布局非常有想法，可以从管线梯队上看到有不少FIC和已验证靶点快速Follow管线。科兴制药GB18是靶向GDF15的创新药物，GDF15是一种多效性细胞因子，其在心血管疾病、肿瘤治疗、代谢性疾病、肾脏疾病等领域均有望被开发为治疗药物，尤其在肿瘤领域已有一定临床证据。辉瑞的Ponsegromab在肿瘤恶病质的二期临床研究展现出巨大潜力，2025年5月已启动注册性临床；GB18是me better产品，采用了独特的纳米抗体结构，可实现每 3~4 周/次的皮下注射频率（提升半衰期），有望成为BIC。关于GB19，Biogen的BDCA2单抗BIIB059刚刚在2026 AAD读出两项阳性，CLE+SLE未来的市场峰值去到15–20亿美元级别；GB19作为仅次于BIIB059的快速跟进管线，同样有很大机会承接靶点验证带来的BD红利。IL-4/IL-31双抗GB12同样值得一提，两个靶点组合，一个聚焦阻断2型炎症，另一个解决瘙痒问题。强生曾经在2024年5月以12.5亿美元收购Numab全资子公司NM26（IL-4Rα/IL-31双抗），可以期待GB12能否解决过往竞争对手存在的问题。科兴制药的差异化创新管线不少，还有肿瘤的几款三抗管线、眼科的双抗管线，这些潜在辐射的市场都非常大，且静待花开。结语：科兴制药的出海模式正在迅速地验证，随着集合的产品在海外陆续获批，公司将成为国内Biotech品种出海的商业化平台，利润将逐渐释放。而TL1A赛道的机遇，在几个先行者MNC的疗效确认后，科兴制药的新一代双抗有机会稳稳抓住，Deal价值或许可以参照明济生物和华深智药案例，甚至价值量还有机会再大。返回搜狐，查看更多

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2026-04-01

·DrG的雍熙路

半个世纪空白或将终结：皮肤型红斑狼疮迎来首个靶向疗法

在经历了近半个世纪的创新药停滞后，皮肤型红斑狼疮（CLE）终于迈向靶向治疗的新阶段。日前，美国生物科技公司Biogen（渤健）宣布，其抗BDCA2单克隆抗体litifilimab在针对皮肤型红斑狼疮（CLE）的II期临床试验Amethyst中取得了成功：第16周时，14.7%的患者达到“皮肤清除或几乎清除”，显著高于安慰剂组的2.9%（p<0.05）。图源：shutterstock 这不是一次孤立的成功。在此之前，II期LILAC研究已给出积极信号；而Amethyst的再度验证，使litifilimab成为目前唯一在多项CLE临床中持续显示积极疗效的候选药物。目前CLE患者治疗选择非常有限，若获批，litifilimab有望成为首个CLE靶向治疗药物。切断炎症信号的新思路皮肤型红斑狼疮（CLE）属于红斑狼疮的一种亚型，也是一种慢性自身免疫性疾病，以皮肤病变为主，患者长期承受皮疹、瘙痒、疼痛与光敏感等症状，部分人群甚至会进展为不可逆瘢痕、脱发及色素异常，对外观和生活质量有显著影响。目前尚无获批的CLE靶向治疗药物，上一款相关药物的批准还要追溯至20世纪50年代。渤健开发的litifilimab是一种人源化IgG1单克隆抗体，靶向BDCA2，旨在干预狼疮患者过度活跃的免疫系统，从而抑制炎症反应。 BDCA2表达于浆细胞样树突状细胞（plasmacytoid dendritic cells, pDCs），这是一类在狼疮发病中发挥作用的罕见免疫细胞。与BDCA2结合能抑制I型干扰素、炎症性细胞因子及趋化因子，从而改善临床结局。潜在首个：疗效显著且安全可控 Amethyst研究评估了皮下注射litifilimab相较安慰剂在不同严重程度CLE患者中的疗效与安全性。据介绍，该研究有74%为女性，33%为非白人，这一人群分布符合CLE的流行病学特征（女性及多种族人群患病比例更高）。这些患者包含活动性亚急性以及慢性CLE，且对抗疟药治疗无效或不耐受。结果显示，研究达到了主要终点：在第16周，基于皮肤型狼疮活动研究者总体评估修订版（CLA-IGA-R）红斑评分（0–1，表示“清除/几乎清除”），每4周皮下注射一次litifilimab的患者中，有14.7%达到了“皮肤清除或几乎清除”的状态。相比之下，安慰剂组中达到该状态的患者不足3%。除主要终点外，多个次要终点疗效指标呈现一致趋势。首先是，litifilimab起效速度快，第4周皮肤型红斑狼疮疾病面积与严重程度指数改善≥50%（CLASI-50）达标率即显著分离（19.3% vs 5.5%）。症状改善的速度是CLE药物研发的一个重要考量因素。该公司负责阿尔茨海默病与痴呆、多发性硬化及免疫学研发的负责人Diana Gallagher博士曾表示，CLE患者存在皮肤炎症和脱发问题，因此快速缓解症状具有重要意义。随着时间的延长，这一改善优势进一步扩大，在第24周时，litifilimab治疗组CLASI-50提升至40.8%（安慰剂组为21%）。在研究中，litifilimab还展现出更高的缓解深度，CLASI-70达标率21.7%（vs 5.8%）。此外，第24周，接受litifilimab治疗的患者中约六分之一达到了最小或无疾病活动状态（CLASI 0–3），而安慰剂组则无人达到该水平。值得注意的是，尽管部分次要终点未进行多重性校正，但整体数据在不同维度上表现出一致性优势。安全性方面整体可控，不良事件以轻中度为主，严重不良事件发生率较低（6.8% vs 2.9%）。目前，该研究的III期部分仍在进行中，结果尚处于盲态。总体而言，这些研究数据不仅进一步验证了litifilimab的起效快且疗效持久，也证实了靶向BDCA2机制的可靠性。参考信源： 1.Biogen Announces Second Positive Phase 2 Litifilimab Trial in Cutaneous Lupus Erythematosus at 2026 American Academy of Dermatology Annual Meeting, Showing a Significant Reduction in Skin Disease Activity | Biogen 2.#AAD26: Biogen declares Phase 2 lupus success for anti-BDCA2 antibody 免责声明 :本文所含的信息来源于文中可靠信源，仅供读者一般参考之用，不应作为决策依据，DrG的雍熙路对因使用本文内容而造成的一切损失，不承担任何责任。部分图片来源于网络，如涉及版权问题，敬请联系我们以便采相应处理举措。我们鼓励转发分享及合理引用本文内容，但请在引用时于明显位置标注文章来源。

2026-04-01

·BioSpace

Biopharma M&A Heats Up, Rare Diseases Win Three Approvals, Wave Crashes

Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart Biogen, Eli Lilly and Merck spent more than $20 billion in the past week to swallow biotechs with approved products or promising drug candidates—representing three of this year’s four biggest takeovers. First, Merck picked up Terns Pharmaceuticals and its mid-stage leukemia drug for $6.7 billion; for the record, BioSpace called this one back in December. Then, on Tuesday, Lilly and Biogen struck, acquiring Centessa Pharmaceuticals and Apellis Pharmaceuticals respectively. Those big-ticket deals aren’t the only recent transactions, however. Others include Novartis’ up to $2 billion pick up of Excellergy and Gilead’s $2.1 billion purchase of Ouro Medicines. Meanwhile, Kevin Tang—the newly minted CEO of Aurinia Pharmaceuticals—again has his sights set on Kezar Life Sciences , which he previously targeted in 2024. This time, biopharma’s “clean-up” man is offering $50 million for the chronic disease–focused biotech. We’ve spent a lot of time this past year writing about challenges facing rare disease drug developers, but this week, we saw some wins as the FDA approved three new therapies. Last week saw nods for Denali Therapeutics’ Avlayah, the first treatment for Hunter syndrome to target the disease’s neurological complications, and Rocket Pharmaceuticals’ Kresladi for leukocyte adhesion deficiency-I. And it’s been a big week for Biogen, which besides moving on Apellis, won approval of a high-dose formulation of spinal muscular atrophy drug Spinraza and scored a Phase 2 win for lupus candidate litifilimab in cutaneous lupus erythematosus. On the weight loss front, Wave Life Sciences ’ stock was cut in half after its obesity candidate WVE-007 failed to impress investors in a Phase 1 trial. And all eyes are trained on the FDA, which is expected to render a verdict on Lilly’s oral obesity drug orforglipron by April 10. And don’t forget to check out—or sign up for —BioPharm Executive, where we take a deep dive into delayed pharmaceutical launches in Europe and how AI is shaping the biotech IPO landscape.

临床1期并购上市批准

100 项与利替非利单抗相关的药物交易

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研发状态

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
皮肤红斑狼疮	临床3期	美国	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	中国	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	日本	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	阿根廷	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	比利时	Biogen Idec Research Ltd.	2023-10-03
皮肤红斑狼疮	临床3期	巴西	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	保加利亚	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	加拿大	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	智利	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	哥伦比亚	Biogen, Inc.	2023-10-03

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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)	鬱淵夢夢選獵繭鏇膚醖(憲糧衊窪鹽糧遞窪夢壓) = 繭膚糧糧遞網繭齋繭鏇鬱範遞鹹獵積衊獵齋獵 (憲衊淵構顧網築齋餘築, 10.3) 更多	-	2023-05-15
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	鬱淵夢夢選獵繭鏇膚醖(憲糧衊窪鹽糧遞窪夢壓) = 艱築鑰衊膚鹽淵構鹽憲鬱範遞鹹獵積衊獵齋獵 (憲衊淵構顧網築齋餘築, 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	窪襯壓顧鑰願糧壓築廠(窪繭膚範築積齋鑰窪鹽): 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	鏇簾網觸鏇鏇繭艱網鬱(淵餘鑰範顧蓋繭廠膚選) = Litifilimab was associated with one case of herpes zoster infection 繭壓淵蓋鹹齋構獵蓋鑰 (鏇糧願鑰鬱築網簾獵遞 ) 更多	积极	2022-07-28
				Litifilimab 150 mg
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	鏇遞齋積繭齋鹹繭憲壓(鬱鬱鹹醖網範構繭夢膚) = 廠簾鬱醖鑰鬱淵製構鏇餘蓋鏇鏇醖糧餘艱窪構 (鹹繭糧網選醖鹽繭淵選 ) 更多	积极	2022-06-01
				Placebo	鏇遞齋積繭齋鹹繭憲壓(鬱鬱鹹醖網範構繭夢膚) = 築製鹹壓廠網壓鹹膚鑰餘蓋鏇鏇醖糧餘艱窪構 (鹹繭糧網選醖鹽繭淵選 ) 更多
NCT02847598 (LILAC study, EULAR2022)	临床2期	皮肤红斑狼疮 BDCA2	-	BIIB059	願鏇獵窪願鏇鏇範遞膚(繭鑰選遞顧憲艱壓鑰鹹) = 膚蓋餘餘醖齋齋壓窪獵簾夢遞齋壓夢壓蓋願築 (夢夢願糧觸繭構網夢鬱 ) 更多	积极	2022-06-01
NCT02847598 (LILAC, ACR2020) 人工标引	临床2期	系统性红斑狼疮	120	BIIB059	鏇醖鑰窪築淵齋鹹願築(齋鑰蓋製夢願選選糧網) = 積憲範築選壓積壓鑰齋壓鏇醖衊鏇憲範鏇醖製 (餘鹹願窪網醖網壓蓋齋, 1.2) 更多	积极	2020-11-07
				Placebo	鏇醖鑰窪築淵齋鹹願築(齋鑰蓋製夢願選選糧網) = 壓顧顧夢簾憲衊夢鹽淵壓鏇醖衊鏇憲範鏇醖製 (餘鹹願窪網醖網壓蓋齋, 1.3) 更多
NCT02847598 (LILAC, EULAR2020)	临床2期	皮肤红斑狼疮	132	BIIB059 50 mg	繭衊構蓋糧淵構廠憲鏇(範獵鑰淵獵構鹽鹽夢簾) = 62 (62.6%) 80 (60.6%) 艱鏇鬱簾襯願鹹艱積醖 (鬱顧餘艱簾鏇窪願糧簾 ) 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	餘積遞憲艱顧觸窪壓醖(餘鬱廠蓋製蓋淵淵範簾) = 憲艱夢餘鬱築繭鑰築衊窪淵壓簾壓淵鑰齋壓鹽 (齋齋範艱顧膚衊窪壓夢 ) 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	糧遞構淵憲鹽衊獵構淵(構鏇衊遞壓襯顧淵觸襯) = 齋鑰顧構觸鹹襯壓願憲廠簾繭壓蓋醖觸夢構顧 (鬱積積艱鑰觸淵鏇壓襯 ) 更多	积极	2019-03-01
				Placebo	糧遞構淵憲鹽衊獵構淵(構鏇衊遞壓襯顧淵觸襯) = 餘構壓餘窪餘繭鏇襯範廠簾繭壓蓋醖觸夢構顧 (鬱積積艱鑰觸淵鏇壓襯 ) 更多
NCT02106897 (EULAR2018)	临床1期	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	淵積鬱構夢鹹顧鏇構艱(範齋糧衊範顧鏇蓋糧窪) = 選膚廠網糧糧壓憲鹹築醖鹹鹹艱夢構遞簾範夢 (壓鏇鹹願醖繭顧構蓋壓 ) 更多	-	2018-06-13
				BIIB059 20, 50 or 150 mg SC	願壓淵糧鹹餘齋廠積壓(蓋廠顧製淵遞構淵夢憲) = 夢觸繭獵膚壓簾鹹淵製遞淵淵網願膚鹽築製網 (獵繭鏇壓憲糧蓋遞網膚 ) 更多