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.

CTR20234203

/ Recruiting临床3期

一项在患有活动性亚急性皮肤型红斑狼疮和/或慢性皮肤型红斑狼疮（有或无全身表现）且抗疟药治疗反应不佳和/或不耐受的受试者中评价 BIIB059 疗效和安全性的 2 部分无缝设计（A 部分 [II 期]/B 部分 [III 期]）、随机、双盲、安慰剂对照、多中心临床研究 (AMETHYST)

本研究的总体目的是在患有活动性 SCLE 和/或 CCLE（有或无全身表现）且抗疟药治疗反应不佳和/或不耐受的受试者中评价 BIIB059 与安慰剂相比的疗效和安全性。

开始日期2024-06-26

申办/合作机构

Biogen Idec Research Ltd.

[+2]

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 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 study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.
The main objective of the study is learning 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 medical 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 assess the effect litifilimab and CLE has on the quality of life of participants using a group of questionnaires. They will also study 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.
* The treatment period will last up to 104 weeks, or 2 years.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 33 study visits.
* The total study duration for participants will be up to 128 weeks.

开始日期2023-10-03

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转化医学

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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）

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%).

2025-03-04·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A focused report on IFN-1 targeted therapies for lupus erythematosus

Review

作者: Furie, Richard ; Vashistha, Himanshu ; Bhatt, Anushka ; Gupta, Pramiti

INTRODUCTION:

Patients with Systemic Lupus Erythematosus (SLE) experience varied manifestations and unpredictable flares, complicating treatment and drug development. Despite these challenges, anifrolumab, voclosporin, and belimumab were approved by FDA. These treatments complement, but don't replace, traditional therapies like NSAIDs, corticosteroids, antimalarials, and immunosuppressives. Therefore, there remains an unmet need for more effective medications targeting excessive proinflammatory cytokines in SLE patients.

AREAS COVERED:

This review summarizes the clinical trial outcomes of four upcoming medications targeting cytokine activity: Litifilimab showed a 7-point reduction in CLASI-A in its phase II trial. Daxdilimab was unsuccessful in its phase II trial. Anifrolumab reduced SLE activity in both phase II and III trials. Deucravacitinib decreased disease activity by multiple measures in its phase II trial.

EXPERT OPINION:

High levels of IFN-I (type 1 interferon) are present in most SLE patients, making this pathway an attractive target for drug development. Litifilimab downregulates IFN-I by targeting BDCA2, while dexadilimab targets ILT7 to recruit effector cells, reducing IFN-I production by killing PDCs. Anifrolumab binds to the IFN-I receptor, blocking the activity of all IFN-Is, and deucravacitinib reduces IFN-I by inhibiting TYK2, thereby interfering with downstream signaling. Therapies that target IFN-I represents a promising class of medications for SLE patients.

2025-02-11·Immunotherapy

Part A of the LILAC study of litifilimab for systemic lupus erythematosus: a plain language summary

Article

作者: Meyers, Adam ; Carroll, Hua ; Romero-Diaz, Juanita ; Franchimont, Nathalie ; Furie, Richard A ; Musselli, Cristina ; Navarra, Sandra ; Werth, Victoria ; van Vollenhoven, Ronald F ; Kalunian, Kenneth ; Huang, Xiaobi ; Barbey, Catherine

项与利替非利单抗相关的新闻（医药）

2025-08-25

·FiercePharma

BeOne bags $885M upfront in Royalty deal on Amgen's lung cancer drug Imdelltra

The Imdelltra transaction with BeOne Medicines is consistent with Royalty Pharma’s business model of acquiring royalties on commercially promising drugs. BeOne Medicines is monetizing its stake in Amgen’s first-in-class lung cancer drug Imdelltra for up to $950 million.Royalty Pharma will pay BeOne $885 million upfront for certain royalty payments from Amgen tied to ex-China sales of its DLL3 T-cell engager Imdelltra.Within the next 12 months, BeOne has an option to sell additional royalty rights to Royalty for up to $65 million.The royalties represent “a significant portion” of “tiered mid-single digit” payments based on Imdelltra’s annual sales above $1.5 billion, BeOne said in an Aug. 25 securities filing. Royalty, in a separate release, said the royalty level is about 7%.BeOne, formerly known as BeiGene, gained the Imdelltra rights through a broad-ranging strategic collaboration with Amgen in 2019. That deal includes commercialization of Amgen’s oncology products in China, and a global clinical development alliance.Imdelltra became the first FDA-approved DLL3 agent in May of 2024 with an accelerated approval in previously treated extensive-stage small cell lung cancer (SCLC) following platinum-based chemotherapy.A full approval looks within reach after the phase 3 DeLLphi-304 trial recently linked the bispecific antibody to a 40% reduction in the risk of death in SCLC patients who have tried one line of platinum-based chemo. Separately, with the phase 3 DeLLphi-305 and DeLLphi-306 studies, Amgen aims to move Imdelltra into first-line treatment. In China, BeOne is running the DeLLphi-307 trial in the hopes of getting Imdelltra approved in the country in third-line SCLC.As the first DLL3-targeting agent to reach the market, Imdelltra has shown great market potential. Its sales reached $215 million in the first half of 2025, and its revenue in the second quarter, at $134 million, came 41% above analysts’ expectations.As SCLC affects about 360,000 patients worldwide each year, analysts’ consensus currently pegs the drug could reach $2.8 billion in sales by 2035, according to Royalty.However, Imdelltra’s profile, including its side effects, still leaves room for improvement. And the promise of the DLL3 target, as validated by Imdelltra, has attracted several large companies.At the beginning of 2025, Roche and Innovent Biologics unveiled a potential $1 billion deal that grants the Swiss pharma the Chinese biotech’s DLL3-targeted antibody-drug conjugate IBI3009. Last year, Merck & Co. bought Harpoon Therapeutics, with a lead candidate being a rival DLL3 T-cell engager.Companies like Boehringer Ingelheim and a partnership between Ideaya Biosciences and Jiangsu Hengrui Pharmaceuticals are among players eyeing the DLL3 field.For BeOne, the royalty deal gives the newly Switzerland-domiciled company immediate cash to advance its internal pipeline while reducing risks from potential Imdelltra competition. “By monetizing a significant portion of our royalty interest in Imdelltra, we are able to strengthen our balance sheet and unlock substantial value,” BeOne CEO John V. Oyler said in a statement, adding that the deal “provides us with increased operational and strategic flexibility.” For Royalty, the transaction is consistent with the New York company’s business model of acquiring royalties on commercially promising drugs. Some of the drugs Royalty has tapped include Syndax Pharmaceuticals’ graft-versus-host disease drug Niktimvo, Revolution Medicines’ phase 3 RAS candidate daraxonrasib and Biogen’s phase 3 lupus asset litifilimab.“Imdelltra is expected to further enhance Royalty Pharma’s long-term growth and portfolio diversification, and we remain incredibly excited given our robust transaction pipeline,” the company’s CEO, Pablo Legorreta, said in a statement.“We view this deal as positive given it highlights Royalty’s preference for commercial/late-stage high-impact compounds with large [total addressable market size] alongside the company’s commitment to business development,” Citi analysts said in a Monday note.

上市批准引进/卖出临床3期抗体药物偶联物加速审批

2025-06-24

·FierceBiotech

Royalty signs off on $2B to bankroll Revolution\'s RAS cancer drug\'s road to regulators

Royalty Pharma’s CEO Pablo Legorreta described this morning’s deal with Revolution Medicines as a “groundbreaking partnership.”\n Revolution Medicines has secured a potential funding infusion of up to $2 billion from Royalty Pharma in return for a slice of the profits if Revolution’s lead cancer drug makes it to market.Revolution launched a second phase 3 study of the candidate, a RAS(ON) multi-selective inhibitor called daraxonrasib, in patients with RAS mutant non-small cell lung cancer (NSCLC) last month. A late-stage study of daraxonrasib in patients with pancreatic ductal adenocarcinoma (PDAC) is ongoing.This morning’s deal gives Revolution the financial firepower to take daraxonrasib through to commercialization without the need for a Big Pharma partner. The biotech also plans to use the funding to accelerate work on the rest of its RAS(ON) inhibitor portfolio, which includes a RAS(ON) G12D-selective inhibitor called zoldonrasib being tested in patients with KRAS G12C-mutant NSCLC.RAS mutations are one of the most common oncogenic drivers of NSCLC, occurring in around 30% of cases, according to the Revolution.A total of $1.25 billion of the money pledged by Royalty has been agreed in exchange for tiered royalties on net sales of daraxonrasib over 15 years. The royalty rate begins at 4.55% on the first $2 billion of sales before shrinking as sales increase until stopping altogether for sales above $8 billion.Revolution has already received the first $250 million tranche of funding from Royalty, and is due to receive the same amount again should the phase 3 PDAC study hit its goals. The remaining $750 million of the $1.25 billion can be accessed by Revolution after daraxonrasib is approved and certain other milestones are hit.But if Revolution does decide to use all $1.25 billion of the funding on offer, it would boost the royalty rate to 7.8% for sales below $2 billion before reducing to 2.4% for sales between $4 billion and $8 billion.If zoldonrasib eventually gets approved for the same indications as daraxonrasib, then these sales would also be included in net sales figures used to decide the royalties due to Royalty, Revolution explained in the release. On top of that $1.25 billion royalty-related funding deal, Royalty will also offer $750 million to Revolution as a loan spread across three $250 million tranches. This loan will be linked to the commercialization of daraxonrasib, with the first tranche available if the drug gets approved for PDAC and the other two tied to hitting certain sales milestones.Even before the financing deal, Revolution was hardly short of money—having ended March with $2.1 billion to hand in cash and equivalents, which it expected to last into 2027.“Today’s announcement represents a major boost to our bold vision on behalf of patients with RAS-addicted cancers,” Revolution’s CEO Mark Goldsmith, M.D., Ph.D., said in the release.“This funding agreement significantly increases the financial resources we can deploy while preserving optionality as we scale our operations to create the industry-leading global targeted medicines franchise for patients with RAS-addicted cancers based on our highly differentiated RAS(ON) inhibitor portfolio,” Goldsmith added.Royalty, a buyer of biopharmaceutical royalties, penned a similar financing deal in February to enable Biogen to bankroll the phase 3 development of its lupus candidate litifilimab.Royalty’s CEO Pablo Legorreta described this morning’s deal with Revolution as a “groundbreaking partnership.”“This partnership exemplifies a new funding paradigm for highly innovative biotech companies,” Legorreta added. “In contrast to a conventional pharma partnership, this large-scale and flexible funding agreement enables Revolution Medicines to retain control of the clinical development of daraxonrasib, as well as the ability to capture significant value creation that would result from the successful clinical development and commercialization of its pipeline.”

$Royalty signs off on $2B to bankroll Revolution\'s RAS cancer drug\'s road to regulators$

临床3期引进/卖出临床1期

2025-05-30

·BiG生物创新社

对标K药，三生制药赢麻了

作者｜momo2025年5月，三生制药以一场震撼行业的“王炸级”操作赢麻了，60.5亿美元天价BD交易刷新国产创新药出海天花板，其PD-1/VEGF双抗SSGJ-707凭借“Best-in-Class”临床数据成为“下一个K药”有力竞争者。 01 天价BD，孕育下一个K药2025年5月20日，中国生物医药行业迎来历史性时刻——三生制药宣布与辉瑞达成总额60.5亿美元的授权协议，将其PD-1/VEGF双抗SSGJ-707的全球（除中国内地）权益授予辉瑞。这一交易以12.5亿美元首付款刷新国产创新药出海纪录，远超此前康方生物AK112与Summit Therapeutics达成的50亿美元总交易规模（图1）。三生制药SSGJ-707正在PD-1赛道上演与K药的“王座继承战”。图1.三生制药与辉瑞达成总额60.5亿美元的授权协议SSGJ-707的成功源于其独特的技术设计与临床数据优势。作为三生制药基于专有CLF2平台开发的双抗药物，其采用天然IgG4结构设计，通过消除ADCC和CDC效应，显著降低了免疫系统误伤正常组织的风险，从而在安全性上优于同类竞品。这一差异化设计使其在临床中展现出“Best-in-Class”潜力。图2.SSGJ-707 临床早期数据2025年JPM大会披露的II期数据显示，在单药一线治疗PD-L1阳性非小细胞肺癌（NSCLC）患者中，SSGJ-707的客观缓解率（ORR）达70.8%，疾病控制率（DCR）为100%；联合化疗时，鳞癌患者ORR更飙升至81.3%，且3级及以上不良反应发生率仅为23.5%（图2）。相比之下，康方生物的AK112在III期临床试验中ORR为50%，安全性数据亦稍逊（3级及以上不良反应发生率29.4%）。尽管两者尚未开展头对头试验，但SSGJ-707的疗效与安全性组合已为其赢得“BIC”标签。图3.PD-(L)1/VEGF双抗全球研发进展PD-1/VEGF双抗的崛起源于其能够同时抑制免疫检查点PD-1和促血管生成因子VEGF“双重抗癌机制”。康方生物AK112于2024年9月公布的HARMONi-2 III期研究数据首次在头对头试验中击败默沙东的K药，成为该赛道的引爆点。此后，全球药企加速布局，而三生制药凭借SSGJ-707的快速推进（全球进度第二）抢占先机。目前，全球在研PD-(L)1/VEGF双抗达35款，其中中国占据20款（图3），但仅康方AK112上市，三生（SSGJ-707）、礼新（LM-299）、普米斯（PM8002）等紧随其后。辉瑞选择SSGJ-707而非进度更早的AK112，既因其临床数据亮眼，亦与其适应症拓展潜力及联合疗法开发空间密切相关。 02 展开合作，扩大治疗领域近年来，三生制药通过密集的对外合作与产品引进，持续拓宽治疗领域边界，逐步构建起覆盖多疾病领域的创新产品管线（图4）。在肿瘤领域，三生制药通过ADC、双抗等前沿技术组合探索治疗潜力。2025年2月，三生制药与百利天恒达成合作，共同推进其PD-1/VEGF双抗SSGJ-707与百利天恒全球首创的EGFR×HER3双抗ADC药物BL-B01D1的联用研究。BL-B01D1作为全球唯一进入临床阶段的靶向EGFR×HER3双抗ADC，已在中美开展约30项临床试验，覆盖非小细胞肺癌、乳腺癌等适应症，其中联合奥希替尼用于一线非小细胞肺癌的III期试验已完成首例受试者入组。此外，2025年1月，三生制药引进映恩生物HER2 ADC药物DB-1303，获得其在中国内地及港澳的商业化权利。DB-1303采用拓扑异构酶-1抑制剂载荷，已获FDA及NMPA突破性疗法认定，针对HER2低表达乳腺癌的III期临床试验全球领先，疾病控制率（DCR）高达94.1%。图4.公司近年来开展的合作项目（部分）在血液疾病领域，三生制药聚焦中国高发的急性髓性白血病（AML）。2024年11月，三生制药获得东阳光药第二代FLT3抑制剂苯磺酸克立福替尼的独家商业化权利。该药物针对FLT3-ITD突变型AML，其III期临床试验数据显示更强的靶点抑制活性及更低脱靶风险，有望成为国内首个上市的国产高选择性FLT3抑制剂。 2024年5月，三生蔓迪与翰宇药业合作开发司美格鲁肽注射液，切入千亿减重市场（图5）。该产品是国内首个进入III期临床的国产司美格鲁肽类似物，依托三生制药的营销网络，有望在超重/肥胖率超50%的中国市场快速渗透。同时，公司在痛风领域从EnzymeRx 引进的SEL-212（Pegsiticase）已于2024年7月向FDA提交生物制品许可申请（BLA），其通过重组酶代谢尿酸的机制为顽固性痛风患者提供新选择，潜在市场空间达百亿级。三生制药在剂型革新上亦取得显著进展。2024年10月，三生获得海和药物紫杉醇口服溶液（柏瑞素）的独家商业化权利（图5）。该产品采用脂质自乳化技术（DH-LASED），突破紫杉醇传统注射限制，生物利用度提升且过敏风险降低，无需预处理即可居家服用，极大提升晚期胃癌患者依从性。其针对HER2阴性乳腺癌的国际多中心III期研究已进入随访阶段，未来适应症拓展潜力显著。图5.三生制药在多个领域展开密集合作在血小板减少症领域，三生制药与则正医药合作的艾曲泊帕乙醇胺干混悬剂（特艾升）于2024年12月获批上市。该干混悬剂型适口性更佳，支持精准剂量调整，尤其适合儿童及吞咽困难患者，进一步巩固了公司在骨髓保护产品线的领导地位（图5）。更令人关注的是，三生制药通过引进Cosmo 附属公司 Cassiopea 旗下Winlevi（柯拉特龙乳膏）进一步切入痤疮治疗领域。作为40年来首个新机制外用雄激素受体抑制剂，Winlevi在美国市场处方量已超109万张，其在中国内地的III期桥接试验预计2025年完成，有望成为国内首个AR拮抗剂类痤疮药物，覆盖中重度患者群体。 03 发力自免，创造第二增长曲线随着全球自身药物市场加速扩容，三生制药控股子公司三生国健作为国内自免领域先行者，已构建覆盖IL-17A、IL-4R、IL-5、IL-1β等核心靶点的产品矩阵，并前瞻性布局BDCA2、TL1A等下一代靶点，推动自免业务成为继肿瘤领域后的第二增长曲线。其中，SSGJ-608是是国内进度第二的IL-17A单抗，针对斑块状银屑病，为全新的氨基酸序列，在体外和体内动物模型中显示出和同靶点抗体Cosentyx 和 Taltz 相当的生物活性。其针对中重度斑块状银屑病的III期临床试验显示，12周主要疗效数据优异，短期内快速起效、疗效优势明显、维持治疗期，SSGJ-608给药间隔延长至Q4W或Q8W疗效持续维持高位，有望在PsO上实现更长给药间隔（图6）。图6.SSGJ-608 III期临床研究数据相较于已上市的司库奇尤单抗（诺华）和依奇珠单抗（礼来），SSGJ-608通过优化氨基酸序列实现更高生物活性，并计划拓展中轴型脊柱炎适应症，预计2025年递交NDA，成为国产IL-17A领域的重要竞争者。此外，SSGJ-611是全球第三款靶向IL-4Rα的生物制剂。它通过精准阻断IL-4/IL-13炎症信号通路，抑制2型免疫反应过度激活，从而快速缓解瘙痒、修复皮肤屏障。在特应性皮炎（AD）II期临床中（图7），300mg每两周给药组的EASI-75应答率达72.5%，优于度普利尤单抗同阶段数据（67%），并计划于2026年提交NDA。其适应症布局覆盖AD、COPD及慢性鼻窦炎伴鼻息肉（CRSwNP），目标患者群体超1.6亿人，有望复制度普利尤单抗“一药多适应症”的放量路径。图7.SSGJ-611 II期临床研究数据值得注意的是，针对急性痛风性关节炎的重组抗白介素1-β（IL-1β）人源化单克隆抗体SSGJ-613的II期临床结果显示，使用SSGJ-613治疗12周复发率仅8.3%，显著低于阳性对照组倍他米松（28.6%），且疼痛评分降幅达70%以上。目前国内尚无IL-1β单抗上市，长春高新的金纳单抗虽已递交NDA，但SSGJ-613凭借更优疗效数据和三生国健在风湿科的渠道优势，有望在2025年NDA后快速抢占市场。与此同时，三生国建持续布局BDCA2、TL1A等自免领域前沿靶点。BDCA2靶点通过抑制浆细胞样树突状细胞（pDC）产生干扰素α/β，直击红斑狼疮核心病理机制。三生国健的SSGJ-626已在中美同步获批IND，进度仅次于Biogen的Litifilimab（III期临床中），有望成为全球第二款进入临床的BDCA2单抗（图8）。图8.SSGJ-626有望成为全球第二款进入临床的BDCA2单抗另外，TL1A靶点在溃疡性结肠炎、克罗恩病等适应症中展现突破性潜力，辉瑞、默沙东等跨国药企已通过BD交易押注该赛道。三生制药的SSGJ-627于2025年1月获准IND，成为国内首个进入临床的TL1A单抗，有望在消化系统自免领域建立先发优势。结语三生制药凭60.5亿美元天价BD交易、SSGJ-707强劲数据及肿瘤、自免多线布局实力“赢麻”，以创新硬实力与前瞻战略，在出海与本土市场双制霸，成国产药企“顶流”标杆！参考资料[1]https://www.3sbio.com/ImgUpload/files/202501/2025012104430567755.pdf[2]https://www.3sbio.com/ImgUpload/files/202408/2024082206294824405.pdf[3]三生制药官网、官微、国盛证券研报、中泰证券研报、各种公开资料等共建Biomedical创新生态圈！如何加入BiG会员？

100 项与利替非利单抗相关的药物交易

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研发状态

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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)	鏇簾醖製鏇願積齋醖積(壓獵範鬱築鏇糧簾淵齋) = 夢糧夢鏇觸積鹽餘積齋夢願蓋積蓋夢膚觸壓醖 (遞淵淵夢衊選鑰窪網廠, 10.3) 更多	-	2023-05-15
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	鏇簾醖製鏇願積齋醖積(壓獵範鬱築鏇糧簾淵齋) = 蓋廠獵鬱鏇顧糧觸鹽顧夢願蓋積蓋夢膚觸壓醖 (遞淵淵夢衊選鑰窪網廠, 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	膚選遞築製觸窪築壓願(餘衊壓淵繭窪範齋衊艱): 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	範鏇鏇獵繭鑰憲窪鬱壓(淵醖襯構襯範鹹積衊觸) = Litifilimab was associated with one case of herpes zoster infection 鹹獵簾鏇憲範網蓋鹹齋 (積醖選觸觸範壓網齋齋 ) 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	鏇醖鑰積築構簾壓選繭(顧獵夢構鹽構憲鬱鑰糧) = 選憲鹽糧淵構願繭夢糧醖築淵鹹餘廠鏇鏇願製 (獵襯艱壓夢願鑰築鏇艱 ) 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	餘憲醖襯憲網鏇顧觸觸(憲夢艱膚蓋獵膚鹽構艱) = 選蓋齋壓鹽繭醖窪襯憲鬱製觸繭壓獵衊選餘願 (獵糧鹽製鹹遞構壓鏇膚 ) 更多	积极	2022-06-01
				Placebo	餘憲醖襯憲網鏇顧觸觸(憲夢艱膚蓋獵膚鹽構艱) = 獵廠蓋蓋窪淵壓選蓋遞鬱製觸繭壓獵衊選餘願 (獵糧鹽製鹹遞構壓鏇膚 ) 更多
NCT02847598 (LILAC, ACR2020) 人工标引	临床2期	系统性红斑狼疮	120	BIIB059	獵構糧鏇醖範鹽壓憲艱(衊蓋選範構顧襯廠襯憲) = 餘積獵憲網鹽餘廠壓觸製夢網選膚齋鹽襯繭製 (壓積餘製夢醖壓衊獵壓, 1.2) 更多	积极	2020-11-07
				Placebo	獵構糧鏇醖範鹽壓憲艱(衊蓋選範構顧襯廠襯憲) = 憲觸築憲鹽膚窪願簾鬱製夢網選膚齋鹽襯繭製 (壓積餘製夢醖壓衊獵壓, 1.3) 更多
NCT02847598 (LILAC, EULAR2020)	临床2期	皮肤红斑狼疮	132	BIIB059 50 mg	齋醖壓簾築願獵獵積構(壓膚簾積網廠齋範齋蓋) = 62 (62.6%) 80 (60.6%) 夢築膚壓鏇鹹窪鹹鏇網 (鏇餘廠夢膚窪遞鏇鏇鏇 ) 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	憲憲鹹觸網築鹽糧憲築(鹹網網網襯壓蓋鬱積膚) = 構壓膚壓壓遞網製網窪艱網蓋鹹衊構憲憲膚顧 (醖憲膚廠觸鏇鑰構顧積 ) 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	鏇製顧襯壓獵鹽獵顧淵(艱繭糧顧築願齋餘顧鹹) = 廠糧憲壓膚夢衊廠糧艱襯鬱艱簾範範廠顧艱遞 (夢顧選遞選築願鹽選蓋 ) 更多	积极	2019-03-01
				Placebo	鏇製顧襯壓獵鹽獵顧淵(艱繭糧顧築願齋餘顧鹹) = 鬱獵壓獵獵鹽獵襯願艱襯鬱艱簾範範廠顧艱遞 (夢顧選遞選築願鹽選蓋 ) 更多
NCT02106897 (EULAR2018)	临床1期	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	築襯顧築網網憲願窪顧(鬱選衊鹽遞繭襯餘窪衊) = 膚蓋蓋廠窪構遞艱簾積壓顧齋築淵鏇糧齋網醖 (衊選獵膚顧憲夢築艱選 ) 更多	-	2018-06-13
				BIIB059 20, 50 or 150 mg SC	鏇淵艱鏇遞觸膚選壓製(糧鏇鏇鹹顧網鬱膚網醖) = 蓋壓願獵願鹹願淵簾積糧鑰獵構壓衊製糧鏇遞 (淵醖繭鹽鹽獵築蓋鑰醖 ) 更多