This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

开始日期2020-11-30

申办/合作机构

Swedish Orphan Biovitrum AB

NCT04513366

/ Completed临床3期

A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy was performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

开始日期2020-08-18

申办/合作机构

Swedish Orphan Biovitrum AB

NCT03905512

/ Completed临床2期

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.

开始日期2019-05-07

申办/合作机构

Selecta Biosciences, Inc.

100 项与 SEL-212 相关的临床结果

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100 项与 SEL-212 相关的转化医学

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100 项与 SEL-212 相关的专利（医药）

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项与 SEL-212 相关的文献（医药）

2024-04-02·Rheumatology (Oxford, England)

The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout

Article

作者: DeHaan, Wesley ; Azeem, Rehan ; Traber, Peter G ; Kivitz, Alan J ; Choi, Hyon K ; Baraf, Herbert S B ; Strand, Vibeke ; Terkeltaub, Robert ; Keenan, Robert T ; Dalbeth, Nicola ; Khanna, Puja P

Abstract:

Objectives:

Serum urate (SU) lowering with PEGylated uricases in gout can reduce flares and tophi. However, treatment-emergent anti-drug antibodies adversely affect safety and efficacy and the currently approved PEGylated uricase pegloticase requires twice-monthly infusions. Investigational SEL-212 therapy aims to promote uricase-specific tolerance via monthly sequential infusions of a proprietary rapamycin-containing nanoparticle (ImmTOR) and pegadricase.

Methods:

COMPARE was a randomized, phase 2, open-label trial of SEL-212 vs pegloticase in adults with refractory gout. SEL-212 [ImmTOR (0.15 mg/kg) and pegadricase (0.2 mg/kg)] was infused monthly or pegloticase (8 mg) twice monthly for 6 months. The primary endpoint was the proportion of participants with SU <6 mg/dl for ≥80% of the time during 3 and 6 months. Secondary outcomes were mean SU, gout flares, number of tender and/or swollen joints and safety.

Results:

During months 3 and 6 combined, numerically more participants achieved and maintained a SU <6 mg/dl for ≥80% of the time with SEL-212 vs pegloticase (53.0% vs 46.0%, P = 0.181). The percentage reductions in SU levels were statistically greater during months 3 and 6 with SEL-212 vs pegloticase (−73.79% and −47.96%, P = 0.0161). Reductions in gout flare incidence and number of tender and/or swollen joints were comparable between treatments. There were numerical differences between the most common treatment-related adverse events of interest with SEL-212 and pegloticase: gout flares (60.2% vs 50.6%), infections (25.3% vs 18.4%) and infusion-related reactions (15.7% vs 11.5%), respectively. Stomatitis (and related terms) was experienced by eight participants (9.6%) with SEL-212 and none with pegloticase. Stomatitis, a known event for rapamycin, was associated with ImmTOR only.

Conclusions:

SEL-212 efficacy and tolerability were comparable to pegloticase in refractory gout. This was associated with a substantial reduction in treatment burden with SEL-212 due to decreased infusion frequency vs pegloticase.

Clinical trial registration:

NCT03905512.

2024-01-01·Journal of molecular graphics & modelling

Theoretical investigation of asphaltene molecules in crude oil viscoelasticity enhancement

Article

作者: Cui, Peng ; Yuan, Shideng ; Zhang, Heng ; Yuan, Shiling

Understanding the mechanisms of viscosity enhancement in crude oil phases is crucial for optimizing extraction and transportation processes. The enhanced viscosity mechanism of crude oil phase can be attributed to the intricate intermolecular interactions between asphaltene molecules. However, the molecular mechanism of the viscosification of asphaltene molecules in crude oil is not yet to be fully understood. In this work, molecular dynamics simulations were employed to investigate the dynamic behavior and viscosification mechanism of asphaltene molecules in complex oil phases. Research suggests that the neutral surface of asphaltenes features abundant positive and negative electrostatic potential regions, facilitating complementary pairing between these areas. This significantly augments electrostatic interactions among asphaltene molecules. Besides, the expansive nonpolar expanse on the normal asphaltene surface facilitates interactions between asphaltenes and crude oil molecules. This leads the crude oil viscosity of the system containing normal asphaltene is higher than that of the system containing acidic asphaltene under the same mass fraction (382 μ Pa·s for AAsp and 416 μ Pa·s for NAsp). This work provides insight into the viscosity enhancement mechanisms in crude oil phases and is helpful in improving the efficiency of crude oil extraction and transportation.

2022-06-01·Journal of animal science2区 · 农林科学

Evaluating the potential of lignosulfonates and chitosans as alfalfa hay preservatives using in vitro techniques

2区 · 农林科学

Article

作者: Perkins, Lewis B ; Killerby, Marjorie ; Wu, Changqing ; Almeida, Saulo T ; Guimarães, Bianca C ; Ma, Zhengxin ; Romero, Juan J ; Zhang, Jinglin ; Leon-Tinoco, Angela Y ; Annis, Seanna L ; Jeong, Kwangcheol C

Abstract:

Our objectives were to compare the antifungal activity of 5 lignosulfonates, and 2 chitosans against fungi isolated from spoiled hay, and assess the effects of an optimized lignosulfonate, chitosan, and propionic acid (PRP) on high-moisture alfalfa hay. In experiment 1, we determined the minimum inhibitory concentration and minimum fungicidal concentration of 4 sodium lignosulfonates, 1 magnesium lignosulfonate, 2 chitosans, and PRP (positive control) against Aspergillus amoenus, Mucor circinelloides, Penicillium solitum, and Debaromyces hansenii at pH 4 and 6. Among sodium lignosulfonates, the one from Sappi Ltd. (NaSP) was the most antifungal at pH 4. However, chitosans had the strongest fungicidal activity with the exception of M. circinelloides at both pH 4 and 6. PRP had more antifungal effects than NaSP and was only better than chitosans for M. circinelloides. In experiment 2, we evaluated the effects of 3 additives (ADV): optimized NaSP (NaSP-O, UMaine), naïve chitosan (ChNv, Sigma–Aldrich), and PRP on high-moisture alfalfa hay. The experimental design was a randomized complete block design replicated 5 times. Treatment design was the factorial combination of 3 ADV× 5 doses (0, 0.25, 0.5, 1, and 2% w/w fresh basis). Additives were added to 35 g of sterile alfalfa hay (71.5 ± 0.23% DM), inoculated with a mixture of previously isolated spoilage fungi (5.8 log cfu/fresh g), and aerobically incubated in vitro for 23 d (25°C). After incubation, DM losses were reduced by doses as low as 0.25% for both NaSP-O and PRP (x¯=1.61) vs. untreated hay (24.0%), partially due to the decrease of mold and yeast counts as their doses increased. Also, hay NH3-N was lower in NaSP-O and PRP, with doses as low as 0.25%, relative to untreated hay (x¯=1.13 vs. 7.80% of N, respectively). Both NaSP-O and PRP increased digestible DM recovery (x¯=69.7) and total volatile fatty acids (x¯=94.3), with doses as low as 0.25%, compared with untreated hay (52.7% and 83.8 mM, respectively). However, ChNv did not decrease mold nor yeast counts (x¯=6.59 and x¯=6.16 log cfu/fresh g, respectively) and did not prevent DM losses relative to untreated hay. Overall, when using an alfalfa hay substrate in vitro, NaSP-O was able to prevent fungal spoilage to a similar extent to PRP. Thus, further studies are warranted to develop NaSP-O as a hay preservative under field conditions.

项与 SEL-212 相关的新闻（医药）

2026-02-18

·PRNewswire

Sobi Capital Markets Day 2026: Bringing brilliant ideas to life and building the next chapter with ambition to deliver SEK 55bn by 2030

STOCKHOLM, Feb. 18, 2026 /PRNewswire/ -- Sobi® (STO: SOBI) today hosts its Capital Markets Day, where senior management will provide an update on the company's strategy and outline its new mid-term outlook, aiming to achieve SEK 55bn revenue by 2030, while building a resilient platform for sustained growth beyond 2030. Sobi aims to have an adjusted EBITA margin in the upper 30s percentage of revenue by 2030. Sobi has delivered strong and profitable growth in recent years, transforming and diversifying its portfolio and positioning the company to deliver on six major launches. Additionally, Sobi is advancing priority development programs enabling longer term growth and continuing its international expansion. "Sobi today is a stronger, more global and more scientifically driven company," says Guido Oelkers, CEO of Sobi. "We have delivered on our commitments, built a diversified, robust foundation for future growth, and are entering the next phase of expansion with multiple launches and compelling opportunities to unlock growth well beyond 2030." Highlights of the Capital Markets Day Sobi shares its ambition to reach SEK 55bn in revenues by 2030, effectively doubling the company revenue driven by six major launches, continued strong performance of strategic products, and international expansion. Sobi outlines major launches either ongoing or in preparation, expected to drive the majority of growth to 2030, including Altuvoct®, Gamifant®, Aspaveli®, Tryngolza®, NASP, and pozdeutinurad, across haematology, immunology, and specialty care. Deep dives demonstrate Sobi's scientific leadership in: Uncontrolled and progressive gout and two potentially transformative treatment innovations in an area of high unmet patient needs. Severe hypertriglyceridemia, where acute pancreatitis is a major risk and a severe medical emergency, and ApoC-III inhibition with olezarsen has shown significant and meaningful reductions in acute pancreatitis risk. Precision medicine in sepsis: In biomarker-selected patients with interferon gamma-driven sepsis (the proof-of-concept EMBRACE study), Sobi will share topline data for empalumab demonstrating improvement in SOFA-based organ function (achieving primary endpoint at end of treatment in 60% patients receiving high dose emapalumab vs 40% in the standard of care plus placebo arm). High dose emapalumab additionally showed a 12-percentage point absolute mortality reduction after 28-days (40% mortality in the high dose emapalumab arm vs 52% in the standard of care plus placebo arm). Additional information provided New peak sales expectations for the following products: Haemophilia A franchise (Altuvoct and Elocta) greater than SEK 10bn, Aspaveli between SEK 7-10bn, Gamifant in HLH between SEK 5-7bn, NASP between SEK 4-6bn, Tryngolza greater than SEK 10bn, pozdeutinurad greater than SEK 10bn and Gamifant in IDS greater than SEK 10bn. R&D expenses to remain between 11-14 per cent of sales on a given year between now and 2030. Agenda in brief The Capital Markets Day includes presentations from Sobi's executive leadership on strategy, pipeline and innovation, commercial opportunities and financial outlook as well as disease deep dives with experts and leaders in their respective fields, and a concluding Q&A session. Pre-registration for online attendance: click here A recording of the presentations and supporting materials will be made available on . Sobi Sobi® is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2025 revenue amounted to SEK 28 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:00 CET on 18 February 2026. Gerard Tobin Head of Investor Relations This information was brought to you by Cision The following files are available for download: SOURCE Swedish Orphan Biovitrum AB 21% more press release views with Request a Demo

临床结果

2026-02-10

·Bio-centrix

痛风（高尿酸）药物开发的多个研报解读

中国高尿酸血症与痛风市场需求旺盛，患者规模分别达 1.97 亿和 1550-4229 万，呈年轻化趋势，治疗达标率仅 10%，现有药物（别嘌醇、非布司他等）存在安全隐患，未被满足需求显著。2015-2016 年，美国成年人痛风总患病率为 3.9%，患病总人数约为 920 万；美国成人高尿酸患病率为 20.1%，患病人数约 4700 万。行业以化药为主（占比超 95%），非布司他市占率领先，但创新药成发展核心。在研管线聚焦 URAT1 抑制剂（AR882、SHR4640 等）和 IL-1β 抑制剂（伏欣奇拜单抗），兼具更优疗效与安全性，部分已进入 Ⅲ 期或获批上市。部分研报原文放在文末。【药企研发人员关注】 • 巨大的未满足临床需求是核心驱动力：中国高尿酸血症患者约1.77亿，痛风患者约1466万，且呈年轻化趋势。主流药物存在明显缺陷：别嘌醇有致死性超敏反应风险（汉族人群相关基因频率10-20%）；非布司他有心血管事件黑框警告；苯溴马隆存在肝毒性风险。同时，约30%患者使用非布司他无法将血尿酸降至目标水平（<6mg/dL）。 • 靶点集中于URAT1，差异化是关键：约90%的高尿酸血症源于肾脏尿酸排泄缺陷，因此抑制肾脏尿酸重吸收的URAT1成为最热门的靶点。恒瑞的SHR4640已提交上市申请。但未来竞争激烈，痛风石溶解能力可能成为重要差异点。一品红的AR882在II期研究中显示能显著溶解痛风石（75mg组29%患者至少一个痛风石完全溶解），这是其区别于其他在研URAT1抑制剂的核心优势。双靶点药物=通化东宝 THDBH151=同时抑制 XO 和 URAT1，可平衡尿酸生成与排泄，临床 I 期显示降尿酸效果显著且副作用更低。 • 分子设计优化以解决前代药物毒性：新一代URAT1抑制剂主要通过结构改造规避毒性。例如，一品红AR882在苯溴马隆分子中引入4个氘原子和1个羟基，改变其代谢路径，旨在降低肝毒性风险。而恒瑞SHR4640、璎黎药业YL-90148等则基于另一款有肾毒性的药物雷西纳德（lesinurad）进行结构优化。 • 临床试验设计需关注“溶晶痛”和长期疗效：降尿酸治疗初期，血尿酸快速下降可能诱发急性痛风发作（即“溶晶痛”），这会影响患者依从性和试验结果。sUA <5mg/dL和<4mg/dL是有效减少复发和溶解痛风石的两个关键阈值，可作为更严格的疗效终点。此外，对sUA持续达标（如连续多次测量<360μmol/L）的考察，以及长达6-12个月的痛风石溶解数据，将成为证明药物优势的重要证据。 • 急性期治疗靶点IL-1β已获验证：：IL-1β是痛风急性炎症的核心细胞因子。长春高新自主研发的伏欣奇拜单抗（国产首款IL-1β抑制剂）已于2025年7月获批，其III期研究显示，在止痛效果非劣于激素的同时，能将12周内复发风险降低超90%。这为对传统抗炎药不耐受的患者提供了新选择。 • 技术前沿呈现多元化：除了小分子和单抗，其他技术平台也在探索中。例如，丽珠医药的YJH-012是一种靶向肝脏XDH（黄嘌呤脱氢酶）的siRNA药物，临床前显示单次给药可持续降尿酸3-6个月，有望实现超长效治疗。三生制药引进的SEL-212是聚乙二醇尿酸酶与免疫调节剂的组合，旨在解决尿酸酶类药物易产生抗药抗体的问题。・特殊人群用药研发成重点方向：青少年高尿酸血症男生患病率达 56.3%，但针对性药物缺乏；轻中度肾损伤患者（eGFR≥30mL/min）需优化剂量，AR882 在此人群中无需调整剂量且安全性良好；合并高血压 / 糖尿病患者优先选择氯沙坦、二甲双胍等兼具降尿酸作用的药物。【投资者关注】 • 市场空间广阔，潜在规模超300亿元：根据华福证券测算，假设痛风创新药日治疗费用为40元（约为现有一线药非布司他的4倍），患者平均用药1年，在痛风患者中渗透率达到30%，则对应的国内市场空间可达314.6亿元。 • 竞争格局：URAT1抑制剂赛道拥挤，头部公司具先发优势：降尿酸治疗是主战场，URAT1抑制剂是国内创新药研发最集中的领域。恒瑞医药（SHR4640）国内进度最快（已报产），一品红（AR882）海外临床进度领先（全球III期）。此外，信诺维（XNW3009）、新元素医药/康哲药业（ABP-671）、海创药业（HP501）等均处于临床III期，未来2-3年将迎来产品密集上市期，竞争激烈。 • 关注具备差异化临床优势的“大单品”潜力：一品红的AR882凭借突出的痛风石溶解数据和良好的安全性，有望成为“创新药大单品”。在急性期治疗领域，长春高新的伏欣奇拜单抗作为国产首款IL-1β抑制剂，拥有降低90%复发风险的显著优势，具备成为该细分领域领导者的潜力。 • 患者基数、治疗费用与渗透率：核心投资逻辑可简化为：1.77亿高尿酸血症患者 → 1466万痛风患者（就诊率、治疗率）→ 使用创新药的患者数（渗透率）→ 年化治疗费用（日均药价×治疗时长）→ 市场规模。当前痛风治疗达标率仅约10%，渗透率提升是核心增长驱动。 • 政策风险与机遇并存：集采与医保谈判：传统抗痛风药（如非布司他）已受带量采购影响，销售额下滑。但创新药可通过国家医保谈判快速放量。例如，卫材的多替诺雷（dotinurad，新一代URAT1抑制剂）于2024-12在国内获批。【高校科研人员关注】 • 遗传与环境互作机制：高尿酸血症的遗传可能性为45%-73%，痛风的遗传可能性约为30%。全基因组关联研究（GWAS）已发现多个易感基因，其中汉族人群特有的RFX3和KCNQ1基因可能与免疫应答和胰岛细胞功能缺陷相关。环境因素占比高达90%，其通过表观遗传修饰（如DNA甲基化）影响基因表达，这为可逆性干预提供了新思路。 • 疾病病理机制，为靶点发现提供多层次机会：痛风病理链条明确：嘌呤代谢紊乱/排泄减少→高尿酸血症→尿酸盐晶体沉积→激活NLRP3炎症小体→释放IL-1β等炎症因子→急性关节炎。这为药物研发提供了从上游（XO、URAT1）到下游（NLRP3、IL-1β）的系列靶点。例如，Olatec公司的Dapansutrile就是直接靶向NLRP3的小分子抑制剂。 • 多学科交叉：肠道菌群与代谢调控：研究指出，尿酸排泄约1/3通过肠道。肠道微生物群可能通过影响宿主代谢物和尿酸分解来调节尿酸水平。例如，在研的ALLN346是一种口服尿酸酶，旨在在肠道内分解尿酸，这为不依赖肾脏的降尿酸疗法提供了全新思路。 • 从“老药”到“新药”的结构优化是成功的转化路径：多数URAT1抑制剂源于对两个“老药”的结构优化：一是针对苯溴马隆（肝毒性）改造出多替诺雷、AR882、ABP-671等；二是针对雷西纳德（肾毒性）改造出SHR4640、YL-90148、D-0120等。这是基于已知靶点进行安全性优化的案例。 • siRNA带来治疗范式变革可能：丽珠医药的YJH-012项目展示了siRNA技术在慢性病管理中的潜力。其设计靶向肝脏中的黄嘌呤脱氢酶（XDH）mRNA，从源头抑制尿酸生成，临床前研究显示单次给药效果可持续数月。这种“一次治疗，长期有效”的模式可能彻底改变痛风需每日服药的现状。 • 未被探索的研究方向：痛风石形成的分子机制（中性粒细胞细胞外陷阱的作用）、肠道尿酸排泄途径（占尿酸排泄 1/3）的药物开发、高尿酸血症合并代谢综合征的协同干预机制等，均为未被充分探索的重点方向。部分参考文献： 1-2024中国高尿酸及痛风行业大数据及产业竞争分析白皮书 2-2025医药生物行业专题报告_痛风新药物崛起_多靶点药物百花齐放 3-2025华福证券-医药生物_痛风专题_有望诞生创新药大单品的蓝海

2026-01-09

·伊顿健康

痛风四大关键场景精准抗炎，XO抑制剂/IL - 1抑制剂/URAT1抑制剂等怎么选？

伊顿健康导读痛风，被称为“疼痛之王”的代谢性疾病，正迎来治疗变革。《2021年中国高尿酸及痛风趋势白皮书》显示，我国高尿酸血症患者约1.77亿，痛风已成仅次于糖尿病的第二大代谢类疾病。传统治疗手段存在局限，急性期药物如非甾体抗炎药可能致肾损害，苯溴马隆有肝毒性隐患。未满足的临床需求推动新一代痛风治疗药物研发。 2025年11月，由中华预防医学会风湿病预防专业委员会牵头，邹和建等教授领衔，多学科专家制定的《痛风抗炎症治疗指南（2025版）》发布。这是全球首部痛风抗炎症治疗权威指南，标志我国痛风诊疗从“降尿酸为主”进入“抗炎与降尿酸并重”新时代。一、为什么痛风治疗必须“抗炎+降尿酸”双管齐下？长期以来，痛风治疗重降尿酸、轻炎症控制，致患者复发、关节及器官受损。临床显示，仅降尿酸治疗，患者依从性不足50%，40%仍频繁发作，未联合抗炎治疗的患者痛风石形成率达22%，5年内复发超60%。这些数据表明，单纯降尿酸难控痛风，新指南强调抗炎与降尿酸达标并重，实现“双达标”才能改善预后。二、指南核心解读：痛风四大关键场景，精准抗炎全覆盖场景一：急性发作期——尽早干预，严重者可考虑IL - 1抑制剂指南明确，痛风急性发作需在36小时内（优先12小时内）抗炎。一般患者：一线选低剂量秋水仙碱或达峰时间短的NSAIDs，也可用糖皮质激素。严重发作患者：可联用2种不同类抗炎药，联用不佳推荐IL - 1抑制剂单用或联合用药。特殊人群：对一线药不耐受等情况，推荐IL - 1抑制剂。二、指南核心解读：四大关键场景，精准抗炎全覆盖场景一：急性发作期——尽早干预，严重者可考虑IL - 1抑制剂指南明确，痛风急性发作需在36小时内（优先12小时内）抗炎。一般患者：一线选低剂量秋水仙碱或达峰时间短的NSAIDs，也可用糖皮质激素。严重发作患者：可联用2种不同类抗炎药，联用不佳推荐IL - 1抑制剂单用或联合用药。特殊人群：对一线药不耐受等情况，推荐IL - 1抑制剂。场景二：合并基础病患者——个体化用药，生物制剂提供新选择合并心血管疾病：建议用秋水仙碱或IL - 1抑制剂，可考虑糖皮质激素，谨慎用NSAIDs。合并消化系统疾病：合并腹泻等：建议IL - 1抑制剂或外用NSAIDs，单关节受累可关节腔注射糖皮质激素。合并溃疡者：积极治合并症，可考虑秋水仙碱等，不推荐糖皮质激素或NSAIDs全身用药。合并肝功能损害者：首选糖皮质激素等，用秋水仙碱等应减量并监测。合并慢性肾脏病： G1 - G2期：建议秋水仙碱等，可考虑NSAIDs。 G3期：建议糖皮质激素等，可考虑减量秋水仙碱。 G4 - G5期：建议糖皮质激素，可考虑IL - 1抑制剂，禁用NSAIDs，G4期酌情减量秋水仙碱，G5期禁用。场景三：痛风石患者——长程抗炎，保护关节与脏器痛风石患者易受损，指南建议用秋水仙碱或IL - 1抑制剂长疗程抗炎，降低风险。场景四：起始降尿酸治疗——预防性抗炎，减少发作指南推荐用0.5mg/天秋水仙碱预防，严重者可增至1mg/天，不耐受建议IL - 1抑制剂等，仍不适用可考虑NSAIDs。三、痛风创新药物密集上市，治疗格局被重新定义 2024年12月，新型URAT1抑制剂多替诺雷在中国率先上市；2025年初，恒瑞医药SHR4640申报上市获受理；6月，三生国健提交抗IL - 1β单抗上市申请，一品红公布氘泊替诺雷（AR882）积极临床数据；7月，金赛药业伏欣奇拜单抗获批用于急性痛风性关节炎。不到一年，多个药物密集申报或上市。业内认为，“精准降酸”“靶向抗炎”新时代开启，诸多新药在多靶点形成梯队，全球痛风治疗格局或被重新定义。四、痛风主流技术路径一：尿酸代谢通路精准调控 1. XO抑制剂——从别嘌呤醇到新一代非嘌呤类药物 1966年别嘌呤醇获FDA批准后，黄嘌呤氧化酶（XO）抑制剂成降尿酸重要策略。因嘌呤类药物副作用大，非嘌呤类XO抑制剂取得进展，如2009年美国上市的非布司他和2013年日本获批的托吡司他，疗效优于别嘌呤醇，但也有副作用，托吡司他仅在亚洲国家上市。 LG化学研发的Tigulixostat进展较快，已进入III期临床，适用于不耐受传统XO抑制剂的痛风患者。2022年12月，信达生物引进其中国权益（IBI350）。II期研究显示，其疗效显著优于安慰剂和非布司他。 2. URAT1抑制剂——痛风新一代高选择性药物尿酸盐转运蛋白1（URAT1）是促尿酸排泄关键靶点，上市的主要有苯溴马隆和多替诺雷。苯溴马隆因严重肝毒性在欧美撤市，仅在亚洲国家受限使用。日本卫材的多替诺雷2024年12月在中国获批上市，规避了肝毒性风险。中国III期数据显示，其疗效显著优于非布司他。 URAT1靶点是热门研发方向，超10款药物处于临床不同阶段。恒瑞医药的SHR4640是国内进度最快的URAT1抑制剂，2025年1月上市申请获受理。II期数据显示，其联合治疗效果显著优于安慰剂联合组。一品红的氘泊替诺雷2024年获美国FDA快速通道资格，2025年3月完成全球III期入组。IIb试验数据亮眼，且安全性良好。此外，有企业开发XO/URAT1双靶点抑制剂，可双重降尿酸。辉瑞的PF - 06743649因肾损伤终止研发，国内代表项目有通化东宝的THDBH151片（II期临床）和东阳光药的HEC93077。 3. 尿酸氧化酶类药物——难治性痛风的新选择尿酸氧化酶类药物催化尿酸转化为尿囊素，为痛风治疗提供新思路。已上市的拉布立酶和普瑞凯希，因免疫原性强、价格贵且易耐药，应用受限。当前研发重点是降低免疫原性，如聚乙二醇化修饰或联合免疫调节剂。进展较快的SEL - 212已提交上市申请，结合聚乙二醇化尿酸酶与ImmTOR免疫调节技术，可减少抗药物抗体形成、延长疗效。III期研究显示，高剂量组治疗6个月后缓解率分别达56%和47%。该药每月给药一次，提升患者依从性，有望成新治疗选择。五、痛风主流技术路径二：炎症信号通路靶向阻断痛风急性发病核心机制是尿酸盐晶体被吞噬后诱导NLRP3炎性体形成，激活半胱天冬酶，引发炎症反应释放细胞因子，最终导致痛风症状。抑制该炎症途径任一环节的药物，对痛风治疗有帮助。 1. IL - 1抑制剂——改写痛风抗炎治疗逻辑全球已批准多个IL - 1抑制剂，阿纳白滞素、利纳西普未获批痛风适应症。2023年8月，卡那奴单抗成FDA首个急性痛风性关节炎IL - 1β抑制剂。 2025年7月，金赛药业伏欣奇拜单抗国内获批，适用于特定成人痛风性关节炎急性发作患者。III期数据显示，其72小时疼痛VAS评分改善非劣于复方倍他米松，24周时首次复发风险降低87%，安全性优于激素组。除伏欣奇拜单抗，三生国健IL - 1β单抗SSGJ - 613针对痛风性关节炎适应证已递交上市申请，交晨生物GR007处于临床Ⅱ期。SSGJ - 613 III期研究显示，在疼痛缓解和预防复发方面达双主要疗效终点，预防复发显著优于阳性对照药。 2. NLRP3炎症小体抑制剂——从源头阻断炎症启动 NLRP3炎性小体是痛风炎症“上游开关”，抑制它可从源头阻断炎症，是研发热点。全球尚无上市品种，进展最快的Dapansutrile处于临床II/III期。二、新兴前沿技术：siRNA药物实现“一针长效” 2025年6月，丽珠集团YJH - 012注射液临床试验申请获NMPA批准。该药物通过GalNAc肝靶向递送系统将siRNA递送至肝脏，在肝细胞内切割靶蛋白mRNA，阻断尿酸生成通路。依托多种优势，YJH - 012单次给药可3 - 6个月持续降尿酸，临床前研究初步验证安全性。区别于传统药物，YJH - 012采用siRNA技术，有望从基因层面长效抑制尿酸生成，若临床成功，将改变痛风治疗模式。临床招募目前有类似靶点的临床项目在开展，符合条件、用药、体检由申办方承担，不收取费用，同时会有交通补贴和营养补贴。有需要的患者可以【扫描下方二维码报名登记】也可添加客服二维码详细咨询参考文献： 1. 中华预防医学会风湿病预防专业委员会. 痛风抗炎症治疗指南(2025版) ［J ］. 中华风湿病学杂志, ，2025, 29(11）：897-922.DOI:10.3760/cma.j.cn141217-20250926-00286 2. 中华预防医学会风湿病预防专业委员会,朱小霞,段利华,等.痛风抗炎症治疗指南（2025版）[J].中国预防医学杂志,2025，26（11）：1302-1328.DOI：10.16506/j.1009-6639.2025.11.004. 本文仅做参考，不构成对任何药物或诊疗方案的推荐、推广或宣传，也不可替代专业医疗建议。如有问题，请咨询医疗卫生专业人士。材料图片等源自网络，侵删。

临床结果

100 项与 SEL-212 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
慢性痛风	申请上市	美国	Swedish Orphan Biovitrum AB	2024-07-02
痛风	临床3期	美国	Selecta Biosciences, Inc.	-
痛风性关节炎	临床2期	美国	Selecta Biosciences, Inc.	2019-05-07
高尿酸血症	临床2期	美国	Selecta Biosciences, Inc.	2016-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04596540 (DISSOLVE II, CTgov)	临床3期	慢性痛风	153	Placebo	衊願願簾製衊壓鏇築鬱 = 遞鏇淵齋壓膚製積願築鏇構廠夢衊膚鹽願積積 (衊網鹹鑰淵鬱鬱簾選壓, 鏇鏇夢繭夢壓糧襯艱壓 ~ 淵膚鹽鬱製壓壓觸膚餘) 更多	-	2025-12-03
NCT04513366 (DISSOLVE I, ACR2025)	临床3期	痛风	229	NASP (high-dose)	夢鹽構艱選糧顧網夢壓(顧夢衊衊選範餘積構衊) = 選選餘糧觸廠繭網壓願網築鬱廠廠顧膚襯窪觸 (鏇窪艱獵製衊觸網鹽鏇 ) 更多	积极	2025-10-24
				NASP (low-dose)	夢鹽構艱選糧顧網夢壓(顧夢衊衊選範餘積構衊) = 範選壓淵網餘鑰鹹醖積網築鬱廠廠顧膚襯窪觸 (鏇窪艱獵製衊觸網鹽鏇 ) 更多
NCT04513366 (DISSOLVE I, CTgov)	临床3期	慢性痛风	112	normal saline	選鏇鑰襯淵窪窪簾夢願 = 製憲積鹽襯餘齋積鏇糧襯夢齋餘襯範壓壓餘憲 (憲構簾夢糧窪醖積淵襯, 範構鑰遞糧鹹齋糧鏇廠 ~ 簾醖顧觸蓋鹹獵鬱願顧) 更多	-	2025-09-11
NCT04513366 (DISSOLVE I, ACR2024)	临床3期	慢性痛风	265	SEL-212 High-Dose (US)	餘膚鹽齋製蓋膚壓壓窪(鬱醖獵鏇積繭淵遞鑰築) = 願窪鏇鬱鬱壓網鹽範鏇鑰獵選夢觸鏇夢網獵鹽 (鬱顧選艱範鹹壓觸構壓 )	积极	2024-11-10
				SEL-212 Low-Dose (US)	餘膚鹽齋製蓋膚壓壓窪(鬱醖獵鏇積繭淵遞鑰築) = 壓鏇構齋餘齋構膚簾繭鑰獵選夢觸鏇夢網獵鹽 (鬱顧選艱範鹹壓觸構壓 )
NCT04596540 \| NCT04513366 (DISSOLVE II, EULAR 12024 \| EULAR 22024) 人工标引	临床3期	痛风	265	SEL-212 0.15 mg/kg (high-dose)	鹽鹹艱顧遞網鬱範夢鹹(醖選網鑰鏇鹹壓製選願) = 艱蓋壓築製廠窪壓齋艱窪築餘夢願繭顧範願遞 (衊淵膚鹽構蓋窪膚齋積, 9.5) 更多	积极	2024-06-14
				SEL-212 0.1 mg/kg (low-dose)	鹽鹹艱顧遞網鬱範夢鹹(醖選網鑰鏇鹹壓製選願) = 襯鑰顧蓋淵窪襯構顧簾窪築餘夢願繭顧範願遞 (衊淵膚鹽構蓋窪膚齋積, 9.4) 更多
NCT04513366 (DISSOLVE I, EULAR2024)	临床3期	痛风	38	SEL-110 at 0.15 mg/kg + SEL-037 at 0.2 mg/kg	獵鹽製繭網遞餘膚廠齋(膚襯糧獵糧繭廠窪廠廠) = The most common adverse event of special interest across all three treatment arms was gout flare 憲願獵襯範齋積壓鏇廠 (築衊製鬱願衊淵鹹餘網 ) 更多	积极	2024-06-05
				SEL-110 at 0.1 mg/kg + SEL-037 at 0.2 mg/kg
NCT03905512 (COMPARE, CTgov)	临床2期	痛风 \| 慢性痛风 \| 痛风性关节炎	170	SEL-212 (SEL-212)	壓觸製蓋衊齋願構鹽壓 = 構壓廠顧廠願鏇願餘鑰築鹽餘齋淵觸艱廠蓋鑰 (淵遞願顧窪願醖簾廠醖, 築繭選醖夢築餘壓願壓 ~ 餘壓鹹鹹鏇夢醖蓋蓋齋) 更多	-	2023-10-17
				KRYSTEXXA® (KRYSTEXXA)	壓觸製蓋衊齋願構鹽壓 = 襯蓋壓衊鹽製製獵遞遞築鹽餘齋淵觸艱廠蓋鑰 (淵遞願顧窪願醖簾廠醖, 鹽膚鏇艱築窪顧蓋獵繭 ~ 襯觸襯衊壓醖築窪窪構) 更多
NCT03905512 (COMPARE, Corporate Publications) 人工标引	临床2期	慢性痛风	170	SEL-212	鬱夢壓蓋觸願願齋艱觸(網壓餘繭窪膚製壓齋壓) = 獵糧觸遞構鹽選鏇簾艱齋願製憲顧壓鹹艱鹽夢 (蓋鬱糧製獵夢壓範廠選 ) 更多	积极	2020-09-30
				Pegloticase	鬱夢壓蓋觸願願齋艱觸(網壓餘繭窪膚製壓齋壓) = 膚築網觸蓋鏇製鹹遞艱齋願製憲顧壓鹹艱鹽夢 (蓋鬱糧製獵夢壓範廠選 ) 更多
NCT02959918 (ACR2019) 人工标引	临床2期	痛风	152	SEL-212	築積範範網窪選鏇艱顧(艱憲製艱淵獵顧範醖製) = 繭餘糧範顧蓋製壓淵繭鹽鹹鹹積壓構築鹹製鹹 (構簾壓鏇鹽鑰遞顧鏇淵 ) 更多	积极	2019-11-11
				Pegadricase	-
SEL-212 (EULAR2019)	临床2期	痛风	152	SEL-212 (0.1 mg/kg ImmTOR + 0.2 mg/kg pegadricase)	繭廠窪糧獵範網膚網範(築醖構鑰壓餘選夢餘鑰) = All evaluable patients receiving 0.1 or 0.15 mg/kg ImmTOR administered with 0.2 mg/kg pegadricase who achieved three months of SUA control maintained SUA control in months four and five of combination treatment 範遞餘齋餘糧製簾衊鏇 (艱壓夢鬱膚淵選願夢繭 ) 更多	-	2019-06-12
				SEL-212 (0.15 mg/kg ImmTOR + 0.2 mg/kg pegadricase)