A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (Proposed Ustekinumab Biosimilar) Compared to Stelara® in Subjects With Moderate to Severe Plaque Psoriasis

This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.

开始日期2021-07-06

申办/合作机构

Samsung Bioepis Co., Ltd.

NCT04772274

/ Completed临床1期

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Ustekinumab (SB17, EU Sourced Stelara®, and US Sourced Stelara®) in Healthy Subjects

This is a randomised, double-blind, three-arm, parallel group, single-dose study to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 compared to EU sourced Stelara® and US sourced Stelara® in healthy subjects

开始日期2021-02-04

申办/合作机构

Samsung Bioepis Co., Ltd.

100 项与乌司奴单抗生物类似药（Samsung Bioepis）相关的临床结果

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100 项与乌司奴单抗生物类似药（Samsung Bioepis）相关的转化医学

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100 项与乌司奴单抗生物类似药（Samsung Bioepis）相关的专利（医药）

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项与乌司奴单抗生物类似药（Samsung Bioepis）相关的文献（医药）

2026-06-01·ANNALS OF PHARMACOTHERAPY

Pyzchiva (ustekinumab-ttwe): A New Biosimilar for Psoriasis

Review

作者: Lindecker, Bianca ; Kale-Pradhan, Pramodini B. ; Giuliano, Christopher

Objective::

The objective of the study is to analyze the pharmacology, efficacy, and safety of ustekinumab-ttwe in the treatment of moderate-to-severe plaque psoriasis.

Data Sources::

PubMed, Embase, and ClinicalTrials.gov were searched using the following search terms: ustekinumab, biosimilar, ustekinumab-ttwe, Pyzchiva, SB17, and psoriasis.

Study Selection and Data Extraction::

Articles published in English between January 9, 2015, and June 21, 2025, related to the pharmacology, pharmacokinetics, efficacy, safety, immunogenicity, and clinical trials were reviewed.

Data Synthesis::

Search results from PubMed and EMBASE yielded 259 articles, and 12 studies from Clinicaltrials.gov. Only 2 clinical trials of ustekinumb-ttwe’s use in psoriasis were identified and were included in analysis. The pharmacokinetic parameters of ustekinumab-ttwe (SB17), European Union-sourced ustekinumab (EU-UST) and United States-sourced ustekinumab (US-UST) were similar in its phase I trial. In addition, a phase III trial comparing the efficacy of ustekinumab-ttwe to ustekinumab showed that the difference of percent change from baseline of the Psoriasis Area and Severity Index (PASI) score between the 2 groups was comparable with a change of 85.7% for ustekinumab-ttwe (95% confidence interval [CI] = [–3.78, 2,58]) and 86.4% for ustekinumab (90% CI = [–3.34, 1.93]).

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

The pharmacology, pharmacokinetics, efficacy, safety, and immunogenicity of ustekinumab-ttwe and reference ustekinumab were equivalent, demonstrating its role as a biosimilar. There are no current clinical trials directly comparing ustekinumab-ttwe with ustekinumab’s other biosimilars.

Conclusion::

Ustekinumab-ttwe’s equivalence to its reference biologic ustekinumab creates another treatment option for patients with moderate- to- severe plaque psoriasis.

2026-03-20·ORGANIC LETTERS

Talamangins A–C, Immunosuppressive and Anti-inflammatory Nitrogenated Azaphilone Hybrids from Talaromyces mangshanicus SB17

Article

作者: Zhou, Ting ; Sun, Yi-Kai ; Li, Wan-Peng ; Zhou, Yin-Hui ; Ruan, Han-Li ; Yu, Xiao-Kun ; Qin, Chun-Lun

Three unprecedented nitrogenated azaphilone hybrids, talamangins A-C (1-3), were isolated from the endophytic fungus Talaromyces mangshanicus SB17. Their structures, along with their absolute configurations, were determined by extensive spectroscopic data analysis and single-crystal X-ray diffraction. Compounds 1-3 represent the first examples of nitrogenated azaphilone hybrids, distinguished by a novel fused scaffold formed through the angular fusion of nitrogenated azaphilone and a benzophenone unit, with the azaphilone fragment featuring a pyridine ring. Plausible biosynthetic pathways for 1-3 are proposed. Compounds 1-3 exhibit potent immunosuppressive activities against concanavalin A (ConA)-induced T cell proliferation, with IC₅₀ values of 13.0, 14.3, and 24.1 μM, respectively, as well as against lipopolysaccharide (LPS)-induced B cell proliferation, with IC₅₀ values of 14.5, 18.5, and 19.2 μM, respectively. Additionally, compounds 1-3 inhibit nitric oxide production in LPS-induced RAW264.7 cells, with IC₅₀ values of 6.2, 9.4, and 10.5 μM, respectively.

2025-06-03·EXPERT OPINION ON BIOLOGICAL THERAPY

The ‘totality of evidence’ and ‘extrapolation’ of SB17, a ustekinumab biosimilar

Review

作者: Luis Puig ; Alessandro Armuzzi ; Byong Duk Ye ; Hojung Jung ; Florian Rieder ; Steven R. Feldman ; Jae Hee Cheon ; Giampiero Girolomoni

INTRODUCTION:

SB17 is a ustekinumab (UST) biosimilar targeting interleukin-12/23 for treating immune-mediated inflammatory diseases (IMIDs). The development of UST biosimilars like SB17 may help address the high cost of innovator biologics, offering affordable alternatives without compromising efficacy or safety.

AREAS COVERED:

This review encompasses the totality of evidence supporting SB17's similarity to UST, its regulatory approval, and indication extrapolation. It also discusses SB17's lower immunogenicity relative to UST.

EXPERT OPINION:

The approval of UST biosimilars represents a significant advancement in managing chronic IMIDs including psoriasis, plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, providing cost-effective, efficacious alternatives. A randomized double-blind 28-week study involving over 500 patients with moderate-to-severe chronic plaque psoriasis demonstrated SB17's equivalence to UST, with more than 80% of patients achieving over 90% improvement in psoriasis severity indices. Treatment-emergent adverse events were comparable between SB17 and UST. Despite their potential to transform clinical outcomes, economic burdens, and drug utilization patterns, the adoption of UST biosimilars faces challenges, including concerns about equivalence and regulatory inconsistencies. Addressing these issues through education, consistent regulatory frameworks, real-world data, and ongoing monitoring is crucial for their successful integration into clinical practice.

项与乌司奴单抗生物类似药（Samsung Bioepis）相关的新闻（医药）

2026-08-30

·IBD Daily

CGH：乌司奴单抗生物类似药转换治疗克罗恩病后的临床结局

乌司奴单抗生物类似药转换治疗克罗恩病后的临床结局：USBIOS IG-IBD研究 Clinical Outcomes After Ustekinumab Biosimilar Switching in Crohn’s Disease: the USBIOS IG-IBD Study Clinical Gastroenterology and Hepatology PMID: 42660257 [IF=16.2] 背景乌司奴单抗作为一种靶向IL-12/IL-23 p40亚基的单克隆抗体，已被证实是治疗中重度克罗恩病 (CD) 的有效药物，具有良好的疗效和安全性。然而，随着生物制剂使用量的增加，其长期经济负担对医疗系统和患者治疗可及性构成显著压力。生物类似药的开发旨在提高治疗可持续性，在抗肿瘤坏死因子α (TNF-α) 生物类似药领域已有较多证据支持非医学转换的安全性和有效性，但对于乌司奴单抗生物类似药，尽管其获批基于分析可比性、药代动力学相似性及在银屑病等敏感人群中的临床试验数据，并将适应症外推至IBD，但这一外推并不能替代CD患者特异性真实世界证据，尤其是针对已在参照产品上长期稳定治疗的患者。目前已发表的早期观察性研究虽初步显示乌司奴单抗生物类似药转换后效果良好，但普遍存在样本量小、人群混杂 (IBD亚型不统一)、缺乏同期参照治疗对照组等局限。因此，亟需设计更严谨、样本量更大、包含纯CD人群和同期对照的前瞻性真实世界研究，以评估采购驱动下非医学转换至乌司奴单抗生物类似药的短期临床结局，为临床实践提供更有力的证据支持。方法本研究为一项在意大利18个中心开展的前瞻性、非随机、观察性队列研究，纳入462例临床稳定的成人CD患者，其中337例 (73.0%) 因采购政策从原研乌司奴单抗转换为三种生物类似药之一 (SB17/Pyzchiva®组114例、CT-P43/Steqeyma®组92例、AVT04/Uzpruvo®组131例)，125例 (27.0%) 继续原研药作为对照，旨在比较转换生物类似药与继续原研治疗的6个月结局。入组标准包括：年龄≥18岁、接受参照治疗≥8个月、基线处于临床缓解 (HBI<5) 且至少8个月未使用糖皮质激素。主要终点为扩大临床成功复合终点 (HBI<5、无糖皮质激素暴露、未停药、无IBD相关住院及手术)，方案预设非劣效性界值为-15%。分析采用组间比较、风险差估计及倾向性评分逆概率治疗加权校正混杂，多变量分析采用逐步逻辑回归，连续变量切点通过Youden指数选取，产品间比较经Holm校正，所有分析基于完整病例。结果患者基线特征本研究两组患者基线特征总体均衡：中位年龄约52~54岁，中位病程14~15年，既往接受原研乌司奴单抗治疗的中位时间约为27~31个月，基线HBI中位数均为1分，提示入组时病情控制良好。值得注意的是，仅4例患者 (0.9%) 采用每4周一次的强化给药方案，绝大多数 (约90%) 为每8周一次的标准维持方案。此外，转换组中基线内镜下有溃疡的患者比例显著高于对照组 (29.4% vs 16.1%，P=0.014)，说明转换组并非更低风险人群，反而客观炎症负担略重。主要终点：扩大临床成功复合终点在主要分析中，转换组332例患者中有306例 (92.2%) 达到扩大临床成功 (即6个月时HBI<5、未用激素、未停药、无IBD相关住院、无肠道手术)，对照组123例中有114例 (92.7%) 达到该终点。两组风险差仅为-0.5% (95% CI：-5.9% ~ 4.9%)，其95%置信区间的下限 (-5.9%) 远高于方案预设的-15%非劣效界值，甚至也超过了更为严格的事后分析基准-10%。这明确表明，在临床稳定的CD患者中，被迫换用生物类似药的效果不比继续用原研药差，两者在6个月内的综合临床结局几乎无差异。图1 六个月的疗效和非劣效性结局图源：参考文献 [1] 次要终点：临床缓解、生化指标与客观炎症评估各项次要终点在两组间均高度一致：方案定义的三组分临床成功 (HBI<5、无激素、未停药) 在转换组和对照组分别为93.1%和93.6%，无激素临床缓解率分别为94.9%和95.2%，单纯HBI临床缓解率分别为96.1%和96.8%，均无统计学差异。客观炎症指标方面，复合生化缓解 (CRP<0.5 mg/dL且FC<250 μg/g) 在两组分别为50.2%和51.5%，风险差仅-1.3% (95% CI：-13.3% ~ 10.6%)；配对分析显示HBI、CRP、FC自基线至6个月均无明显变化。可获取配对影像和内镜数据的亚组中，转换组无一例IUS肠壁厚度恶化 (对照组仅1例)，新发内镜溃疡转换组仅2例、对照组仅1例，均提示换药未引发客观炎症反弹。治疗持续性与安全性生物类似药的6个月治疗持续率为93.7%，仅1.2% (4例) 的患者因各种原因换回原研药，整体停药率极低，说明患者对新药的接受度和耐受性良好。安全性方面，转换组仅报告2例不良事件 (0.6%)，均为使用CT-P43的患者，分别为口腔灼烧感伴味觉障碍和瘙痒性斑丘疹，对照组无一例不良事件报告，两组间无统计学差异 (P=1.000)。6个月内未观察到新的安全信号。表1 6个月结局及效应估计值图源：参考文献 [1] 探索性分析与亚组结果倾向性评分加权后，转换组与对照组临床成功率分别为93.4%和93.8%，加权风险差仅-0.4%，进一步支持主要结论的稳健性。多变量回归分析显示，换药本身与终点失败无关，唯一显著相关的因素是基线HBI≥1 (调整后OR=3.97)，提示即使轻微的症状活动也可能预示转换后效果稍差。三种生物类似药的扩大临床成功率分别为SB17组96.4%、CT-P43组92.4%、AVT04组88.5% (全局P=0.08)，SB17与AVT04的未校正差异P=0.024，但经Holm校正后所有产品间比较均无统计学显著性。各产品组在部分生化指标上存在未调整的差异，但鉴于产品分配为区域性、非随机且基线特征存在明显不均衡 (如AVT04组既往抗TNF暴露率90.8%，SB17组仅77.2%)，这些产品间比较应视为描述性分析，不宜解读为不同生物类似药间存在有效性差异。结论在临床稳定的成人CD患者中，因采购政策被迫从原研乌司奴单抗转换为生物类似药后6个月的临床结局，与继续使用原研药相比无显著差异，已达到统计学非劣效标准。高临床稳定性、高治疗持续率和极低的不良事件发生率，支持在相似人群中可以实施有监测的生物类似药转换。但该结论仅适用于病情稳定、采用标准维持方案 (每8周或12周) 的患者，对于接受每4周强化给药方案的患者，本研究基本未提供证据，需要更长期的随访和更大队列来验证持续有效性、免疫原性以及多次转换的安全性。致谢中南大学湘雅三医院张婧楠中南大学湘雅三医院王思丹中南大学湘雅三医院陈杰中南大学湘雅三医院王晓艳对本篇文章解读做出的贡献题图来源于网络参考文献 1.Ribaldone DG, Tribocco E, Scaldaferri F, Murgiano M, Parello S, Di Vincenzo F, Del Gaudio A, Puca P, Napolitano D, Papa A, Lopetuso LR, Laterza L, Bezzio C, Armuzzi A, Farinola V, Savarino EV, Zingone F, Barberio B, Bertin L, Todeschini A, Variola A, Carvalhas Gabrielli AM, Ferretti F, Cannatelli R, Gravina AG, Pellegrino R, Viola A, De Francesco C, Bossa F, Pastorelli L, Felice C, Dragoni G, Canova D, Cingolani L, Spagnuolo R, Terpin MM, Zilli A, Magiotta A, Segatta F, Saibeni S, Juverdeanu A, Vernero M, Caviglia GP. Clinical Outcomes After Ustekinumab Biosimilar Switching in Crohn's Disease: the USBIOS IG-IBD Study. Clin Gastroenterol Hepatol. 2026 Aug 27:S1542-3565(26)00637-3. doi: 10.1016/j.cgh.2026.08.014. Epub ahead of print. PMID: 42660257. 投稿征集欢迎各位专家分享您的研究成果投稿邮箱：med_chenjie@csu.edu.cn 我们是一群热心于IBD研究的青年医生为您每天分享一个炎症性肠病的小知识免责声明：本平台旨在分享最新科研资讯，所载内容和意见仅供专业人士参考，不构成任何诊疗建议。在任何情况下，作者及作者所在团队不对任何人因使用本平台中的任何内容所致的任何损失负任何责任。本资料难以设置访问权限，若给您造成不便，还请见谅。本文属于医学专业文章，仅供医疗专业人员学术交流。不适合作为非专业人士疾病教育或科普用途。若有转载、合作、投稿需求，请联系团队负责人(邮箱：med_chenjie@csu.edu.cn)。本团队未创建任何交流群，请读者朋友谨防诈骗。

生物类似药临床1期

2026-08-22

·微信

K-Bio周报 | 韩国药企每周动态速览

K-Bio周报 | 韩国药企每周动态速览目录 1. OliX 与豪森药业就两个 siRNA 序列达成全球开发合作 2. SK 生物制药与 MSN 就 Xcopri 美国专利诉讼达成和解 3. 三天堂制药与 Regeneron/Bayer 就 Eylea 生物类似药全球专利纠纷达成和解 4. IntoCell 调整战略，从平台授权转向管线驱动 5. ABL Bio 的 Givastomig 计划年内进入胃癌 3 期临床 6. LG 化学启动 Genuv 授权的 GNV205 实体瘤临床前研究 7. EuBiologics 提交阿尔茨海默双靶点疫苗 PADIVAX 的 1 期 IND 8. 宗健堂进军 PH20 皮下注射制剂平台领域 9. Eyegene 发表 AAV 黄斑变性治疗候选药物研究 10. Celltrion 在日本推出 Steqeyma IV 并新增克罗恩病适应症 11. Alteogen 投资 2532 亿韩元建设首个自主生产设施 --- 一、BD与投融资 1. OliX 与豪森药业就两个 siRNA 序列达成全球开发合作韩国 RNAi 技术公司 OliX Pharmaceuticals 宣布，与中国豪森药业就在两个不同基因的 siRNA 候选序列上签署新的全球开发与商业化授权协议。这是双方在约五年合作基础上的又一次扩展。与传统的“整靶点独占”授权不同，本次合同采用单个 siRNA 序列选择性独占模式：仅覆盖双方选定的特定序列，OliX 仍保留针对同一基因其他 siRNA 序列的开发与再授权权利。这种安排使豪森能够集中资源开发实际选中的候选物，同时让 OliX 保留同一靶点的多次变现机会。 > 值得关注：在 RNAi 领域，不同序列的化学修饰、递送和组织选择性可能产生截然不同的产品价值。OliX 这种“按序列授权”的模式既锁定首付款、里程碑和销售提成，又为后续序列留出空间，是平台型公司资产精细化运营的新尝试。中国药企对韩国 RNAi 平台持续下注，也反映了对 OliX 序列竞争力的认可。 2. SK 生物制药与 MSN 就 Xcopri 美国专利诉讼达成和解 SK 生物制药宣布，与印度仿制药企 MSN Laboratories 就其癫痫新药 Xcopri（cenobamate）在美国特拉华州联邦地区法院的专利诉讼达成和解。这是 Xcopri 的首例专利和解。和解条款未公开。SK 生物制药将根据专利保护范围和相关条件，授予 MSN 未来推出 Xcopri 仿制药的权利。覆盖 cenobamate 的化合物专利将于 2032 年到期，此次和解涉及的为后续专利。 > 值得关注：通过和解，SK 生物制药在化合物专利到期后继续保留了对 Xcopri 的一定市场保护，预计将支撑该药在美国市场的长期稳定销售。Xcopri 近年来是 SK 生物制药的核心增长引擎，专利策略的清晰化对其估值意义重大。 3. 三天堂制药与 Regeneron/Bayer 就 Eylea 生物类似药全球专利纠纷达成和解韩国眼科制药公司 Sam Chun Dang Pharm 宣布，已就 SCD411（Eylea 2 mg / aflibercept 生物类似药）与 Regeneron 和 Bayer 达成全球专利纠纷和解，终止在欧洲、日本和韩国的相关诉讼及专利局程序。此前，加拿大和美国市场已分别通过 Apotex 和 Fresenius Kabi 单独达成和解。 SCD411 在韩国以 Vgenfli 上市，2025 年 12 月进入医保；在欧洲以 Vgenfli 和 Bizenpri 供货；加拿大以 Aflivu 销售。该公司 2026 年上半年眼科产品出口额约 156 亿韩元，已超过 2025 年全年（135 亿韩元）。 > Sam Chun Dang Pharm 是韩国眼科药品和原料药企业，专注于眼科仿制药与生物类似药开发，并在欧洲、北美等市场推进国际化。官网：https://www.scdpharm.com > 值得关注：阿柏西普生物类似药是韩国药企扎堆竞争的赛道。Celltrion（Eydenzelt）、Samsung Bioepis（Opuviz/Afilivu）和 Sam Chun Dang 三家韩国企业通过各自的专利和解协议，按不同时间表进入全球市场。本次和解清除了欧洲和日本市场的最后法律障碍，为日本上市铺平道路。 4. IntoCell 调整战略，从平台授权转向管线驱动韩国 ADC 平台公司 IntoCell 在记者会上表示，由于中国 ADC 企业数量超过 100 家且全球大药企对技术评估日趋严格，公司将从此前的“平台技术授权为主”调整为平台 + 自研管线双轨战略，重点推进自有 ADC 管线的早期数据生成。核心平台包括非肽类连接子 OHPAS、降低正常细胞摄取的 PMT 技术，以及自研 payload Nexatecan / iso-Nexatecan 和新型 TBA linker。自研管线中，ITC-6146RO（B7-H3 ADC）已在韩国三家医院开展 1a 期临床，计划年底获得中期数据；5T4、DLL3、PSMA、HER3 等靶点 ADC 也处于临床前或早期开发阶段。公司此前与 Samsung Bioepis 就最多 5 个靶点开展研究合作，并已就首个靶点签署商业化授权。 > IntoCell 是韩国临床前阶段 ADC 平台生物技术公司，专注于 linker-payload 技术和位点特异性偶联平台开发。官网：https://www.intocell.com > 值得关注：全球 ADC 竞争已从“平台故事”转向“数据说话”。IntoCell 承认此前一款 Nexatecan 化合物与中国公司专利意外重叠，影响了部分授权谈判。年底 ITC-6146RO 的 1a 期数据将成为验证其新 linker/payload 临床转化能力的关键节点。 --- 二、临床与研发进展 5. ABL Bio 的 Givastomig 计划年内进入胃癌 3 期临床 ABL Bio 的美国合作伙伴 NovaBridge Biosciences 宣布，基于 Grabody-T 平台的双特异性抗体 Givastomig 计划今年内启动 3 期注册临床试验，目标通过 FDA 加速批准上市。 Givastomig 同时靶向 CLDN18.2 和 4-1BB，设计为仅在 CLDN18.2 表达的肿瘤微环境中激活 4-1BB，以减少全身毒性。在 1b 期试验中，8 mg/kg 剂量组的客观缓解率（ORR）为 77%，中位无进展生存期（mPFS）为 16.9 个月；疗效不受 PD-L1 和 CLDN18.2 表达水平限制。FDA 已于今年 6 月授予该药联合 Opdivo + 化疗用于 HER2 阴性晚期/转移性胃食管腺癌的快速通道资格。 > 值得关注：Givastomig 的胃癌 3 期路径已获 FDA 确认，与安斯泰来已获批的 Vyloy（zolbetuximab，CLDN18.2 单抗）相比，双抗机制和更广的获益人群是其潜在差异化优势。1b 期数据将于 ESMO 2026 以海报形式公布。 6. LG 化学启动 Genuv 授权的 GNV205 实体瘤临床前研究 LG 化学宣布，已开始对从韩国生物技术公司 Genuv 获得授权的抗体-细胞因子融合候选药 GNV205 进行实体瘤临床前研究。该药由靶向 PD-1 的抗体与 IL-2 融合而成，设计为在酸性肿瘤微环境中活化，以集中 IL-2 活性于肿瘤区域并降低全身毒性。 LG 化学于 2025 年 9 月从 Genuv 获得 GNV205 的全球独家开发与商业化权利，交易包括首付款、里程碑付款和销售分成。LG 化学表示，将把韩国生物技术公司发现的创新资产纳入下一代全球肿瘤产品组合。 > Genuv 是韩国临床前生物技术公司，专注于新型抗体与免疫细胞因子等肿瘤免疫疗法的早期发现。官网：https://www.genuv.com > 值得关注：LG 化学正在通过自主研发与外部引进双轮驱动扩展肿瘤管线。GNV205 属于下一代免疫肿瘤学中的“免疫细胞因子”类别，若能证明在 PD-1 耐药患者中的活性，将填补现有免疫检查点抑制剂的未满足需求。 7. EuBiologics 提交阿尔茨海默双靶点疫苗 PADIVAX 的 1 期 IND 韩国疫苗公司 EuBiologics 宣布，已向韩国 MFDS 提交阿尔茨海默病治疗性疫苗 PADIVAX 的 1 期临床试验申请。该疫苗同时靶向 Aβ 和 tau 蛋白两种致病蛋白，采用公司的 EuIMT 免疫增强技术和 SNAP 抗原展示技术。 1 期试验计划入组轻度认知障碍或轻度阿尔茨海默病患者，每 4 周给药一次、共 5 剂，主要评估安全性和耐受性，次要评估针对 Aβ 和 tau 的免疫原性。 > EuBiologics 是韩国疫苗公司，以口服霍乱疫苗 Euvichol 闻名，近年来拓展至 mRNA 和治疗性疫苗领域。官网：https://www.eubiologics.com > 值得关注：阿尔茨海默病治疗性疫苗研发已失败多年，目前尚无商业化产品。与被动免疫抗体疗法不同，治疗性疫苗旨在诱导人体自身产生抗体，若安全性可控将显著降低治疗负担。EuBiologics 强调未追求最快入组，而是谨慎推进临床前疗效与安全性评估。 8. 宗健堂进军 PH20 皮下注射制剂平台领域韩国大型药企 CKD 制药（Chong Kun Dang Pharmaceutical）宣布，已就基于重组人透明质酸酶 PH20 的改良变体申请专利，正式进军皮下注射（SC）制剂转换平台领域。该专利于 2026 年 2 月提交、8 月 21 日公开。 PH20 可临时分解皮下组织中的透明质酸，降低大分子生物药的皮下注射阻力，使原本需静脉输注的药物转为皮下注射。全球范围内，Keytruda、Opdivo、Tecentriq 等重磅药物的 SC 版本已陆续获批。CKD 表示其变体在酶活性和热稳定性上优于现有 PH20，权利范围覆盖抗体、ADC、免疫抗癌药、蛋白质、核酸及细胞治疗药物。 > 值得关注：韩国 PH20 平台赛道此前由 Alteogen 和 Halozyme 主导，Alteogen 已通过 MSD 的 Keytruda SC 实现商业化。CKD 作为大型传统药企入局，意味着 SC 制剂转换技术竞争从平台型生物技术公司扩展至综合性制药企业。CKD 是否会将自研 PH20 用于自家的 ADC 或生物类似药管线，是后续看点。 9. Eyegene 发表 AAV 黄斑变性治疗候选药物研究韩国基因治疗公司 Eyegene 宣布，其基于 AAV 的黄斑变性治疗候选药物研究发表于《Advanced Healthcare Materials》。该候选药物使用单一 AAV 载体同时表达阿柏西普和 COMP-Ang1（工程化血管生成素-1 变体），一方面抑制 VEGF 阻止异常新生血管形成，另一方面稳定血管屏障减少渗漏。在临床前研究中，三维微流控血管生成芯片和激光诱导脉络膜新生血管大鼠模型均显示，该候选药物呈剂量依赖性减少异常血管面积，最高剂量下的抗血管生成效果与标准疗法 Eylea 相当。 > Eyegene 是韩国临床前基因治疗公司，专注于眼科疾病的 AAV 基因疗法开发。官网：https://www.eyegene.co.kr > 值得关注：湿性黄斑变性患者目前需要反复玻璃体内注射维持疗效，AAV 基因治疗的目标是实现单次给药、长期表达治疗蛋白。全球黄斑变性治疗市场预计到 2030 年达约 179 亿美元，长效基因疗法若能在临床中复现临床前数据，将显著改变治疗模式。 --- 三、业绩与商业动态 10. Celltrion 在日本推出 Steqeyma IV 并新增克罗恩病适应症 Celltrion 宣布，其乌司奴单抗生物类似药 Steqeyma 的静脉注射（IV）制剂在日本上市，并新增克罗恩病适应症。该 IV 制剂于 2026 年 4 月获日本 MHLW 批准，此次上市距获批约四个月。Steqeyma 也是目前日本市场唯一同时拥有 IV 和 SC 两种剂型的乌司奴单抗生物类似药。 Celltrion 计划借助现有自身免疫产品在日本建立的商业网络推广 Steqeyma，并在下半年参加 JDDW 和 JSIBD 等消化领域学术会议。公司同时宣布，主要产品在亚洲市场份额持续领先：Remsima 在新加坡（93%）、香港（84%）、泰国（78%）、马来西亚（72%）排名第一；Vegzelma 在马来西亚已从 bevacizumab 品类第四位跃升至第一位（30%）。 > 值得关注：IV 剂型用于诱导治疗、SC 剂型用于维持治疗，双剂型覆盖克罗恩病全程，是 Steqeyma 在日本市场的核心差异化优势。Celltrion 在生物类似药领域的商业化执行力，尤其是在亚洲直销网络的渗透，正在持续转化为市场份额。 11. Alteogen 投资 2532 亿韩元建设首个自主生产设施 Alteogen 董事会决议投资 2532 亿韩元（约合 13.7 亿元人民币，按 1 CNY≈185 KRW 计），在韩国大田屯谷地区建设公司首个自主原料药和成品药生产设施，目标 2028 年 9 月前完工。该投资额占公司去年自有资本的 55.7%。新设施将生产核心产品 ALT-B4（人透明质酸酶，用于 SC 制剂转换平台）和 ALT-L9（Eylea 生物类似药）的原料药与制剂。公司此前主要依赖国内外多家 CMO 生产。 > 值得关注：这是 Alteogen 从“轻资产平台授权 + CMO 委托生产”向自主生产转型的关键一步。ALT-B4 已通过 MSD 的 Keytruda SC 实现商业化，随着更多 SC 制剂转换合作项目推进，自有产能将保障中长期供应稳定性。巨额资本开支也显示管理层对核心产品商业化前景的强力信心。

临床3期生物类似药siRNA专利到期疫苗

2026-08-12

·PRNewswire

New study from CVS Caremark and Employee Benefit News shows how employers rely on their pharmacy benefit manager to create sustainable pharmacy solutions

Key opportunities include: managing GLP-1s, encouraging biosimilar substitution and employing technology to simplify and personalize the member experience WOONSOCKET, R.I., Aug. 12, 2026 /PRNewswire/ -- CVS Caremark, part of CVS Health® (NYSE: CVS), today announced the findings of a survey conducted in partnership with Employee Benefit News that reveals why employers are increasingly relying on their pharmacy benefit manager (PBM) partners to use their expertise, scale and purchasing power to help them manage their top concern: battling rising drug prices and maintaining access to quality care. This year's The State of Pharmacy Management Survey findings show HR decision makers and executive leaders are focused on navigating the rising price of prescription drugs, managing access to expensive treatments such as GLP-1s, and encouraging the use of more cost-effective biosimilars. Key Findings 91% of employers are concerned about the high prices of medication for employees 88% of employers see PBMs as especially well positioned to reduce prescription drug costs for their businesses 64% say PBMs have the greatest opportunity to improve access to affordable specialty medications "This data reveals the urgency behind employers' need for PBM partners who can address cost, first and foremost," said Ed DeVaney, President, CVS Caremark. "There's a clear opportunity to help employers navigate the evolving pharmacy benefits landscape while driving sustainable benefits for clients and members." Opportunity for employers to encourage greater use of biosimilars The survey findings also illustrate that biosimilars represent one of the largest untapped opportunities for employers to reduce drug costs in the U.S. health care market, offering clinically equivalent therapies to improve affordability and enhance access without compromising safety or efficacy. Today, only about half of employers (49%) are encouraging biosimilar substitution while another 40% are actively considering or exploring it. With just 12% of employers reporting that they are educating employees about the cost savings potential, this study illustrates a significant opportunity for employers to do more to both create better awareness and understanding of the benefits of biosimilars and help their members access them. CVS Caremark has been an industry leader in promoting biosimilar adoption. Since April 2024, biosimilar formulary strategy has helped CVS Caremark clients and members realize more than $3.3 billion in gross savings related to Humira® (adalimumab), and the company is committed to expanding the use of low-cost biosimilars across multiple therapeutic categories. On July 1, 2026, CVS Caremark transitioned from Stelara® (ustekinumab) on its most common commercial template formularies to prefer lower-cost, interchangeable biosimilar alternatives — Pyzchiva® and Yesintek®. Most members will pay $0 out-of-pocket for their therapy. Employers are planning for emerging areas of pharmacy spend, including GLP-1 weight management Weight management has moved into the benefits mainstream, becoming a core component of modern benefits strategy. Seventy-seven percent of employers say the high cost of GLP-1 coverage is a concern — with 80% having either already limited GLP-1 coverage for weight loss or considering limits. CVS Caremark is focused on improving affordability and access to GLP-1s by increasing access to GLP-1 weight management medications this year with expanded coverage options. In addition to negotiating lower prices with drug manufacturers, CVS Caremark works with clients to leverage the right GLP-1 management strategies for each employee population, including utilization management, personalized clinical and nutrition support and more. The lifestyle-first approach of the CVS Weight Management™ program has driven sustainable weight loss results for members and cost savings for plan sponsors. Clients who adopted the program spent up to 26% less on GLP-1 medications for weight-loss compared to those who did not, and members who were previously on anti-obesity medication nearly doubled their pre-program weight loss while working with program clinicians on diet and lifestyle. Digital innovation is central to pharmacy benefits As AI and digital enablement continue to transform the health care experience, employers are looking for pharmacy benefits partners who can leverage digital tools to make support more accessible, personalized and navigable for plan members, with 88% saying that digital tools and innovation as part of the health care experience are "here to stay." CVS Caremark invests over $770 million in technology each year dedicated to member innovation, combining human touch with streamlined digital processes so members can receive the treatment they need quickly. As a founding partner of the Coalition for Health AI (CHAI), CVS Caremark is also helping lead the way in safe and ethical use of AI in health care, all in support of improved health outcomes and a streamlined experience for members, clients and providers. Employers see pharmacy benefit costs as harder to control than other benefits Only 30% of employers said they have significant influence over pharmacy costs, compared to 73% who said they have significant influence over the overall cost of maintaining a competitive benefits package. At the same time, employers are looking for PBMs to help manage pharmacy spending while maintaining access to affordable treatment options. Of those surveyed, 91% say they are very concerned about high medication costs for employees. CVS Caremark helps employers control drug costs and make medications more accessible by working with drug manufacturers to negotiate affordable drug prices for clients and members. Through the industry-leading pricing model, TrueCost™, CVS Caremark allows clients to see true drug costs through acquisition-cost-based pricing and drug-level rebate values, enabling more pricing transparency, predictability and sustainability for plan administrators and members and improving affordability for high-quality treatment. View The State of Pharmacy Management report. About CVS Health CVS Health is a leading health solutions company simplifying health care one person, one family and one community at a time. As of June 30, 2026, the Company had approximately 9,000 retail pharmacy locations, more than 1,000 walk-in and primary care medical clinics and a leading pharmacy benefits manager with approximately 87 million plan members. The Company also serves an estimated 37 million people through a broad range of health insurance products and related services. The Company's integrated model uses personalized, technology driven services to connect people to simply better health, increasing access to quality care, delivering better outcomes, and lowering overall costs. Media contact Phil Blando 202-258-4978 [email protected] SOURCE CVS Health 21% more press release views with Request a Demo

100 项与乌司奴单抗生物类似药（Samsung Bioepis）相关的药物交易

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适应症	国家/地区	公司	日期
银屑病关节炎	欧盟	Samsung Bioepis NL B.V.	2024-04-19
银屑病关节炎	冰岛	Samsung Bioepis NL B.V.	2024-04-19
银屑病关节炎	列支敦士登	Samsung Bioepis NL B.V.	2024-04-19
银屑病关节炎	挪威	Samsung Bioepis NL B.V.	2024-04-19
活动性中度克罗恩病	欧盟	Samsung Bioepis NL B.V.	2024-04-19
活动性中度克罗恩病	冰岛	Samsung Bioepis NL B.V.	2024-04-19
活动性中度克罗恩病	列支敦士登	Samsung Bioepis NL B.V.	2024-04-19
活动性中度克罗恩病	挪威	Samsung Bioepis NL B.V.	2024-04-19
活动性重度克罗恩病	欧盟	Samsung Bioepis NL B.V.	2024-04-19
活动性重度克罗恩病	冰岛	Samsung Bioepis NL B.V.	2024-04-19
活动性重度克罗恩病	列支敦士登	Samsung Bioepis NL B.V.	2024-04-19
活动性重度克罗恩病	挪威	Samsung Bioepis NL B.V.	2024-04-19
斑块状银屑病	欧盟	Samsung Bioepis NL B.V.	2024-04-19
斑块状银屑病	冰岛	Samsung Bioepis NL B.V.	2024-04-19
斑块状银屑病	列支敦士登	Samsung Bioepis NL B.V.	2024-04-19
斑块状银屑病	挪威	Samsung Bioepis NL B.V.	2024-04-19
活动性中度溃疡性结肠炎	欧盟	Samsung Bioepis NL B.V.	2024-04-19
活动性中度溃疡性结肠炎	冰岛	Samsung Bioepis NL B.V.	2024-04-19
活动性中度溃疡性结肠炎	列支敦士登	Samsung Bioepis NL B.V.	2024-04-19
活动性中度溃疡性结肠炎	挪威	Samsung Bioepis NL B.V.	2024-04-19

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临床结果

适应症

分期

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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


NCT04967508 (CTgov)	临床3期	斑块状银屑病	503	SB17 (Proposed Ustekinumab Biosimilar)	築餘觸餘蓋淵餘遞築鹽(齋艱憲衊糧鹽鑰鑰網艱) = 夢鹽艱鬱淵範淵簾簾淵觸廠簾構糧衊壓餘窪觸 (構憲醖醖憲淵艱襯夢顧, 2.53) 更多	-	2025-05-25
AAD2024	临床3期	斑块状银屑病	481	SB17	顧積衊顧襯範膚夢襯淵(蓋廠遞夢繭齋網壓醖觸) = 範憲艱餘築窪醖蓋選鹹齋鏇夢鹹遞夢齋製襯蓋 (淵鏇遞憲糧壓範遞鏇遞 ) 更多	相似	2024-03-08
				UST	顧積衊顧襯範膚夢襯淵(蓋廠遞夢繭齋網壓醖觸) = 艱選鑰構範鹹醖壓膚衊齋鏇夢鹹遞夢齋製襯蓋 (淵鏇遞憲糧壓範遞鏇遞 ) 更多
NCT04967508 (GlobeNewswire) 人工标引	临床3期	斑块状银屑病	-	SB17	遞簾製範鏇鹹醖鏇鹹糧(衊獵餘簾襯鏇繭餘蓋齋): Difference = -0.6 (95% CI, −3.780 ~ 2.579) 达到	积极	2023-10-11
				ustekinumab