A Phase I, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria

The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.

开始日期2023-12-30

申办/合作机构

联合生物制药股份有限公司

CTR20233674 / Recruiting临床2期

一项 II 期、多中心、随机、双盲、安慰剂对照、平行组研究，以评估 UB-221作为添加疗法在慢性自发性荨麻疹(CSU) 患者中的疗效，安全性，药代动力学和药效学

主要目的：评估 CSU 患者中各种 UB-221SC 剂量与安慰剂相比的疗效。次要目的：评估 CSU 患者中不同剂量队列的疗效；评估研究药物首次给药后至完全缓解（UAS7=0）、UAS7≤6和首次复发时间方面的疗效；评估UB-221 SC 对于首次给药后至首次使用补救药物时间、补救药物使用天数和每周使用补救药物的片剂数量方面的疗效；评估 CSU 患者中不同剂量队列的安全性和耐受性；CSU 患者中 UB-221 SC 的药代动力学（PK）；CSU 患者中不同剂量队列的药效学（PD）；CSU 患者中不同剂量队列的免疫原性；评估 CSU 患者不同剂量组的皮肤病生活质量指数(DLQI)。探索性目的：探索 UB-221 SC 在 CSU 患者中的作用机制。

开始日期2023-12-22

申办/合作机构

联生药（扬州）生物医药有限公司

NCT04404023 / Not yet recruiting临床1期

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Dose of UB-221 in Healthy Volunteers

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

开始日期2023-12-01

申办/合作机构

聯生藥大中華控股有限公司

100 项与 UB-221 相关的临床结果

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100 项与 UB-221 相关的转化医学

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100 项与 UB-221 相关的专利（医药）

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项与 UB-221 相关的文献（医药）

2024-06-01·Current opinion in allergy and clinical immunology

New biologics for food allergy

Review

作者: Anderson, Brent ; Sindher, Sayantani B. ; Schuetz, Jackson P.

Purpose of review:

This review aims to explore role of emerging biologics, including ligelizumab, UB-221, dupilumab, and antialarmins, in food allergy management. With a focus on recent developments, we evaluate their promise in mitigating adverse events during oral immunotherapy (OIT), reducing allergic reactions, and addressing the limitations of current therapeutic options.

Recent findings:

Antiimmunoglobulin E mAbs, exemplified by omalizumab, demonstrate efficacy in desensitization and safety improvement during multiallergen OIT. Next-generation antibodies like ligelizumab and UB-221 exhibit enhanced potency and unique mechanisms, holding promise for food allergy treatment. Dupilumab, targeting IL-4 receptor alpha, presents potential benefits in decreasing allergen-specific IgE and modifying the atopic march. Exploration of antialarmins, specifically anti-IL-33 (etokimab) and anti-TSLP (tezepelumab), reveals encouraging results, with etokimab showing early success in peanut allergy trials.

Summary:

Biologics hold promising potential for food allergy treatment. Tailoring therapeutic approaches based on shared decision-making becomes pivotal. While omalizumab remains a significant option, next-generation anti-IgE antibodies and agents targeting alarmins exhibit unique strengths. Dupilumab, despite limited success as monotherapy, shows promise as an adjunct for OIT. Careful consideration of treatment goals, patient preferences, and the evolving landscape of biologics will shape future clinical practice, offering allergists an expanded toolbox for personalized food allergy management.

2022-08-01·The Journal of clinical investigation

IgE-neutralizing UB-221 mAb, distinct from omalizumab and ligelizumab, exhibits CD23-mediated IgE downregulation and relieves urticaria symptoms

Article

作者: Lai, Annie ; Huang, Hong-Xuan ; Yang, Jasper ; Lynn, Shugene ; Shiung, Yu-Yu ; Lee, Chih-Hung ; Chen, Techeng ; Li, Chao-Hung ; Wang, Chang Yi ; Yang, Fu-Hung ; Liao, Mei-June ; Hsu, Cindy ; Lin, Chen-Han ; Tseng, William ; Tsai, Pei-Hua ; Cheng, Yi-Ning ; Liu, Yaw-Jen ; Kuo, Be-Sheng ; Chen, Jiun-Bo ; Su, Hsiao-Wen ; Wu, Ming-Syue ; Chang, Heng-Kwei ; Lung, Meng-Chung ; Li, Ywan-Feng ; Chu, Chia-Yu ; Lin, Chia-Yin ; Kuo, Je-Hung ; Ho, Yueh-Feng ; Wang, Yi-Jen

Over the last 2 decades, omalizumab is the only anti-IgE antibody that has been approved for asthma and chronic spontaneous urticaria (CSU). Ligelizumab, a higher-affinity anti-IgE mAb and the only rival viable candidate in late-stage clinical trials, showed anti-CSU efficacy superior to that of omalizumab in phase IIb but not in phase III. This report features the antigenic-functional characteristics of UB-221, an anti-IgE mAb of a newer class that is distinct from omalizumab and ligelizumab. UB-221, in free form, bound abundantly to CD23-occupied IgE and, in oligomeric mAb-IgE complex forms, freely engaged CD23, while ligelizumab reacted limitedly and omalizumab stayed inert toward CD23; these observations are consistent with UB-221 outperforming ligelizumab and omalizumab in CD23-mediated downregulation of IgE production. UB-221 bound IgE with a strong affinity to prevent FcԑRI-mediated basophil activation and degranulation, exhibiting superior IgE-neutralizing activity to that of omalizumab. UB-221 and ligelizumab bound cellular IgE and effectively neutralized IgE in sera of patients with atopic dermatitis with equal strength, while omalizumab lagged behind. A single UB-221 dose administered to cynomolgus macaques and human IgE (ε, κ)-knockin mice could induce rapid, pronounced serum-IgE reduction. A single UB-221 dose administered to patients with CSU in a first-in-human trial exhibited durable disease symptom relief in parallel with a rapid reduction in serum free-IgE level.

2022-03-04·Expert opinion on investigational drugs2区 · 医学

Emerging treatments for chronic urticaria

2区 · 医学

Review

作者: Wedi, Bettina

INTRODUCTION:

Across the globe, chronic urticaria (CU), i.e. chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CINDU), is common, long-persisting and difficult to manage. Still, at least one-fifth is not sufficiently controlled by guideline-recommended treatment with H1-antihistamines and add-on therapy with the anti-IgE monoclonal antibody omalizumab.

AREAS COVERED:

Using PubMed, ClinicalTrials.gov, Congress websites, and websites of the manufacturers, this review explored the pipeline, namely anti-IgE-, anti-cytokine-, anti-receptor biologics, and small molecules, in clinical development for CU.

EXPERT OPINION:

The CU pipeline is promising. While three omalizumab biosimilars are investigated, the assumed early approval of ligelizumab will expand the effective and safe anti-IgE approach observed with omalizumab. For other anti-IgEs like UB-221, the development is behind. Data are too limited so far to clearly define the role of anti-cytokine and anti-cytokine receptor biologics such as dupilumab, tezepelumab, mepolizumab, benralizumab, and CDX-0159, of which only dupilumab is actually investigated in phase 3. Among three selective oral BTK inhibitors, remibrutinib, rilzabrutinib, and fenebrutinib, the development of remibrutinib is most advanced (phase 3). As the pipeline addresses different targets, study results will give deeper insights into the pathomechanisms of CU. Hopefully, in the next future additional approved and also more targeted approaches will be available.

项与 UB-221 相关的新闻（医药）

2022-12-15

·药渡Daily

Daily速递|10余款1类新药获批临床！涉及礼来、凌科药业、亚盛药业等

2022年12月14日，根据国家药品监督管理局药品审评中心（CDE）最新数据显示，今日新增十余款1类新药的默示许可信息（不含补充申请）。经过梳理，这些1类新药适应症涉及肿瘤、荨麻疹、高钾血症、糖尿病等，靶点涉及MDM2-p53、Bcl-2、CEA、TROP2等。MDM2-p53抑制剂：APG-115胶囊APG-115胶囊是苏州亚盛药业开发的一款口服有效、高度选择性靶向MDM2-p53蛋白相互作用的小分子抑制剂，此次临床默示许可适应症为急性髓系白血病、混合表型急性白血病、骨髓增生异常综合征和慢性粒单核细胞白血病。p53基因是最广泛研究的肿瘤抑制基因，p53基因的失活对肿瘤形成起重要作用，而MDM2是p53的一个最重要的抑制因子，当两者结合的时候，会使p53蛋白降解, 活性降低，抑癌作用减弱。以MDM2-p53为靶点设计开发全新机制的抗肿瘤药物，是当下全球肿瘤药物研发领域热点与重点之一。然而由于MDM2-p53蛋白相互作用的特殊性给小分子抑制剂的开发带来相当大的困难，导致全球该领域的在研药物屈指可数，全球针对该靶点尚未有上市药物。APG-115是第二代MDM2-p53抑制剂，目前在国内已经开展了4项临床试验，最高研发阶段为临床II期。Bcl-2抑制剂：APG-2575片APG-2575片是苏州亚盛药业开发的新型口服Bcl-2选择性小分子抑制剂，此次临床默示许可适应症为急性髓系白血病、混合表型急性白血病、骨髓增生异常综合征和慢性粒单核细胞白血病。APG-2575可通过选择性抑制Bcl-2蛋白来恢复肿瘤细胞程序性死亡机制（细胞凋亡），从而诱导肿瘤细胞凋亡。该产品正在美国、中国、澳大利亚、欧洲等全球多地开展多种血液肿瘤和实体瘤的临床研究，并已有适应症相继获得FDA授予的孤儿药资格，目前全球最高研发进度为临床II期。自体免疫T细胞疗法：BRG01注射液BRG01注射液是广州百吉生物开发的一款通过基因修饰技术将以EBV抗原为靶点的受体表达在T细胞表面而制成的自体T细胞免疫治疗产品，此次临床默示许可适应症为经标准治疗后失败，且无有效治疗手段的末线复发/转移性EBV阳性鼻咽癌，这是该药首次在国内获批临床。鼻咽癌是发生在鼻咽粘膜上皮的恶性肿瘤，是常见的头颈部恶性肿瘤之一，其发生和发展与EBV感染密切相关。数据显示，2020年全球确诊的鼻咽癌发病数为13.3万人，中国鼻咽癌发病数占全球约50%，特别是广东和广西是高发地区，占全中国约60%，BRG01市场潜力巨大。靶向CEA的CAR-T细胞疗法：C-13-60细胞制剂12月14日， CDE官网公示，重庆精准生物申报的C-13-60细胞制剂获得临床试验默示许可，拟开发用于经标准治疗后进展或不耐受，现已无有效治疗手段的晚期末线恶性实体肿瘤，这也是该药首次在国内获批临床。公开资料显示，C-13-60细胞制剂是一款靶向CEA的CAR-T细胞注射液。C-13-60来源于该公司研发的RESCAR和PHICAR技术平台，该平台可以促进CAR细胞向肿瘤部位聚集，克服肿瘤抑制免疫微环境以提高疗效，同时增强了在肿瘤环境中存活。临床前小鼠体内研究结果显示，C-13-60具有明显的有效性，有望帮助更多的直肠癌、胃癌和食管癌患者成功摆脱病痛。TROP2 ADC抗体：DS-1062aDS-1062a（Datopotamab deruxtecan，DS-1062）是第一三共研发的一种以滋养细胞表面糖蛋白抗原2 (TROP2)为靶点的抗体-药物偶联药物(ADC)，此次临床默示许可适应症为三阴性乳腺癌。该药由人源化的抗TROP2单克隆抗体、酶切多肽连接剂和一种新型拓扑异构酶I抑制剂DXd——Exatecan (DX-8951)的衍生物组成，目前已在全球包括中国开展多项III期临床试验，适应症包含非小细胞肺癌、乳腺癌等。（数据来源：CDE临床试验登记平台）2020年7月，第一三共与阿斯利康达成60亿美元的重磅协议，共同开发和商业化DS-1062a。2021年6月ASCO大会上，第一三共与阿斯利康公布了DS-1062a治疗晚期或转移性NSCLL更新数据和转移性三阴性乳腺癌（TNBC）的I期试验TROPION-PanTumor01数据。总体数据非常优秀，市场潜力不俗。IL-4Rα单克隆抗体：GR1802注射液GR1802注射液是重庆智翔金泰生物开发的一款抗IL-4Rα单克隆抗体，此次临床默示许可适应症为慢性自发性荨麻疹。目前GR1802在国内开展了三项临床试验，涉及哮喘和特应性皮炎两项适应症，两项适应症最高研发进度均为临床II期。双功能补体生物制剂:KP104注射液KP104注射液是科越医药开发的一款双功能生物制剂，旨在通过选择性靶向作用于旁路和终末补体途径中的关键靶点来调节补体活性，此次临床默示许可适应症为拟用于治疗补体介导的肾脏疾病（例如IgA 肾病、C3 肾小球病）。KP104旨在同时选择性抑制补体旁路和终端途径，提供一种强大的协同机制且可能更加有选择性的精准治疗补体介导的疾病。KP104还被设计成具有延长的半衰期和效力，其配方可用于静脉注射和皮下给药。KP104正进入多个适应症的II期临床试验，包括IgA肾病（IgAN）、C3肾小球病（C3G）、继发于系统性红斑狼疮的血栓性微血管病（SLE-TMA）和PNH。II期临床试验将在全球范围内进行，包括美国、中国、澳大利亚和韩国。国内目前开展了一项适应症为阵发性睡眠性血红蛋白尿症的II期临床试验。阵发性睡眠性血红蛋白尿症（PNH）是一种罕见的危及生命的血液疾病，其特征是红细胞破坏、血栓形成和骨髓功能受损。KP104有望能够给该种疾病患者带来新的治疗选择。三靶点JAK1/JAK2/FLT3激酶抑制剂：LNK01002胶囊LNK01002胶囊是凌科药业自主研发的一款创新三靶点JAK1/JAK2/FLT3激酶抑制剂，此次临床默示许可适应症为骨髓增殖性肿瘤。LNK01002 的优势是可以同时有效地靶向三个驱动激酶靶点，可潜在地用于治疗对于传统治疗方案无效，或者耐药的病人群体，因此极大地满足了未被满足的临床需求，具有全球首创的潜力。目前LNK01002在国内开展了一项I期临床试验，适应症为原发性骨髓纤维化。RNAi基因疗法：LY3819469注射液LY3819469注射液是礼来开发的一款RNAi基因疗法药物，此次临床试验默示许可适应症为适用于降低已诊断ASCVD（动脉粥样硬化性心血管疾病）的患者或ASCVD高危患者的Lp(a)（脂蛋白）血浆稳态水平，这是该药首次在国内获批临床。RNA干扰（RNAi）是一种进化过程中高度保守的转录后基因沉默现象。它由双链RNA（dsRNA）诱发，导致同源mRNA高度特异性降解，阻断mRNA翻译出致病蛋白质的过程，从而发挥治疗作用。目前LY3819469已经开展了两项临床试验，其中脂蛋白紊乱适应症临床试验处于临床II期。UB-221 皮下注射剂UB-221 皮下注射剂是联生药（联亚生技的分割子公司）一款靶向 IgE 的单克隆抗体，此次临床试验默示许可适应症为多剂量UB-221作为慢性自发性荨麻疹患者的添加治疗。UB-221可通过与B 细胞表面的 FcεRII (CD23) 受体结合来中和可溶性 IgE 并抑制 IgE 合成。临床前研究表明，UB-221 的药理作用优于目前针对 IgE 的治疗性抗体（Xolair ）8倍；体外数据中显示出 2 至 5 倍的 IgE 合成抑制作用，需要 1/10 剂量才能在 huIGHE 敲入小鼠模型中达到相同的效果。1 期临床试验显示，慢性自发性荨麻疹患者对 UB-221 单次给药后反应迅速，并将其血清游离 IgE 抑制数周至数月，表明 UB-221 可以比 Xolair（奥马珠单抗）更有效地缓解慢性自发性荨麻疹症状。UB-221已经在多个国家或地区开展临床试验，最高研发阶段为临床II期。钾离子结合剂：WS016干混悬剂WS016干混悬剂是华世通生物开发的一款高分子聚合药物，此次临床试验默示许可适应症为高钾血症，这是该药在国内首次获批临床。该药是一种新型的钾离子结合剂，2022年09月05日，由中美华世通生物医药科技（武汉）股份有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗高钾血症，为化药一类（CXHL2200645）。靶向 CD19 非病毒 PD1 定点整合 CAR-T 细胞注射液靶向CD19非病毒PD1定点整合CAR-T细胞注射液（研发代码：BRL-201）是上海邦耀生物开发的首个可在不使用病毒载体的情况下实现基因组定点整合的自体CAR-T细胞产品。此次临床默示许可适应症为复发/难治性B细胞非霍奇金淋巴瘤（R/R B-NHL），也是该药首次在国内获批临床。BRL-201是利用Quikin CART®平台开发的靶向CD19的CAR-T产品，具有成本低、制备时间短、工艺简单、安全性和有效性高等优点。目前其在治疗复发/难治性非霍奇金淋巴瘤的研究者发起的临床试验中（IIT）已取得良好的效果，有8例患者接受治疗后，未观察到CAR-T相关的神经毒性和2级以上细胞因子风暴，完全缓解率超87%，证明了BRL-201具有出色的临床安全性。BRL-201作为世界首个非病毒PD1定点整合CAR-T产品，邦耀生物将继续推进该产品的临床转化，希望能造福更多的肿瘤患者。FGF21/GLP-1双功能蛋白：注射用AP026注射用AP026是安源医药开发的FGF21/GLP-1双功能蛋白药物，此次临床默示许可适应症为2型糖尿病，这是该药首次在国内获批临床。AP026是一种FGF21/GLP-1双功能蛋白，利用安源特有的连接肽平台技术与抗体Fc端融合，能够有效增加分子在血液中的稳定性。基于GLP-1代谢领域中已经展示出的良好效果以及FGF21的强大潜力，该药物有望应用于非酒精性脂肪性肝炎（NASH）、2型糖尿病（T2DM）等代谢领域。2022年4月，安源医药与正大天晴达成合作，将AP025和AP026在NASH和2型糖尿病治疗领域的大中华区开发和商业化权益授予正大天晴。相关阅读继新冠疫苗后，下一个黄金疫苗赛道或是它？IDH抑制剂市场再添一员，拜耳、诺华、和黄医药等国内外药企积极布局双抗迎来大爆发，国内玩家该如何突围？GSK宣布BCMA ADC撤市，竞争激烈又路途坎坷网红靶点👇欢迎关注药渡数据媒体矩阵

免疫疗法细胞疗法临床1期孤儿药临床2期

2022-08-08

·PRNewswire

United BioPharma's Study Reveals New Class of Monoclonal Antibody for Effective Relief of Urticaria Symptoms

TAIPEI, Aug. 5, 2022 /PRNewswire/ -- United BioPharma (UBP) today announced their latest results featuring unprecedented and unique functional characteristics of UB-221 monoclonal antibody in the phase I single-dose clinical trial, with chronic spontaneous urticaria (CSU) patients, to exhibit durable disease symptom relief. The results were published in the latest Journal of Clinical Investigation (JCI). A New Treatment Option for CSU The chronic spontaneous urticaria (CSU) has known to be caused by a type of protein or antibodies produced by the immune system, known as Immunoglobulin E (IgE). While the existing approved CSU therapy (omalizumab; Xolair® ) and investigational drug (ligelizumab), have exerted positive reaction to reduce the disease symptoms over the last two decades, United BioPharma's latest results have shown that the potential of a newer class of anti-IgE monoclonal antibody UB-221 has superior efficacy in CSU and can prolong the suppression of the disease symptoms. In the study, UB-221 has proven to be a potent IgE neutralizer and a significant inhibitor of IgE neo-synthesis. Meaning, UB-221 binds IgE with a higher affinity and inhibits IgE production at a far greater scale in comparison with other anti-IgE antibodies like omalizumab and ligelizumab. The study also suggests this new class of monoclonal antibody shows promise for the prevention of the development of allergic symptoms, through targeting both high-affinity IgE receptor (FcϵRI) and low affinity IgE receptor (CD23) pathways. In addition, a notable observation of the study is that UB-221 in free form can interact unrestricted with CD23. This unprecedented feature not found in any other anti-IgE antibodies, supports the contention that it could be of benefit to target IgE toward the non-inflammatory CD23 pathway. In other words, UB-221 can down-regulate IgE production and reduce serum IgE levels in urticaria patients. Other findings highlighted from the data published in the JCI include: In studies with animal models, such as cynomolgus macaques and human IgE (ε, κ)-transgenic hIGHE (immunoglobulin heavy epsilon)-knockin mice, a single dose of UB-221 can induce a rapid, profound reduction of serum IgE. The prolong suppression of urticaria symptoms and reduction of serum IgE levels suggests that a single dose of >2.0 mg/kg could potentially allow UB-221 to be administered every 3 to 6 months and achieve complete response (UAS7 = 0) or well controlled stage (UAS7 ≤ 6) in the treatment of CSU. Advances in UB-221 for Allergic Diseases Recent studies have shown that the combined prevalence of allergic diseases has increased to affect more than 30% of the world population. The condition underscores unmet medical need, burden on healthcare systems and the global economy as well. In response to the situation, UB-221 is being developed as therapeutic biologics. It aims to treat various types of allergic (atopic) diseases, including chronic spontaneous urticaria, food allergy, atopic dermatitis, asthma, and allergic rhinitis. About United BioPharma United BioPharma (UBP) is a late clinical stage biopharmaceutical company that is dedicated to the research, development and manufacture of novel monoclonal antibodies (mAbs) for infectious and immunological diseases. UBP is headquartered in Taiwan, with subsidiary companies in Shanghai and Yangzhou China, and liaison offices in the U.S. The company has built a passionate global team, developing high-quality therapeutic mAbs and delivering affordable treatments to bring the patients better quality of life. For more information, please visit the website at: http://www.unitedbiopharma.com

抗体合作

2022-05-31

·新浪医药新闻

联合生物：UB-221治疗慢性自发性荨麻疹2期IND获TFDA批准

2022年5月29日，台湾联合生物宣布台湾食品药品监督管理局 (TFDA) 已批准新型抗 IgE 单克隆抗体 UB-221 的2 期临床试验。这项 2 期临床试验（双盲、安慰剂对照）旨在评估 UB-221 作为一种长效附加疗法治疗慢性自发性荨麻疹（ CSU ）的疗效，并证明UB-221 两个高剂量组治疗6个月期间的潜力。 UB-221 是一种 IgG1，靶向 IgE 抗体的 Cε3 结构域，通过与B 细胞表面的 FcεRII (CD23) 受体结合来中和可溶性 IgE 并抑制 IgE 合成。临床前研究表明，UB-221 的药理作用优于目前针对 IgE 的治疗性抗体（Xolair ）8倍；体外数据中显示出 2 至 5 倍的 IgE 合成抑制作用，需要 1/10 剂量才能在 huIGHE 敲入小鼠模型中达到相同的效果。1 期临床试验显示，CSU 患者对 UB-221 单次给药后反应迅速，并将其血清游离 IgE 抑制数周至数月，表明 UB-221 可以比 Xolair 更有效地缓解 CSU 症状。UB-221 还可以通过与低亲和力受体 CD23 上已经结合的 IgE 结合来抑制新 IgE 的产生，因此，停药后IgE的反弹速度会变慢。自发性荨麻疹分为急性（<六周）和慢性（>六周）变体。发病率约为0.5-1%，患者随时可能患上该病。目前，非镇静 H1 抗组胺药是对症治疗的主要药物，使用许可剂量的治疗可有效缓解 <50% 的患者的症状。由于患者从 H1-抗组胺药中获益甚少，因此需要新的治疗策略。 IgE抗体在所有免疫球蛋白中浓度最低、半衰期最短，在自发性荨麻疹等过敏性疾病的发病中起到决定性作用。自第一代IgE抗体Xolair（奥马珠单抗）上市已经历20余年，同为第一代IgE抗体的ligelizumab在2b期临床头对头治疗自发性荨麻疹击败奥马珠单抗。第二代IgE抗体的代表药物FB825，2020年4月，利奥制药、合一生技及中天上海针对FB825的开发签订合作协议，合一生技将负责于美国执行异位性皮肤炎2a期临床试验，中天上海将于中国大陆执行过敏性气喘2a期临床试验，利奥制药将于这两项2a期临床试验后，承担后续药物开发。联合生物的UB-221作为第三代IgE抗体，未来的发展我们拭目以待。将目前处于临床开发阶段的IgE药物统计如下：联合生物的创新单抗药物产品线涵盖了传染病、免疫失调疾病和癌症。其中， UB-421是一种可应用于治疗HIV感染的抗CD4抗体，抗HSV抗体UB-621正处于研究治疗复发性生殖器疱疹的2期临床试验。在处于临床前开发阶段的三项抗肿瘤抗体中，UB-925 是一种新型抗VEGFR2单株抗体， UB-923和 UB-926 是以联合生物专有的去岩藻糖技术(defucosylation technology) 开发的抗CD20 和抗HER2 抗体，该技术可提升修饰后单株抗体的抗肿瘤活性。内容来源于网络，如有侵权，请联系删除，谢谢

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