The main purpose of this study is to look at the amount of the study drug, LY3454738 that gets into the blood stream and how long it takes the body to get rid of it when given under the skin comparing a test formulation versus a reference formulation in healthy participants. The study will also evaluate the safety and tolerability of LY3454738 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening period.

开始日期2024-01-12

申办/合作机构

Eli Lilly & Co.

CTR20232562 / Recruiting临床2期

主方案标题：用于治疗中重度特应性皮炎成人患者的多种治疗方法的随机、对照、2期临床试验的主方案。 ISA标题：一项评估LY3454738在中重度特应性皮炎成人患者中有效性和安全性的2期、随机、双盲、平行组、安慰剂对照、52周研究

主要比较LY3454738 vs.安慰剂（通过EASI-75测量）治疗中重度AD受试者（生物制剂和小分子药物初治）的有效性次要比较LY3454738 vs.安慰剂（通过体征和症状的改善情况评价）治疗中重度AD受试者（生物制剂和小分子药物初治）的有效性描述LY3454738在中重度AD受试者中的PK特征;描述在中重度AD受试者中观察到的LY3454738安全性

开始日期2023-08-08

申办/合作机构

礼来苏州制药有限公司

[+2]

NCT05911841 / Recruiting临床2期

A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52 Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).

开始日期2023-06-21

申办/合作机构

Eli Lilly & Co.

100 项与 Ucenprubart 相关的临床结果

登录后查看更多信息

100 项与 Ucenprubart 相关的转化医学

登录后查看更多信息

100 项与 Ucenprubart 相关的专利（医药）

登录后查看更多信息

项与 Ucenprubart 相关的文献（医药）

2023-07-01·Journal of leukocyte biology

CD200Fc limits dendritic cell and B-cell activation during chronic allergen exposures.

Article

作者: Courtemanche, Olivier ; Marsolais, David ; Bissonnette, Elyse Y ; Patoine, Dany ; Huppé, Carole-Ann ; Blais-Lecours, Pascale ; Bouchard, Karine ; Lauzon-Joset, Jean-Francois

Allergic asthma is a chronic inflammatory disease characterized by Th2, conventional dendritic cell, and B-cell activation. In addition to excessive inflammation, asthma pathogenesis includes dysregulation of anti-inflammatory pathways, such as the CD200/CD200R pathway. Thus, we investigated whether a CD200R agonist, CD200Fc, could disrupt the inflammatory cascade in chronic allergic asthma pathogenesis using a mice model of experimental asthma. Mice were exposed to house dust mites for 5 wk, and CD200Fc treatment was initiated after chronic inflammation was established (starting on week 4). We demonstrate that chronic house dust mite exposure altered CD200 and CD200R expression on lung immune cell populations, including upregulation of CD200 on alveolar macrophages and reduced expression of CD200 on conventional dendritic cells. CD200Fc treatment does not change bronchoalveolar cellular infiltration, but it attenuates B-cell activation and skews the circulating immunoglobulin profile toward IgG2a. This is accompanied by reduced activation of conventional dendritic cells, including lower expression of CD40, especially on conventional dendritic cell subset 2 CD200R+. Furthermore, we confirm that CD200Fc can directly modulate conventional dendritic cell activation in vitro using bone marrow-derived dendritic cells. Thus, the CD200/CD200R pathway is dysregulated during chronic asthma pathogenesis, and the CD200R agonist modulates B-cell and dendritic cell activation but, in our chronic model, is not sufficient to alter inflammation measured in bronchoalveolar lavage.

2023-01-01·Immunotherapy advances

Combination CD200R/PD-1 blockade in a humanised mouse model.

Article

作者: Fellermeyer, Martin ; Cornall, Richard J ; Davis, Simon J ; Paluch, Christopher ; Gileadi, Uzi ; Anzilotti, Consuelo

There is an increasing number of immune-checkpoint inhibitors being developed and approved for cancer immunotherapy. Most of the new therapies aim to reactivate tumour-infiltrating T cells, which are responsible for tumour killing. However, in many tumours, the most abundant infiltrating immune cells are macrophages and myeloid cells, which can be tumour-promoting as well as tumouricidal. CD200R was initially identified as a myeloid-restricted, inhibitory immune receptor, but was subsequently also found to be expressed within the lymphoid lineage. Using a mouse model humanised for CD200R and PD-1, we investigated the potential of a combination therapy comprising nivolumab, a clinically approved PD-1 blocking antibody, and OX108, a CD200R antagonist. We produced nivolumab as a murine IgG1 antibody and validated its binding activity in vitro as well as ex vivo. We then tested the combination therapy in the immunogenic colorectal cancer model MC38 as well as the PD-1 blockade-resistant lung cancer model LLC1, which is characterised by a large number of infiltrating myeloid cells, making it an attractive target for CD200R blockade. No significant improvement of overall survival was found in either model, compared to nivolumab mIgG1 monotherapy. There was a trend for more complete responses in the MC38 model, but investigation of the infiltrating immune cells failed to account for this. Importantly, MC38 cells expressed low levels of CD200, whereas LLC1 cells were CD200-negative. Further investigation of CD200R-blocking antibodies in tumours expressing high levels of CD200 could be warranted.

2021-12-01·Molecular therapy oncolytics2区 · 医学

Local adenoviral delivery of soluble CD200R-Ig enhances antitumor immunity by inhibiting CD200-β-catenin-driven M2 macrophage

2区 · 医学

ArticleOA

作者: Choi, Kyungho ; Shin, Seung-Phil ; Kim, Jong-Kwang ; Goh, A-Ra ; Kim, Seok-Jun ; Jung, Yuh-Seog ; Lee, Sang-Jin ; Park, Eun-Jung ; Kang, Hyeon-Gu ; Bae, Yong-Soo ; Ju, Ji-Min

CD200 is known as an immune checkpoint molecule that inhibits innate immune cell activation. Using a head and neck squamous cell carcinoma (HNSCC) model, we sought to determine whether localized delivery of adenovirus-expressing sCD200R1-Ig, the soluble extracellular domain of CD200R1, enhances antitumor immunity. Mouse-derived bone marrow cells and M1/M2-like macrophages were cocultured with tumor cells and analyzed for macrophage polarization. As an in vivo model, C57BL/6 mice were subcutaneously injected with MEER/CD200^High cells, CD200-overexpressing mouse HNSCC cells. Adenovirus-expressing sCD200R1-Ig (Ad5sCD200R1) was designed, and its effect was tested. Components in the tumor-immune microenvironment (TIME) were quantified using flow cytometry. CD200 promoted tumor growth and induced the expression of immune-related genes, especially macrophage colony-stimulating factor (M-CSF). Interestingly, CD200 induced M2-like polarization both in vitro and in vivo. Consequently, CD200 recruited more regulatory T (Treg) cells and fewer CD8⁺ effector T cells. These effects were effectively abolished by local injection of Ad5sCD200R1. These protumor effects of CD200 were driven through the β-catenin/NF-κB/M-CSF axis. CD200 upregulated PD-L1, and the combined targeting of CD200 and PD-1 thus showed synergy. The immune checkpoint CD200 upregulated immune-related genes through β-catenin signaling, reprogrammed the TIME, and exerted protumor effects. Ad5sCD200R1 injection could be an effective targeted strategy to enhance antitumor immunoediting.

项与 Ucenprubart 相关的新闻（医药）

2024-07-09

·医药观澜

32亿美元收购！盘点礼来10多款免疫学管线中国研发进展

业内传来一条重磅消息，礼来公司（Eli Lilly and Company）将以总额约32亿美元收购生物医药公司Morphic Holding，后者主打项目在研口服整合素疗法正在开发用以治疗炎症性肠病（IBD）。公开信息显示，这是礼来2024年披露的首笔生物技术公司收购，此次收购将扩展礼来的免疫学管线。这一新闻备受行业瞩目。自身免疫疾病是以局部或全身性异常炎症免疫反应为特征的炎症免疫性疾病，全球患者人群和药物规模都在增加，是当前全球生物医药产业的热门研发领域之一。免疫学也是礼来公司布局的四大核心领域之一。本文将基于公开资料盘点下礼来公司的免疫学研发管线，以及这些管线在中国的研发进展。根据礼来官网披露的管线信息，该公司在免疫学领域有诸多布局，靶点涉及JAK、IL-17和IL-23、PD-1、CD19、RIPK1等等。除了已获批上市的JAK1/2抑制剂巴瑞替尼、IL-17单抗依奇珠单抗、IL-23p19拮抗剂mirikizumab、IL-13特异性抗体lebrikizumab，还有10多款临床在研的免疫学研发管线，治疗领域涉及类风湿关节炎、斑秃、特应性皮炎、银屑病等。在中国，依奇珠单抗注射液和巴瑞替尼片也已经获批上市。 Mirikizumab：一款人源化IgG4单克隆抗体，可与IL-23的p19亚基结合，阻断IL-23介导的炎症反应。2023年10月，美国FDA批准该产品用于治疗中重度活动性溃疡性结肠炎（UC）成人患者。根据礼来此前新闻稿，这是首个用于治疗这一患者群体的IL-23p19拮抗剂。此外，今年5月，礼来宣布mirikizumab治疗中重度克罗恩病的关键3期研究取得积极结果，礼来已经向FDA递交该产品针对克罗恩病的新适应症上市申请。在中国，mirikizumab注射液已经被NMPA纳入突破性治疗品种，拟开发用于治疗中重度活动性克罗恩病成人患者。其在中国已经完成了针对克罗恩病的3期临床研究患者招募工作。 Lebrikizumab：一款由Almirall公司和礼来联合开发的IL-13特异性抗体疗法，礼来拥有在欧洲以外全球其他地区的独家开发和商业化权利。Lebrikizumab于2023年11月在欧盟获得批准上市，用于青少年和成人中度至重度特应性皮炎患者。该产品已经展示出短期和长期的有效性和安全性，且维持剂量为每月一次。在中国，礼来已启动lebrikizumab注射液治疗中重度特应性皮炎的国际多中心（含中国）3期临床研究。 Peresolimab：一款PD-1激动剂抗体疗法，正在研究用于治疗类风湿性关节炎和其他自身免疫性疾病。该产品可与人类PD-1结合并作为其激动剂，抑制淋巴细胞的激活和扩增，从而恢复免疫调节，有望成为一种治疗自身免疫性疾病或自身炎症性疾病患者的新方法。2023年5月，该产品治疗难治性类风湿关节炎的2a期研究发表于《新英格兰医学杂志》（NEJM）。在中国，研究人员正在开展该产品治疗类风湿关节炎的国际多中心（含中国）2b期临床研究。 DC-806：礼来以约24亿美元收购DICE公司获得的一款口服银屑病（又称牛皮癣）疗法，为一款细胞因子白细胞介素（IL）-17A的小分子抑制剂。据悉，DICE公司专有的技术平台旨在开发能够影响蛋白-蛋白相互作用（PPI）的创新口服小分子药物，这类药物能够改变蛋白整体结构，且影响PPI的效果与抗体类药物相当。目前，公开信息尚未查阅到该药物在中国的注册进展。 LY3972406：一款离子通道蛋白Kv1.3的高选择性小分子抑制剂，目前正在研究用于治疗银屑病。2022年6月，礼来与D. E. Shaw Research公司达成合作，获得了后者在研的高选择性离子通道蛋白Kv1.3靶向治疗药物用于治疗免疫和炎症性疾病在全球的临床开发和商业化权利，并支付6000万美元的首付款及4.75亿美元后续里程碑付款。Kv1.3是一种参与效应记忆T（TEM）细胞激活和增殖的特殊离子通道，TEM细胞是许多自身免疫性疾病及某些罕见癌症的根源。目前，公开信息尚未查阅到该药物在中国的注册进展。 LY3541860：一款抑制B细胞活性的新型非耗竭CD19抗体，拟开发治疗多发性硬化。B细胞参与自身免疫性疾病的多个方面，B细胞靶向治疗已被证明对多种自身免疫性疾病有效。根据文献报道，研究表明LY3541860是一种高效的B细胞抑制剂，在治疗自身免疫性疾病时，可能比目前可用的B细胞靶向疗法疗效更佳，且不会导致B细胞耗竭。目前，公开信息尚未查阅到该药物在中国的注册进展。 Eltrekibart（LY3041658）：一款单抗疗法，可中和与CXCR1或CXCR2受体结合的趋化因子，目前正在研究用于治疗化脓性汗腺炎。据文献报道，CXCR1和CXCR2信号在中性粒细胞迁移、血管生成和肿瘤发生中起着关键作用。人体中共有7种趋化因子通过这些受体发出信号，组成了ELR+CXC趋化因子家族。为了充分拮抗CXCR1和CXCR2信号，有效的治疗方法应该阻断两种受体或全部七种配体。Eltrekibart正是一款可中和所有7种人和食蟹猴ELR+CXC趋化因子的单抗疗法。目前，公开信息尚未查阅到该药物在中国的注册进展。 Ocadusertib（LY3871801）：靶向RIPK1的小分子药物，正在研究用于治疗类风湿性关节炎。受体相互作用蛋白激酶1（RIPK1）是肿瘤坏死因子受体信号通路中的关键性信号蛋白，它能调节全身组织中的炎症和细胞死亡。目前，公开信息尚未查阅到该药物在中国的注册进展。 Ucenprubart（LY3454738）：一款免疫检查点受体蛋白激动剂，为一种靶向激活CD200R的单克隆抗体，正在被开发用于治疗特应性皮炎和其他自身免疫性疾病。CD200R在先天和适应性免疫细胞表面表达，激活这一受体可以降低细胞因子的释放和减少细胞增生。根据中国药物临床试验登记与信息公示平台官网，礼来已经在中国启动了该产品的国际多中心2期研究，评估其针对中重度特应性皮炎成人患者的疗效和安全性。除了以上产品，礼来还有几款免疫领域产品处于1期研究阶段，已披露的产品包括了DC853（小分子新药）、GITR拮抗剂、衣康酸盐类似物（Itaconate Mimetic）等。参考资料： [1] Lilly to Acquire Morphic to Improve Outcomes for Patients with Inflammatory Bowel Disease. Retrieved July 8, 2024 from https://www.prnewswire.com/news-releases/lilly-to-acquire-morphic-to-improve-outcomes-for-patients-with-inflammatory-bowel-disease-302190489.html [2]礼来官网管线信息. From https://www.lilly.com/discovery/clinical-development-pipeline# [3]中国药物临床试验登记与信息公示平台官网. From http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml 内容来源于网络，如有侵权，请联系删除。

并购上市批准

2024-06-05

·GlobeNewswire-Health Care

Arcutis Announces Multiple Abstracts, Including Oral Presentation, Accepted at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference

New long-term safety and efficacy data of investigational roflumilast cream 0.15% in mild to moderate atopic dermatitis will be presented in an oral sessionPreclinical data on ARQ-234, CD200R agonist, for the treatment of atopic dermatitisAdditional presentation of the consistent tolerability profile of topical roflumilast in psoriasis, seborrheic dermatitis, and atopic dermatitis WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that five abstracts will be presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference, which will take place in Chicago, IL from June 8-10, 2024. Among these presentations will be new long-term safety and efficacy data for roflumilast cream 0.15% in patients ≥6 years of age with mild to moderate atopic dermatitis, and an encore of preclinical data on ARQ-234, a CD200 receptor agonist the Company is investigating for atopic dermatitis. In addition, the Company will present investigator- and patient-rated local tolerability data evaluating topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. “We are committed to providing therapeutic innovation and advancing the standard of care for those living with chronic, immune-mediated skin diseases and look forward to sharing these exciting scientific findings including data for roflumilast cream for adults and children with atopic dermatitis from our INTEGUMENT program,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “We also look forward to sharing preclinical data from our pipeline for ARQ-234, a biologic we are developing for the treatment of atopic dermatitis.” Presentation details follow: Oral Poster PresentationLong-term Safety and Efficacy of Roflumilast Cream 0.15% in Adults and Children Aged ≥6 Years With Mild to Moderate Atopic Dermatitis:A 52-week, Phase 3, Open-Label Safety TrialPresenting Author: Melinda Gooderham, MD, FRCPCTime: June 10, 1:30 pm CTAbstract number: 634 The following posters will be electronically available for the entirety of the conference and online beginning Saturday, June 8, 2024 at 6:00 pm CT. Pooled Efficacy, Patient-Reported Outcomes, and Safety of Roflumilast Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Clinical Trials of Adults and Children With Atopic DermatitisSimpson, E et al.ePoster 641 Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients 2 to 5 Years of Age with Mild to Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled TrialEichenfield, L et al.ePoster 639 ARQ-234: a high affinity CD200-Fc fusion protein for the treatment of atopic dermatitisSheridan, J et al.ePoster 637 Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitisBunick, C et al.ePoster 640 About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including two FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. INDICATIONSZORYVE cream is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE cream include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE foam include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream. Forward-Looking StatementsArcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for topical roflumilast to advance the standard of care in inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Investor Relationslvairavan@arcutis.com

临床3期

2023-06-03

·CPHI制药在线

贝达1类新药甲磺酸贝福替尼胶囊获批；君圣泰向港交所递交上市申请 | CPHI制药在线一周药闻复盘

点击蓝字关注我们本周，审评审批方面，比较热闹，多个药取得关键进展，最值得关注的就是贝达1类新药、第三代EGFR-TKI甲磺酸贝福替尼胶囊获批上市，同时，多个5.1类化药也获批上市，比如亿腾医药1.69亿美元引进的二十碳五烯酸乙酯软胶囊以及北海康成引进的IBAT抑制剂氯马昔巴特口服溶液均获批；研发来说，进展不是很多，但优卡迪CAR-T产品值得关注，最新临床数据显示，完全缓解率超95%；看看交易及投融资，贝达药业引进BiDAC降解剂，总交易额高达4亿美元；上市方面，君圣泰向港交所递交上市申请。本期盘点包括审评审批、研发、交易及投融资和上市4大板块，统计时间为5.29-6.2，包含26条信息。审评审批NMPA上市批准 1、5月30日，NMPA官网显示，康哲药业3.1类生物制品替瑞奇珠单抗注射液（tildrakizumab）获批上市，用于治疗适合接受系统治疗的中度至重度斑块状银屑病成人患者。替瑞奇珠单抗注射液为一款特异性靶向IL-23的新型单克隆抗体，2019年6月，康哲药业通过与Sun Pharma合作获得了在大中华地区开发、销售等的许可权利。2、5月30日，NMPA官网显示，正大天晴3.3类生物制品利妥昔单抗注射液（代号：TQB2303）获批上市，用于治疗弥漫性大B细胞淋巴瘤（DLBCL）初治患者。TQB2303是一款抗CD20单克隆抗体，属于利妥昔单抗生物类似药，原研公司为罗氏，已获批治疗非霍奇金淋巴瘤、慢性淋巴细胞白血病、滤泡性淋巴瘤维持治疗、类风湿性关节炎（RA）等适应症。3、5月30日，NMPA官网显示，赛诺菲3.1类生物制品度普利尤单抗注射液（商品名：达必妥）新适应症获批，用于6个月至5岁患有中重度特应性皮炎（AD）的婴幼儿。度普利尤单抗是由赛诺菲和再生元联合开发的一种全人源化单克隆抗体，可以抑制IL-4和IL-13蛋白的信号传导。4、5月31日，NMPA官网显示，贝达药业1类化药甲磺酸贝福替尼胶囊（代号：BPI-D0316）获批上市，用于治疗既往使用EGFR-TKI耐药后产生T790M突变的局部晚期或转移性非小细胞肺癌。贝福替尼是贝达药业自主研发的一款针对T790M突变的第三代EGFR-TKI。5、5月31日，NMPA官网显示，勃林格殷格翰、礼来5.1类化药恩格列净片（商品名：欧唐静）新适应症获批，用于联合胰岛素治疗（伴或不伴口服降糖药），在饮食和运动基础上改善2型糖尿病患者血糖控制。该药是一种口服、每日一次、高选择性SGLT2抑制剂，已在国内获批治疗成人2型糖尿病、射血分数降低的成人心力衰竭和射血分数保留的成人心力衰竭等。6、6月1日，NMPA官网显示，亿腾子公司西克罗制药5.1类化药二十碳五烯酸乙酯软胶囊获批上市，用于降低重度高甘油三酯血症（≥500mg/dL）成年患者的甘油三酯（TG）水平（VHTG）。该药是Amarin开发的一款含高度纯化活性成分二十碳五烯酸乙酯（IPE）的单分子处方药，已获FDA批准上市，商品名为Vascepa，亿腾拥有在大中华区的开发及商业化权利。7、6月2日，NMPA官网显示，北海康成5.1类化药氯马昔巴特口服溶液（maralixibat，代号：CAN108）获批上市，用于治疗1岁及以上Alagille综合征（阿拉杰里综合征）患者胆汁淤积性瘙痒。CAN108是Mirum Pharmaceuticals公司开发的一种口服、每日一次的回肠胆汁酸转运蛋白（IBAT）抑制剂。8、6月2日，NMPA官网显示，葛兰素史克5.1化药多替拉韦钠分散片（dolutegravir，商品名：Tivicay）获批上市，用于治疗儿科HIV-1感染。多替拉韦（dolutegravir，商品名：Tivicay）是一款HIV整合酶抑制剂，可以通过阻止病毒DNA整合至人体免疫细胞的遗传物质来阻断HIV的复制。9、6月2日，NMPA官网显示，齐鲁制药4类化药阿普米司特片获批上市，用于治疗符合接受光疗或系统治疗指征的中度至重度斑块状银屑病的成人患者，这是国内第二款获批上市的阿普米司特仿制药。阿普米司特是一种口服小分子磷酸二酯酶4（PDE4）抑制剂，原研公司为安进。10、6月2日，NMPA官网显示，扬子江3类化药帕拉米韦注射液获批上市，用于治疗甲乙型流感。原研帕拉米韦是一款环戊类抗流感病毒药物，原研公司为Biocryst Pharmaceuticals，于2014年获FDA批准上市，是FDA唯一批准的抗流感注射剂。申请11、5月30日，CDE官网显示，施贝康生物1类新药sbk002片递交上市申请并获受理，拟用于治疗预防动脉粥样硬化血栓形成事件，如：近期心肌梗死患者、急性冠脉综合征的患者、缺血性卒中患者或确诊外周动脉性疾病的患者。临床批准 12、5月29日，CDE官网显示，安进1类生物制品tarlatamab获批临床，拟用于治疗接受含铂一线化疗后的复发性小细胞肺癌患者。tarlatamab是一款靶向DLL3和CD3的双特异性T细胞衔接蛋白（BiTE），正在海外开展治疗小细胞肺癌的Ⅲ期临床试验，百济神州拥有该药的中国商业化权益。13、5月29日，CDE官网显示，礼来1类生物制品LY3454738注射液获批临床，拟用于治疗特应性皮炎。LY3454738是该公司在研的免疫检查点受体蛋白激动剂，为一种靶向激活CD200R的单克隆抗体。14、5月29日，CDE官网显示，海正药业1类新药HS336片获批临床，拟用于治疗晚期实体瘤，如食管鳞状细胞癌（ESCC）、头颈部鳞状细胞癌（HNSCC）、非小细胞肺癌（NSCLC）、结直肠癌（CRC）等。HS336是一种SHP2小分子抑制剂。15、5月30日，CDE官网显示，泰诺麦博1类生物制品TNM006注射液获批临床，拟用于预防器官移植后巨细胞病毒感染。TNM006注射液是泰诺麦博利用其第四代抗体研发技术获得的一款重组抗人巨细胞病毒天然全人源单克隆抗体。16、5月30日，CDE官网显示，赛诺菲1类生物制品注射用SAR443579获批临床，拟用于治疗12岁及以上复发/难治性恶性血液病。SAR443579是一款单克隆抗体，也是一款基于NKp46/CD16的NK细胞接合剂，靶向肿瘤抗原CD123。17、5月30日，CDE官网显示，康佰裕1类生物制品CBG002 CAR-T细胞注射液获批临床，拟用于治疗复发/难治性多发性骨髓瘤。这是一款使用临床级规模化生产的精纯逆转录病毒制备的新一代CAR-T细胞疗法。FDA上市批准18、5月31日，FDA官网显示，阿斯利康的PARP抑制剂奥拉帕利（商品名：Lynparza）的补充新药申请（sNDA）获FDA批准，用于联合阿比特龙和泼尼松或泼尼松龙一线治疗携带BRCA突变（BRCAm）的转移性去势抵抗性前列腺癌（mCRPC）成年患者。该适应症已于2022年12月在欧盟获批。研发临床状态19、5月29日，药物临床试验登记与信息公示平台显示，兰州生物制品研究所、国药中生生物技术研究院、北京生物制品研究所联合启动一项重组诺如病毒双价（GI.1/GII.4）疫苗的Ⅲ期临床试验，针对适应症为预防由GI.1型和GII.4型诺如病毒感染引起的中/重度急性胃肠炎。该试验拟在中国境内入组8000人。20、5月31日，药物临床试验登记与信息公示平台显示，维亚臻在研1类新药VSA001注射液针对适应症为家族性乳糜微粒血症综合征（FCS）成人患者在北京大学第三医院顺利完成首例受试者给药。VSA001是一款小干扰RNA（siRNA）药物。临床数据21、5月29日，康方生物旗下子公司康融东方在EAS 2023上公布了伊努西单抗（AK102）治疗原发性高胆固醇血症和混合型高脂血症患者的一项关键Ⅲ期研究成果。结果显示，该产品可有效降低低密度脂蛋白胆固醇（LDL-C）水平，结果具有显著的临床意义和统计学差异，且整体安全性佳。伊努西单抗是一款针对PCSK9的新型全人源IgG1单克隆抗体。22、5月30日，优卡迪与苏州大学附属第一医院吴德沛/唐晓文教授团队在Blood Cancer J.上公布了串联CD19/CD22 CAR-T细胞治疗急性淋巴细胞白血病的单中心Ⅰ/Ⅱ期临床研究结果。结果显示，串联CD19/CD22 CAR-T细胞治疗比单纯CD19 CAR-T细胞治疗可获得更好的临床效果，且与序贯CD19/CD22 CAR-T细胞治疗效果相似。23、5月30日，辉瑞公布了marstacimab（PF-06741086）治疗A型以及B型血友病的关键Ⅲ期BASIS临床研究（NCT03938792）结果。结果显示，该研究已达到主要终点，能够显著降低重度A型血友病以及中重度B型血友病患者的年出血率（ABR）。交易及投融资24、5月30日，贝达药业宣布与C4 Therapeutics达成合作，引进CFT8919项目。根据协议，贝达前期将向C4 支付3500万美元，以及最多达3.57亿美元的里程碑付款总额、CFT8919在授权地区约定比例的销售提成等。CFT8919是一种具有口服生物利用度的变构BiDAC降解剂，对携带EGFR L858R突变具有良好的活性和选择性。25、6月2日，英派药业宣布与Eikon Therapeutics达成合作，就IMP1734及其他PARP1选择性抑制剂签订独家授权及合作协议。根据协议，Eikon获得除大中华区以外所有区域内独家开发、生产和商业化的权利。IMP1734是英派药业自主研发的高选择性PARP1抑制剂，预计将于2023年进入Ⅰ期临床试验。上市港交所26、5月30日，香港证券交易所官网显示，君圣泰医药已递交IPO申请并获受理。君圣泰成立于2011年，创始人及首席执行官为刘利平博士，目前，该公司产品管线中已有2款产品进入临床开发阶段，分别是口服多功能小分子药物HTD1801及TLR4抑制剂HTD4010。【企业推荐】智药研习社近期课程报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准免疫疗法细胞疗法生物类似药

100 项与 Ucenprubart 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
特应性皮炎	临床2期	美国	Eli Lilly & Co.	2023-06-21
特应性皮炎	临床2期	中国	Eli Lilly & Co.	2023-06-21
特应性皮炎	临床2期	日本	Eli Lilly & Co.	2023-06-21
特应性皮炎	临床2期	加拿大	Eli Lilly & Co.	2023-06-21
特应性皮炎	临床2期	匈牙利	Eli Lilly & Co.	2023-06-21
特应性皮炎	临床2期	墨西哥	Eli Lilly & Co.	2023-06-21
特应性皮炎	临床2期	波兰	Eli Lilly & Co.	2023-06-21
特应性皮炎	临床2期	韩国	Eli Lilly & Co.	2023-06-21
特应性皮炎	临床2期	中国台湾	Eli Lilly & Co.	2023-06-21
慢性荨麻疹	临床2期	美国	Eli Lilly & Co.	2019-11-15

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EADV2022	临床1期	特应性皮炎	40	LY3454738 500 mg	廠範網艱淵蓋鏇鹽鑰淵(艱簾餘餘壓壓獵顧願艱) = 願鹹繭艱襯憲憲糧簾獵糧繭膚選網壓繭鏇壓襯 (簾鹽襯繭窪憲壓艱鹹製 ) 更多	-	2022-09-07
				Placebo	廠範網艱淵蓋鏇鹽鑰淵(艱簾餘餘壓壓獵顧願艱) = 壓製獵膚網艱網廠鏇鏇糧繭膚選網壓繭鏇壓襯 (簾鹽襯繭窪憲壓艱鹹製 ) 更多