预约演示
更新于：2024-12-27
Crovalimab
可伐利单抗
更新于：2024-12-27
概要
基本信息
药物类型 单克隆抗体 |
别名 Complement c5 inhibitory humanized recycling monoclonal antibody (rg-6107 )、Crovalimab (genetical recombination) (JAN)、Crovalimab (USAN/INN) + [18] |
靶点 |
作用机制 C5抑制剂(补体C5抑制剂) |
在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-02-06), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、突破性疗法 (中国) |
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结构/序列
Sequence Code 26187541H
来源: *****
Sequence Code 229613448L
来源: *****
关联
16
项与 可伐利单抗 相关的临床试验CTR20212792
一项在儿童非典型溶血尿毒综合征（aHUS）患者中评价CROVALIMAB的有效性、安全性、药代动力学和药效学的III期、多中心、单臂研究
本研究将评价 crovalimab 治疗非典型溶血尿毒综合征（aHUS）儿童患者的有 效性、安全性、免疫原性、药代动力学和药效学。
开始日期2023-12-19 |
申办/合作机构 |
NCT05494619
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Patients With Guillain-Barré Syndrome
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab compared with placebo as an add-on therapy to intravenous immunoglobulin (IVIg) in participants with severe GBS.
开始日期2022-11-30 |
申办/合作机构 |
CTR20211368
一项在成人和青少年非典型溶血尿毒综合征（aHUS）患者 中评价 CROVALIMAB 的有效性、安全性、药代动力学和药效学的 III 期、多中心、单臂研究
本研究将评 crovalimab治疗非典型溶血尿毒综合征（aHUS）成人和青少年患者的有效性、安全性、免疫原性、药代动力学和药效学
开始日期2022-05-05 |
申办/合作机构 |
100 项与 可伐利单抗 相关的临床结果
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100 项与 可伐利单抗 相关的转化医学
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100 项与 可伐利单抗 相关的专利（医药）
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29
项与 可伐利单抗 相关的文献（医药）2024-09-01·AMERICAN JOURNAL OF HEMATOLOGY
Phase 3 randomized COMMODORE 1 trial: Crovalimab versus eculizumab in complement inhibitor‐experienced patients with paroxysmal nocturnal hemoglobinuria
Article
作者: Patel, Himika ; Hus, Marek ; Bonito, Debora ; Nur, Erfan ; Clé, Diego Villa ; Edwards, John ; Ueda, Yasutaka ; Sreckovic, Sasha ; Scheinberg, Phillip ; Panse, Jens ; Yenerel, Mustafa N. ; Lekue, Cristina Barrenetxea ; Kulasekararaj, Austin G. ; Gentile, Brittany ; Barcellini, Wilma ; Kiialainen, Anna ; Giai, Valentina ; Kim, Jin Seok ; Buatois, Simon ; Lee, YooJin ; Uguen, Marianne ; Nagy, Zsolt
Abstract:
Crovalimab, a novel C5 inhibitor, allows for low‐volume, every‐4‐ week, subcutaneous self‐administration. COMMODORE 1 (NCT04432584) is a phase 3, global, randomized trial evaluating crovalimab versus eculizumab in C5 inhibitor‐experienced patients with paroxysmal nocturnal hemoglobinuria (PNH). Adults with lactate dehydrogenase ≤1.5 × upper limit of normal and receiving approved eculizumab doses for ≥24 weeks were randomized 1:1 to receive crovalimab (weight‐based tiered dosing) or continue eculizumab. The original primary study objective was efficacy; however, given the evolving treatment landscape, target recruitment was not met, and all efficacy endpoints became exploratory, with safety as the new primary objective. Exploratory efficacy endpoints included transfusion avoidance, hemolysis control, breakthrough hemolysis, hemoglobin stabilization, FACIT‐Fatigue score, and patient preference (crovalimab vs. eculizumab). Eighty‐nine patients were randomized (45 to crovalimab; 44 to eculizumab). During the 24‐week primary treatment period, adverse events (AEs) occurred in 77% of patients receiving crovalimab and 67% receiving eculizumab. No AEs led to treatment withdrawal or death, and no meningococcal infections occurred. 16% of crovalimab‐treated patients had transient immune complex reactions (also known as Type III hypersensitivity events), an expected risk when switching between C5 inhibitors that bind to different C5 epitopes; most were mild/moderate and all resolved without treatment modification. Crovalimab‐treated patients had sustained terminal complement activity inhibition, maintained disease control, and 85% preferred crovalimab over eculizumab. Together with phase 3 COMMODORE 2 results in complement inhibitor‐naive patients, these data support crovalimab's favorable benefit–risk profile. Crovalimab is a new C5 inhibitor for PNH that is potentially less burdensome than existing therapies for this lifelong disease.
2024-09-01·AMERICAN JOURNAL OF HEMATOLOGY
Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition
Article
作者: Sun, Jing ; Kelly, Richard J. ; Röth, Alexander ; Rojnuckarin, Ponlapat ; Buatois, Simon ; Beveridge, Leigh ; Chai‐Adisaksopha, Chatree ; Silva, Fernando ; Risitano, Antonio ; Wang, Xiaoqin ; Nishimura, Jun‐ichi ; Brodsky, Andres ; Lee, Je‐Hwan ; Hantaweepant, Chattree ; Jang, Jun Ho ; He, Guangsheng ; Gaya, Anna ; Dumagay, Teresita E. ; Tong, Hongyan ; Obara, Naoshi ; Lundberg, Pontus ; Han, Bing ; Lin, Zenghua ; Chebon, Sammy ; Höglund, Martin ; Sreckovic, Sasha ; Demichelis‐Gómez, Roberta ; Gentile, Brittany
Abstract:
Crovalimab is a novel C5 complement inhibitor that enables rapid and sustained C5 inhibition with subcutaneous, low‐volume self‐administration every 4 weeks. COMMODORE 2 (NCT04434092) is a global, randomized, open‐label, multicenter, phase 3 trial evaluating the non‐inferiority of crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria not previously treated with C5 inhibition. C5 inhibitor‐naive patients with lactate dehydrogenase (LDH) ≥2 × upper limit of normal (ULN) were randomized 2:1 to crovalimab or eculizumab. Co‐primary efficacy endpoints were proportion of patients with hemolysis control (centrally assessed LDH ≤1.5 × ULN) and proportion with transfusion avoidance. Secondary efficacy endpoints were proportions of patients with breakthrough hemolysis, stabilized hemoglobin, and change in FACIT‐Fatigue score. The primary treatment period was 24 weeks. Two hundred and four patients were randomized (135 crovalimab; 69 eculizumab). Crovalimab was non‐inferior to eculizumab in the co‐primary endpoints of hemolysis control (79.3% vs. 79.0%; odds ratio, 1.0 [95% CI, 0.6, 1.8]) and transfusion avoidance (65.7% vs. 68.1%; weighted difference, −2.8 [−15.7, 11.1]), and in the secondary efficacy endpoints of breakthrough hemolysis (10.4% vs. 14.5%; weighted difference, −3.9 [−14.8, 5.3]) and hemoglobin stabilization (63.4% vs. 60.9%; weighted difference, 2.2 [−11.4, 16.3]). A clinically meaningful improvement in FACIT‐Fatigue score occurred in both arms. Complete terminal complement activity inhibition was generally maintained with crovalimab. The safety profiles of crovalimab and eculizumab were similar with no meningococcal infections. Most patients who switched from eculizumab to crovalimab after the primary treatment period preferred crovalimab. These data demonstrate the positive benefit–risk profile of crovalimab.
2024-07-01·Kidney International Reports
A Cell-Based Assay to Measure the Activity of the Complement Convertases
Article
作者: Stasiłojć, Małgorzata ; Kuźniewska, Alicja ; Stasiłojć, Grzegorz ; Rodriguez de Córdoba, Santiago ; Okrój, Marcin
Introduction:
The complement system serves as a crucial defense mechanism against invading pathogens; however, dysregulation of this system can result in harmful consequences. Central to the complement cascade are the classical pathway (CP) or lectin pathway (LP) and the alternative pathway (AP) convertases. Aberrant regulation of the convertases is often implicated in the development of rare complement-related diseases. However, analyzing convertase activity poses a significant challenge due to their labile nature and intricate interactions with serum proteins.
Methods:
In this study, we propose a novel assay for the functional evaluation of these complexes. Our approach leverages a widely available human lymphoma cell line, which when sensitized with antibodies, triggers activation of the CP with a substantial amplification by the AP. The combined action of 2, C5 blockers eculizumab and crovalimab let the cascade proceed up to the level of convertases but not further. In the next step, C5 inhibitors were washed away and guinea pig serum in ethylenediamine tetraacetic acid (EDTA) buffer supported the development of lytic sites on the platform of preexisting convertases.
Results:
The assay detects recombinant gain-of-function (GoF) components of both convertase types within human serum or plasma. Furthermore, we demonstrate the assay's practical utility in analyzing nephrological patients harboring C3 genetic variants and illustrate its capacity to distinguish between patients and asymptomatic relatives carrying the same pathogenic C3 variant.
Conclusion:
We provided a proof-of-concept of a new assay that detects convertase overactivity in individuals carrying variants of both pathogenic character or those of unknown significance in ubiquitous complement proteins such as C3.
196
项与 可伐利单抗 相关的新闻（医药）2024-12-24
启动 III 期临床，意味着新药研发距离上市又近了一大步。12月（数据范围 12.1-12.23），多款国产创新药进入关键 III 期临床，涉及 GLP-1、GIP 和 TSLP 等一些明星靶点。这些新药进展来自恒瑞、正大天晴、甘李药业、博瑞医药等企业，我们从中选择部分重点项目跟大家分享。
正大天晴 TQC2731
12 月 3 日，正大天晴在国内启动了一项多中心、随机、双盲、安慰剂对照的 III 期临床试验，主要目的是评价 TQC2731 注射液（Bosakitug）在控制不佳的重度哮喘患者中的有效性和安全性。
截图来源：Insight 数据库
TQC2731 是博奥信原研的一款人源化单克隆抗体，靶向胸腺基质淋巴细胞生成素（TSLP），阻止 TSLP 靶向的免疫细胞释放促炎细胞因子。
2017 年，博奥信和正大天晴就 TQC2731 签署合作开发协议，正大天晴获得大中华区的开发和商业化权利。2024 年 11 月，Aclaris Therapeutics 获得此药和 BSI-502 在大中华区以外的全球开发及商业化权利，作为回报，博奥信将获得超过 4000 万美元的现金付款和超过 9 亿美元的开发及销售里程碑付款以及单位数比例的销售分成。
目前，该药的在研适应症除了哮喘以外，还在开展鼻窦炎、鼻息肉、慢性阻塞性肺疾病和特应性皮炎的研究。其中特应性皮炎已经在美国开启临床 II 期研究。
Insight 数据库显示，全球有 31 款 TSLP 单靶点药物处于活跃状态，仅安进的特泽利尤单抗 1 款获批上市。其中国产药物有 18 款，占比达到一半以上，但大多都处于临床早期。TQC2731 是目前国内研究进展最快的 TSLP 单靶点药物。
恒瑞 HRS-5965
12 月 4 日，恒瑞 HRS-5965 在国内启动了一项多中心、单臂、开放标签 III 期临床研究，评估 HRS-5965 胶囊对既往稳定使用 C5 补体抑制剂（依库珠单抗/可伐利单抗）后仍存在贫血的阵发性睡眠性血红蛋白尿（PNH）患者的疗效和安全性。
截图来源：Insight 数据库
此前 HRS-5965 胶囊已于今年 9 月启动了一项头对头依库珠单抗用于 PNH 的 III 期临床研究（NCT06593938）。
HRS-5965 是一种新型口服选择性补体因子 B（CFB）抑制剂，该因子是补体旁路途径的关键组成部分，通过抑制补体系统的过度激活，从而抑制补体系统介导的溶血。该药拟用于治疗 PNH、非典型溶血性尿毒症综合征、冷凝集素病等补体参与介导的溶血性贫血和 IgA 肾病、特发性膜性肾病、C3 肾病和狼疮性肾炎等补体参与介导的原发性或继发性肾小球疾病。除了 PNH 适应症以外，其他适应症均处于临床早期阶段。
恒瑞就 HRS-5965 开发了片剂和胶囊两种形式，其片剂早在 2022 年 8 月首次获批临床。2024 年 ASH 大会上，恒瑞公布了一项概念验证、多中心、随机、开放标签 II 临床研究结果（NCT06051357），评估该药片剂单药治疗未接受补体抑制剂治疗的 PNH 患者的积极研究结果。主要终点是血红蛋白从基线到第 12 周的变化。结果显示：
结果显示，在第 12 周，50 mg 和 75 mg 滴定剂量组（每日两次）的血红蛋白（Hb）水平均较基线明显升高。在没有输血的情况下，50 mg 滴定剂量组有 12 例 (100%)、75 mg 滴定剂量组有 10 例 (83.3%) 患者的血红蛋白水平较基线基线增加 ≥20 g/L。
50 mg 滴定剂量组乳酸脱氢酶（LDH）水平为 255.80 U/L，相对基线平均下降 87% ；75 mg 滴定剂量组 LDH 水平为 300.86 U/L，相对基线平均下降 85%。
博瑞医药 BGM0504
12 月 4 日，博瑞医药 BGM0504 在国内启动了两项 III 期临床，分别用于比较 BGM0504 注射液与安慰剂对仅靠饮食和运动无法充分控制的 2 型糖尿病患者的疗效和安全性（NCT06716203），以及比较 BGM0504 注射液（5 mg 或 10 mg，每周一次）与司美格鲁肽（1 mg，每周一次）作为二甲双胍和/或磺脲类药物的附加治疗对 2 型糖尿病患者的疗效和安全性（NCT06716216）。
截图来源：Insight 数据库
BGM0504 注射液是博瑞医药自主研发的 GLP-1/GIP 受体双重激动剂，可同时激活 GIP 和 GLP-1 下游通路，产生控制血糖、减重和治疗代谢功能障碍相关脂肪性肝炎（MASH，曾用名 NASH）等生物学效应，展现多种代谢疾病治疗潜力。
2024 年 8 月，博瑞医药官方公布 BGM0504 注射液与司美格鲁肽注射液在 2 型糖尿病的头对头研究（II 期，CTR202232464）中取得积极结果。
结果显示，在首要终点部分：
目标剂量给药第 12 周时，BGM0504 注射液 5 mg 组、10 mg 组、15 mg 组和司美格鲁肽注射液（1.0 mg）糖化血红蛋白（HbA1c）较基线平均降幅（扣除安慰剂）分别为 1.99%、2.21%、2.76% 和 1.71%，其中 BGM0504 注射液 15 mg 组与司美格鲁肽注射液疗效差异为 1.05%。
在次要终点部分：
目标剂量给药第 12 周时，BGM0504 注射液 5 mg 组、10 mg 组、15 mg 组和司美格鲁肽注射液控糖达标率方面（给药治疗后 HbA1c<7.0% 的受试者比例）分别为 76.9%、81.8%、91.7% 和 75%。其中中高剂量组中分别有 27.3% 和 50% 的受试者达到了糖化正常水平（HbA1c<5.7%），远高于司美格鲁肽注射液组的 12.5%。
目标剂量给药第 12 周时，体重方面，BGM0504 各剂量组与基线相比均有不同程度的降低，其中中高剂量组体重下降分别可达 4.8 kg 和 7.9 kg，司美格鲁肽注射液组下降仅为 2.7 kg。
目标剂量给药第 12 周时，BGM0504 注射液在 HbA1c/体重复合达标率方面优势明显，其中中高剂量组分别有 27.3% 和 41.7% 的受试者在使用 BGM0504 注射液后可以达到 HbA1c<6.5% 且体重同时相对基线降低 ≥10% 的水平，而司美格鲁肽注射液组仅为 6.3%。
在安全性方面，整体安全性与耐受性良好，研究过程中所发生的基本均为与同作用靶点药物类似且相关的不良事件，其中绝大多数为轻度一过性的胃肠道不良事件。
截图来源：Insight 数据库
除了 2 型糖尿病以外，肥胖适应症于 2024 年 10 月在国内进入 III 期临床阶段。值得一提的是，同适应症也于 2024 年 12 月在美国启动 I 期临床研究。
甘李药业 GZR18
12 月 11 日，甘李药业 GZR18（博凡格鲁肽）在美国启动了一项多中心、随机、双盲、平行、安慰剂对照的 III 期临床研究，旨在评估 GZR18 注射液对成年肥胖/超重受试者的疗效和安全性。
截图来源：Insight 数据库
GZR18 是一种每周注射一次的长效 GLP-1 受体激动剂类药。2021 年， GZR18 在中国和美国获得 2 型糖尿病适应症临床试验的批准。2024 年 12 月 13 日，该药获得 FDA 批准临床，适应症为肥胖/超重体重，包括伴有和不伴有 2 型糖尿病。
2024 年 11 月，甘李药业在 ObesityWeek 2024 上以口头汇报的形式，公布了 GZR18 注射液在 IIb 期临床研究（CTR20231695）的积极结果。这是一项多中心、随机、双盲、安慰剂对照、剂量探索研究。研究共纳入了 340 名经饮食运动控制不佳的成年肥胖或超重并伴有至少一种体重相关合并症的受试者。
研究结果显示，12 mg、18 mg、24 mg 、 48 mg Q2W 和 24 mg QW 组体重分别下降了 11.15%、13.22%、14.25%、17.29% 和 17.78%（vs 安慰剂组 0.99%）。在 48 mg Q2W 组中，体重减轻 ≥5%、10%、20% 的比例分别为 97.8%、82.2% 和 37.8%。
在安全性方面，GZR18 的安全性和耐受性良好。最常见的不良事件为轻度至中度的胃肠道反应。
截图来源：Insight 数据库
甘李药业就 GZR18 还开发了口服片剂，已于 2024 年 11 月公布了 I 期临床的阳性结果，服药两周内平均体重较基线减轻 4.16%，并且停药一周后，平均体重继续减轻 0.51%，与基线相比平均总减轻量达到 4.67%。
推荐阅读：
国产首个！恒瑞降脂新药首次启动 III 期临床
头对头司美格鲁肽！甘李启动 「GLP-1RA 双周制剂」糖尿病 III 期
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临床3期引进/卖出
2024-12-16
随着医学科技的迅猛发展和创新药物研发的不断深入，2024年再次见证了FDA在药物审批方面的重大进展。这一年，FDA批准了多种新药上市，这些药物不仅为患者带来了全新的治疗方案，更在疾病治疗领域取得了突破性进展。
作者｜momo
相关阅读：2024年FDA批准的重磅小分子药物
表1. FDA批准的17种大分子药物
截至2024年12月16日，FDA已经批准44款新药上市，其中包括17款生物大分子药物（图1），在获批的生物大分子药物中，单抗药物依旧是创新主力，以59%（10款）的占比遥遥领先；其次是双抗，有3款（占比17%）；蛋白类药物2款（占比12%）；小核酸药物和甲状旁腺激素类似物各1款（分别占比6%）。
图1. 2024 年 FDA 批准生物大分子药物类型
本文将对2024年FDA批准上市的生物大分子药物进行详细介绍，探讨其在各自疾病领域的重要性及潜在影响。
1.Letybo（letibotulinumtoxinA-wlbg）
适应症：中度至重度眉间纹的外观改善
靶点：BoNT/A
批准日期：2024年2月29日
企业：Hugel Inc.
Letybo是一种乙酰胆碱释放抑制剂和神经肌肉阻滞剂，通过肌肉内注射，用于暂时改善成年患者与皱眉肌和/或降眉肌活动相关的中度至重度眉间纹外观。Letybo获得FDA的批准得到了三项已完成的3期试验的积极结果支持，这些试验在美国和欧洲招募了1000多名受试者。Letybo的临床试验结果证明了其在治疗眉间纹方面的有效性和安全性。
2.Tevimbra （tislelizumab-JSGR）
适应症：不可切除、局部晚期或转移性食管鳞状细胞癌
靶点：PD-1
批准日期：2024年3月13日
企业：百济神州
Tevimbra是一款人源化IgG4抗PD-1单克隆抗体，设计目的旨在最大限度地减少与巨噬细胞中的Fcγ受体结合，帮助人体免疫细胞检测和对抗肿瘤细胞。用于治疗既往接受过全身化疗（不包括PD-1或PD-L1类疗法），患有不可切除或转移性食管鳞状细胞癌（ESCC）的成年患者。这是Tevimbra首次在美国获批。Tevimbra于2023年获得欧盟委员会批准用于治疗既往曾接受过化疗的晚期或转移性ESCC患者，并于2024年2月获得欧洲药品管理局（EMA）人用药品委员会的推荐，用于治疗非小细胞肺癌。在中国，该疗法已有12个适应症获得批准。
3.Winrevair （sotatercept-CSRK）
适应症：肺动脉高压
靶点：INHBA
批准日期：2024年3月26日
企业：默克
Winrevair是一款“first-in-class”的IIA型激活素受体（ActRIIA）融合蛋白。它将ActRIIA经过改造的细胞外域与抗体的Fc端融合在一起。它可以阻断激活素与细胞膜上的受体结合，从而降低激活素介导的信号传导。用于治疗肺动脉高压（PAH）患者。Winrevair是默沙东于2021年以约115亿美元收购Acceleron Pharma公司获得的关键疗法。值得一提的是，这款疗法被行业媒体Evaluate评为2024年有望获批的潜在重磅疗法之一。
4.Anktiva （nogapendekin alfa inbakicept-pmln）
适应症：膀胱癌
靶点：IL-15R
批准日期：2024年4月22日
企业：Altor Bioscience Corp.
Anktiva是一款IL-15超级激动剂。IL-15通过影响自然杀伤（NK）细胞和免疫T细胞的发育、维持和功能，在免疫系统中发挥着至关重要的作用。Anktiva由与IL-15受体α/IgG1 Fc融合蛋白结合的IL-15突变体（IL-15N72D）组成。用于治疗对BCG无应答且伴有原位癌（CIS）的非肌层浸润性膀胱癌（NMIBC）成年患者。Anktiva在2019年获FDA授予突破性疗法认定，用于与BCG联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。此外，行业媒体Evaluate在今年初将这款疗法列为今年有望获批的10款潜在重磅疗法之一。
5.Imdelltra （tarlatamab-dlle）
适应症：广泛期小细胞肺癌
靶点：CD3E、DLL3
批准日期：2024年5月16日
企业：安进
Imdelltra是一款“first-in-class”双特异性抗体（bsAbs），通过结合肿瘤细胞上的 DLL3 蛋白和 T 细胞上的 CD3 抗原，激活人体的免疫细胞并诱导表达 DLL3 的癌细胞被破坏。用于治疗铂类化疗期间或之后疾病进展的广泛期小肺癌（SCLC）患者。Imdelltra在今年5月获FDA加速批准用于治疗ES-SCLC成人患者，他们在接受化疗时或之后出现疾病进展。值得一提的是，Imdelltra是首款用于治疗实体瘤的获批BiTE疗法。
6.Rytelo （imetelstat）
适应症：低危骨髓增生异常综合征伴输血依赖性贫血
靶点：Telomerase
批准日期：2024年6月6日
企业：Geron Corp.
Rytelo是一款“first-in-class”的寡核苷酸端粒酶抑制剂，通过抑制端粒酶活性，抑制癌变干细胞和祖细胞不可控制的增殖，导致癌变细胞的凋亡。用于治疗患有低风险至中等-1风险的骨髓增生异常综合征（MDS）成年患者。Rytelo是40年来首个获美国FDA批准的端粒酶靶向疗法。Rytelo被行业媒体Evaluate列为今年10大潜在重磅疗法之一。
7.Piasky （crovalimab-akkz）
适应症：阵发性睡眠性血红蛋白尿症
靶点：C5
批准日期：2024年6月20日
企业：Sino-Foreign Pharmaceutical Co., Ltd.
Piasky是一款靶向补体蛋白C5的可循环使用人源化单克隆抗体，能够阻止C5裂解为C5a和C5b，阻止终末补体通路，从而防止红细胞在阵发性睡眠性血红蛋白尿症（PNH）等疾病中的破坏。用以治疗阵发性睡眠性血红蛋白尿症（PNH）患者。Piasky是PNH的首个每月皮下注射治疗药物，且患者可以选择在受监督的医疗机构之外进行自我给药。
8.Kisunla（Donanemab-azbt）
适应症：阿尔茨海默病
靶点：pGlu3Aβ
批准日期：2024年7月2日
企业：礼来
Kisunla是一款靶向β淀粉样蛋白（Aβ）的单克隆抗体，它能与N3pG的淀粉样蛋白亚型特异性结合，从而促进淀粉样斑块的清除。用于治疗出现早期症状的阿尔茨海默病（AD）的成年人。Kisunla是首个有证据表明在淀粉样斑块清除后可停止治疗的淀粉样斑块靶向疗法。2021年6月，Donanemab被FDA授予突破性疗法认定。
9.Yorvipath（palopegteriparatide）
适应症：甲状旁腺功能亢进
靶点：PTH1R
批准日期：2024年8月9日
企业：Ascendis Pharma.
Yorvipath是一种长效甲状旁腺激素（PTH）前药，旨在将甲状旁腺功能减退（HP）患者的PTH恢复至生理水平，以解决HP导致的血钙含量降低、血液磷酸盐水平升高等问题。用于治疗成人慢性甲状旁腺功能减退。该产品为甲状旁腺功能减退的首款激素替代疗法。
10.Nemluvio（nemolizumab-ilto）
适应症：结节性痒疹
靶点：IL-31
批准日期：2024年8月12日
企业：Galderma Pharma.
Nemluvio是一种”first-in-class”单克隆抗体，它通过与IL-31受体α相结合，可以阻断IL-31的信号通路，用于治疗成人结节性痒疹（prurigo nodularis）患者。Nemluvio是首款获得FDA批准用以抑制IL-31信号的单克隆抗体，它曾在2019年获得美国FDA授予突破性疗法认定，并在今年2月获得治疗结节性痒疹的优先审评资格。
11.Niktimvo（axatilimab-csfr）
适应症：慢性移植物抗宿主病
靶点：CSF-1R
批准日期：2024年8月14日
企业：Incyte/Syndax制药
Niktimvo是一种靶向集落刺激因子-1受体（CSF-1R）的单克隆抗体，用于治疗慢性移植物抗宿主病（cGVHD）成人和体重40公斤以上的儿科患者。Niktimvo是全球首个获得批准用于治疗慢性移植物抗宿主病（GVHD）的CSF-1R单克隆抗体疗法。
12.Ebglyss（lebrikizumab-lbkz）
适应症：中度至重度特应性皮炎
靶点：IL-13
批准日期：2024年9月13日
企业：礼来
Ebglyss是一种单克隆抗体，能高亲和力结合IL-13，有效阻止IL-13Rα1/IL-4Rα异二聚体复合物的形成及其后续信号传导。用于治疗中度至重度特应性皮炎（AD）成年和青少年患者。Ebglyss于2023年获得欧盟委员会批准，并于2024年1月在日本获得批准。
13.Hympavsi（marstacimab-hncq）
适应症：预防或减少与血友病A或B相关的出血事件
靶点：BCMA
批准日期：2024年10月11日
企业：辉瑞
Hympavsi是一种靶向TFPI的人源IgG1单克隆抗体，通过靶向TFPI的Kunitz-2结构域，重新建立出血和凝血之间的平衡；用于预防或减少患有 A 型血友病（先天性第 VIII 因子缺乏症）和B 型血友病（先天性第 IX 因子缺乏症）成人和 12 岁及以上儿童患者的出血发作频率。Hympavzi是FDA批准治首款只需每周一次皮下注射的血友病B疗法。
14.Vyloy（Zolbetuximab-clzb）
适应症：胃或胃食管结合部腺癌
靶点：Claudin 18.2
批准日期：2024年10月18日
企业：安斯泰来
Vyloy是一种“first-in-class”的靶向CLDN18.2的单克隆抗体，被美国FDA批准与氟尿嘧啶和铂类化疗联合用于一线治疗HER2阴性、其肿瘤经FDA批准的检测确定为Claudin18.2阳性的局部晚期不可切除或转移性胃或胃食管交界处（GEJ）腺癌。Vyloy是全球首个获批的靶向Claudin 18.2的治疗药物。
15.Ziihera（zanidatamab）
适应症：HER2阳性（IHC 3+）的经治无法切除或转移性胆道癌
靶点：HER2
批准日期：2024年11月20日
企业：Jazz Pharmaceuticals
Ziihera是一种具有新作用机制的HER2靶向双特异性抗体，可靶向HER2蛋白上两个不重复的抗原表位，用于治疗经FDA批准检测确诊为HER2阳性（IHC 3+）的经治无法切除或转移性胆道癌（BTC）成人患者。FDA曾授予Ziihera突破性疗法认定，快速通道资格、孤儿药资格。
16.Bizengri（zenocutuzumab）
适应症：胰腺导管腺癌或非小细胞肺癌
靶点：HER2、HER3
批准日期：2024年12月4日
企业：Merus
Bizengri是一种双特异性抗体，能结合表达在细胞（包括肿瘤细胞）表面的HER2和HER3的细胞外结构域，抑制HER2与HER3形成二聚体并阻止NRG1与HER3的结合，用于治疗携带NRG1基因融合（NRG1+）的晚期不可切除或转移性胰腺导管腺癌或非小细胞肺癌（NSCLC）成年患者。Bizengri是FDA批准的首款治疗这一患者群体的靶向疗法，FDA也曾授予Bizengri突破性疗法认定。
17.Unloxcyt（cosibelimab）
适应症：皮肤鳞状细胞癌
靶点：PD-L1
批准日期：2024年12月14日
企业：Checkpoint Therapeutics
Unloxcyt是一种完全人源化、具有高亲和力的单克隆抗体，可直接与PD-L1结合，从而阻断其与PD-1以及B7.1受体的相互作用，进而除去PD-L1对CD8阳性T细胞的抑制效果，恢复其毒杀性T细胞反应。用于治疗转移性皮肤鳞状细胞癌（cSCC）或不适合治愈性手术或放疗的局部晚期cSCC成年患者。Unloxcyt是首个获批用于治疗晚期cSCC患者的PD-L1靶向抗体。
参考资料
[1] https://www.fda.gov/
[2]各种公开资料
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2024-12-13
Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing1,2,3
First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration time4
Positive results for Roche's two bispecifics antibodies validate the company's efforts to provide multiple treatment options that suit the diverse needs of lymphoma patients and healthcare providers5,6
10 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody programme were presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, 7-10 December 2024. With more than 20 bispecific antibody abstracts accepted for presentation, data showcase the benefits of fixed-duration Columvi® (glofitamab) and Lunsumio® (mosunetuzumab) across different types of aggressive and indolent lymphomas. This research supports Roche’s efforts to continue innovating for patients by advancing treatment standards at earlier stages of disease while exploring additional forms of administration that could further improve the patient experience.
“The data being presented at ASH offer further evidence that Columvi and Lunsumio can provide lasting remissions for people with advanced lymphoma,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The results underscore our ambition to transform the treatment of B-cell malignancies with a range of innovative therapeutic options.”
“Lymphoma patients face challenges that extend well beyond the clinical manifestations of their disease, including the physical and emotional strain of frequent appointments and treatments,” said Elizabeth Budde, M.D., Ph.D., City of Hope’s executive medical director of its Enterprise Immune Effector Cell Program and associate professor in its Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. “While Lunsumio’s fixed duration intravenous formulation has already offered a valuable treatment option, the introduction of a subcutaneous route could provide a shorter administration time. With both routes available, we can better tailor therapy to each patient’s needs, supporting a flexible and patient-centered approach to follicular lymphoma care.”
Follow-up data reinforce benefits of fixed-duration therapies beyond the end of treatment
Three-year follow-up from the pivotal phase II NP30179 study of Columvi in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) showed 40.0% of patients achieved a complete response (CR), with a median duration of CR of 29.8 months (95% CI: 22.0–not estimable [NE]). The majority of patients in complete remission at the end of therapy remained in remission two years after therapy completion. Safety appeared consistent with the previous analysis.1
Long-term data at four years from the pivotal phase II GO29781 study of Lunsumio in patients with R/R follicular lymphoma (FL) showed long-lasting remissions, with nearly two-thirds (64.0% [95% CI: 50.1-78.0]) of patients with a CR alive and without disease progression at 45 months. The overall response rate (ORR) and CR rates in the overall population were 77.8% and 60.0%, respectively. Consistent results were seen in patients with a history of disease progression within 24 months of frontline treatment (POD24), which is typically harder to treat. No new safety signals were observed since the previous analysis.2
Both studies also showed restoration of B-cell levels, starting from 12-18 months following Columvi treatment and after a median of 19 months following Lunsumio treatment, indicating immune system recovery and supporting the use of a fixed-duration treatment approach.1,2 Recovery of B cells following treatment for lymphoma is important so that patients can maintain immune system function.
A US real-world data study and economic model evaluating R/R non-Hodgkin lymphoma patient treatment-related travel burden across different bispecific antibody therapies highlight the impact of travel distance, time and associated costs, an often-overlooked aspect of the patient experience beyond clinical efficacy and safety. These factors play a crucial role in treatment decision-making, further emphasising the importance of patient-centred treatment options. The study found fixed-duration therapies, such as Columvi and Lunsumio, reduce treatment-related travel burden due to less frequent dosing.3
Studies investigating subcutaneously-administered Lunsumio show positive results
Data from a primary analysis of the phase II GO29781 study of investigational Lunsumio administered subcutaneously in patients with third-line or later FL were presented for the first time. Results show pharmacokinetic non-inferiority compared to intravenous (IV) administration, with fixed-duration Lunsumio achieving high rates of deep and durable remissions, with 76.6% of patients experiencing an ORR and a 61.7% CR rate, as evaluated by the independent review committee. The median progression-free survival was 23.7 months (95% CI: 14.6-NE), while the median overall survival was not reached. The most common all-grade adverse events (AEs) were injection-site reactions (60.6%; all Grade 1-2), fatigue (35.1%), and cytokine release syndrome (CRS; 29.8%). The rate and severity of CRS events were low (Grade 1-2, 27.6%; Grade 3, 2.1%); all occurred during cycle 1 and were resolved.4 Data has been submitted to health authorities with the aim of offering patients and healthcare providers an alternative treatment and more choice when it comes to administration options depending on their needs.
New data from a randomised phase II cohort of the investigational GO40516 study showed improved efficacy and manageable safety with outpatient, subcutaneously administered, fixed-duration Lunsumio in combination with Polivy® (polatuzumab vedotin) versus MabThera®/Rituxan® (rituximab) in combination with Polivy, in people with R/R LBCL. In the Lunsumio-Polivy arm, the ORR was 77.5% (95% CI: 61.6-89.2) versus 50.0% (95% CI: 33.8–66.2) for MabThera/Rituxan-Polivy, and the CR rate was 57.5% (95% CI: 40.9-73.0) versus 35.0% (95% CI: 20.6-51.7). AEs of special interest occurring in ≥30% of patients in the Lunsumio-Polivy arm were injection-site reactions (55.0%) and neutropoenia (40.0%). CRS events occurred in four (10.0%) patients, all of which were Grade 1-2, occurred during cycle 1 and were resolved.5 These data support further exploration of this investigational treatment combination in the ongoing phase III SUNMO study, which could provide an alternative option in second-line DLBCL to meet diverse patient needs.
Additional data support Roche’s goal to elevate treatment standards in earlier stages of LBCL
Updated data from the phase I/Ib investigational NP39488 study showed high and durable response rates in people with R/R LBCL treated with Columvi in combination with Polivy, including those with high-grade disease and prior treatment with CAR T-cell therapy. Of the 128 efficacy-evaluable patients, the best ORR was 80.6%, with a CR rate of 62.0%, and the median duration of CR was 31.8 months (95% CI: 21.9-NE). Among patients previously treated with CAR T-cell therapy (n=28), the ORR was 75.0%, with a CR rate of 50.0%. The safety profile was manageable and consistent with the known profiles of the individual drugs. The most common AE was CRS (44.4%), which was mostly Grade 1-2.6 Results support ongoing development of this investigational combination in the phase III SKYGLO study investigating Columvi with Polivy-MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL.
Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma.
Lunsumio is a first-in-class CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells. Polivy is being developed by Roche using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL.
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
References
[1] Dickinson MJ, et al. Fixed-duration Glofitamab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed or Refractory Large B-Cell Lymphoma: 3-year Follow-Up From a Pivotal Phase II Study. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #865.
[2] Shadman M, et al. Mosunetuzumab Continues to Demonstrate Clinically Meaningful Outcomes in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies Including Those with a History of POD24: 4-Year Follow-up of a Pivotal Phase II Study. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #4407.
[3] Huntington SF, et al. Travel Burden and Travel Costs of Bispecific Antibodies in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Relapsed/Refractory Follicular Lymphoma. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #782.
[4] Bartlett NL, et al. Subcutaneous Mosunetuzumab Leads to High Rates of Durable Responses, Low Rates of Cytokine Release Syndrome, and Non-Inferior Exposure Compared with Intravenous Administration in Patients with Relapsed/Refractory Follicular Lymphoma: Primary Analysis of a Pivotal Phase II. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #1645.
[5] Chavez JC, et al. A Randomized Phase II Study of Mosunetuzumab SC Plus Polatuzumab Vedotin Demonstrates Improved Outcomes Versus Rituximab Plus Polatuzumab Vedotin in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL). Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #989.
[6] Hutchings M, et al. Glofitamab in Combination with Polatuzumab Vedotin Maintains Durable Responses and a Manageable Safety Profile in Patients with Heavily Pre-treated Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Including High-Grade B-Cell Lymphoma (HGBCL): Extended Follow-Up of a Phase Ib/II Study. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #988.
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临床结果ASH会议
100 项与 可伐利单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 阵发性睡眠性血红蛋白尿症 | 中国 | 2024-02-06 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 格林-巴利综合征 | 临床3期 | - | 2022-11-30 | |
| 格林-巴利综合征 | 临床3期 | - | 2022-11-30 | |
| 非典型溶血性尿毒症综合征 | 临床3期 | 美国 | 2021-10-22 | |
| 非典型溶血性尿毒症综合征 | 临床3期 | 中国 | 2021-10-22 | |
| 非典型溶血性尿毒症综合征 | 临床3期 | 日本 | 2021-10-22 | |
| 非典型溶血性尿毒症综合征 | 临床3期 | 比利时 | 2021-10-22 | |
| 非典型溶血性尿毒症综合征 | 临床3期 | 巴西 | 2021-10-22 | |
| 非典型溶血性尿毒症综合征 | 临床3期 | 加拿大 | 2021-10-22 | |
| 非典型溶血性尿毒症综合征 | 临床3期 | 法国 | 2021-10-22 | |
| 非典型溶血性尿毒症综合征 | 临床3期 | 德国 | 2021-10-22 |
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临床结果
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适应症
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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 |
|---|
临床3期 | 阵发性睡眠性血红蛋白尿症 C5 inhibitor (C5i)‐naive | C5i‐switched | 393 | 齋選遞蓋齋構鏇獵蓋築(觸鏇窪顧製膚築膚廠鏇) = 鹽憲艱襯膚糧壓網醖餘 構鬱衊淵窪衊積襯願鹹 (築蓋顧製憲鹽齋顧網製 ) 更多 | 积极 | 2024-11-13 | ||
Eculizumab | 齋選遞蓋齋構鏇獵蓋築(觸鏇窪顧製膚築膚廠鏇) = 糧糧構繭願鏇網衊襯顧 構鬱衊淵窪衊積襯願鹹 (築蓋顧製憲鹽齋顧網製 ) 更多 | ||||||
临床3期 | 488 | 簾簾淵窪鏇衊淵遞簾簾(壓構遞蓋艱顧襯鏇觸醖) = Type 3 hypersensitivity reactions, associated with complexes, occurred in 18% (33/185; 21 grade 1-2, 12 grade 3) of switch pts. 窪願淵範鑰壓鹹淵觸觸 (鬱鏇蓋觸獵淵鑰鹽觸獵 ) | 积极 | 2024-04-01 | |||
Eculizumab | |||||||
临床3期 | 204 | 鑰蓋鏇築鏇餘艱膚獵簾(鹹齋願遞廠觸糧鑰餘窪) = 鏇鬱壓艱繭鏇獵窪窪憲 網鏇壓積壓齋積獵醖壓 (遞淵遞獵願鬱簾鏇觸鬱 ) | - | 2023-12-11 | |||
鑰蓋鏇築鏇餘艱膚獵簾(鹹齋願遞廠觸糧鑰餘窪) = 窪艱憲構餘範願糧獵衊 網鏇壓積壓齋積獵醖壓 (遞淵遞獵願鬱簾鏇觸鬱 ) | |||||||
临床3期 | 488 | 廠選鑰醖網壓觸艱鑰鏇(壓窪積網鏇齋積齋衊廠) = 鬱製衊鹹蓋廠獵積糧繭 糧選鹹膚築蓋糧鹽鏇齋 (遞醖簾範蓋網繭廠齋憲 ) 更多 | - | 2023-12-10 | |||
廠選鑰醖網壓觸艱鑰鏇(壓窪積網鏇齋積齋衊廠) = 鏇鑰齋醖獵築積醖蓋觸 糧選鹹膚築蓋糧鹽鏇齋 (遞醖簾範蓋網繭廠齋憲 ) 更多 | |||||||
临床3期 | 51 | 鑰夢襯餘壓築壓顧艱網(顧蓋壓簾簾糧繭淵觸製) = 製遞蓋範製醖網壓顧醖 齋醖獵簾鹹糧繭醖襯壓 (獵願夢衊願積壓遞構壓, 57.7 ~ 91.4) 更多 | - | 2023-06-08 | |||
临床3期 | 89 | 醖淵醖齋繭積積鹹願積(廠範醖選衊遞餘簾鹽糧) = 繭衊鬱鏇顧簾製選鬱夢 醖構鹹衊蓋廠齋壓築襯 (網繭糧簾獵糧鬱廠鹹鑰 ) 更多 | - | 2023-06-08 | |||
醖淵醖齋繭積積鹹願積(廠範醖選衊遞餘簾鹽糧) = 艱蓋齋網夢壓觸衊夢鬱 醖構鹹衊蓋廠齋壓築襯 (網繭糧簾獵糧鬱廠鹹鑰 ) 更多 | |||||||
临床3期 | 51 | 憲積鏇遞醖憲艱蓋憲製(願築鹽鏇鑰齋獵壓艱鏇) = 壓築淵窪襯繭遞餘夢簾 鬱蓋壓積醖築壓鏇簾顧 (觸壓簾網醖壓膚鑰糧遞, 67.8 ~ 86.6) 达到 更多 | 积极 | 2022-11-15 | |||
临床3期 | 500 | 鬱廠艱廠鏇獵網構製艱(願淵願憲糧範積淵構積) = 达到共同主要终点 鑰壓獵淵繭觸鑰糧鹹觸 (製鬱齋夢網製鹽鑰顧簾 ) 更多 | 积极 | 2022-05-23 | |||
临床1/2期 | 44 | 觸顧願鹽餘醖憲鏇範衊(獵鏇齋鹹糧觸築鑰鬱蓋) = Three serious adverse events (SAEs) were reported, none related to study treatment. One patient had two SAEs: bile duct stone and cholelithiasis. A second patient had an SAE of upper respiratory tract infection with admission to the hospital, which occurred after 20 months and was resolved while on treatment. 鏇醖齋憲壓糧夢膚夢餘 (鏇網鹹鏇壓繭簾鏇網繭 ) | 积极 | 2020-05-14 | |||
临床1/2期 | 13 | 齋膚膚糧壓廠觸觸鏇蓋(築襯淵鑰築願襯遞鬱築) = no serious treatment-related adverse events were observed 製鹽衊衊範積觸夢廠廠 (廠夢獵遞糧範製願艱膚 ) | - | 2020-05-14 |
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