A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW031 and Prolia® in Healthy Adults

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.

开始日期2020-06-02

申办/合作机构

迈威（上海）生物科技股份有限公司

CTR20201149 / Completed临床1期

随机、双盲、单剂量、平行对照设计，比较MW031与Prolia药代动力学、药效学、安全性比对研究。

主要目的：评价健康受试者单次皮下注射MW031与参照药Prolia后药代动力学相似性。次要目的：评价健康受试者单次皮下注射MW031与参照药Prolia后安全性和免疫原性相似性；同时，初步评价MW031与Prolia®药效学相似性。

开始日期2020-06-02

申办/合作机构

江苏泰康生物医药有限公司

CTR20200407 / Completed临床3期

多中心、随机、双盲、平行对照评价MW032与地舒单抗在实体瘤骨转移患者中有效性和安全性Ⅲ期临床研究

评价重组全人源抗RANKL单克隆抗体注射液（MW032）在实体瘤骨转移患者中有效性和安全性

开始日期2020-03-20

申办/合作机构

江苏泰康生物医药有限公司

100 项与地舒单抗生物类似药 (江苏泰康) 相关的临床结果

登录后查看更多信息

100 项与地舒单抗生物类似药 (江苏泰康) 相关的转化医学

登录后查看更多信息

100 项与地舒单抗生物类似药 (江苏泰康) 相关的专利（医药）

登录后查看更多信息

项与地舒单抗生物类似药 (江苏泰康) 相关的文献（医药）

2024-02-08·JAMA oncology

Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared With Denosumab for Solid Tumor-Related Bone Metastases: A Randomized, Double-Blind, Phase 3 Equivalence Trial.

Article

作者: Shaohua Zhang ; Yongmei Yin ; Hailin Xiong ; Jingfen Wang ; Hu Liu ; Junguo Lu ; Qingyuan Zhang ; Longzhen Zhang ; Jincai Zhong ; Jianyun Nie ; Kaijian Lei ; Hong Wang ; Shu Yang ; Herui Yao ; Huijing Wu ; Ding Yu ; Xuening Ji ; Hua Zhang ; Fang Wu ; Weimin Xie ; Wei Li ; Weirong Yao ; Diansheng Zhong ; Hongmei Sun ; Tao Sun ; Zengqing Guo ; Rui Wang ; Yanzhen Guo ; Zhuang Yu ; Dairong Li ; Hongyan Jin ; Haifeng Song ; Xiaoyuan Chen ; Wen Ma ; Zhitian Hu ; Datao Liu ; Yinhan Guo ; Jinhai Tang ; Zefei Jiang

Importance:

The bioequivalence of denosumab biosimilar has yet to be studied in a 53-week, multicenter, large-scale, and head-to-head trial. A clinically effective biosimilar may help increase access to denosumab in patients with solid tumor-related bone metastases.

Objectives:

To establish the biosimilarity of MW032 to denosumab in patients with solid tumor-related bone metastases based on a large-scale head-to-head study.

Design, Setting, and Participants:

In this 53-week, randomized, double-blind, phase 3 equivalence trial, patients with solid tumors with bone metastasis were recruited from 46 clinical sites in China. Overall, 856 patients were screened and 708 eligible patients were randomly allocated to receive either MW032 or denosumab.

Interventions:

Patients were randomly assigned (1:1) to receive MW032 or reference denosumab subcutaneously every 4 weeks until week 49.

Main Outcomes and Measures:

The primary end point was percentage change from baseline to week 13 of natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr).

Results:

Among the 701 evaluable patients (350 in the MW032 group and 351 in the denosumab group), the mean (range) age was 56.1 (22.0-86.0) years and 460 patients were women (65.6%). The mean change of uNTx/uCr from baseline to week 13 was -72.0% (95% CI, -73.5% to -70.4%) in the MW032 group and -72.7% (95% CI, -74.2% to -71.2%) in the denosumab group. These percent changes corresponded to mean logarithmic ratios of -1.27 and -1.30, or a difference of 0.02. The 90% CI for the difference (-0.04 to 0.09) was within the equivalence margin (-0.13 to 0.13); the mean changes of uNTx/uCr and bone-specific alkaline phosphatase (s-BALP) at each time point were also similar during 53 weeks. The differences of uNTx/uCr change were 0.015 (95% CI, -0.06 to 0.09), -0.02 (95% CI, -0.09 to 0.06), -0.05 (95% CI, -0.13 to 0.03) and 0.001 (95% CI, -0.10 to 0.10) at weeks 5, 25, 37, and 53, respectively. The differences of s-BALP change were -0.006 (95% CI, 0.06 to 0.05), 0.00 (95% CI, -0.07 to 0.07), -0.085 (95% CI, -0.18 to 0.01), -0.09 (95% CI, -0.20 to 0.02), and -0.13 (95% CI, -0.27 to 0.004) at weeks 5, 13, 25, 37 and 53, respectively. No significant differences were observed in the incidence of skeletal-related events (-1.4%; 95% CI, -5.8% to 3.0%) or time to first on-study skeletal-related events (unadjusted HR, 0.86; P = .53; multiplicity adjusted HR, 0.87; P = .55) in the 2 groups.

Conclusions and Relevance:

MW032 and denosumab were biosimilar in efficacy, population pharmacokinetics, and safety profile. Availability of denosumab biosimilars may broaden the access to denosumab and reduce the drug burden for patients with advanced tumors.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04812509.

2023-03-09·Expert opinion on biological therapy

Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial.

Article

作者: Yinhan Guo ; Tingting Guo ; Yujing Di ; Wenyu Xu ; Zhitian Hu ; Yanfeng Xiao ; Heze Yu ; Jie Hou

BACKGROUND:

MW031 is a biosimilar candidate of denosumab (Prolia®). This study aimed to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of MW031 to denosumab in healthy Chinese participants.

RESEARCH DESIGN AND METHODS:

In this single-center, randomized, double-blind, parallel-controlled, single-dose trial, participants were given 60 mg MW031 (N = 58) or denosumab (N = 61) by subcutaneous injection and observed for 140 days. The primary endpoint was the bioequivalence of PK parameters (C_max, AUC_0-∞), and secondary endpoints including PD parameter, safety, and immunogenicity.

RESULTS:

A comparison of main PK parameters showed that the geometric mean ratios (GMR) (90% confidence intervals [CIs]) of AUC_0-∞ and C_max for MW031 over denosumab were 105.48% (98.96%, 112.43%) and 98.58% (92.78%, 104.75%), respectively. The inter-CV values of AUC_0-∞ and C_max for MW031 ranged from 19.9% to 23.1%. PD parameter (sCTX) in the MW031 and denosumab groups were similar, and the positivity rates of immunogenicity were 0% in both groups. This study also showed similar safety profiles in both groups, and there were no drug-related, high-incidence and previously unreported adverse reactions.

CONCLUSION:

This trial confirmed similar pharmacokinetic profiles of MW031 and denosumab in healthy male participants, and pharmacodynamic profile, immunogenicity and safety were comparable for both drugs.

TRIAL REGISTRATION:

NCT04798313; CTR20201149.

2022-03-12·International immunopharmacology2区 · 医学

The similarity of pharmacokinetics, pharmacodynamics, safety, and immunogenicity between recombinant fully human anti-RANKL monoclonal antibody injection (MW032) and denosumab (Xgeva®) in healthy Chinese subjects: A single-center, randomized, double-blind, single-dose, parallel-controlled clinical study.

2区 · 医学

Article

作者: Jie Hou ; Zhitian Hu ; Wenyu Xu ; Yujing Di ; Chunli Song ; Fan Wu ; Jintao Liu ; Yinhan Guo

OBJECTIVE:

To compare the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity between MW032 (denosumab biosimilar) and Xgeva® (denosumab) in healthy Chinese subjects.

STUDY DESIGN:

In this single-center, randomized, double-blind, single-dose, parallel-controlled design study, 120 healthy male subjects were randomized 1:1 to receive a single dose subcutaneous injection of 120 mg MW032 or Xgeva®, with an observation period of 161 days. The primary endpoint was the bioequivalence of PK parameters (C_max, AUC_0-t), and secondary endpoints including PD parameters, safety, and immunogenicity.

RESULTS:

One hundred and twelve subjects completed the study, including 56 subjects in each group. The geometric mean ratio and 90% CI for AUC_0-t and C_max were 1.117 (1.034, 1.205) and 1.060 (0.984, 1.142), respectively, which were both within the equivalence interval (0.8, 1.25). The inter-subject variation ranged from 21.37% to 27.37%. The PD parameters between MW032 and Xgeva® were similar. There was no statistically significant difference in the positive incidence of anti-drug antibody test between the two groups. Both MW032 and Xgeva® appeared to be well-tolerated and no Grade 3 or above serious adverse reactions occurred. The adverse reactions observed in the study were reported for denosumab generally. Moreover, there were no high-incidence or previously unreported adverse reactions.

CONCLUSION:

This study evidenced that the PK profiles of MW032, a denosumab biosimilar, and Xgeva® were bioequivalent. We also found that the PDs, safety, and immunogenicity were similar between the two drugs. Therefore, our results supported the next confirmatory studies for the development of MW032.

项与地舒单抗生物类似药 (江苏泰康) 相关的新闻（医药）

2024-04-05

·Pharma CMC

国内首款地舒单抗生物类似药新适应症获批！治疗骨巨细胞瘤

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。4月3日，NMPA发布药品批准证明文件送达信息，迈威（上海）生物科技股份有限公司全资子公司江苏泰康生物医药有限公司提交的地舒单抗注射液（迈卫健®，9MW0321）新适应症获批，用于治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤，包括成人和骨骼发育成熟（定义为至少1处成熟长骨且体重≥45kg）的青少年患者。地舒单抗注射液原研厂家为安进，2019年在中国上市，商品名为：安加维®，获批适应症包括：1. 用于实体肿瘤骨转移患者和多发性骨髓瘤患者的治疗，以延迟或降低骨相关事件（病理性骨折、脊髓压迫、骨放疗、骨手术）的发生风险；2. 用于治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤包括成人和骨骼发育成熟（定义为至少1处成熟长骨且体重≥45kg）的青少年患者。除迈卫健®外，目前国内尚未有其他生物类似药上市。与临床治疗常用药双膦酸盐类药物相比，地舒单抗有如下优势：①具有靶向性，可通过特异性结合RANKL阻断RANKL/RANK/OPG信号通路，发挥对骨转移SREs防治作用；②临床疗效显著优于双膦酸盐类药物，且对双膦酸盐类药物治疗失败的患者仍有效；③安全性好，不通过肾脏清除，应用地舒单抗的患者更少出现肾毒性的副作用。迈卫健®为重组全人源抗RANKL单克隆抗体注射液，是安加维®的生物类似药。2022年和2024年，迈威生物先后于《InternationalImmunopharmacology》和国际顶级期刊《JAMAOncology》分别发表了地舒单抗生物类似药的Ⅰ期和III期临床研究成果，通过“头对头”的药代动力学比对和实体瘤骨转移患者人群临床有效性比对研究，全面系统地证明了9MW0321与原研药在药代动力学、药效动力学、临床有效性和安全性的相似性。来源：迈威生物公告

临床3期生物类似药临床1期上市批准

2024-04-04

·医药魔方

迈威生物第2款地舒单抗生物类似药获批上市

近日，迈威生物发布一则公告，宣布其全资子公司泰康生物提交的地舒单抗（迈卫健，9MW0321）上市申请获得国家药品监督管理局批准，用于治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤，包括成人和骨骼发育成熟（定义为至少1处成熟长骨且体重≥45kg）的青少年患者，为中国首款获批上市的安加维生物类似药。2019年，安进的安加维在中国上市。据百济神州年报披露，安加维2022年中国销售额为4.2亿元。迈卫健也是迈威生物获批上市的第2款地舒单抗生物类似药。2023年，其迈利舒已获国家药品监督管理局批准，用于骨折高风险的绝经后妇女的骨质疏松症。迈利舒是全球第2款获批上市的普罗力生物类似药。迈威生物已深度部署地舒单抗生物在海外新兴市场的商业化。2023年，迈威生物与巴基斯坦制药公司Searle达成许可协议，Searle将负责相关产品在巴基斯坦的本地灌装、注册和商业化；与埃及市场战略合作公司已签署授权许可及商业化协议；与Legrand就地舒单抗注射液在哥伦比亚和厄瓜多尔市场达成战略合作，根据协议，Legrand 将负责该产品在哥伦比亚以及厄瓜多尔的注册和商业化；与泰国制药公司Innobic（亚洲）达成许可和供应协议，在药品检查合作计划（PIC/S）成员国之一的泰国进行相关产品的注册和商业化。Copyright © 2024 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

生物类似药上市批准

2024-04-03

·迈威生物

迈卫健®国内首款地舒单抗生物类似药 (120mg) 获批上市

重要新闻迈威生物 (688062.SH)，一家全产业链布局的创新型生物制药公司，宣布其全资子公司泰康生物开发的地舒单抗注射液（商品名：迈卫健®，项目代码：9MW0321）正式获得国家药品监督管理局 (NMPA) 上市许可批准（药品批准文号：国药准字 S20240010）。迈卫健®是国内首款获批上市的地舒单抗生物类似药(120mg)。迈卫健®为重组全人源抗 RANKL 单克隆抗体注射液，获批适应症为：用于治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤，包括成人和骨骼发育成熟（定义为至少 1 处成熟长骨且体重≥45kg）的青少年患者。迈威生物于 2022 年和 2024 年先后在《International Immunopharmacology》和国际顶级期刊《JAMA Oncology》发表了地舒单抗生物类似药 I 期和 III 期的临床研究成果，通过“头对头”的药代动力学比对和实体瘤骨转移患者人群临床有效性比对研究，全面系统地证明了 9MW0321（迈卫健®）与原研药在药代动力学、药效动力学、临床有效性和安全性的相似性。迈威生物亦在推进迈卫健®其他适应症的上市工作。地舒单抗因其展现的良好治疗效果，被多个专家共识或治疗指南推荐。医生和患者对地舒单抗的认可度较高。与临床治疗常用药双膦酸盐类药物相比，地舒单抗有如下优势：①具有靶向性，可通过特异性结合 RANKL 阻断 RANKL/RANK/OPG 信号通路，发挥对骨转移 SREs 防治作用；②临床疗效显著优于双膦酸盐类药物，且对双膦酸盐类药物治疗失败的患者仍有效；③安全性好，不通过肾脏清除，应用地舒单抗的患者更少出现肾毒性的副作用。关于地舒单抗原研药（安加维®）2019 年，原研药安加维®在中国上市，获批适应症：用于实体肿瘤骨转移患者和多发性骨髓瘤患者的治疗，以延迟或降低骨相关事件（病理性骨折、脊髓压迫、骨放疗、骨手术）的发生风险；用于治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤包括成人和骨骼发育成熟（定义为至少 1 处成熟长骨且体重 ≥45 kg）的青少年患者。除迈卫健®外，目前国内尚未有其他生物类似药上市；2022 年中国销售额为 4.27 亿元。往期资讯关于迈威生物迈威生物 (688062.SH) 是一家全产业链布局的创新型生物制药公司，始终秉承“让创新从梦想变成现实”的愿景，践行“探索生命，惠及健康”的使命，通过源头创新，为患者提供疗效更好、可及性更强的生物创新药，满足全球未被满足的临床需求。2017 年成立以来，迈威生物构建了以抗体药物靶点发现与分子发现为起点，覆盖成药性研究、临床前研究、临床研究和生产转化等药品研发全周期的创新体系，实现集研发、生产、营销于一体的全产业链布局。我们专注于肿瘤和年龄相关疾病，涉及肿瘤、自身免疫、代谢、眼科、感染等治疗领域，凭借国际领先的特色技术平台和研发创新能力，建立了丰富且具有竞争力的管线。现有 14 个品种处于不同阶段，包括 10 个创新品种和 4 个生物类似药，其中 3 个品种上市，1 个品种药品上市许可申请已获受理，3 个品种处于关键注册临床试验阶段。并独立承担 1 项国家“重大新药创制”重大科技专项、2 项国家重点研发计划和多个省市级科技创新项目。迈威生物以创新为本，注重产业转化，符合中国 NMPA、美国 FDA、欧盟 EMA GMP标准的抗体和重组蛋白药物产业化基地已在江苏泰州投入使用，并已通过欧盟 QP 审计，位于上海金山和江苏泰州的大规模商业化生产基地正在建设中。欲了解更多信息，请访问：www.mabwell.com。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。（滑动查看全部内容）

上市批准临床3期生物类似药临床结果临床1期

100 项与地舒单抗生物类似药 (江苏泰康) 相关的药物交易

登录后查看更多信息

研发状态

适应症	最高研发状态	国家/地区	公司
绝经期后骨质疏松	批准上市	中国更多	江苏泰康生物医药有限公司更多
骨转移癌	临床3期	中国更多	迈威（上海）生物科技股份有限公司更多
实体瘤	临床3期	中国更多	江苏泰康生物医药有限公司更多
乳腺癌	临床1期	中国更多	江苏泰康生物医药有限公司更多
骨癌	临床1期	中国更多	迈威（上海）生物科技股份有限公司更多

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


NCT04812509 (Literature) 人工标引	临床3期	骨转移癌	701	MW032	(鑰範淵鹹繭艱簾餘遞醖) = 積構齋範選網製繭積構齋糧糧夢鑰壓築壓膚窪 (壓構壓襯醖遞願淵襯鹽, -73.5 ~ -70.4)	相似	2024-02-08
				Xgeva	(鑰範淵鹹繭艱簾餘遞醖) = 範鏇鬱繭築齋醖壓窪顧齋糧糧夢鑰壓築壓膚窪 (壓構壓襯醖遞願淵襯鹽, -74.2 ~ -71.2)