Delving into the Latest Updates on Infliximab biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Infliximab Biosimilar (Shanghai Biomabs Pharmaceuticals Co., Ltd.), 英夫利西单抗生物类似药（Shanghai Biomabs Pharmaceuticals Co., Ltd.）

+ [5]

Target

TNF-α

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [1]

Active Indication

Crohn DiseaseAnkylosing SpondylitisColitis, Ulcerative+ [3]

Inactive Indication-

Originator Organization

Shanghai Biomabs Pharmaceuticals Co., Ltd.

Active Organization

Taizhou Mabtech Pharmaceutical Co. Ltd.

Inactive Organization

Shanghai Biomabs Pharmaceuticals Co., Ltd.

Shanghai Zhangjiang Biotechnology Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (14 Jul 2021),

Ankylosing SpondylitisColitis, UlcerativePediatric Crohn's Disease+ [2]

Regulation-

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Gene Sequence

Sequence Code 69035L

The sequence is quoted from: *****

Sequence Code 69038H

The sequence is quoted from: *****

主要目的： ● 比较类停®与类克®在男性健康受试者中单次静脉输注给药的药代动力学相似性。次要目的： ● 评价类停®与类克®在男性健康受试者中单次静脉输注给药的药代动力学特征； ● 评价类停®与类克®在男性健康受试者中单次静脉输注给药的安全性； ● 评价类停®与类克®在男性健康受试者中单次静脉输注给药的免疫原性。

[Translation]

Primary objectives: ● To compare the pharmacokinetic similarity of Retinol® and Remicade® in male healthy subjects after a single intravenous infusion. Secondary objectives: ● To evaluate the pharmacokinetic characteristics of Retinol® and Remicade® in male healthy subjects after a single intravenous infusion; ● To evaluate the safety of Retinol® and Remicade® in male healthy subjects after a single intravenous infusion; ● To evaluate the immunogenicity of Retinol® and Remicade® in male healthy subjects after a single intravenous infusion.

Start Date22 Mar 2023

Sponsor / Collaborator

Taizhou Mabtech Pharmaceutical Co. Ltd.

CTR20200409 / CompletedPhase 1

注射用CMAB008与类克在健康男性志愿者的随机、双盲、平行对照、单次给药药代动力学、安全性和免疫原性的I期比对研究

[Translation] A randomized, double-blind, parallel-controlled, single-dose, phase I comparative study of the pharmacokinetics, safety, and immunogenicity of CMAB008 for injection versus levofloxacin in healthy male volunteers

比较注射用CMAB008与类克®在健康成年男性受试者中的单次静脉输注给药的药代动力学、安全性和免疫原性，为两药相似性评价提供依据。

[Translation]

To compare the pharmacokinetics, safety and immunogenicity of CMAB008 for injection and Remicade® after single intravenous infusion in healthy adult male subjects, and to provide a basis for the similarity evaluation of the two drugs.

Start Date26 Feb 2020

Sponsor / Collaborator

Shanghai Zhangjiang Biotechnology Co. Ltd.

100 Clinical Results associated with Infliximab biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)

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100 Translational Medicine associated with Infliximab biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)

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100 Patents (Medical) associated with Infliximab biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)

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6

Literatures (Medical) associated with Infliximab biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)

01 Jun 2023·Rheumatology and therapy

Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study.

Article

Author: Huang, Xiangyang ; Tie, Ning ; Zhang, Yan ; Xie, Qibing ; He, Dongyi ; Li, Jing ; He, Lan ; Wang, Meimei ; Li, Yang ; Wei, Wei ; Su, Yin ; Hu, Jiankang ; Bi, Liqi ; Liu, Xiangyuan ; Sun, Erwei ; Liu, Huaxiang ; Hua, Bingzhu ; Fang, Yongfei ; Huang, Qingchun ; Liu, Shengyun ; Xu, Jian ; Wang, Xiaofei ; Chai, Kexia ; Ye, Hua ; Li, Yan ; Zhou, Mingxuan ; Li, Jingyang ; Zhang, Zhuoli ; Zhang, Zhiyi ; Zhao, Dongbao ; Liu, Ying ; Jiang, Zhenyu ; Li, Xiaomei

OBJECTIVESThe aim of this work is to verify the non-inferior efficacy and safety of CMAB008 compared with innovator infliximab in rheumatoid arthritis patients combined with methotrexate.METHODSWe conducted a randomized, double-blinded, parallel, positive control design, multicenter study, with a stable dose of methotrexate. Patients were enrolled randomly with a ratio of 1:1 to receive intravenously CMAB008 3 mg/kg or innovator infliximab 3 mg/kg at weeks 0, 2, 6, 14, 22 and 30. The primary efficacy endpoint was American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 30. The non-inferiority was established if the lower limit of the one-sided 97.5% confidence interval (CI) for the difference was more than - 15% and the equivalence was established if the two-sided 95% CI was within ± 15% in an exploratory equivalence analysis. The secondary endpoints included other efficacy assessment parameters, as well as immunogenicity, safety, and pharmacokinetics.RESULTSIn the full analysis population (FAS), 110 (57.6%) of 191 patients in the CMAB008 group and 120 (62.2%) of 193 patients in the innovator infliximab group reached the primary outcome of ACR20 at week 30. The differences of the rates were - 4.6% and the lower limit of one-sided 97.5% confidence interval was - 14.29%, not less than the lower limit of the non-inferiority margin (- 15%); so CMAB008 was non-inferior to innovator infliximab. Further, CMAB008 was equivalent to innovator infliximab both in FAS (difference - 4.6%, 95% CI - 14.29% to 5.12%) and PPS (difference - 3.3%, 95% CI - 13.18% to 6.62%). The efficacy, safety, immunogenicity, and pharmacokinetics are highly similar between CMAB008 and innovator infliximab.CONCLUSIONSNon-inferior efficacy of CMAB008 to innovator infliximab is illustrated with similar early and lasting therapeutic effects, and the equivalence is further demonstrated. CMAB008 is well tolerated and has semblable safety compared with the innovator infliximab.TRIAL REGISTRATION NUMBERNCT03478111.

01 Mar 2023·Advances in Therapy

Population Pharmacokinetics of CMAB008 (an Infliximab Biosimilar) and Remicade® in Healthy Subjects and Patients with Moderately to Severely Active Rheumatoid Arthritis

Article

Author: Ou, Lun ; Zhang, Xunmin ; Guo, Huaizu ; Li, Jing ; Hou, Sheng ; Su, Yin ; Deng, Chenhui ; Wang, Jinwei ; Wang, Chenguang

INTRODUCTIONCMAB008 is a monoclonal antibody developed as a biosimilar to infliximab (Remicade^®, Janssen). The pharmacokinetic characteristics of CMAB008 and Remicade^® in healthy subjects and patients with moderately to severely active rheumatoid arthritis (RA) were investigated using a population modeling approach, and the pharmacokinetic similarity of CMAB008 to Remicade^® was assessed.METHODSThe population pharmacokinetic model was developed on the basis of intensive pharmacokinetic data from a phase 1 study in healthy male subjects and combined intensive and sparse pharmacokinetic data from a phase 3 study in patients with RA.RESULTSA two-compartment model with first-order elimination adequately described CMAB008 and Remicade^® concentration data in healthy subjects and patients with RA. The analysis of covariates identified anti-drug antibody (ADA), neutralizing antibody (NAB), real-time body weight (BWT), and real-time albumin (ALB) as significant covariates on clearance, and BWT was also a significant covariate for the central volume of distribution. The treatment type (CMAB008 versus Remicade^®) and the study population (healthy subjects versus patients with RA) were not identified as significant covariates on the pharmacokinetics of infliximab, demonstrating pharmacokinetic similarity between CMAB008 and Remicade^® in both study populations. The effect of BWT and ALB changes on exposures to infliximab was within the acceptable range, suggesting that the 3 mg/kg regimen is appropriate in clinical practice for patients with RA and BTW and ALB distribution within the range evaluated in the current analysis.CONCLUSIONSThe pharmacokinetic characteristics were similar between CMAB008 and Remicade^® in healthy subjects and patients with RA. CMAB008 can be considered bioequivalent to Remicade^®.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov identifiers NCT04779892, NCT03478111.

01 Sep 2022·Clinical Pharmacology in Drug Development

A Randomized, Double‐Blind, Parallel Controlled, Single‐Dose Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of the Infliximab Biosimilar CMAB008 and the Reference Product in Healthy Chinese Male Subjects

Article

Author: Li, Jing ; Qian, Weizhu ; Ou, Lun ; Chen, Qian ; Jiang, Fan ; Zhou, Ruirui ; Jia, Jingying ; Wang, Hao ; Guo, Huaizu ; Chen, XiaoFei ; Hou, Sheng

AbstractThis study aimed to evaluate the pharmacokinetics (PK), safety, and immunogenicity of the infliximab biosimilar CMAB008 compared to the reference product (Remicade) in healthy Chinese male subjects to provide the basis for the similarity evaluation of the 2 drugs. In this phase I randomized, double‐blind, parallel‐controlled, single‐dose study, a total of 90 subjects were randomized 1:1 to receive CMAB008 or infliximab reference product with single intravenous injections (5 mg/kg). Blood samples were collected at designed time points for PK and immunogenicity assessment. If the 90%CI of the geometric mean ratio of area under the plasma concentration–time curve from 0 to the time of the last observation, maximum observed plasma concentration, area under the plasma concentration–time curve from 0 to infinity was completely within the range of 80% to 125%, the PK bioequivalence was established. Other PK parameters including time to maximum plasma concentration, half‐life time, clearance, apparent volume of distribution, and last measurable concentration time point were also assessed. Adverse events (AEs) were recorded. Serum concentration–time profiles were similar across the 2 groups, and PK parameters were comparable in the 2 groups. The 90%CI of the geometric mean ratio of test to reference was within the predefined bioequivalence range of 80% to 125%. The AEs occurred similarly in 2 groups. One serious AE (rhabdomyolysis, grade 3) occurred in the test group. The total positive rates of antidrug antibody and neutralizing antibodies in the test group (85.7% and 5.6%, respectively) were numerically lower than infliximab reference product group (90.9% and 15%, respectively). The PK profile of the 2 groups is statistically equivalent. The preliminary safety and immunogenicity evaluation of the 2 drugs are comparable.

100 Deals associated with Infliximab biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Crohn Disease	PE	Taizhou Mabtech Pharmaceutical Co. Ltd.	02 Jul 2024
Ankylosing Spondylitis	CN	Taizhou Mabtech Pharmaceutical Co. Ltd.	14 Jul 2021
Colitis, Ulcerative	CN	Taizhou Mabtech Pharmaceutical Co. Ltd.	14 Jul 2021
Pediatric Crohn's Disease	CN	Taizhou Mabtech Pharmaceutical Co. Ltd.	14 Jul 2021
Psoriasis	CN	Taizhou Mabtech Pharmaceutical Co. Ltd.	14 Jul 2021
Rheumatoid Arthritis	CN	Taizhou Mabtech Pharmaceutical Co. Ltd.	14 Jul 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	CN	Shanghai Biomabs Pharmaceuticals Co., Ltd.	30 Mar 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03478111 (Pubmed)	Phase 3	Rheumatoid Arthritis	390	CMAB008 3 mg/kg	(pkoeifexkw) = zxjhqygkkh edcxxdwtir (qswuhoeoet )	-	25 Mar 2023
				Innovator infliximab 3 mg/kg	(pkoeifexkw) = hiryuthnuq edcxxdwtir (qswuhoeoet )