Delving into the Latest Updates on Denosumab Biosimilar (Biomabs Pharma) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Denosumab biosimilar

Target

RANKL

Mechanism

RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors)

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal DiseasesOther Diseases

Active Indication

Fractures, BoneOsteoporosis, Postmenopausal

Inactive Indication-

Originator Organization

Shanghai Biomabs Pharmaceuticals Co., Ltd.

Active Organization

Shanghai MabLab Biotechnology Co., Ltd.

Shanghai Biomabs Pharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 143522H

The sequence is quoted from: *****

Sequence Code 94568L

The sequence is quoted from: *****

This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose

Start Date02 Nov 2023

Sponsor / Collaborator

Taizhou Mabtech Pharmaceutical Co. Ltd.

CTR20233241 / CompletedPhase 1

一项随机、双盲、平行对照，比较生产场地变更后的 CMAB807注射液与普罗力®在中国成年男性健康受试者中单次给药的药代动力学、药效学、安全性和免疫原性的 I 期比对研究

[Translation] A randomized, double-blind, parallel-controlled Phase I study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of CMAB807 injection after a change of manufacturing site with Prolix® in healthy adult male subjects in China

主要目的：比较生产场地变更后的 CMAB807 注射液与普罗力®在中国成年男性健康受试者的药代动力学特征相似性。次要目的：比较生产场地变更后的 CMAB807 注射液与普罗力®在中国成年男性健康受试者的安全性、药效学和免疫原性相似性。

[Translation]

Primary objective: Compare the pharmacokinetic characteristics of CMAB807 injection after the change of production site and Proli® in Chinese adult male healthy subjects. Secondary objective: Compare the safety, pharmacodynamics and immunogenicity of CMAB807 injection after the change of production site and Proli® in Chinese adult male healthy subjects.

Start Date02 Nov 2023

Sponsor / Collaborator

Shanghai MabLab Biotechnology Co., Ltd.

[+1]

CTR20202319 / CompletedPhase 3

一项随机、双盲、平行对照，比较CMAB807注射液与Prolia治疗中国高骨折风险的绝经后女性骨质疏松症的临床有效性、安全性和免疫原性的III期比对研究

[Translation] A randomized, double-blind, parallel-controlled Phase III study comparing the clinical efficacy, safety, and immunogenicity of CMAB807 injection with Prolia in the treatment of osteoporosis in postmenopausal women at high risk of fracture in China

主要目的：评价CMAB807注射液与Prolia在中国高骨折风险的绝经后女性骨质疏松症受试者中的疗效相似性次要目的：评价CMAB807注射液与Prolia在中国高骨折风险的绝经后女性骨质疏松症受试者中的安全性、群体药代动力学特征、免疫原性

[Translation]

Primary objective: To evaluate the efficacy similarity between CMAB807 injection and Prolia in Chinese postmenopausal women with osteoporosis at high risk of fracture Secondary objective: To evaluate the safety, population pharmacokinetic characteristics, and immunogenicity of CMAB807 injection and Prolia in Chinese postmenopausal women with osteoporosis at high risk of fracture

Start Date31 Mar 2021

Sponsor / Collaborator

Shanghai MabLab Biotechnology Co., Ltd.

[+1]

100 Clinical Results associated with Denosumab Biosimilar (Biomabs Pharma)

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100 Translational Medicine associated with Denosumab Biosimilar (Biomabs Pharma)

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100 Patents (Medical) associated with Denosumab Biosimilar (Biomabs Pharma)

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1

Literatures (Medical) associated with Denosumab Biosimilar (Biomabs Pharma)

Frontiers in PharmacologyQ2 · MEDICINE

Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of CMAB807, a New Denosumab Biosimilar, in Healthy Chinese Subjects

Q2 · MEDICINE

ArticleOA

Author: Li, Xuening ; Chen, Hanjing ; Guo, Qingcheng ; Chen, Weili ; Zhang, Xunmin ; Yuan, Fei ; Wang, Chenguang

Objective: Pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity studies were conducted to evaluate the bioequivalence of CMAB807, a biosimilar to denosumab (Prolia®), which is the only approved RANKL inhibitor for the treatment of osteoporosis.Methods: In this randomized, double-blind, single-dose phase I study, 132 healthy Chinese male subjects received a subcutaneous injection of 60 mg of CMAB807 or denosumab at a 1:1 ratio. The PK, PD, safety and immunogenicity results were assessed prior to and up to 126 days after administration.Results: The PK profiles of CMAB807 and denosumab were similar. The geometric mean ratios of the maximum concentration (Cmax), AUC0-t and AUCo-∞ were 102.41, 104.15 and 103.89%, respectively, and the 90% confidence interval was observed to be within 80.00–125.00%, which indicated the bioequivalence of CMAB807 and denosumab. The PD profiles of the two groups were also comparable. The production of the C-terminal cross-linking telopeptide of type I collagen (CTX1) was inhibited by up to 85% for 10 days, and this inhibition was sustained for up to 126 days in both the CMAB807 and denosumab groups. No subjects in the CMAB807 group, three subjects in the denosumab group before administration, and two subjects in the denosumab group after administration were positive for anti-drug antibody (ADA). Adverse events (AEs) were observed in 98.5% of subjects in both groups. The most common AE recorded was increased parathyroid hormone (PTH) levels, with incidences of 92.4 and 95.5% in the CMAB807 and denosumab groups, respectively. No clinically meaningful differences were observed in safety and immunogenicity between CMAB807 and denosumab.Conclusion: CMAB807 represents a new potential treatment option for patients with osteoporosis.Clinical Trial Registration:https://clinicaltrials.gov (Registration No. NCT03925051), http://www.chinadrugtrial/org.cn/index.html (Registration No. CTR20190800).

100 Deals associated with Denosumab Biosimilar (Biomabs Pharma)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fractures, Bone	Phase 3	CN	Shanghai Biomabs Pharmaceuticals Co., Ltd.	31 Mar 2021
Osteoporosis, Postmenopausal	Phase 3	CN	Shanghai MabLab Biotechnology Co., Ltd.	31 Mar 2021
Osteoporosis, Postmenopausal	Phase 3	CN	Shanghai Biomabs Pharmaceuticals Co., Ltd.	31 Mar 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03925051 (Pubmed \| Front Pharmacol) Manual	Phase 1	Osteoporosis	132	CMAB807	(edxdvstrkk) = hkfdipnvlk nqupsxzqdx (epazsnrsvs )	Positive	24 Jan 2022
				Denosumab	(edxdvstrkk) = fqjomsvori nqupsxzqdx (epazsnrsvs )