Delving into the Latest Updates on Aflibercept biosimilar (Mabwell Bioscience) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Fusion protein

Synonyms

Aflibercept Biosimilar (Mabwell (Shanghai) Bioscience Co., Ltd.), 阿柏西普生物类似药（Mabwell (Shanghai) Bioscience Co., Ltd.）

+ [1]

Target

PGF x VEGF-A

Mechanism

PGF inhibitors(Placental Growth Factor inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

Cardiovascular DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication

Diabetic macular oedemaWet age-related macular degeneration

Inactive Indication-

Originator Organization

Mabwell (Shanghai) Bioscience Co., Ltd.

Active Organization

Mabwell (Shanghai) Bioscience Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 4715606

The sequence is quoted from: *****

主要研究目的：比较在 DME 患者中玻璃体腔内注射 9MW0813 注射液和阿柏西普眼内注射溶液（EYLEA®）的临床有效性的相似性。次要研究目的：（1）比较在 DME 患者中玻璃体腔内注射 9MW0813 注射液和阿柏西普眼内注射溶液（EYLEA®）的临床安全性的相似性；（2）比较在 DME 患者中玻璃体腔内注射 9MW0813 注射液和阿柏西普眼内注射溶液（EYLEA®）的免疫原性的相似性；（3）探索在部分 DME 患者中玻璃体腔内注射 9MW0813 注射液和阿柏西普眼内注射溶液（EYLEA®）的药代动力学特征。

[Translation]

Primary study objectives: To compare the similarity of clinical efficacy of intravitreal 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in patients with DME. Secondary study objectives: (1) To compare the similarity of clinical safety of intravitreal 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in patients with DME; (2) To compare the similarity of immunogenicity of intravitreal 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in patients with DME; (3) To explore the pharmacokinetic characteristics of intravitreal 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in some patients with DME.

Start Date17 Feb 2022

Sponsor / Collaborator

Mabwell (Shanghai) Bioscience Co., Ltd.

[+2]

CTR20202549

/ CompletedPhase 1

多中心、随机、双盲、平行对照比较 9MW0813 和阿柏西普（EYLEA®）在糖尿病性黄斑水肿（DME）患者中单次给药后的安全性、药代动力学及有效性的 I 期临床研究

[Translation] A multicenter, randomized, double-blind, parallel-controlled Phase I clinical study comparing the safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with diabetic macular edema (DME)

主要目的：比较在DME患者中单次玻璃体腔内注射（IVT）9MW0813注射液和阿柏西普眼内注射溶液（EYLEA®）后的安全性。次要目的：（1）比较在DME患者中单次玻璃体腔内注射（IVT）9MW0813注射液和阿柏西普眼内注射溶液（EYLEA®）后的药代动力学特征；（2）比较在DME患者中单次玻璃体腔内注射（IVT）9MW0813注射液和阿柏西普眼内注射溶液（EYLEA®）后的免疫原性；（3）初步评价在DME患者中单次玻璃体腔内注射（IVT）9MW0813注射液和阿柏西普眼内注射溶液（EYLEA®）后的临床有效性。

[Translation]

Primary objective: To compare the safety of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) after a single intravitreal injection (IVT) in patients with DME. Secondary objectives: (1) To compare the pharmacokinetic characteristics of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) after a single intravitreal injection (IVT) in patients with DME; (2) To compare the immunogenicity of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) after a single intravitreal injection (IVT) in patients with DME; (3) To preliminarily evaluate the clinical efficacy of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) after a single intravitreal injection (IVT) in patients with DME.

Start Date26 Feb 2021

Sponsor / Collaborator

Mabwell (Shanghai) Bioscience Co., Ltd.

[+2]

100 Clinical Results associated with Aflibercept biosimilar (Mabwell Bioscience)

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100 Translational Medicine associated with Aflibercept biosimilar (Mabwell Bioscience)

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100 Patents (Medical) associated with Aflibercept biosimilar (Mabwell Bioscience)

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100 Deals associated with Aflibercept biosimilar (Mabwell Bioscience)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 3	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	17 Feb 2022
Wet age-related macular degeneration	Phase 3	-	Mabwell (Shanghai) Bioscience Co., Ltd.	-