Delving into the Latest Updates on TAB014 with Synapse

Overview

Basic Info

Drug Type

Recombinant protein

Synonyms

TAB014 monoclonal antibody injection, TAB 014, TAB-014

+ [1]

Target

VEGF

Action

inhibitors

Mechanism

VEGF inhibitors(Vascular endothelial growth factor inhibitors)

Therapeutic Areas

Congenital DisordersEye Diseases

Active Indication

Wet age-related macular degeneration

Inactive Indication

Glycogen Storage Disease Type II

Originator Organization

TOT BIOPHARM International Co. Ltd.

Active Organization

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

TOT BIOPHARM International Co. Ltd.

Tot Biopharm Co. Ltd.

Inactive Organization

Lee's Pharmaceutical Holdings Ltd.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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主要目的：比较TAB014和雷珠单抗（诺适得®）在新生血管性年龄相关性黄斑变性患者中的有效性次要目的：比较TAB014和雷珠单抗（诺适得®）在新生血管性年龄相关性黄斑变性患者中的安全性；评价TAB014在新生血管性年龄相关性黄斑变性患者中的免疫原性

[Translation]

Primary objective: To compare the efficacy of TAB014 and ranibizumab (Linosider®) in patients with neovascular age-related macular degeneration Secondary objective: To compare the safety of TAB014 and ranibizumab (Linosider®) in patients with neovascular age-related macular degeneration; To evaluate the immunogenicity of TAB014 in patients with neovascular age-related macular degeneration

Start Date20 Jun 2022

Sponsor / Collaborator

TOT BIOPHARM International Co. Ltd.

CTR20180360

/ CompletedPhase 1

TAB014治疗湿性(新生血管性)年龄相关性黄斑变性（AMD）的I期临床研究

[Translation] Phase I clinical study of TAB014 for the treatment of wet (neovascular) age-related macular degeneration (AMD)

要目的：评估TAB014单抗注射液玻璃体单次和多次注射给药的安全性和耐受性；评估TAB014单抗注射液玻璃体单次和多次注射给药后血药代动力学参数。次要目的：评估TAB014单抗注射液剂量限制性毒性及不良反应；评估TAB014单抗注射液治疗湿性(新生血管性)年龄相关性黄斑变性(AMD)的有效性；评估TAB014单抗注射液的免疫原性；为II期确定给药剂量提供依据。

[Translation]

Primary objectives: To evaluate the safety and tolerability of single and multiple intravitreal injections of TAB014 monoclonal antibody injection; To evaluate the blood pharmacokinetic parameters after single and multiple intravitreal injections of TAB014 monoclonal antibody injection. Secondary objectives: To evaluate the dose-limiting toxicity and adverse reactions of TAB014 monoclonal antibody injection; To evaluate the efficacy of TAB014 monoclonal antibody injection in the treatment of wet (neovascular) age-related macular degeneration (AMD); To evaluate the immunogenicity of TAB014 monoclonal antibody injection; To provide a basis for determining the dosage in Phase II.

Start Date29 Aug 2019

Sponsor / Collaborator

TOT BIOPHARM International Co. Ltd.

100 Clinical Results associated with TAB014

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100 Translational Medicine associated with TAB014

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100 Patents (Medical) associated with TAB014

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100 Deals associated with TAB014

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 3	United States	Tot Biopharm Co. Ltd.	12 May 2022
Glycogen Storage Disease Type II	Phase 1	China	Lee's Pharmaceutical Holdings Ltd.	15 Jun 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05461339 (NEWS) Manual	Phase 3	Wet age-related macular degeneration	488	TAB014	xcvvniuotn(hljtgmnwxf) = 成功达到主要研究终点 hxraiebplv (ckoaorizfd ) Met	Non-inferior	02 Jan 2025
				Lucentis

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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