Delving into the Latest Updates on SHR-2010 with Synapse

Overview

Basic Info

Drug Type

Antibody

Synonyms

Target

MASP2

Action

inhibitors

Mechanism

MASP2 inhibitors(Mannan-binding lectin serine protease 2 inhibitors)

Therapeutic Areas

Immune System DiseasesUrogenital Diseases

Active Indication

Glomerulonephritis, IGA

Inactive Indication-

Originator Organization

Guangdong Hengrui Pharmaceutical Co., Ltd.

Active Organization

Guangdong Hengrui Pharmaceutical Co., Ltd.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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主要研究目的：评估单次静脉/皮下注射SHR-2010在健康受试者中的安全性、耐受性。次要研究目的：描述单次静脉/皮下注射SHR-2010在健康受试者中的药代动力学（PK）特征；描述单次静脉/皮下注射SHR-2010在健康受试者中的药效动力学（PD）特征；评估单次静脉/皮下注射SHR-2010在健康受试者体内的免疫原性。

[Translation]

Primary study objectives: To evaluate the safety and tolerability of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects. Secondary study objectives: To describe the pharmacokinetic (PK) characteristics of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects; To describe the pharmacodynamic (PD) characteristics of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects; To evaluate the immunogenicity of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects.

Start Date30 Jun 2022

Sponsor / Collaborator

Guangdong Hengrui Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with SHR-2010

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100 Translational Medicine associated with SHR-2010

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100 Patents (Medical) associated with SHR-2010

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100 Deals associated with SHR-2010

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glomerulonephritis, IGA	Phase 2	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	04 Jun 2023
Glomerulonephritis, IGA	Phase 2	China	Guangdong Hengrui Pharmaceutical Co., Ltd.	04 Jun 2023

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Clinical Result

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Approval

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Biosimilar

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