Delving into the Latest Updates on Recombinant human anti-PCSK9 monoclonal antibody(Tasly Pharmaceutical Group Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

B-1655, B1655

Target

PCSK9

Action

inhibitors

Mechanism

PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Hypercholesterolemia

Inactive Indication-

Originator Organization

Tasly Pharmaceutical Group Co., Ltd.

Active Organization

Shanghai Tasly Pharmaceutical Co. Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评估健康受试者接受B1655单次给药后的安全性和耐受性；次要目的：评估B1655单次给药在健康受试者体内的药代动力学特征；评估B1655单次给药在健康受试者体内的药效动力学特征；评估B1655单次给药在健康受试者体内的免疫原性

[Translation]

Primary purpose: To evaluate the safety and tolerability of B1655 after a single administration in healthy subjects; Secondary purpose: To evaluate the pharmacokinetic characteristics of B1655 after a single administration in healthy subjects; To evaluate the pharmacodynamic characteristics of B1655 after a single administration in healthy subjects; To evaluate the immunogenicity of B1655 after a single administration in healthy subjects

Start Date01 Mar 2021

Sponsor / Collaborator

Shanghai Tasly Pharmaceutical Co. Ltd.

100 Clinical Results associated with Recombinant human anti-PCSK9 monoclonal antibody(Tasly Pharmaceutical Group Co., Ltd.)

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100 Translational Medicine associated with Recombinant human anti-PCSK9 monoclonal antibody(Tasly Pharmaceutical Group Co., Ltd.)

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100 Patents (Medical) associated with Recombinant human anti-PCSK9 monoclonal antibody(Tasly Pharmaceutical Group Co., Ltd.)

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100 Deals associated with Recombinant human anti-PCSK9 monoclonal antibody(Tasly Pharmaceutical Group Co., Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypercholesterolemia	Phase 1	China	Shanghai Tasly Pharmaceutical Co. Ltd.	01 Mar 2021

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Clinical Result

Indication

Phase

Evaluation

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Deal

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Clinical Trial

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Approval

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Biosimilar

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