Delving into the Latest Updates on Hasten Biopharmaceutical Co., Ltd. with Synapse

Overview

Tags

Congenital Disorders

Endocrinology and Metabolic Disease

Cardiovascular Diseases

Fusion protein

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Fusion protein	1

Top 5 Target	Count

PCSK9(Proprotein convertase subtilisin kexin type 9)	1

"主要目的：本研究的主要目的是评估HST101单次皮下（SC）给药在中国高胆固醇水平的健康成人研究参与者中的安全性和耐受性。次要目的：？评估HST101单次SC给药后的药代动力学（PK）和剂量比例关系；？评估HST101单次SC给药对血清未结合（游离）前蛋白转化酶枯草溶菌素 9（PCSK9）浓度和血清LDL-C浓度的药效学（PD）影响；？评估HST101单次SC给药对血脂，包括总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、极低密度脂蛋白胆固醇（VLDL-C）和甘油三酯（TG）的影响；？评估HST101单次SC给药对血清载脂蛋白B（Apo B）、Apo A1和脂蛋白（a）[Lp(a)]浓度的影响；？评估HST101单次SC给药的PK-PD关系；？评估HST101单次SC给药后的免疫原性[抗药抗体（ADAs）/中和抗体（NAbs）]的发生率、滴度及存续时间。"

[Translation]

"Primary Objectives: The primary objective of this study is to evaluate the safety and tolerability of a single subcutaneous (SC) administration of HST101 in healthy adult study participants with high cholesterol levels in China. Secondary Objectives: ? To evaluate the pharmacokinetic (PK) and dose proportionality relationship of HST101 after a single SC administration; ? To evaluate the pharmacodynamic (PD) effect of a single SC administration of HST101 on serum unbound (free) proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration and serum LDL-C concentration; ? To evaluate the effect of a single SC administration of HST101 on blood lipids, including total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol (VLDL-C), and triglycerides (TG); ? To evaluate the effect of a single SC administration of HST101 on serum apolipoprotein B (Apo B), Apo A1, and lipoprotein (a) [Lp(a)] concentrations; ? To evaluate the PK-PD relationship of a single SC administration of HST101; ? To evaluate the incidence, titer, and duration of immunogenicity [anti-drug antibodies (ADAs)/neutralizing antibodies (NAbs)] of HST101 after a single SC administration.

Start Date-

Sponsor / Collaborator

Lyophilization Services of New England, Inc.

[+3]

NCT06568471 / Not yet recruitingPhase 3

A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients With Hypercholesterolemia

This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W [≤31 days]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high/high risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.

Start Date01 Sep 2024

Sponsor / Collaborator

Hasten Biopharmaceutical Co., Ltd.

NCT06504043 / Not yet recruitingPhase 1

A Randomized, Double-Blind, Placebo-Controlled, Single-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Study Participants With Elevated LDL-C Levels

This is a single-center, randomized, double-blind, placebo-controlled, single SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Participants with Elevated LDL-C Levels.

Start Date01 Aug 2024

Sponsor / Collaborator

Hasten Biopharmaceutical Co., Ltd.

[+2]

100 Clinical Results associated with Hasten Biopharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Hasten Biopharmaceutical Co., Ltd.

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100 Deals associated with Hasten Biopharmaceutical Co., Ltd.

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100 Translational Medicine associated with Hasten Biopharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 3 Clinical

1

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