Delving into the Latest Updates on HRS-5041 with Synapse

Overview

Basic Info

Drug Type

Proteolysis-targeting chimeras (PROTAC)

Synonyms

HRS 5041, HRS-5041, HRS5041

Target

AR

Action

degraders

Mechanism

AR degraders(Androgen Receptor degraders)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Metastatic Prostate CarcinomaAdvanced Prostate CarcinomaMetastatic castration-resistant prostate cancer+ [1]

Inactive Indication-

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.Atridia Pty Ltd.

Fudan University

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors.
This is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.

Start Date01 Aug 2025

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

CTR20252197

/ CompletedPhase 1

在健康参与者中评价利福平对口服HRS-5041药代动力学影响的单中心、单臂、开放、固定序列研究

[Translation] A single-center, single-arm, open-label, fixed-sequence study to evaluate the effect of rifampicin on the pharmacokinetics of oral HRS-5041 in healthy participants

主要目的：研究在健康参与者中利福平对HRS-5041药代动力学的影响。次要目的：观察在健康参与者中HRS-5041单次给药或与利福平同时给药的安全性。

[Translation]

Primary objective: To investigate the effect of rifampicin on the pharmacokinetics of HRS-5041 in healthy participants. Secondary objective: To observe the safety of HRS-5041 as a single dose or concurrently with rifampicin in healthy participants.

Start Date20 Jun 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

[+1]

NCT07014488

/ CompletedPhase 1

A Single-center, Single-arm, Open-label, Fixed-sequence Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Oral HRS-5041 in Healthy Subjects

The study was designed to evaluate the pharmacokinetic effects of Rifampicin on HRS-5041 after oral administration of HRS-5041 tablets in healthy subjects.

Start Date20 Jun 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with HRS-5041

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100 Translational Medicine associated with HRS-5041

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100 Patents (Medical) associated with HRS-5041

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100 Deals associated with HRS-5041

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Prostate Carcinoma	Phase 2	China	Fudan University	31 Dec 2024
Advanced Prostate Carcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	06 Sep 2024
Metastatic castration-resistant prostate cancer	Phase 1	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	03 Aug 2023
Advanced cancer	IND Approval	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	18 Oct 2024