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+ [2]

Inactive Indication-

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Fudan UniversityAtridia Pty Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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The study aims to assess the safety and tolerability of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer, and determine the recommended Phase II dose (RP2D); To evaluate of the efficacy of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer based on Prostate-Specific Antigen (PSA) response rate.

Start Date01 Mar 2026

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

NCT07115446

/ RecruitingPhase 1

A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer

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 Date19 Aug 2025

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

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
PSMA-Positive Prostatic Cancer	IND Approval	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	19 Dec 2025
Advanced cancer	IND Approval	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	18 Oct 2024