Delving into the Latest Updates on HRS-4357 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug, Therapeutic radiopharmaceuticals

Synonyms

HRS 4357, HRS-4357, HRS4357

Target

PSMA

Action

inhibitors

Mechanism

PSMA inhibitors(Prostate-specific membrane antigen inhibitors)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Metastatic castration-resistant prostate cancerPSMA-Positive Castration-Resistant Prostatic CancerAdvanced Prostate Carcinoma+ [1]

Inactive Indication-

Originator Organization

Tianjin Hengrui Pharmaceutical Co., Ltd

Active Organization

Tianjin Hengrui Pharmaceutical Co., Ltd

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.

Start Date01 Jan 2026

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

CTR20232716

/ RecruitingPhase 1/2

HRS-4357用于PSMA阳性晚期前列腺癌患者治疗的药代动力学及辐射剂量学、安全性及初步有效性评价的I/II期临床研究

[Translation] A Phase I/II clinical study of HRS-4357 for the treatment of patients with PSMA-positive advanced prostate cancer: pharmacokinetics, radiation dosimetry, safety, and preliminary efficacy evaluation

本研究的目的是在晚期前列腺癌成年患者中评价HRS-4357注射液的安全性、PK特征、辐射剂量学特征及初步有效性

[Translation]

The purpose of this study is to evaluate the safety, PK characteristics, radiation dosimetry characteristics and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer.

Start Date10 Nov 2023

Sponsor / Collaborator

Tianjin Hengrui Pharmaceutical Co., Ltd

NCT06006104

/ Unknown statusPhase 1/2

A Phase I/II Clinical Study to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-4357 in Patients With PSMA Positive Advanced Prostate Cancer

The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer.

Start Date30 Sep 2023

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with HRS-4357

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100 Translational Medicine associated with HRS-4357

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100 Patents (Medical) associated with HRS-4357

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100 Deals associated with HRS-4357

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 2026
PSMA-Positive Castration-Resistant Prostatic Cancer	Phase 3	China	Tianjin Hengrui Pharmaceutical Co., Ltd	23 Dec 2025
Advanced Prostate Carcinoma	Phase 2	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Sep 2023
PSMA-Positive Prostatic Cancer	Phase 2	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Sep 2023