Last update 04 Apr 2026

HRS-1358

Overview

Basic Info

Drug Type
Proteolysis-targeting chimeras (PROTAC)
Synonyms
HRS 1358, HRS-1358, HRS1358
Target
ER
Action
degraders
Mechanism
ERs degraders(Estrogen receptors degraders)
Therapeutic Areas
NeoplasmsSkin and Musculoskeletal Diseases
Active Indication
Advanced breast cancerLocally Advanced Unresectable Breast CarcinomaLocally advanced breast cancer+ [1]
Inactive Indication-
Originator Organization
Shandong Suncadia Medicine Co., Ltd.
Active Organization
Henan Cancer HospitalHenan Cancer HospitalShandong Suncadia Medicine Co., Ltd.
Jiangsu Hengrui Pharmaceuticals Co., Ltd.Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Inactive Organization-
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
Regulation-
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Related

4
Clinical Trials associated with HRS-1358
NCT07125950
/ Not yet recruitingPhase 2IIT
A Phase 2 Trial of SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer
NCT06679036
/ RecruitingPhase 1/2
An Open, Multicenter Phase Ib/II Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Initial Efficacy of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer
NCT06555068
/ RecruitingPhase 1/2
An Open-Label, Multi-Center Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer
100 Clinical Results associated with HRS-1358
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100 Translational Medicine associated with HRS-1358
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100 Patents (Medical) associated with HRS-1358
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100 Deals associated with HRS-1358
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced breast cancerPhase 2
China
Henan Cancer HospitalHenan Cancer Hospital
30 Sep 2025
Locally Advanced Unresectable Breast CarcinomaPhase 2
China
Jiangsu Hengrui Pharmaceuticals Co., Ltd.Jiangsu Hengrui Pharmaceuticals Co., Ltd.
12 Aug 2024
Locally advanced breast cancerPhase 1
China
Shandong Suncadia Medicine Co., Ltd.
07 Feb 2023
Advanced cancerIND Approval
China
Shandong Suncadia Medicine Co., Ltd.
18 Oct 2024
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Clinical Result

Indication
Phase
Evaluation
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Clinical Trial

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Approval

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Regulation

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