Delving into the Latest Updates on HRS-8080 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HRS 8080, HRS-8080, HRS8080

Target

ER

Action

degraders

Mechanism

ERs degraders(Estrogen receptors degraders)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Locally advanced breast cancerMetastatic breast cancerLocally Advanced Unresectable Breast Carcinoma+ [3]

Inactive Indication-

Originator Organization

Shandong Suncadia Medicine Co., Ltd.

Active Organization

Shandong Suncadia Medicine Co., Ltd.

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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[Translation] An open, multicenter, phase Ib/II clinical study of the safety, tolerability, pharmacokinetics, and preliminary efficacy of HRS-2189 combined with fulvestrant ± HRS-6209, or combined with HRS-8080 ± HRS-6209, or combined with HRS-6209 + HRS-1358 in patients with advanced unresectable or metastatic breast cancer

评价HRS-2189联合氟维司群±HRS-6209、或联合HRS-8080±HRS-6209、或联合HRS-6209+HRS-1358在晚期不可切除或转移性乳腺癌患者中的剂量限制性毒性（DLT）、最大耐受剂量（MTD）和Ⅱ期临床研究推荐剂量（RP2D）、药代动力学（PK）特征、安全性及初步有效性。

[Translation]

To evaluate the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose for Phase II clinical study (RP2D), pharmacokinetic (PK) characteristics, safety and preliminary efficacy of HRS-2189 combined with fulvestrant ± HRS-6209, or combined with HRS-8080 ± HRS-6209, or combined with HRS-6209 + HRS-1358 in patients with advanced unresectable or metastatic breast cancer.

Start Date21 Jan 2025

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

100 Clinical Results associated with HRS-8080

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100 Translational Medicine associated with HRS-8080

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100 Patents (Medical) associated with HRS-8080

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100 Deals associated with HRS-8080

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally advanced breast cancer	Phase 3	China	Shandong Suncadia Medicine Co., Ltd.	23 Jul 2025
Metastatic breast cancer	Phase 3	China	Shandong Suncadia Medicine Co., Ltd.	23 Jul 2025
Locally Advanced Unresectable Breast Carcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	12 Aug 2024
ER-positive/HER2-negative Breast Cancer	Phase 2	China	Shandong Suncadia Medicine Co., Ltd.	20 Dec 2023
Advanced breast cancer	Phase 1	China	Shandong Suncadia Medicine Co., Ltd.	17 Feb 2022
Advanced cancer	IND Approval	China	Shandong Suncadia Medicine Co., Ltd.	18 Oct 2024