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

Early Stage Breast CarcinomaER-positive/HER2-negative Breast CancerLocally advanced breast cancer+ [4]

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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Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study

This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.

Start Date01 Feb 2026

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

NCT07320521

/ Not yet recruitingPhase 1

A Phase I Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects.

This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.

Start Date01 Jan 2026

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
Early Stage Breast Carcinoma	Phase 3	China	Shandong Suncadia Medicine Co., Ltd.	04 Mar 2026
ER-positive/HER2-negative Breast Cancer	Phase 3	China	Shandong Suncadia Medicine Co., Ltd.	02 Feb 2026
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
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