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 Date27 Mar 2026

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

NCT07354022

/ RecruitingPhase 3

A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.

The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.

Start Date04 Mar 2026

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

NCT07349069

/ RecruitingPhase 3

A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy

The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with high-risk early breast cancer.

Start Date04 Mar 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