HRS-8080

Phase 2Small molecule

SShandong Suncadia Medicine Co., Ltd.

HRS-8080 is one of 68 small molecule programs targeting Breast Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerNot yet recruiting

RandomizedNot yet recruiting

FemaleNot yet recruiting

Breast CancerPhase 2

Not yet recruiting

RandomizedPhase 1

Not yet recruiting

FemalePhase 1

Not yet recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

HRS-8080

SShandong Suncadia Medicine Co., Ltd.

Phase 2

4 2

Lexiscan

Astellas

Preclinical

1 3

Vfend

PPrism Pharmaceuticals

Preclinical

—4

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 5

Tianeptine

Pfizer

Preclinical

1 6

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 7

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 8

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

1 10

QBX258

Novartis

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Breast Cancer

NCT06679036

Q1 2027

Phase 1Not yet recruiting

Breast Cancer

NCT07876596

Q4 2027

Phase 3Recruiting

Locally Advanced Breast Cancer

NCT07024173

Q1 2028

Phase 2Recruiting

Advanced Breast Cancer

NCT07125950

Clinical

Trials by Indication[1]

Breast Cancer4 trials

A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients

Recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1/2·NCT06679036·300 enrolled

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer

Not yet recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1/2·NCT07389733·180 enrolled

A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer

Recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 3·NCT07349069·4,800 enrolled

Show 1 more trial

A Single-center, Single-arm, Open-label, Fixed-sequence Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Oral HRS-8080 in Healthy Participants

Not yet recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT07876596·18 enrolled

Trial1 trial

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT07229560·16 enrolled

Randomized1 trial

A Phase 1, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects

Not yet recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT06619873·24 enrolled

Female1 trial

A Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects.

Not yet recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT07320521·6 enrolled

Advanced Breast Cancer1 trial

A Phase 2 Trial of SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer

Recruiting·HHenan Cancer Hospital·Phase 2·NCT07125950·30 enrolled

1 more indication

Locally Advanced Breast Cancer1 trial

A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy

Recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 3·NCT07024173·240 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for HRS-8080. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HRS-8080 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HRS-8080. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shandong Suncadia Medicine Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SShandong Suncadia Medicine Co., Ltd.

HRS-8080

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Breast Cancer4 trials

Trial1 trial

Randomized1 trial

Female1 trial

Advanced Breast Cancer1 trial

Locally Advanced Breast Cancer1 trial

References

Drug Info

Quick Facts

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