SHR-A1811

Phase 3Small molecule

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

SHR-A1811 is one of 400 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

399

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaRecruiting

AdenocarcinomaRecruiting

Triple-Negative Breast CancerNot yet recruiting

Biliary Tract CancerActive, not recruiting

Non-Small Cell Lung CancerRecruiting

Breast CancerRecruiting

Colorectal CancerActive, not recruiting

Ovarian CancerNot yet recruiting

Gastric CancerNot yet recruiting

Cervical CancerRecruiting

Gastroesophageal Junction AdenocarcinomaPhase 3

Recruiting

AdenocarcinomaPhase 2

Recruiting

Triple-Negative Breast CancerPhase 2

Not yet recruiting

Biliary Tract CancerPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Recruiting

Breast CancerPhase 3

Recruiting

Colorectal CancerPhase 3

Active, not recruiting

Ovarian CancerPhase 3

Not yet recruiting

Gastric CancerPhase 2

Not yet recruiting

Cervical CancerPhase 2

Recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SHR-A1811

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

24 2

Adenocard

Astellas

Preclinical

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Spravato

WWim Janssens

Preclinical

2 6

Duragesic

CCephalon

Preclinical

1 7

Chantix

PPrism Pharmaceuticals

Preclinical

1 8

Nubain

AAultman Health Foundation

Preclinical

1 9

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Breast Cancer

NCT05594095

PreclinicalRecruiting

Ovarian Cancer

NCT06840002

Phase 2Active, not recruiting

Salivary Gland Carcinoma

NCT05924256

Q1 2027

Phase 1/2Recruiting

Cervical Cancer

NCT06859775

Phase 1/2Recruiting

Breast Cancer

NCT06718933

Phase 2Recruiting

Triple-Negative Breast Cancer

NCT05076682

Clinical

Trials by Indication[1]

Breast Cancer24 trials

SNF Platform Study of HR+/ HER2-advanced Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05594095·620 enrolled

SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

Recruiting·SShengjing Hospital·Phase 2·NCT06340230·93 enrolled

Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients

Not yet recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 2·NCT06592625·60 enrolled

Show 21 more trials

SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response

Not yet recruiting·CChuan Wang·Phase 2·NCT07129187·30 enrolled

Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype

Not yet recruiting·FFudan University·Phase 3·NCT07382687·248 enrolled

SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression

Not yet recruiting·—·Phase 2·NCT07047443·18 enrolled

A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Recruiting·SShengjing Hospital·Phase 2·NCT05635487·65 enrolled

A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases

Not yet recruiting·PPeking University Cancer Hospital & Institute·Phase 1/2·NCT07177950·51 enrolled

Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT07340398·200 enrolled

SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study

Not yet recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT07417241·100 enrolled

A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Active, not recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT05424835·381 enrolled

Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis

Recruiting·FFudan University·Phase 1/2·NCT06718933·74 enrolled

Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases

Not yet recruiting·FFudan University·Phase 2·NCT07466927·30 enrolled

Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer

Not yet recruiting·—·Phase 2·NCT07317778·249 enrolled

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Recruiting·FFudan University·Phase 2·NCT05582499·716 enrolled

Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer（GALAXY）

Active, not recruiting·FFudan University·Phase 1/2·NCT05824325·56 enrolled

Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer

Not yet recruiting·FFirst Hospital of China Medical University·Phase 2·NCT07305246·120 enrolled

SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases

Not yet recruiting·HHuihua Xiong·Phase 2·NCT06361979·30 enrolled

SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07307287·30 enrolled

Study of SHR-A1811 in HER2-expression Advanced Breast Cancer with Brain Metastases

Recruiting·HHenan Cancer Hospital·Phase 2·NCT05769010·125 enrolled

A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus as First- to Third-Line Treatment for Luminal Androgen Receptor Subtype of Triple-Negative Breast Cancer

Not yet recruiting·FFudan University·Phase 3·NCT07760844·180 enrolled

A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer

Active, not recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT05814354·551 enrolled

Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy: A Randomized, Controlled, Open-Label, Multicenter Phase III Clinical Study

Recruiting·FFudan University·Phase 3·NCT07528716·280 enrolled

A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab as First- to Third-Line Treatment for Basal-like Immune-suppressed Triple-Negative Breast Cancer

Not yet recruiting·FFudan University·Phase 3·NCT07669610·140 enrolled

Advanced Breast Cancer4 trials

Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT06710990·32 enrolled

A Single-Center, Single-Arm, Open-Label Phase II Study of SHR-A1811 in Patients With Advanced Breast Cancer With Ultra-Low HER2 Expression

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07817082·30 enrolled

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer：A Prospective, Open-label, Phase 2 Trial

Recruiting·FFudan University·Phase 2·NCT06649331·160 enrolled

Show 1 more trial

A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer

Recruiting·BBeijing GoBroad Hospital·Phase 2·NCT06433609·113 enrolled

Ovarian Cancer4 trials

A Study of SHR-A1811 in Subjects With Ovarian Cancer

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT06828354·300 enrolled

SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer

Not yet recruiting·TTongji Hospital·Phase 1/2·NCT06990516·90 enrolled

SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer

Not yet recruiting·TTongji Hospital·Phase 3·NCT06990503·300 enrolled

Show 1 more trial

An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

Recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Preclinical·NCT06840002·150 enrolled

SHR-A18113 trials

A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04513223·101 enrolled

A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT05896020·225 enrolled

A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers

Unknown status· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 2·NCT05349409·212 enrolled

Non-Small Cell Lung Cancer3 trials

A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT06430437·300 enrolled

A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

Active, not recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 1/2·NCT04818333·157 enrolled

A Randomized, Controlled, Open-label, Multicenter Phase III Study of SHR-A1811 Combined With Adebrelimab for the First-line Treatment of Patients With HER2-overexpressing Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

Not yet recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 3·NCT07896005·436 enrolled

16 more indications

Cervical Cancer2 trials

SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer

Recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 1/2·NCT06859775·100 enrolled

A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT07051486·60 enrolled

Biliary Tract Cancer2 trials

A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 2·NCT06778031·54 enrolled

A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy

Active, not recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT06413745·59 enrolled

Triple-Negative Breast Cancer2 trials

Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer

Not yet recruiting·XXijing Hospital·Phase 2·NCT07466303·84 enrolled

Reverse Triple Negative Immune Resistant Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05076682·90 enrolled

Advanced Malignant Solid Tumors1 trial

A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04446260·396 enrolled

Colorectal Cancer1 trial

Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

Active, not recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 3·NCT06199973·130 enrolled

Neoadjuvant Treatment1 trial

SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC

Recruiting·HHenan Cancer Hospital·Phase 2·NCT06927180·180 enrolled

Second-line Therapy1 trial

Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC

Not yet recruiting·TThe First Affiliated Hospital of Guangzhou Medical University·N/A·NCT07377916·60 enrolled

Refractory to Standard Therapies1 trial

Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies

Recruiting·SSheng Zhang·Phase 2·NCT07309770·90 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT06123494·360 enrolled

Gastric Cancer1 trial

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping

Not yet recruiting·—·Phase 2·NCT06881017·140 enrolled

Solid Tumor1 trial

A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor

Recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 1·NCT07275242·107 enrolled

Adenocarcinoma1 trial

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT07102901·351 enrolled

Salivary Gland Carcinoma1 trial

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing

Active, not recruiting·FFudan University·Phase 2·NCT05924256·88 enrolled

HER2-positive Breast Cancer1 trial

A Randomized, Open-Label, Phase II Study of Intensified Adjuvant SHR-A1811 Versus Trastuzumab Plus Pertuzumab in Patients With Initially Stage IIB-IIIC HER2-Positive Early Breast Cancer Who Achieved Pathologic Complete Response After Neoadjuvant Therapy and Have Postoperative ctDNA Positivity

Not yet recruiting·FFudan University·Phase 2·NCT07856303·358 enrolled

Metastatic Breast Cancer1 trial

A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer

Active, not recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT06057610·868 enrolled

Primary Breast Cancer1 trial

A Phase III, Multicenter, Randomized, Open-Label, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy

Active, not recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT06126640·1,615 enrolled

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for SHR-A1811. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SHR-A1811 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SHR-A1811. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Suzhou Suncadia Biopharmaceuticals Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

SHR-A1811

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Breast Cancer24 trials

Advanced Breast Cancer4 trials

Ovarian Cancer4 trials

SHR-A18113 trials

Non-Small Cell Lung Cancer3 trials

Cervical Cancer2 trials

Biliary Tract Cancer2 trials

Triple-Negative Breast Cancer2 trials

Advanced Malignant Solid Tumors1 trial

Colorectal Cancer1 trial

Neoadjuvant Treatment1 trial

Second-line Therapy1 trial

Refractory to Standard Therapies1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Gastric Cancer1 trial

Solid Tumor1 trial

Adenocarcinoma1 trial

Salivary Gland Carcinoma1 trial

HER2-positive Breast Cancer1 trial

Metastatic Breast Cancer1 trial

Primary Breast Cancer1 trial

References

Drug Info

Quick Facts

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