SHR-A1811

Phase 3Small molecule

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

SHR-A1811 is one of 307 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

306

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaActive, not recruiting

AdenocarcinomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Biliary Tract CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerNot yet recruiting

Colorectal CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Gastric CancerActive, not recruiting

Cervical CancerActive, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 3

Active, not recruiting

AdenocarcinomaPhase 2

Active, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Biliary Tract CancerPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 1/Phase 2

Active, not recruiting

Breast CancerPhase 3

Not yet recruiting

Colorectal CancerPhase 3

Active, not recruiting

Ovarian CancerPhase 3

Active, not recruiting

Gastric CancerPhase 2

Active, not recruiting

Cervical CancerPhase 1/Phase 2

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SHR-A1811

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

27 2

Tecentriq

Roche

Preclinical

36 3

Trodelvy

Gilead

Preclinical

37 4

Halaven

Eisai

Preclinical

38 5

Tykerb

GSK

Preclinical

80 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Advanced Breast Cancer

NCT06710990

Phase 2Recruiting

Cervical Cancer

NCT07051486

Q4 2026

Phase 1/2Active, not recruiting

Breast Cancer

NCT05824325

Phase 2Recruiting

Breast Cancer

NCT05594095

Phase 2Active, not recruiting

Salivary Gland Carcinoma

NCT05924256

Q1 2027

Phase 1/2Recruiting

Cervical Cancer

NCT06859775

Clinical

Trials by Indication[1]

Breast Cancer27 trials

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

Recruiting·FFudan University·Phase 2·NCT05582499·716 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

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

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

Show 24 more trials

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

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

Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer

Not yet recruiting·—·Phase 2·NCT06433609·131 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

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

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

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

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

SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT05814354·530 enrolled

Reverse Triple Negative Immune Resistant Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05076682·80 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

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

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

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Recruiting·FFudan University·Phase 2·NCT06649331·160 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

A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer

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

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

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

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

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

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

Ovarian Cancer4 trials

A 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.·Phase 1/2·NCT06840002·150 enrolled

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

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

A Study of SHR-A1811 in Subjects With Ovarian Cancer

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

Show 1 more trial

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

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

SHR-A18113 trials

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

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

Biliary Tract Cancer2 trials

Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT06413745·65 enrolled

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

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

14 more indications

Non-Small Cell Lung Cancer2 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

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

Triple-Negative Breast Cancer1 trial

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

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

Refractory to Standard Therapies1 trial

Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies

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

Advanced Breast Cancer1 trial

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

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

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

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

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

Neoadjuvant Treatment1 trial

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

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

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 — 53 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

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Breast Cancer27 trials

Ovarian Cancer4 trials

SHR-A18113 trials

Biliary Tract Cancer2 trials

Cervical Cancer2 trials

Non-Small Cell Lung Cancer2 trials

Gastric Cancer1 trial

Triple-Negative Breast Cancer1 trial

Refractory to Standard Therapies1 trial

Advanced Breast Cancer1 trial

Colorectal Cancer1 trial

Second-line Therapy1 trial

Solid Tumor1 trial

Adenocarcinoma1 trial

Salivary Gland Carcinoma1 trial

Advanced Malignant Solid Tumors1 trial

Neoadjuvant Treatment1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Primary Breast Cancer1 trial

References

Drug Info

Quick Facts

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