SHR-1316

Phase 3Small molecule

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

SHR-1316 is one of 164 small molecule programs targeting Triple-Negative Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

163

Competitors

Pipeline

Status by Indication[3][1]

Indication

Triple-Negative Breast CancerActive, not recruiting

Biliary Tract CancerActive, not recruiting

Breast CancerActive, not recruiting

Cervical CancerActive, not recruiting

Small Cell Lung CancerActive, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Biliary Tract CancerPhase 2

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Cervical CancerPhase 3

Active, not recruiting

Small Cell Lung CancerPhase 1/Phase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SHR-1316

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

4 2

Tecentriq

Roche

Preclinical

36 3

Megace

Bristol-Myers Squibb

Preclinical

4 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Zoladex

Luye Pharma Group Ltd.

Preclinical

8 6

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 7

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 8

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 9

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 10

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Breast Cancer

NCT05205200

Q1 2027

Phase 2Recruiting

Breast Cancer

NCT05076682

Q4 2027

Phase 1/2Recruiting

Patients With Solid Tumors

NCT07229586

Phase 1/2Recruiting

NSCLC

NCT06754930

Q3 2028

Phase 2Recruiting

Breast Cancer

NCT05582499

Phase 2Recruiting

Biliary Tract Cancer

NCT06778031

Clinical

Trials by Indication[1]

Breast Cancer4 trials

Reverse Triple Negative Immune Resistant Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05076682·80 enrolled

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02

Recruiting·FFudan University·Phase 2·NCT05205200·338 enrolled

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

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

Show 1 more trial

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

Small Cell Lung Cancer3 trials

Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT03711305·462 enrolled

A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1/2·NCT04400188·25 enrolled

A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT04647357·60 enrolled

Advanced3 trials

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT03995472·14 enrolled

Safety, Tolerability and Pharmacokinetics of the New Formulation SHR-1316 in Subjects With Advanced Tumors

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04979390·15 enrolled

Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT03474289·134 enrolled

Cervical Cancer2 trials

A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer

Active, not recruiting·SShanghai Shengdi Pharmaceutical Co., Ltd·Phase 2·NCT06237257·56 enrolled

A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer

Recruiting·SShanghai Shengdi Pharmaceutical Co., Ltd·Phase 3·NCT07168200·720 enrolled

Triple-Negative Breast Cancer2 trials

A Phase II Study of Triple-negative Breast Cancer Brain Metastases.

Recruiting·FFudan University·Phase 2·NCT04303988·35 enrolled

A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer

Recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 3·NCT07111832·400 enrolled

7 more indications

Esophageal Squamous Cell Cancer1 trial

SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT03732508·30 enrolled

Malignant Solid Tumors1 trial

A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors

Recruiting· Shanghai Hengrui Pharmaceutical Co., Ltd. logo

Shanghai Hengrui Pharmaceutical Co., Ltd.·Phase 2·NCT07268040·400 enrolled

Patients With Solid Tumors1 trial

A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors

Recruiting· Shanghai Hengrui Pharmaceutical Co., Ltd. logo

Shanghai Hengrui Pharmaceutical Co., Ltd.·Phase 1/2·NCT07229586·100 enrolled

NSCLC1 trial

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

Recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 1/2·NCT06754930·400 enrolled

Cancer1 trial

A Trial to Evaluate Safety and Tolerability of SHR-1316 in Cancer Patients

Completed·AAtridia Pty Ltd.·Phase 1·NCT03133247·37 enrolled

Biliary Tract Cancer1 trial

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

Small Cell Lung Carcinoma1 trial

An Open Label, Multicenter Phase I Clinical Study on the Pharmacokinetics, Safety, Tolerability, and Efficacy of SHR-1316 (SC) Combined With Carboplatin and Etoposide in First-line Treatment of Extensive Stage Small Cell Lung Cancer

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 1·NCT07009457·24 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for SHR-1316. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SHR-1316 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SHR-1316. 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-1316

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q4 2027

Q3 2028

Trials by Indication[1]

Breast Cancer4 trials

Small Cell Lung Cancer3 trials

Advanced3 trials

Cervical Cancer2 trials

Triple-Negative Breast Cancer2 trials

Esophageal Squamous Cell Cancer1 trial

Malignant Solid Tumors1 trial

Patients With Solid Tumors1 trial

NSCLC1 trial

Cancer1 trial

Biliary Tract Cancer1 trial

Small Cell Lung Carcinoma1 trial

References

Drug Info

Quick Facts

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