Product Description
SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.
Mechanisms of Action: PD-L1 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Jiangsu Hengrui Medicine Co
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China
Active Clinical Trial Count: 33
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Bladder Cancer|Hepatocellular Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Lung Cancer|Squamous Cell Carcinoma
Phase 2: Adenocarcinoma|Biliary Tract Cancer|Breast Cancer|Bronchogenic Carcinoma|Cervical Cancer|Cholangiocarcinoma|Colorectal Cancer|Esophageal Cancer|Gastrointestinal Cancer|Male Breast Cancer|Oncology Solid Tumor Unspecified|Pancreatic Cancer|Uterine Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| SHR-1316 | P3 |
Not yet recruiting |
Bladder Cancer |
2031-12-01 |
76% |
2025-03-18 |
|
| MA-BC-II-063 | P2 |
Not yet recruiting |
Male Breast Cancer |
2026-09-30 |
36% |
2024-02-14 |
Primary Endpoints|Treatments |
| NFEC-2023-465 | P2 |
Recruiting |
Bronchogenic Carcinoma|Small Cell Lung Cancer |
2026-06-30 |
38% |
2024-11-27 |
Primary Endpoints|Treatments |
| SHR-8068-301 | P3 |
Recruiting |
Hepatocellular Carcinoma |
2026-03-31 |
70% |
2025-05-16 |
Patient Enrollment|Primary Endpoints|Treatments |
| SHR-A1811-213 | P2 |
Not yet recruiting |
Breast Cancer |
2026-02-28 |
30% |
2024-09-20 |
Primary Endpoints|Treatments |
| SYSKY-2024-027-01 | P2 |
Recruiting |
Biliary Tract Cancer |
2026-02-01 |
12% |
2024-03-21 |
|
| NEO-ERA-01 | P2 |
Recruiting |
Cholangiocarcinoma |
2026-01-01 |
12% |
2024-06-26 |
|
| SHR-1316(sc)-101 | P1 |
Not yet recruiting |
Small Cell Lung Cancer |
2025-09-01 |
2025-06-07 |
Primary Endpoints|Treatments |
|
| SHR-1802-II-202 | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2025-07-01 |
13% |
2023-06-02 |
Primary Endpoints |
| SHR-8068-201-GC | P2 |
Recruiting |
Esophageal Cancer|Gastrointestinal Cancer|Adenocarcinoma|Squamous Cell Carcinoma |
2025-06-30 |
12% |
2024-08-06 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| SHR-A1921-205 | P2 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2025-06-01 |
41% |
2024-05-31 |
Primary Endpoints|Treatments |
| NCT06475417 | P2 |
Recruiting |
Gastrointestinal Cancer |
2025-05-20 |
61% |
2024-06-28 |
Primary Endpoints|Treatments |
| K2024035 | P2 |
Recruiting |
Colorectal Cancer |
2025-03-01 |
2024-02-29 |
Primary Endpoints|Treatments |
|
| DZQH-KYLL-23-26 | P2 |
Recruiting |
Pancreatic Cancer |
2024-12-01 |
32% |
2024-08-17 |
Primary Endpoints|Start Date|Treatments |
| SHR-1316-202 | P2 |
Active, not recruiting |
Cervical Cancer|Uterine Cancer |
2024-12-01 |
12% |
2024-12-27 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| SHR-1316-307 | P3 |
Not yet recruiting |
Squamous Cell Carcinoma|Non-Small-Cell Lung Cancer |
2028-10-01 |
39% |
2024-03-29 |
Primary Endpoints|Treatments |
| LungMate-015 | P3 |
Not yet recruiting |
Small Cell Lung Cancer |
2027-08-01 |
61% |
2023-05-22 |
Primary Endpoints|Start Date|Treatments |
| SHR-8068-201-BTC | P2 |
Recruiting |
Biliary Tract Cancer |
2026-12-30 |
12% |
2024-07-09 |
Primary Endpoints|Start Date |
| 23-OBU-FJ-HCC-II-012 | P2 |
Recruiting |
Hepatocellular Carcinoma |
2026-11-15 |
42% |
2024-02-29 |
Primary Endpoints|Treatments|Trial Status |
| SHR-8068-II-201-HCC | P2 |
Recruiting |
Hepatocellular Carcinoma |
2026-06-30 |
18% |
2024-07-23 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| NJMU- BC03 | P2 |
Not yet recruiting |
Breast Cancer |
2026-06-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
| ACADEMY | P2 |
Recruiting |
Cholangiocarcinoma |
2026-06-01 |
12% |
2025-04-15 |
Primary Endpoints|Treatments |
| SHR-A2102-206 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2026-04-30 |
40% |
2024-11-13 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| NCT06475209 | P2 |
Recruiting |
Small Cell Lung Cancer |
2025-12-20 |
39% |
2024-06-28 |
Primary Endpoints |
| HRS2398-201-PD-L1 | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2025-12-01 |
60% |
2024-07-07 |