Sponsor Pipeline

Shanghai Henlius Biotech Clinical Trial Pipeline

Data updated daily from ClinicalTrials.gov — last refresh 2026-06-12
28
Active Trials
13
Recruiting
5
Phase 3
10
Disease Areas
8
Changes, 30 Days
What Changed in the Last 30 Days
DetectedTrialChange
2026-06-02 NCT07459751
A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43…
overall status: "Enrolling By Invitation" → "Recruiting"
2026-05-30 NCT06115642
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in…
overall status: "Recruiting" → "Enrolling By Invitation"
2026-05-30 NCT07459751
A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43…
overall status: "Not Yet Recruiting" → "Enrolling By Invitation"
2026-05-29 NCT07541534
A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors
Recruitment opened
2026-05-23 NCT07477587
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of…
Recruitment opened
2026-05-23 NCT07477587
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of…
Trial sites expanded: 9 -> 81 locations
2026-05-19 NCT06769113
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC…
Enrollment increased: 72 -> 102 participants
2026-05-19 NCT06769113
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC…
Trial arms changed: 3 -> 4
New Trial Filings, Last 30 Days
First PostedTrialPhaseStatus
2026-05-22 NCT07601620 A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo®… Phase 1 Not Yet Recruiting
Active Trials by Phase
Phase 3
2
Phase 2/3
3
Phase 2
7
Phase 1/2
1
Phase 1
14
Early Phase 1
1
Active Trials — top 25 of 28
NCT IDTitleConditionStatus
Phase 3
NCT06532006 A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for… Gastroesophageal-junction Cancer Recruiting
NCT05353257 A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With… Limited-Stage Small Cell Lung Cancer Active, Not Recruiting
Phase 2/3
NCT07294508 A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive… HER2 + Breast Cancer Recruiting
NCT07459751 A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43… Advanced or Metastatic Squamous Non-Small Cell Lung Cancer Recruiting
NCT07318883 A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and… Squamous NSCLC Not Yet Recruiting
Phase 2
NCT06857279 A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head… Carcinoma of Head and/or Neck Recruiting
NCT06769152 A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC)… Cervical Cancer Recruiting
NCT06769113 A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC… Esophageal Cancer Recruiting
NCT07269782 A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as… Non Small Cell Lung Cancer Recruiting
NCT07459738 A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone… Hormone Receptor Positive HER-2 Negative Breast Cancer Not Yet Recruiting
NCT07487519 Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in… Breast Cancer (Triple Negative Breast Cancer (TNBC)) Not Yet Recruiting
NCT06812260 A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and… SCLC, Extensive Stage Active, Not Recruiting
Phase 1/2
NCT07358585 A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With… Colon Cancer Adenocarcinoma Not Yet Recruiting
Phase 1
NCT07176650 Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and… Hepatocellular Carcinoma (HCC) Recruiting
NCT07416695 A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of… SCLC Recruiting
NCT07160335 A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity… Non-small Cell Lung Cancer Recruiting
NCT07477587 A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of… Multiple Myeloma (MM) Recruiting
NCT07541534 A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors Advanced/Metastatic Solid Tumors Recruiting
NCT07473726 A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in… Advanced/Metastatic Solid Tumors Not Yet Recruiting
NCT07480681 Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and… Advanced/Metastatic Solid Tumors Not Yet Recruiting
NCT07484893 A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase… Healthy Adult Male Not Yet Recruiting
NCT07495930 Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With… Health Adult Subjects Not Yet Recruiting
NCT07518043 A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors Esophageal and/or Cardia Cancer Not Yet Recruiting
NCT07533708 A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours mCRPC or Advanced/Metastatic Solid Tumors Not Yet Recruiting
NCT07543471 A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs… mCRC Not Yet Recruiting
View all 28 active Shanghai Henlius Biotech trials with filters →
Disease Areas
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