Shanghai Henlius Biotech clinical trials

A subsidiary of Fosun Pharma

The registry lists 131 studies whose lead sponsor is Shanghai Henlius Biotech. 55 are recruiting or about to start. Per ClinicalTrials.gov, last updated Oct 21, 2026.

Studies

Recruiting first, then most recently updated. Showing 50 of 131. List all 131 → · All Fosun Pharma studies →

• Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11Not yet recruitingNCT07776132Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid TumorsEnrolling by invitationNCT06115642Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Learn the Safety and Efficacy of HLX37 in Combination With Chemotherapy for First-line Treatment in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung CancerNot yet recruitingNCT07865910Phase 2/3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)RecruitingNCT06907615Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple MyelomaRecruitingNCT07477587Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer PatientsNot yet recruitingNCT07824869Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced TumoursRecruitingNCT07533708Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid TumorsRecruitingNCT07518043Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung CancerRecruitingNCT07253142Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NECRecruitingNCT07416695Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid TumorsRecruitingNCT07473726Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCRecruitingNCT07269782Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung CancerRecruitingNCT07459751Phase 2/3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid TumorsRecruitingNCT07541534Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast CancerNot yet recruitingNCT07601620Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard TherapyRecruitingNCT06769113Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal CancerNot yet recruitingNCT07543471Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant TumorsRecruitingNCT06769152Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®Not yet recruitingNCT07495930Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.Not yet recruitingNCT07487519Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy SubjectsNot yet recruitingNCT07484893Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast CancerRecruitingNCT07294508Phase 2/3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid TumorNot yet recruitingNCT07480681Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular CarcinomaRecruitingNCT07176650Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast CancerNot yet recruitingNCT07459738Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaRecruitingNCT06857279Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid TumorsRecruitingNCT07274813Early Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric CancerRecruitingNCT06532006Phase 3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal CancerNot yet recruitingNCT07358585Phase 1/2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung CancerNot yet recruitingNCT07318883Phase 2/3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic CancerNot yet recruitingNCT07301229Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat CancerNot yet recruitingNCT07294534Phase 2/3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line TherapyRecruitingNCT06839066Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction AdenocarcinomaRecruitingNCT07115485Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active GlomerulonephritisRecruitingNCT07038382Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid TumorsRecruitingNCT06848699Phase 1/2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal CancerRecruitingNCT07106892Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study of HLX42 in Advanced/Metastatic Solid TumorsRecruitingNCT06210815Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer PatientsRecruitingNCT06832202Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple MyelomaNot yet recruitingNCT06895512Phase 3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard TherapyRecruitingNCT06742892Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung CancerNot yet recruitingNCT06847334Phase 3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular CarcinomaNot yet recruitingNCT06841185Phase 3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.RecruitingNCT06349980Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)RecruitingNCT04547166Phase 2/3

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male SubjectsRecruitingNCT06159101Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid TumorsRecruitingNCT04965220Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX51 in Patients With Solid Tumor or LymphomaNot yet recruitingNCT05788107Phase 1

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E MutationRecruitingNCT05641493Phase 1/2

  Sponsor listed in the registry: Shanghai Henlius Biotech

• A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard TherapyRecruitingNCT03941574Phase 2

  Sponsor listed in the registry: Shanghai Henlius Biotech