Shanghai Henlius Biotech is a global biopharmaceutical company focused on developing and commercializing high-quality, affordable biologics. Its pipeline spans oncology, autoimmune disease, ophthalmology, and other therapeutic areas.
DelveInsight pipeline reports reveal robust clinical development across three cancer indications, with 45+ companies advancing cutaneous squamous cell carcinoma therapies, 70+ companies developing liver cancer treatments, and multiple hepatocellular carcinoma candidates receiving FDA designations in 2025-2026.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
Shanghai Henlius Biotech received approval from China's National Medical Products Administration to begin a phase 1 clinical trial of HLX316, a B7-H3-targeting sialidase Fc fusion protein for advanced or metastatic solid tumors.
A comprehensive market report reveals over 180 companies are developing more than 200 PD-1 and PD-L1 inhibitor drugs, with recent fast-track designations and successful Phase III trial results driving expansion in cancer immunotherapy.
Shanghai Henlius Biotech received U.S. FDA approval to begin phase 1 trials of HLX15-SC, a subcutaneous biosimilar of daratumumab, for multiple myeloma treatment with significant commercial potential.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07601620 |
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 Cancer |
NOT_YET_RECRUITING | PHASE1 |
| NCT07543471 |
A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | PHASE1 |
| NCT07541534 |
A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07533708 |
A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours |
NOT_YET_RECRUITING | PHASE1 |
| NCT07518043 |
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07495930 |
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® |
NOT_YET_RECRUITING | PHASE1 |
| NCT07487519 |
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_RECRUITING | PHASE2 |
| NCT07484893 |
A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects |
NOT_YET_RECRUITING | PHASE1 |
| NCT07480681 |
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 Tumor |
NOT_YET_RECRUITING | PHASE1 |
| NCT07477587 |
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 Myeloma |
RECRUITING | PHASE1 |
