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Shanghai Henlius Biotech
Chinese biosimilar and biologics company whose PD-1 antibody serplulimab is approved in China and Europe for small-cell lung cancer.
Overview
Shanghai Henlius Biotech, listed in Hong Kong as 2696.HK, is a Chinese biosimilar and biologics company whose PD-1 antibody serplulimab is approved in China and Europe for small-cell lung cancer. Serplulimab was proved in the ASTRUM-005 trial and received EU approvals in 2025 for extensive-stage small-cell lung cancer, squamous non-small-cell lung cancer and other indications, a US bridging trial has completed enrolment, and the company also sells trastuzumab and bevacizumab biosimilars. OnCo links it to small-cell lung cancer, to serplulimab and the trastuzumab biosimilars records, and to the bottleneck of regulatory divergence between regions. Whether a Chinese PD-1 antibody can gain US approval on a bridging study, having already won Europe, is the open question. Serplulimab and ASTRUM-005 have their own pages.
Headquarters
Shanghai, CN
Scorecard
All companies#42of 1244 companies, score 77
- approved products +12
- phase 3 +9
- phase 1/2 +1
- targets +10
- modalities +4
- regions +7
- 24-month regulatory events +4
- registry trials +30
2 approved, 3 in phase 3, 1 earlier, 5 targets, 225 registry studies. Formula on the scorecards page.
Type
Biotech · 2696.HK
Stage
Public
Website
ApprovedMonoclonal antibody (anti-PD-1)
Serplulimab · Hansizhuang / Hetronifly
Serplulimab is a Chinese PD-1 antibody with the largest survival gain of any first-line small-cell lung cancer immunotherapy trial, approved in China, Europe, and the UK but not yet the US.
ApprovedBiosimilar monoclonal antibody (anti-HER2)
Trastuzumab biosimilars · Ogivri, Herzuma, Kanjinti, Trazimera, Ontruzant, Hercessi
Near-identical copies of Herceptin, approved since 2017, that cut the price of HER2 treatment and widened access worldwide.
Phase 3ADC
HLX43 is an experimental antibody-drug conjugate from Shanghai Henlius Biotech in phase 3 trials for non-small-cell lung cancer, cervical cancer and ovarian cancer, aimed at PD-L1 and EGFR.
Phase 3monoclonal antibody
HLX22 is an experimental monoclonal antibody from Shanghai Henlius Biotech in phase 3 trials for gastric & gastro-oesophageal junction cancer and HR-positive / HER2-negative breast cancer, aimed at HER2.
Phase 3monoclonal antibody
HLX11 is an experimental monoclonal antibody from Shanghai Henlius Biotech in phase 3 trials for HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, aimed at HER2.
Phase 2monoclonal antibody
HLX26 is an experimental monoclonal antibody from Shanghai Henlius Biotech in phase 2 trials for non-small-cell lung cancer, aimed at LAG-3.
Similar pages
- PersonYing Cheng
Shares ASTRUM-005, Serplulimab, Extensive-stage small-cell lung cancer, Small-cell lung cancer and the tag china.
- InstitutionJilin Cancer Hospital
Shares ASTRUM-005, Serplulimab, Small-cell lung cancer and the tag china.
- TrialCAPSTONE-1
Shares ASTRUM-005, Small-cell lung cancer and the tag china.
- CompanyWuXi AppTec
Shares Regulatory divergence between regions and the tag china.
- CompanyWuXi Biologics
Shares Regulatory divergence between regions and the tag china.
- TreatmentAdebrelimab
Shares Extensive-stage small-cell lung cancer, Small-cell lung cancer and the tag china.
- TreatmentAnlotinib
Shares Small-cell lung cancer and the tag china.
- CompanyJiangsu Hengrui Pharmaceuticals
Shares Regulatory divergence between regions, Small-cell lung cancer and the tag china.
cancers
fronts
drugs
Phase 3monoclonal antibody
Phase 3monoclonal antibody
Phase 2monoclonal antibody
Phase 3ADC
ApprovedMonoclonal antibody (anti-PD-1)
Serplulimab · Hansizhuang / Hetronifly
ApprovedBiosimilar monoclonal antibody (anti-HER2)
Trastuzumab biosimilars · Ogivri, Herzuma, Kanjinti, Trazimera, Ontruzant, Hercessi
trials
A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With MetaA Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC PatientsA 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 CancerA Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid TumorsA Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal CancerA Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung CancerA Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard TherapyA Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard TherapyA Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic CancerA Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant TumorsA Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer PatientsA Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line TherapyA Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCA Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or PembrolizumabA Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric CancerA Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLCA Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamousA Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast CancerA Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast CancerA Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-StageA 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.ASTRUM-005Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRCPhase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative BrPhase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancerto Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 VersuTo Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC