{"entity":{"id":"henlius","kind":"company","name":"Shanghai Henlius Biotech","aka":[],"tldr":"Chinese biosimilar and biologics company whose PD-1 antibody serplulimab is approved in China and Europe for small-cell lung cancer.","summary":"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.","asOf":"2026-09-07","links":[{"label":"Official website","url":"https://www.henlius.com"}],"tags":["china"],"related":[],"cancers":["sclc"],"sections":["immunotherapy"],"technologies":[],"targets":[],"drugs":["serplulimab","trastuzumab-biosimilars","hlx43","hlx22","hlx11","hlx26"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["astrum-005","nct05353257","nct04547166","nct05468489","nct06769152","nct07253142","nct07269782","nct06848699","nct06839066","nct07294508","nct06769113","nct06349980","nct07106892","nct06812260","nct06742892","nct05787613","nct06907615","nct06832202"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hq":"Shanghai","country":"CN","companyType":"biotech","website":"https://www.henlius.com","ticker":"2696.HK","investors":[],"funding":[]},"route":"/companies/henlius/","neighbours":{"cancer":[{"id":"extensive-stage-sclc","kind":"cancer","name":"Extensive-stage small-cell lung cancer","route":"/cancers/extensive-stage-sclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"section":[{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"drug":[{"id":"hlx11","kind":"drug","name":"HLX11","route":"/drugs/hlx11/"},{"id":"hlx22","kind":"drug","name":"HLX22","route":"/drugs/hlx22/"},{"id":"hlx26","kind":"drug","name":"HLX26","route":"/drugs/hlx26/"},{"id":"hlx43","kind":"drug","name":"HLX43","route":"/drugs/hlx43/"},{"id":"serplulimab","kind":"drug","name":"Serplulimab","route":"/drugs/serplulimab/"},{"id":"trastuzumab-biosimilars","kind":"drug","name":"Trastuzumab biosimilars","route":"/drugs/trastuzumab-biosimilars/"}],"trial":[{"id":"nct04547166","kind":"trial","name":"A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Meta","route":"/trials/nct04547166/"},{"id":"nct05787613","kind":"trial","name":"A 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 Patients","route":"/trials/nct05787613/"},{"id":"nct07459751","kind":"trial","name":"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 Cancer","route":"/trials/nct07459751/"},{"id":"nct06848699","kind":"trial","name":"A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors","route":"/trials/nct06848699/"},{"id":"nct07358585","kind":"trial","name":"A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer","route":"/trials/nct07358585/"},{"id":"nct07253142","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer","route":"/trials/nct07253142/"},{"id":"nct06742892","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy","route":"/trials/nct06742892/"},{"id":"nct06769113","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy","route":"/trials/nct06769113/"},{"id":"nct06907615","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)","route":"/trials/nct06907615/"},{"id":"nct07301229","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer","route":"/trials/nct07301229/"},{"id":"nct06769152","kind":"trial","name":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors","route":"/trials/nct06769152/"},{"id":"nct06832202","kind":"trial","name":"A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients","route":"/trials/nct06832202/"},{"id":"nct06839066","kind":"trial","name":"A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy","route":"/trials/nct06839066/"},{"id":"nct07269782","kind":"trial","name":"A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC","route":"/trials/nct07269782/"},{"id":"nct07318883","kind":"trial","name":"A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab","route":"/trials/nct07318883/"},{"id":"nct06532006","kind":"trial","name":"A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer","route":"/trials/nct06532006/"},{"id":"nct06812260","kind":"trial","name":"A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC","route":"/trials/nct06812260/"},{"id":"nct06847334","kind":"trial","name":"A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous","route":"/trials/nct06847334/"},{"id":"nct07294508","kind":"trial","name":"A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer","route":"/trials/nct07294508/"},{"id":"nct05346224","kind":"trial","name":"A 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 Cancer","route":"/trials/nct05346224/"},{"id":"nct05353257","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage","route":"/trials/nct05353257/"},{"id":"nct06349980","kind":"trial","name":"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.","route":"/trials/nct06349980/"},{"id":"astrum-005","kind":"trial","name":"ASTRUM-005","route":"/trials/astrum-005/"},{"id":"nct05239650","kind":"trial","name":"Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC","route":"/trials/nct05239650/"},{"id":"nct07487519","kind":"trial","name":"Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Br","route":"/trials/nct07487519/"},{"id":"nct07106892","kind":"trial","name":"Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer","route":"/trials/nct07106892/"},{"id":"nct04301739","kind":"trial","name":"to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versu","route":"/trials/nct04301739/"},{"id":"nct05468489","kind":"trial","name":"To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC","route":"/trials/nct05468489/"}],"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}