# Shanghai Henlius Biotech

Source: https://onco.cc/companies/henlius/  
OnCo record `henlius` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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, its US bridging study, ASTRIDE, reported in October 2026 a numerically longer median overall survival than atezolizumab with chemotherapy in descriptive analyses that were not designed to prove superiority, 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.

## Fields

- Kind: Company
- Last checked: 2026-10-29
- Tags: china
- HQ: Shanghai
- Type: biotech
- Website: https://www.henlius.com
- Ticker: 2696.HK

## Notes

- Checked 29 October 2026. Henlius's release of 27 October 2026 reports ASTRIDE, serplulimab plus chemotherapy against atezolizumab plus chemotherapy in first-line extensive-stage small-cell lung cancer, with a data cutoff of 18 February 2026 and median follow-up of 14.1 months: median overall survival 12.4 against 10.2 months, hazard ratio 0.82 (95% CI 0.56 to 1.20). The release says the analyses were descriptive, with no formal superiority or non-inferiority testing, and it does not state a date for a US filing. In February 2026 Eisai licensed serplulimab for Japan.

## Sources

- Official website: https://www.henlius.com
- ASTRIDE US bridging study results (Henlius): https://www.henlius.com/en/newsd/0/31608.html

## Connected records

- cancers: [Extensive-stage small-cell lung cancer](https://onco.cc/cancers/extensive-stage-sclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- drugs: [HLX11](https://onco.cc/drugs/hlx11/), [HLX22](https://onco.cc/drugs/hlx22/), [HLX26](https://onco.cc/drugs/hlx26/), [HLX43](https://onco.cc/drugs/hlx43/), [Serplulimab](https://onco.cc/drugs/serplulimab/), [Trastuzumab biosimilars](https://onco.cc/drugs/trastuzumab-biosimilars/)
- trials: [A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Meta](https://onco.cc/trials/nct04547166/), [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](https://onco.cc/trials/nct05787613/), [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](https://onco.cc/trials/nct07459751/), [A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors](https://onco.cc/trials/nct06848699/), [A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer](https://onco.cc/trials/nct07358585/), [A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer](https://onco.cc/trials/nct07253142/), [A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy](https://onco.cc/trials/nct06742892/), [A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy](https://onco.cc/trials/nct06769113/), [A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct06907615/), [A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer](https://onco.cc/trials/nct07301229/), [A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors](https://onco.cc/trials/nct06769152/), [A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients](https://onco.cc/trials/nct06832202/), [A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy](https://onco.cc/trials/nct06839066/), [A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC](https://onco.cc/trials/nct07269782/), [A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab](https://onco.cc/trials/nct07318883/), [A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer](https://onco.cc/trials/nct06532006/), [A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC](https://onco.cc/trials/nct06812260/), [A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous](https://onco.cc/trials/nct06847334/), [A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer](https://onco.cc/trials/nct07294508/), [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](https://onco.cc/trials/nct05346224/), [A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage](https://onco.cc/trials/nct05353257/), [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.](https://onco.cc/trials/nct06349980/), [ASTRUM-005](https://onco.cc/trials/astrum-005/), [Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC](https://onco.cc/trials/nct05239650/), [Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Br](https://onco.cc/trials/nct07487519/), [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](https://onco.cc/trials/nct07106892/), [to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versu](https://onco.cc/trials/nct04301739/), [To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC](https://onco.cc/trials/nct05468489/)
- bottlenecks: [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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