# 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, 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.

## Fields

- Kind: Company
- Last checked: 2026-09-07
- Tags: china
- HQ: Shanghai
- Type: biotech
- Website: https://www.henlius.com
- Ticker: 2696.HK

## Sources

- Official website: https://www.henlius.com

## 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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