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Chinese biosimilar and biologics company whose PD-1 antibody serplulimab is approved in China and Europe for small-cell lung cancer.
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.
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.
Near-identical copies of Herceptin, approved since 2017, that cut the price of HER2 treatment and widened access worldwide.
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.
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.
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.
HLX26 is an experimental monoclonal antibody from Shanghai Henlius Biotech in phase 2 trials for non-small-cell lung cancer, aimed at LAG-3.
Shares ASTRUM-005, Serplulimab, Extensive-stage small-cell lung cancer, Small-cell lung cancer and the tag china.
Shares ASTRUM-005, Serplulimab, Small-cell lung cancer and the tag china.
Shares ASTRUM-005, Small-cell lung cancer and the tag china.
Shares Regulatory divergence between regions and the tag china.
Shares Regulatory divergence between regions and the tag china.
Shares Extensive-stage small-cell lung cancer, Small-cell lung cancer and the tag china.
Shares Small-cell lung cancer and the tag china.
Shares Regulatory divergence between regions, Small-cell lung cancer and the tag china.
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