HANSIZHUANG (Serplulimab Injection)

HANSIZHUANG (Serplulimab Injection)
Product Description

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and Indonesia. Up to date, 4 indications are approved for marketing, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was approved in China in March 2022 and has been approved by the National Medicinal Products Administration (NMPA) for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). The marketing applications of th...

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Shanghai Henlius Biotech, Inc.

  • CN
  • 2019
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
Generics/Biosimilars Manufacturer
Primary activities
Biopharmaceutical
Pharmaceutical Company (innovator finished products)
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Specifications
  • Selling Points
    International Approvals/Standards; Product Features; Product Performance; Quality Service; World's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer. Serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

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Shanghai Henlius Biotech, Inc.

  • CN
  • 2019
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
Generics/Biosimilars Manufacturer
Primary activities
Biopharmaceutical
Pharmaceutical Company (innovator finished products)
View company profile

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