Serplulimab (Hansizhuang)

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General information

Class/mechanism: PD-1 receptor antibody.
Route: IV
Extravasation: no information

For conciseness and simplicity, currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Toxicity management

Diseases for which it is used

History of changes in NMPA indication

  • 2022-03-25: Initial approval for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumors that have failed to respond to previous standard treatments. (Based on HLX10-010-MSI201)
  • 2022-11-01: Approved in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). (Based on ASTRUM-004)
  • 2023-01-18: Approved for ES-SCLC in combination with carboplatin & etoposide. (Based on ASTRUM-005)

Also known as

  • Code name: HLX-10
  • Brand name: Hansizhuang