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A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects

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Trial Profile

A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Aug 2024

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At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Breast cancer; Gastric cancer
  • Focus Pharmacokinetics
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 22 Aug 2024 According to a Shanghai Henlius Biotech media release, HLX02 was granted approval by the Health Canada based on a comprehensive package of analytical, non-clinical and clinical study data submitted by Henlius. Company has conducted a series of head-to-head studies for HLX02, including comparative quality analytical studies, a phase 1 PK similarity study and a global multicentre phase 3 clinical study.
  • 22 Aug 2024 According to a Shanghai Henlius Biotech media release, company announced that the companys business partner, Accord Healthcare Inc. (an affiliate of Intas Pharmaceuticals, Ltd.), has received marketing approval (Notice of Compliance) from the Health Canada for HLX02 (trade name: HANQUYOU in China, HERCESSI in U.S., Zercepac in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius.
  • 29 Apr 2024 According to an Accord Biopharma media release, the U.S. Food and Drug Administration (FDA) has approved HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinomabased on this trial.

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