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Compare IBI305 to Avastin on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study

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Trial Profile

Compare IBI305 to Avastin on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Bevacizumab (Primary)
  • Indications Colorectal cancer; Non-small cell lung cancer
  • Focus Pharmacokinetics; Registrational
  • Sponsors Innovent Biologics

    • Most Recent Events

    • 18 Jun 2020 According to an Innovent Biologics media release, BYVASDA (bevacizumab biosimilar) has been officially approved by the National Medical Products Administration (NMPA) of China for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.
    • 30 Mar 2020 According to an Innovent Biologics media release, NDA approval is expected in 2020.
    • 28 Jan 2019 According to an Innovent Biologics media release, based on the data of CIBI305A301 and CIBI305A201 studies, the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for bevacizumab biosimilar product, IBI-305.

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