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A 400 - Sichuan Kelun-Biotech Biopharmaceutical

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Drug Profile

A 400 - Sichuan Kelun-Biotech Biopharmaceutical

Alternative Names: A-400-Sichuan Kelun-Biotech Pharmaceutical; A400 - Sichuan Kelun-Biotech Biopharmaceutical; EP-0031; KL-590586

Latest Information Update: 14 Jul 2024

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At a glance

  • Originator Sichuan Kelun-Biotech Biopharmaceutical
  • Developer Ellipses Pharma; Sichuan Kelun-Biotech Biopharmaceutical
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Proto-oncogene protein c-ret inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Solid tumours
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Non-small cell lung cancer; Solid tumours; Thyroid cancer
  • Preclinical Brain metastases

Most Recent Events

  • 31 May 2024 Updated efficacy, pharmacokinetics and adverse events data from a phase I trial in Solid tumours presented at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)
  • 01 May 2024 US FDA successfully completes phase I data review of phase I/II for A 400 in Solid tumors
  • 05 Mar 2024 Ellipses Pharma anticipates to submit a New Drug Application (NDA) for A 400
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