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8MW 0511

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Drug Profile

8MW 0511

Alternative Names: 8MW-0511; MW-05; Recombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein - Mabwell (Shanghai) Bioscience

Latest Information Update: 21 Dec 2023

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At a glance

  • Originator Mabwell (Shanghai) Bioscience
  • Class Albumins; Granulocyte colony-stimulating factors; Recombinant fusion proteins
  • Mechanism of Action Granulocyte colony stimulating factor replacements; Haematopoiesis stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Neutropenia

Most Recent Events

  • 19 Dec 2023 Preregistration for Neutropenia (Prevention, Chemotherapy-induced) in China (SC)
  • 23 Oct 2023 Mabwell (Shanghai) Bioscience announces intention to submit NDA for Neutropenia in 2023
  • 20 Oct 2023 Efficacy and adverse events data from the phase II trial in Gastric cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)

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