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Meplazumab - Pacific Meinuoke Bio Pharmaceutical

Drug Profile

Meplazumab - Pacific Meinuoke Bio Pharmaceutical

Alternative Names: Anti-CD147 humanized meplazumab; humanized mAb against CD147; Ketantin

Latest Information Update: 05 May 2020

At a glance

  • Originator Fourth Military Medical University
  • Developer Fourth Military Medical University; Pacific Meinuoke Biopharmaceutical
  • Class Antimalarials; Antivirals; Monoclonal antibodies
  • Mechanism of Action Metalloprotease inhibitors
  • Orphan Drug Status

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

    Yes - Malaria
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II COVID 2019 infections
  • Preclinical Malaria

Most Recent Events

  • 25 Apr 2020 Fourth Military Medical University initiates enrolment in a phase I trial in Healthy volunteers in China (NCT04369586)
  • 31 Mar 2020 Pacific Meinuoke Bio Pharmaceutical plans a phase I trial for Malaria (Prevention) (IV) in April 2020 (NCT04327310)
  • 03 Feb 2020 Phase-I/II clinical trials in COVID-2019 infections in China (IV) (NCT04275245)

Development Overview

Introduction

Meplazumab is an intravenously administered, humanised immunoglobulin G2 monoclonal antibody, targeting CD147 antigen being developed by Pacific Meinuoke Bio Pharmaceutical for the potential prevention and treatment of malaria and for treatment of COVID-19 infections caused due to coronavirus (SARS-CoV-2). It acts as an erythrocytic stage-macromolecular antibody drug that has the potential to mediate both treatment and prophylaxis of falciparum malaria. Clinical development for COVID-19 infections is underway in China while preclinical development is ongoing for malaria in China.

Key Development Milestones

In February 2020, Tang-Du Hospital initiated a phase I/II trial to assess the safety and efficacy of meplazumab in patients with COVID-109 pneumonia (20200101; NCT04275245). The open-label trial intends to enrol approximately 20 patients in China [1] .

In April 2020, Xijing Hospital (affiliated to Fourth Military Medical University) initiated a phase I trial to assess the safety, tolerability, pharmacokinetics and occupancy characteristics of peripheral blood cell receptors of meplazumab in healthy volunteers, and provide a reference for the dosage of the drug in a phase II clinical trial (MPZ-I-01; NCT04369586). The randomised trial intends to enrol approximately 56 volunteers in China [2] .

In March 2019, the US FDA granted orphan drug designation to meplazumab for the treatment of malaria [3] .

Preclinical studies and pharmacological studies have indicated that meplazumab for intravenous (IV) injection is safe and effective with well controlled quality (NCT04327310).

Drug Properties & Chemical Synopsis

  • Route of administration IV
  • Formulation Infusion
  • Class Antimalarials, Antivirals, Monoclonal antibodies
  • Target Metalloprotease
  • Mechanism of Action Metalloprotease inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

    L01X-C (Monoclonal antibodies)

    P01B-X (Other antimalarials)

  • EPhMRA code

    J5B9 (Antivirals, others)

    P1D (Anti-Malarials)

  • CAS Registry Number 196078-29-2

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Phase I/II China IV / Infusion Pacific Meinuoke Biopharmaceutical 03 Feb 2020
Malaria - Prevention Preclinical China IV / Infusion Fourth Military Medical University 19 Feb 2020
Malaria - - Preclinical China IV / Infusion Fourth Military Medical University 19 Feb 2020

Orphan Status

Indication Patient Segment Country Organisation Event Date
Malaria - USA Pacific Meinuoke Biopharmaceutical 15 Mar 2019

Commercial Information

Involved Organisations

Organisation Involvement Countries
Fourth Military Medical University Originator China
Fourth Military Medical University Owner China
Pacific Meinuoke Biopharmaceutical Collaborator China

Brand Names

Brand Name Organisations Indications Countries
Ketantin Pacific Meinuoke Biopharmaceutical Malaria China

Future Events

Expected Date Event Type Description Updated
30 Apr 2020 Trial Update Pacific Meinuoke Bio Pharmaceutical plans a phase I trial for Malaria (Prevention) (IV) in April 2020 (NCT04327310) 09 Apr 2020

Development History

Event Date Update Type Comment
25 Apr 2020 Trial Update Fourth Military Medical University initiates enrolment in a phase I trial in Healthy volunteers in China (NCT04369586) Updated 05 May 2020
31 Mar 2020 Trial Update Pacific Meinuoke Bio Pharmaceutical plans a phase I trial for Malaria (Prevention) (IV) in April 2020 (NCT04327310) Updated 09 Apr 2020
03 Feb 2020 Phase Change - I/II Phase-I/II clinical trials in COVID-2019 infections in China (IV) (NCT04275245) Updated 09 Apr 2020
03 Feb 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in China (IV) before February 2020 Updated 09 Apr 2020
15 Mar 2019 Phase Change - Preclinical Preclinical trials in Malaria (Prevention) in China (IV) before March 2019 Updated 09 Apr 2020
15 Mar 2019 Phase Change - Preclinical Preclinical trials in Malaria in China (IV) before March 2019 Updated 09 Apr 2020
15 Mar 2019 Regulatory Status Meplazumab receives Orphan Drug status for Malaria in USA [3] Updated 09 Apr 2020

References

  1. Single Center, Single Arm, Open Clinical Study to Access Safety and Initial Efficacy of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia

    ctiprofile
  2. A Single Center, Double-blinded, ,Placebo-controlled Phase I Clinical Trial in Healthy Volunteer to Evaluate Tolerance and Pharmacokinetics of Meplazumab of Injection

    ctiprofile
  3. US FDA grants orphan drug designation to Meplazumab for malaria. Internet-Doc 2020;.

    Available from: URL: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=676218
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