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Meplazumab - Pacific Meinuoke Bio Pharmaceutical

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Drug Profile

Meplazumab - Pacific Meinuoke Bio Pharmaceutical

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

Latest Information Update: 28 Mar 2024

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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; Virus internalisation 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 III COVID 2019 infections
  • No development reported Malaria

Most Recent Events

  • 28 Mar 2024 No recent reports of development identified for preclinical development in Malaria in China (IV, Infusion)
  • 28 Mar 2024 No recent reports of development identified for preclinical development in Malaria(Prevention) in China (IV, Infusion)
  • 06 Oct 2023 Pacific Meinuoke Bio Pharmaceutical withdraws a phase I trial prior to enrolment for Malaria (Prevention) (IV) due to the reason that same drug has completed the phase I and II clinical trials for COVID-19 (NCT04327310)

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). The candidate is expected to block the binding of the SARS-CoV-2 spike protein to the human host-cell-expressed CD147, thereby blocking entry of SARS-CoV-2 into human tissue. 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 and Brazil while preclinical development is ongoing for malaria in China.

As at March 2024, no recent reports of development had been identified for preclinical development in Malaria in China (IV, Infusion), preclinical development in Malaria (Prevention) in China (IV, Infusion).

Key Development Milestones

In April 2023, Jiangsu Pacific Meinuoke Bio Pharmaceutical is withdrawn prior to enrollment a phase III trial, based on the epidemic situation in China, there was few mild and moderate COVID-19 patients, which was designed to assess the efficacy and safety of meplazumab in patients with COVID-2019 infections (NCT05679492; MPZ-III01). The double-blind, parallel, prospective, randomised trial was planned to be initiated in May 2023, and planned to enrol approximately 1 320 patients in China [1] .

In September 2023, Jiangsu Pacific Meinuoke Bio Pharmaceutical completed a phase III trial that evaluated the safety and efficacy of Meplazumab in the treatment of COVID-19 sequelae (NCT05813587, MPZ-III-02). The randomized, parallel, double-blind, placebo-controlled trial was initiated in March 2023 and enrolled 121 participants in China [2] .

In January 2023, Jiangsu Pacific Meinuoke Bio Pharmaceutical initiated a phase III trial to evaluate the safety and efficacy of meplazumab for injection in severe patients with COVID-2019 infections (MPZ-III01CN; NCT05679479). The double-blind, randomised, placebo-controlled trial intends to enrol approximately 350 patients in China [3] .

In October 2022, Jiangsu Pacific Meinuoke Bio Pharmaceutical completed a phase II/III trial that evaluated the safety and efficacy of meplazumab in patients with COVID-19 (NCT05113784; MPZ-II02CN). The double-blind, randomized controlled trial initiated in January 2022 enrolled 150 patients in China [4] .

In December 2022, Jiangsu Pacific Meinuoke Bio Pharmaceutical completed a phase II/III trial that evaluated the safety and efficacy of meplazumab in addition to standard of care for the treatment of COVID-2019 infections in hospitalised adults (MPZ-II-02; NCT04586153). The randomised trial initiated in February 2021 enrolled 174 patients in Brazil [5] .

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 [6] .

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 [7] .

In September 2023, Jiangsu Pacific Meinuoke Bio Pharmaceutical withdrew a phase I trial prior to enrollment due to the reason that the same drug has completed the phase I and II clinical trials for COVID-19 (NCT04327310; PMZ201501). The randomized, placebo controlled trial was designed to evaluate the safety, tolerability, and pharmacokinetics of meplazumab and to assess its antimalarial activity against Plasmodium falciparum in healthy subjects [8] .

In March 2019, the US FDA granted orphan drug designation to meplazumab for the treatment of malaria [9] .

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, Injection
  • Class Antimalarials, Antivirals, Monoclonal antibodies
  • Target Coronavirus spike glycoprotein; Metalloprotease; Virus internalisation
  • Mechanism of Action Metalloprotease inhibitors; Virus internalisation inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

    L01F (Monoclonal antibodies and antibody drug conjugates)

    P01B-X (Other antimalarials)

  • EPhMRA code

    J5B9 (Antivirals, others)

    P1D (Anti-Malarials)

  • CAS Registry Number 196078-29-2

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

COVID 2019 infections

Detailed Description

basigin (Ok blood group)

1

COVID 2019 infections

Outcome Measure

Tumor necrosis factor alpha (TNF-alpha)

Monocyte chemoattractant protein-1 (MCP-1/CCL2)

Interleukin-8 (IL-8)

Interleukin-6 (IL-6)

Interleukin-17 (IL-17)

Interleukin-10 (IL-10)

Interleukin 1 Beta (IL-1β)

Interferon Gamma (IFNg)

D-dimer

CXCL1

C-X-C motif chemokine ligand 2

C-reactive protein (CRP)

10 more biomarker names

Show less

1

1

1

1

1

1

1

1

1

1

1

2

pneumonia

Outcome Measure

D-dimer

C-reactive protein (CRP)

1

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Meplazumab - Pacific Meinuoke Bio Pharmaceutical basigin (Ok blood group) Detailed Description
C-reactive protein (CRP) Outcome Measure
C-X-C motif chemokine ligand 2 Outcome Measure
CXCL1 Outcome Measure
D-dimer Outcome Measure
Interferon Gamma (IFNg) Outcome Measure
Interleukin 1 Beta (IL-1β) Outcome Measure
Interleukin-10 (IL-10) Outcome Measure
Interleukin-17 (IL-17) Outcome Measure
Interleukin-6 (IL-6) Outcome Measure
Interleukin-8 (IL-8) Outcome Measure
Monocyte chemoattractant protein-1 (MCP-1/CCL2) Outcome Measure
Tumor necrosis factor alpha (TNF-alpha) Outcome Measure
Show all rows
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Trial Landscape

Indication Phase 0 Phase I Phase II Phase III Phase IV
Malaria - 2 1 - -
Falciparum malaria - 1 1 - -
COVID 2019 infections - 1 1 5 -
Pneumonia - - 1 - -

Development Status

Summary Table

Download Data (CSV)
Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Phase III China IV / Infusion Pacific Meinuoke Biopharmaceutical 21 Jan 2023
COVID 2019 infections - Adjunctive treatment Phase II/III Brazil IV / Injection Pacific Meinuoke Biopharmaceutical 15 Feb 2021
Malaria - Prevention No development reported (Preclinical) China IV / Infusion Fourth Military Medical University 28 Mar 2024
Malaria - - No development reported (Preclinical) China IV / Infusion Fourth Military Medical University 28 Mar 2024

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
31 Dec 2021 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical plans a phase II/III trial in COVID-2019 infections (IV, Injection) in December 2021 (NCT05113784) 31 Mar 2022
30 Oct 2020 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical plans a phase II/III trial in COVID-2019 infections (Adjunctive treatment) (IV, Injection) in October 2020 (NCT04586153) (700328776) 10 Aug 2021
30 Apr 2020 Trial Update Pacific Meinuoke Bio Pharmaceutical plans a phase I trial for Malaria (Prevention) (IV) in April 2020 (NCT04327310) 06 Oct 2023

Development History

Event Date Update Type Comment
28 Mar 2024 Phase Change - No development reported No recent reports of development identified for preclinical development in Malaria in China (IV, Infusion) Updated 28 Mar 2024
28 Mar 2024 Phase Change - No development reported No recent reports of development identified for preclinical development in Malaria(Prevention) in China (IV, Infusion) Updated 28 Mar 2024
06 Oct 2023 Trial Update Pacific Meinuoke Bio Pharmaceutical withdraws a phase I trial prior to enrolment for Malaria (Prevention) (IV) due to the reason that same drug has completed the phase I and II clinical trials for COVID-19 (NCT04327310) Updated 06 Oct 2023
06 Sep 2023 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical completes a phase III trial in COVID-2019 infections in China (IV) (NCT05813587) Updated 04 Mar 2024
18 Apr 2023 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical withdraws a phase III trial in COVID-2019 infections (In adults, In the elderly) in China (IV, Injection), prior to enrollment, based on the epidemic situation in China, there is few mild and moderate COVID-19 patients (NCT05679492) Updated 21 Apr 2023
23 Mar 2023 Phase Change - III Phase-III clinical trials in COVID-2019 infections in China (IV) (NCT05813587) Updated 18 Apr 2023
21 Jan 2023 Phase Change - III Phase-III clinical trials in COVID-2019 infections (In adults, In the elderly) in China (IV) (NCT05679479) Updated 08 Mar 2023
16 Jan 2023 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical plans a phase III trial in COVID-2019 infections (Newly diagnosed, In adults, In the elderly) (IV, Injection) Updated 16 Jan 2023
03 Jan 2023 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical plans a phase III trial in COVID-2019 infections (In adults, In the elderly) (IV, Injection) (NCT05679492) Updated 18 Jan 2023
18 Dec 2022 Trial Update Pacific Meinuoke Biopharmaceutical completes a phase-II/III trial in COVID-2019 infections (Adjunctive treatment) in Brazil (IV) (NCT04586153) Updated 25 Sep 2023
08 Oct 2022 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical completes a phase-II/III clinical trials in COVID-2019 infections in China (IV) (NCT05113784) Updated 25 Sep 2023
31 Mar 2022 Trial Update CTP 344627 - Updated KDM & dev line; completed a FE Updated 31 Mar 2022
21 Jan 2022 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections in China (IV) (NCT05113784) Updated 31 Mar 2022
09 Nov 2021 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical plans a phase II/III trial in COVID-2019 infections (IV, Injection) in December 2021 (NCT05113784) Updated 31 Mar 2022
09 Nov 2021 Biomarker Update Biomarkers information updated Updated 11 Nov 2021
15 Feb 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Adjunctive treatment) in Brazil (IV) (NCT04586153) Updated 10 Aug 2021
14 Oct 2020 Trial Update Jiangsu Pacific Meinuoke Bio Pharmaceutical plans a phase II/III trial in COVID-2019 infections (Adjunctive treatment) (IV, Injection) in October 2020 (NCT04586153) Updated 10 Aug 2021
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 06 Oct 2023
03 Feb 2020 Phase Change - I/II Phase-I/II clinical trials in COVID-2019 infections in China (IV) (NCT04275245) Updated 03 Apr 2020
03 Feb 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in China (IV) before February 2020 Updated 03 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 03 Apr 2020
15 Mar 2019 Regulatory Status Meplazumab receives Orphan Drug status for Malaria in USA [9] Updated 03 Apr 2020

References

  1. A Multicenter, Randomized, Double-blind, Placebo-controlled, add-on Phase III Clinical Study on the Efficacy and Safety of Meplazumab for Injection in Adults With Mild and Moderate COVID-19 Infections

    ctiprofile

  2. A Randomized, Double-blind, Placebo-controlled, Loaded Phase III Clinical Trial on the Efficacy and Safety of Mepozumab for Injection in the Treatment of Post-COVID-19

    ctiprofile

  3. A Multicenter, Double-blind, Randomized, Placebo-controlled, Loaded Phase III Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19

    ctiprofile

  4. A Multicenter, Double-blind, Randomized Controlled, add-on Phase 2/3 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19

    ctiprofile

  5. A Multicenter, Seamless, Randomized, Third-Party-Blind, Clinical Trial to Evaluate the Safety and Efficacy of Meplazumab in Addition to Standard of Care for the Treatment of COVID-19 in Hospitalized Adults

    ctiprofile

  6. 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

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

    ctiprofile

  8. A Phase 1, 3 Part, Randomized, Placebo Controlled, Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of Meplazumab and to Assess Its Antimalarial Activity Against Plasmodium Falciparum in a Malaria Challenge Model in Healthy Subjects

    ctiprofile

  9. 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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