| Entry ID | 994 |
| INN | None |
| Status | No development reported |
| Drug code(s) | Meplazumab, HP6H8 |
| Brand name | Ketantin |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD147 |
| Indications of clinical studies | COVID-19/SARS-CoV-2 Infection Pneumonia, malaria |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | No development reported |
| Start of clinical phase (IND filing or first Phase 1) | February 03, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | February 15, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06040346 Phase 2 in malaria started in Apr 2024 active not recruiting as of last update in Oct 2024. No Phase 2/3 or 3 studies are active as of Nov 2024. Studies for COVID-19 (Phase 2/3 NCT05113784) is recruiting as of March 7, 2023, Phase 2/3 NCT04586153 is recruiting as of June 6, 2022, Phase 3 NCT05679479 is recruiting as of April 25, 2023) and Phase 3 study for post-COVID-19 (NCT05813587) is recruiting as of May 24, 2023 NCT05813587 Phase 3 started in March 2023. NCT05679479 Phase 3 in COVID-19 not yet recruiting when first posted on Jan 11 2023. NCT04586153 Phase 2/3 in COVID-19 started Feb 2021; recruiting as of last update in June 2022. NCT04275245 Phase 1/2 in COVID-19 pneumonia; NCT04327310 Phase 1 in malaria. Meplazumab (Ketantin®) is a lyophilized powder for injection of small volume. The main active ingredient of the product, meplazumab, is a humanized immunoglobulin (Ig) G2 monoclonal antibody, consisting of the complementary-determining regions of anti-CD147 murine antibody and the human framework region. It acts as an erythrocytic stage-macromolecular antibody drug that has the potential to mediate both treatment and prophylaxis of falciparum malaria. |
| Full address of company | No.128 Hehai West Road, Xinbei District (National High-Tech Industrial Development Zone), Changzhou City, Jiangsu province, China, Post Code 213022 Asia China http://www.pacificmeinuoke.com/single_lxwm/192.html |
Anti-CD147 Humanized antibody. CD147 is a highly glycosylated cell surface type I transmembrane protein involved in a range of process, including angiogenesis, inflammatory diseases and cancer progression. Wang et al (https://www.biorxiv.org/content/10.1101/2020.03.14.988345v1): Meplazumab, an anti-CD147 humanized antibody, significantly inhibited the viruses from invading host cells, with an EC50 of 24.86 μg/mL and IC50 of 15.16 μg/mL. We validated the interaction between CD147 and SP, with an affinity constant of 1.85×10−7M. Co-Immunoprecipitation and ELISA also confirmed the binding of the two proteins. Finally, the localization of CD147 and SP was observed in SARS-CoV-2 infected Vero E6 cells by immuno-electron microscope. Therefore, the discovery of the new route CD147-SP for SARS-CoV-2 invading host cells provides a critical target for development of specific antiviral drugs.
| Anticipated events | Termination |
| Factor(s) contributing to discontinuation | None |