Overview
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Research Report
Comprehensive Report on 9MW-3011: A Novel TMPRSS6-Targeting Monoclonal Antibody for Iron Homeostasis Disorders
I. Introduction
9MW-3011 (also known by its US R&D code MWTX-003 and as DISC-3405 by Disc Medicine) is an investigational monoclonal antibody engineered to target Transmembrane Serine Protease 6 (TMPRSS6).[1] Developed by Mabwell (Shanghai) Bioscience at its San Diego Innovation and R&D Center, 9MW-3011 represents a novel therapeutic approach aimed at regulating iron homeostasis in the human body.[1] The primary mechanism involves the upregulation of hepcidin, a key hormone controlling iron absorption and mobilization.[1] Mabwell has entered into a significant licensing agreement with Disc Medicine, Inc. for the development and commercialization of 9MW-3011 in major territories outside of Greater China and Southeast Asia.[1]
This report provides a comprehensive analysis of 9MW-3011, detailing its mechanism of action, preclinical evidence, the current status of its clinical development program across various indications, its regulatory designations, the commercial and intellectual property landscape, and its therapeutic potential in addressing unmet medical needs in disorders characterized by iron dysregulation.
Table 1: Key Characteristics of 9MW-3011
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/22 | Phase 2 | Not yet recruiting | |||
2025/01/14 | Phase 1 | Recruiting | |||
2024/12/31 | Phase 1 | Recruiting | |||
2024/04/29 | Phase 1 | Completed | |||
2023/09/22 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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