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Research Report
An In-Depth Analysis of BL-M17D1: A Next-Generation HER2-Targeted Antibody-Drug Conjugate in Early-Stage Clinical Development
Executive Summary
BL-M17D1 is an investigational, clinical-stage antibody-drug conjugate (ADC) engineered to target the Human Epidermal Growth Factor Receptor 2 (HER2). The asset was originated by Sichuan Baili Pharmaceutical Co., Ltd. and is being advanced through a global clinical development program by its U.S. subsidiary, Systimmune, Inc. The molecular architecture of BL-M17D1 consists of three core components: an undisclosed anti-HER2 monoclonal antibody, a proprietary cytotoxic payload of monomethyl auristatin E (MMAE), and a novel, proprietary "next-generation" linker technology. This construction is designed to offer a superior therapeutic window compared to existing HER2-targeted therapies by optimizing the delivery of a potent, well-characterized cytotoxic agent directly to tumor cells.
The development program for BL-M17D1 achieved a critical regulatory milestone on November 8, 2024, with the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA).[1] This clearance has enabled the initiation of a multifaceted Phase 1 clinical trial program that is running in parallel in the United States and China. This ambitious program is strategically designed to evaluate the drug's safety, tolerability, pharmacokinetics, and preliminary efficacy across an unusually broad spectrum of patients. The target population includes not only those with traditionally defined HER2-positive tumors but also those with HER2-expressing (including HER2-low) and HER2-mutant solid tumors, spanning indications such as breast, gastric, lung, and urothelial cancers.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/03 | Phase 1 | Active, not recruiting | |||
2024/07/16 | Phase 1 | Recruiting | |||
2024/07/15 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| 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 |
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| 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 |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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