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Research Report
Comprehensive Report on BBT-002: An Investigational Bispecific Antibody
1. Introduction to BBT-002
1.1. Overview of BBT-002 as an Investigational Therapeutic
BBT-002 is an innovative investigational biologic currently undergoing Phase 1 clinical evaluation. It is engineered as a half-life extended bispecific antibody, possessing a unique "platform in a molecule" design.[1] This design suggests a therapeutic strategy aimed at addressing a wide array of inflammatory and immunological (I&I) conditions. The potential applications span several medical specialties, including respiratory diseases, dermatology, and gastroenterology.[1] The "platform in a molecule" concept implies that BBT-002 targets fundamental inflammatory pathways common to diverse diseases, which, if clinically validated, could offer substantial efficiencies in research, development, and commercialization by leveraging a single molecular entity across multiple indications. The success of this approach hinges on the commonality and dominance of the targeted pathways across these varied conditions and the ability of BBT-002 to demonstrate efficacy and safety in diverse patient groups.
1.2. Developer: Bambusa Therapeutics
The development of BBT-002 is being undertaken by Bambusa Therapeutics, Inc., a clinical-stage biotechnology company established in May 2024.[2] Headquartered in Boston, Massachusetts, Bambusa Therapeutics specializes in the creation of novel biologic therapies, with a particular emphasis on bispecific antibodies for inflammatory and immunological disorders.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/25 | Phase 1 | Recruiting | Bambusa Therapeutics |
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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