Product Description
An antibody-drug conjugate (ADC) consisting of a human immunoglobulin G1 (IgG1) monoclonal antibody directed against the epidermal growth factor receptor (EGFR) conjugated to monomethyl auristatin E (MMAE), an auristatin derivative and potent microtubule disrupting agent, with potential antineoplastic activity. Upon administration of anti-EGFR ADC MRG003, the monoclonal antibody moiety binds to EGFR on tumor cell surfaces. Following receptor internalization, the MMAE moiety is released and binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and apoptosis. This inhibits the proliferation of EGFR-expressing tumor cells. EGFR, overexpressed by a variety of cancers, plays a key role in tumor cell proliferation and survival. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-egfr-antibody-drug-conjugate-mrg003?redirect=true)
Mechanisms of Action: EGFR Inhibior
Novel Mechanism: Yes
Modality: Antibody Drug Conjugate
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Shanghai Miracogen
Company Location: Asia Pacific
Company Founding Year: 2015
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, France
Active Clinical Trial Count: 13
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Head and Neck Cancer|Nasopharyngeal Cancer|Squamous Cell Carcinoma
Phase 2: Adenocarcinoma|Gastrointestinal Cancer|Non-Small-Cell Lung Cancer|Penile Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04868162 |
MRG003-004 | P2 |
Recruiting |
Head and Neck Cancer|Squamous Cell Carcinoma |
2026-06-01 |
2% |
2025-07-09 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06976190 |
Magic-C002 | P3 |
Recruiting |
Nasopharyngeal Cancer |
2029-05-01 |
25% |
2026-01-21 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT07054307 |
MH-Penile-001 | P1 |
Recruiting |
Penile Cancer |
2026-07-30 |
50% |
2026-04-08 |
Primary Endpoints|Start Date|Trial Status |
NCT07586124 |
HX008/MRG003-C004 | P2 |
Not yet recruiting |
Head and Neck Cancer|Squamous Cell Carcinoma |
2027-12-01 |
12% |
2026-05-15 |
Primary Endpoints|Treatments |
NCT05126719 |
MRG003-005 | P2 |
Active, not recruiting |
Nasopharyngeal Cancer |
2024-12-30 |
12% |
2026-02-10 |
Primary Endpoints |
CTR20202063 |
CTR20202063 | P2 |
Recruiting |
Adenocarcinoma |
None |
2025-04-29 |
||
CTR20212039 |
CTR20212039 | P2 |
Recruiting |
Gastrointestinal Cancer |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
CTR20201935 |
CTR20201935 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
CTR20210328 |
CTR20210328 | P2 |
Recruiting |
Squamous Cell Carcinoma|Head and Neck Cancer |
None |
2025-04-29 |
||
CTR20210995 |
CTR20210995 | P2 |
Active, not recruiting |
Nasopharyngeal Cancer |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
CTR20223356 |
CTR20223356 | P3 |
Recruiting |
Squamous Cell Carcinoma|Head and Neck Cancer |
None |
2025-04-29 |
||
NCT06959108 |
IDEAL | P2 |
Recruiting |
Head and Neck Cancer|Squamous Cell Carcinoma |
2029-06-01 |
2% |
2026-04-08 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT07518979 |
MH-Penile-002 | P2 |
Not yet recruiting |
Penile Cancer |
2028-05-01 |
12% |
2026-04-10 |
Primary Endpoints |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/28/2025 |
News Article |
BioDlink Showcases Europe-China CMC Collaboration Amid Developmental Breakthrough |
|
11/21/2025 |
News Article |
BioDlink and Lepu Biopharma Celebrate Successful Launch of the World's First EGFR-Targeting ADC Drug, Marking a Major Milestone in Mutual Collaboration in Biologics CMC |
|
11/05/2025 |
News Article |
BioDlink Congratulates Lepu Biopharma on Securing Approval for the World's First Approved EGFR-Targeted ADC |
|
08/21/2025 |
News Article |
Lepu Biopharma (2157.HK) announces 2025 interim results |