Overview
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Indication
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Associated Conditions
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Research Report
Published: May 13, 2025
RC-88 (English: RC-88)
Generic Name: Misitatug Blivedotin Drug Type: Antibody-drug conjugate (ADC) Target: Mesothelin (MSLN) Payload: Monomethyl auristatin E (MMAE) Developer: RemeGen Biosciences (Shandong China) Manufacturer: Yantai Rongchang Biological Engineering (manufactured by MabPlex) Clinical Domain: Oncology Clinical Indication:
- Mesothelioma
- Bile Duct Carcinoma
- Pancreatic cancer
- Lung Adenocarcinoma
- Ovarian Cancer
- Other Solid Tumors Development Status: Phase 1 and Phase 2 (in China) Regulatory Decisions:
- January 2024: Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.
- December 2023: Investigational new drug (IND) approval by the U.S. FDA for a Phase 2 clinical trial in gynecological tumors.
- March 2023: Approval by the CDE (China) for a Phase I/II clinical study in combination with Sintilimab for advanced malignant solid tumors. Clinical Trials:
- NCT06173037: RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (Phase 2, multi-country, open-label, randomized, dose-optimization).
- NCT06016062: A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors.
- NCT05804526: A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours (Phase I/II, China).
- NCT05508334: A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours (Phase 1).
- NCT04175847: A Phase I/IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors. Mechanism of Action: RC88 is composed of a humanized anti-mesothelin antibody conjugated via a cleavable linker to MMAE, a microtubule-disrupting agent. It binds to mesothelin-expressing tumor cells, leading to internalization and release o
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/15 | Phase 2 | Recruiting | |||
2023/04/07 | Phase 1 | Recruiting | |||
2022/08/19 | Phase 1 | Active, not recruiting | |||
2019/11/25 | 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
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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