Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has received Phase 3 Clinical Trial Application (IND) approval from the Ministry of Food and Drug Safety (MFDS) of Korea for ‘CT-P44’, a biosimilar candidate to Darzalex, enabling patient recruitment and clinical trial execution in South Korea.
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Approval of Phase 3 Clinical Trial Plan in Korea for CT-P44 (Darzalex Biosimilar)
- Target Product: CT-P44 (Biosimilar to Darzalex / Darzalex Faspro, Subcutaneous Injection)
- Clinical Trial Phase: Global Phase 3 Clinical Trial
- Target Indication: Refractory or Relapsed Multiple Myeloma
- Filing & Approval Dates (Regulatory Authority):
- IND Application Date: March 20, 2025
- Approval Date: July 2, 2025 (Fact Confirmation Date: July 2, 2025)
- Regulatory Authority: Ministry of Food and Drug Safety (MFDS), Korea / EU CT Number: 2024-518588-36-00
- Trial Design & Scale:
- Number of Subjects: 486 patients
- Trial Period: Approx. 2 years
- Trial Design: Double-blind, randomized, active-controlled, parallel-group Phase 3 trial (in combination with lenalidomide and dexamethasone)
- Purpose & Future Plans:
- Demonstrating biosimilarity in terms of efficacy and safety compared to the reference drug Darzalex
- Investment Caution:
- Statistically, the average success rate for clinical-stage drugs reaching final regulatory approval is around 10%
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Domestic Clinical Site Activation and First-Patient Dosing Progress
This disclosure confirms that Celltrion has secured IND approval from the Korean MFDS for Phase 3 clinical trials of CT-P44. Following regulatory clearance, it is key to monitor the initiation of patient recruitment and first-patient dosing (FPD) at Korean clinical sites. Tracking subject enrollment and execution of the planned 2-year R&D timeline confirms operational development progress. Clinical progress and enrollment milestones can be verified through future regulatory filings or upcoming periodic reports (Quarterly, Half-Yearly, or Annual Business Reports).
📢 Disclaimer & Source Information
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