[Peijia Bio] PL001 (CD19 CAR-T) Efficacy Passes Phase II Interim Analysis with Statistical Significance
Peijia Bio's CAR-T therapy PL001 achieved significant success in its Phase II interim analysis for B-cell lymphoma, paving the way for accelerated NDA approval in Taiwan.
📋 Article Processing Timeline
- 📰 Published: April 23, 2026 at 09:00
- 🔍 Collected: April 24, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: April 24, 2026 at 08:23 (23 min after Collected)
1. Date: 2026/04/23. 2. Drug: PL001 (CD19 CAR-T). 5. Phase II Results: The interim analysis showed statistical significance (p < 0.0001), exceeding the CDE requirement (p < 0.0087). 14 out of 23 subjects met the primary efficacy indicator (CR+PR). Future Plan: The company will submit an interim report and apply for an NDA under the 'Accelerated Approval' mechanism in Taiwan. 7. Market: The global CAR-T market is expected to reach $6B by 2025 and over $10B by 2030.