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Minhua Chu: Shenzhen Pregene Biopharma Received FDA Orphan Drug Designation
Minhua Chu/LinkedIn
Aug 28, 2025, 14:03

Minhua Chu: Shenzhen Pregene Biopharma Received FDA Orphan Drug Designation

Minhua Chu, Managing Partner at TransitionValue Partner, shared a post on X:

“Shenzhen Pregene Biopharma has received Orphan Drug Designation (ODD) from the FDA for its CD19/CD22-targeted CAR-T therapy for the treatment of acute lymphoblastic leukemia (ALL).

Pregene’s CD19/CD22-targeted CAR-T therapy is in preclinical stage. It is currently undergoing an Investigator-Initiated Trial (IIT) in collaboration with a Chinese hospital.

Results show that all six patients receiving the CAR-T therapy for the first time achieved complete remission (CR), with an objective response rate (ORR) of 100% and a minimal residual disease (MRD) negativity rate of 100%.”

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