CASI PHARMACEUTICALS' PARTNER JUVENTAS ANNOUNCES NEW DRUG APPLICATION FOR CNCT19 ACCEPTED BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION
It has been granted the Orphan Drug Designation from the FDA and the Breakthrough Designation status by the China Center of Drug Evaluation (CDE).
- It has been granted the Orphan Drug Designation from the FDA and the Breakthrough Designation status by the China Center of Drug Evaluation (CDE).
- The r/r B-ALL NDA submission for CNCT19 contains the initial data from study NCT04684147, a Phase II, single-arm, open-label, single-dose, multicenter clinical trial.
- CASI and Juventas will work side by side to deliver CNCT19 to patients in China, and eventually worldwide."
- The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China.