Heyuan Biosciences Submits IPO Prospectus Following Breakthrough Therapy Designation for CD19-Targeted CAR-T in Relapsed/Refractory ALL

On December 11, the CDE updated its Breakthrough Therapy Designation list, proposing to include Juventas’s “Anti-CD19 Chimeric Antigen Receptor T-Cell Injection” in the breakthrough therapy program, with the proposed indication being relapsed or refractory acute lymphoblastic leukemia.

Juventas’ Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (i.e., CNCT19 Cell Injection) is a CAR-T cell therapy product targeting CD19, with independent intellectual property rights, originating from the Hospital of Hematology, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences).

According to the Insight database, the product has currently received approval for two clinical trials: one targeting relapsed or refractory acute lymphoblastic leukemia (ALL) and the other targeting relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL). The former is the indication proposed for inclusion in the Breakthrough Therapy designation. According to previous press releases from Juventas, the clinical trial of CNCT19 Cell Injection for the treatment of R/R B-NHL has entered Phase 2 registration trials, and patient enrollment for the Phase 2 registration trial treating R/R ALL is also imminent.

In addition, in June 2019, CASI Pharma, a biopharmaceutical company listed on the NASDAQ in the United States, formally signed a licensing agreement with Juventas, obtaining exclusive global commercial rights to its CNCT19 project.