2023-01-17| ChinaPartnerships

CARsgen Taps Huadong to Commercialize Multiple Myeloma CAR-T in China

by Joy Lin
Share To

Shanghai’s CARsgen has inked a collaboration with Huadong Medicine, giving the Hangzhou-based company the exclusive right to commercialize CARsgen’s lead CAR-T cell product for a form of multiple myeloma, CT053, in mainland China. 

CT053, also known as zevorcabtagene autoleucel or zevor-cel, is being investigated in the treatment of relapsed or refractory multiple myeloma (R/R MM), a rare blood cancer caused by malignant B-cells. It targets the B-cell maturation antigen (BCMA), which is essential for B-cell survival. 

“Leveraging Huadong’s strong commercial presence in hematology, Huadong is committed to bringing CT053, an innovative and highly effective new treatment, to more R/R MM patients in China, and improving their survival and quality of life,” said Liang Lu, Chairman of Huadong in a press statement. 

Under the terms of the agreement, CARsgen will receive an upfront cash payment of RMB 200 million (around $30 million) and could receive up to RMB 1025 million (around $152 million) in regulatory and commercial milestones. CARsgen will remain responsible for developing and manufacturing CT053, as well as securing its regulatory approval in mainland China. 

Related Article: Will Breakthrough Therapy Lead the Way? An Overview of the Approved Gene and Cell Therapies for 2022

China Has Accepted Zevor-cel NDA

The New Drug Application (NDA) for zevor-cel was accepted by the National Medical Products Administration, China’s drug regulator, in October 2022. The ongoing review is based on zevor-cel data from the Phase 1/2 LUMMICAR Study 1 in China. In the Phase 2 portion, zevor-cel demonstrated a 100% objective response rate (ORR) in the 14 treated R/R MM patients. Complete response or stringent complete response (CR/sCR) to zevor-cel stood at a rate of 78.6%.

CARsgen is conducting Phase 1b2 LUMMICAR Study 2 in North America to evaluate zevor-cel for R/R MM in that population. The company has mentioned plans for additional clinical trials where zevor-cel is used in earlier lines of treatment. 

Zevor-cel received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. FDA in 2019, and is also a designated Priority Medicines (PRIME) and Orphan Medicinal Product according to the European Medicines Agency (EMA). In China, CAR-T cell therapy holds the Breakthrough Therapy designation. 

© All rights reserved. Collaborate with us:
Related Post
Junshi’s PD-1 Antibody Meets Endpoint In Phase 3 Lung Cancer Trial
Junshi’s PD-1 Antibody Meets Endpoint In Phase 3 Lung Cancer Trial
Moderna Welcomes Phase 3 Win For RSV Vaccine
Moving Beyond COVID With mRNA Technology
Rob Knight and Jing-Yuan Fu Elaborate On Microbiome Research Trends at the 7th Asia Microbiome Conference(AMC)
Scientists Study Imaging Probes in First-Ever Amputated Human Limb Model
EMA Plans to Issue Liver Failure Warning for Novartis’ Gene Therapy
Bayer Signs Up To Google Cloud To Boost Drug Discovery
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!