CARsgen Therapeutics announced the collabortransformation Jointly with Huadong Medicine to commercialize zevorcabtagene autoleucel (zevor-cel), CT053 in mainland China.
CARsgen’s fully human autologous BCMA CAR T cell product candidate, CT053, was developed to treat relapsed/refractory multiple myeloma (R/R MM).
This involves autologous T cells genetically modified with a CAR containing a fully human anti-BCMA single chain fragment variant with high binding affinity.
Under the partnership, Huadong Medicine will receive exclusive rights to commercialize CARsgen’s CT053 in mainland China.
Under the terms of the deal, CARsgen will receive an upfront payment of $29.7 million (RMB 200 million) and will also be eligible for up to $152.4 million (RMB 10.25 million) in regulatory and commercial milestones.
Additionally, the company will continue to handle the development, regulatory approval and production of CT053 domestically.
Dr. Zonghai Li, Chairman, CEO and Chief Scientific Officer of the CARsgen Therapeutics Board said:
“Zevor-cel, a differentiated BCMA CAR T-cell therapy, has shown promising data in clinical programs and is currently under NDA priority review by NMPA.
“We are confident that this partnership with Huadong Medicine will facilitate the successful commercialization of zevor-cel in mainland China.”
Last October, CARsgen submitted a New Drug Application (NDA) for CT053 to China’s National Medicines Administration (NMPA).
The U.S. Food and Drug Administration (FDA) granted the company’s zevor-cel advanced regenerative medicine (RMAT) and orphan drug designations in 2019.
CT053 also received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) in the same year.
It received Orphan Drug Designation from the EMA and Breakthrough Therapy Designation from the NMPA in 2020.
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