2023-01-17| ChinaPartnerships

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

by Joy Lin
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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. 

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