On January 16, 2023 CARsgen Therapeutics Holdings Limited (2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, and Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine; SZ: 000963), reported a collaboration for the commercialization of CARsgen’s BCMA CAR-T product CT053 in mainland China (Press release, Carsgen Therapeutics, JAN 16, 2023, View Source [SID1234626267]).
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CT053, zevorcabtagene autoleucel ("zevor-cel"), is CARsgen’s lead drug candidate and an autologous CAR T-cell product treating relapsed/refractory multiple myeloma (R/R MM). CT053 NDA was submitted to NMPA in October 2022. With strong commercial capability and network, Huadong Medicine is granted the exclusive right to commercialize zevor-cel in mainland China.
"Huadong’s extensive commercialization experience in mainland China along with their strategic goal of being a leader in the oncology therapeutic area created the opportunity for a strong, strategic and mutually beneficial partnership between our two companies," said Dr. Zonghai Li, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, "Despite advancements in recent years, there are still significant unmet medical needs for the treatment of multiple myeloma. Zevor-cel, a differentiated BCMA CAR T cell therapy, has shown promising data in clinical programs and is now under NDA priority review by NMPA. We believe this collaboration with Huadong Medicine will enhance the successful commercialization of zevor-cel in mainland China."
"CARsgen is a leading biotech company in the development of innovative cell therapies for cancer patients and has built integrated R&D and manufacturing capabilities," added Liang Lv, Chairman of Huadong Medicine. "We are excited to collaborate with CARsgen to commercialize CT053. 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 improve their survival and quality of life."
Under the terms of the agreement, CARsgen will receive an upfront payment of RMB200 million and is eligible to receive regulatory and commercial milestone payments up to RMB1,025 million. CARsgen will continue to be responsible for the development, regulatory approval, and manufacturing of CT053 in mainland China.
About CT053
CT053, zevorcabtagene autoleucel ("zevor-cel"), is a fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. The New Drug Application (NDA) based on the phase I/II data from LUMMICAR STUDY 1 in China has been accepted by NMPA. CARsgen is conducting the phase 1b/2 LUMMICAR STUDY 2 in North America to evaluate the safety and efficacy of CT053 for R/R MM in that population. The Company also plans additional clinical trials for earlier line multiple myeloma treatment.
CT053 received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. FDA in 2019, as well as the Priority Medicines (PRIME) and Orphan Medicinal Product designations from the European Medicines Agency (EMA) in 2019 and 2020, respectively. CT053 also received Breakthrough Therapy designation from the NMPA in 2020.