In January 2023, Huadong Medicine successfully introduced the exclusive commercialisation rights of Zevorcabtagene Autoleucel in mainland China, with a total transaction value of over RMB 1.2 billion.
Zevorcabtagene Autoleucel Injection (CT053) is an autologous BCMA CAR-T cell candidate developed by Keji Pharmaceuticals, incorporating a CAR structure with a fully human anti-BCMA-specific single-chain antibody with lower immunogenicity and higher stability. According to relevant studies, Zevorcabtagene Autoleucel is able to reduce the auto-activation of CAR-T cells in the absence of tumour-associated targets, thus overcoming problems such as T-cell depletion.
Zevorcabtagene Autoleucel was granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug status by the FDA, Priority Drug status and Orphan Drug status by the European Medicines Agency (EMA), and included in the CDE's list of Breakthrough Therapeutic Categories.2022 In October 2022, Zevoqui Orense's marketing application for Zevorcabtagene Autoleucel Injection for the treatment of relapsed/refractory multiple myeloma was accepted by the CDE and included in the Priority Review, and was recently formally approved for marketing.
The approval of Zevorcabtagene Autoleucel is based on LUMMICAR STUDY 1, an open-label, single-arm, multi-centre Phase II clinical trial in China, according to a report by CARsgen.
Multiple myeloma is a malignant plasma cell proliferative disease that accounts for approximately 10% of all haematological tumours and has a very high incidence of kidney injury (up to 70%). Frost & Sullivan estimates that the number of people with multiple myeloma in China will grow to 266,300 in 2030. The successful approval and marketing of Zevorcabtagene Autoleucel brings more choices in the field of multiple myeloma treatment.
