China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that sales of its subsidiary company Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), reached USD 55 million as of December 31, 2022. This figure, yet to be independently audited, aligns with the sales data announced in late October 2022.
Global Sales and Commercialization
The CAR-T therapy is being commercialized in the US, Europe, and other global markets by Janssen Biotech, a subsidiary of Johnson & Johnson. Janssen, which provided the sales data, has played a pivotal role in advancing Carvykti’s global footprint.
Regulatory Landscape and Clinical Development
Carvykti is currently awaiting regulatory decisions in China. The therapy has already secured approvals in the US, European Union, and Japan to treat patients with recurrent or refractory multiple myeloma (MM) who have received at least four lines of treatment. These approvals were granted within the last year. Additionally, Carvykti is undergoing multiple clinical studies, exploring its potential as a first-line treatment for patients with MM, regardless of their suitability for transplantation.-Fineline Info & Tech
