China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has revealed 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 September 30, 2022. The drug is being commercialized in the US, Europe, and other global markets by Janssen Biotech, a subsidiary of Johnson & Johnson.
Sales Data and Accounting Policies
The sales data was provided by Janssen to Legend Biotech and has not been independently verified. According to Legend Biotech’s accounting policies and international financial reporting standards, the company will not recognize the reported sales as income.
Regulatory Approvals and Market Access
Carvykti was approved by the US FDA in February 2022 and granted conditional marketing authorization by the European Commission in May of the same year. The drug secured further approval in Japan last month. The first approved global indication for Carvykti is for fifth-line or later use in relapsed or refractory multiple myeloma. Legend Biotech first partnered with Janssen on the drug in a December 2017 deal.
Market Landscape in China
Carvykti is not yet approved in China. Two CD19-targeted CAR-T therapies have been approved in China: Fosun Kite Bio’s Yescarta (axicabtagene ciloleucel) and JW Therapeutics’ Carteyva (relmacabtagene autoleucel injection). These therapies are available at respective prices of RMB 1.2 million (USD 166,106) and RMB 1.29 million (USD 178,563). Carteyva has passed the National Reimbursement Drug List (NRDL) formality review this year and is under consideration for national reimbursement, while Yescarta is covered by several local city-level “huiminbao” commercial insurance schemes.
Future Outlook
The reported sales milestone for Carvykti highlights the growing market acceptance of CAR-T therapies globally. As Legend Biotech continues to expand its commercial reach, the company aims to further penetrate key markets and address significant unmet needs in oncology.-Fineline Info & Tech
