CARsgen's CAR-T Cell Therapy Becomes China's Fifth to Win Approval(Yicai) March 4 -- The chimeric antigen receptor T-cell immunotherapy developed by Chinese biotechnology company CARsgen Therapeutics Holdings has become the fifth of its kind to get greenlit in China.
The National Medical Products Administration of China approved the New Drug Application of CARsgen's zevorcabtagene autoleucel for the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least three prior lines of therapy, the Shanghai-based firm announced on March 1.
Multiple myeloma is an incurable malignant plasma cell disorder that accounts for approximately 10 percent of all hematological cancers. The prevalence of multiple myeloma in China was about 153,000 last year, and the number of new cases is expected to reach 23,200 per year, CARsgen noted, citing statistics from consultancy firm Frost & Sullivan. It is estimated that the prevalence of multiple myeloma in China will grow to 266,300 by 2030, it added.
Zevorcabtagene autoleucel is CARsgen's first product to achieve such a milestone since its inception in 2014. The company has over 10 products in the research and development phase.
CAR-T therapy kills tumor cells in a highly effective manner by transforming human body's T-cells with immunologic function into CAR-T cells dedicated to identifying tumor cells. CAR-T therapy has become a popular tumor treatment in recent years despite its high price. The four CAR-T therapies approved by the NMPA before zevorcabtagene autoleucel are priced at about CNY1 million (USD138,920).
To accelerate the commercialization of zevorcabtagene autoleucel, CARsgen joined hands with Chinese drug dealer Huadong Medicine in January last year. Huadong won zevorcabtagene autoleucel's exclusive commercial interests and rights in the Chinese mainland for CNY1.2 billion (USD166.7 million), including a CNY200 million (USD27.8 million) down payment.
CARsgen's shares [HKG: 2171] were trading up 0.3 percent at HKD6.64 (85 US cents) as of 1.45 p.m. in Hong Kong today.
Editors: Dou Shicong, Futura Costaglione
