Newly approved CAR T-Cell therapies in China
Recently approved CAR T Cell therapy in China
According to "Science and Technology Innovation Board Daily," Heyuan Biotechnology's CAR-T product was just approved and is now priced at CNY999,000/USD140,000, making it the lowest-cost domestically approved product. According to the most recent Tianjin Radio and Television news, Heyuan Biotech's CAR-T therapy (Nagiolenza Injection) for leukemia has been prescribed for the first time at the Chinese Academy of Medical Sciences' Hematology Hospital.
Previously, on November 8, the State Food and Drug Administration's official website announced that Heyuan Biotech's CD19-targeted CAR-T cell therapy drug product, Nachiolense Injection (formerly known as Herkiolense Injection), had been approved for marketing, for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia. This is China's first CAR-T therapy for this indication, as well as the first wholly independent and innovative CD19-targeting CAR-T product to be approved for marketing.
So far, four CAR-T products have been approved for marketing in China. In addition to Heyuan Biotech, Fosun Kite's Aquilenza Injection and WuXi Junuo's RegiOlenza Injection both target CD19, while Reindeer Biotech's Akilonsai Injection targets the BCMA.
Whether it's CD19 or BCMA, both are targets. The term "target" is commonly used to refer to tumor antigens, which are antigenic compounds that emerge or are overexpressed during the occurrence and growth of tumors. They are essential to focused therapy. The initial stage in CAR-T therapy (Chimeric Antigen Receptor T-Cell Therapy, or CAR-T for short) is to identify the tumor's major target and then change T cells to destroy the tumor in a specific manner.
Because the selling price of CAR-T items reaches one million yuan, the pricing and commercialization of such products are constantly debated. The CAR-T cell therapy product is a highly personalized medicine, which accounts for its expensive price. The entire treatment process involves collecting the patient's peripheral blood mononuclear cells, T cell separation and activation, in vitro genetic modification of T cells, and CAR- The cost comprises six major steps: in vitro T cell multiplication, quality monitoring of CAR-T cells, and reinfusion of CAR-T cells into the patient. The price comprises the whole cost of operations, R&D, logistics, and so on.
Previously, Xinhua Finance and other media reported that the unit prices of Fosun Kite and WuXi Junuo's CAR-T products were 1.2 million yuan and 1.29 million yuan, respectively. According to Yigu, Reindeer Biotech's CAR-T product, Ichiolense Injection, cost 1.166 million yuan in August of this year. It is clear that Heyuan Biotech's CAR-T is less expensive than the first three approved medicines. CAR T-Cell therapy in China has taken a huge leap, for sure.
