Newly Approved CAR-T Around USD140,000

On November 20, “Science and Technology Innovation Board Daily” mentioned in a report that Heyuan Biotechnology’s CAR-T product has just been approved and is priced at CNY999,000/USD140,000, which is currently the lowest priced among domestic approved products. According to the latest report from Tianjin Radio and Television, the CAR-T therapy (Nagiolenza Injection) developed by Heyuan Biotech to treat leukemia has been issued its first prescription at the Hematology Hospital of the Chinese Academy of Medical Sciences.

Previously, on November 8, the official website of the State Food and Drug Administration announced that Heyuan Biotech’s CD19-targeted CAR-T cell therapy drug product Nachiolense Injection (formerly known as: Herkiolense Injection) was approved for marketing. , for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This is the first CAR-T therapy for this indication in China, and the first fully independent and innovative CD19-targeting CAR-T product approved for marketing in China.

So far, 4 CAR-T products have been approved for marketing in China. In addition to Heyuan Biotech, there are also Fosun Kite’s Aquilenza Injection and WuXi Junuo’s RegiOlenza Injection, which also target CD19; in addition, Reindeer Biotech’s Akilonsai Injection targets to the BCMA.

Whether it is CD19 or BCMA, they are both targets. In popular understanding, target refers to tumor antigen, which generally refers to antigenic substances that newly appear or are overexpressed during the occurrence and development of tumors. They are the key to targeted therapy. In CAR-T therapy (Chimeric Antigen Receptor T-Cell Therapy, CAR-T for short), the first step is to find the key target of the target tumor, and then modify the T cells to kill the tumor in a targeted manner.

In the field of CAR-T products, since the selling price exceeds one million yuan, the price and commercialization of such products are always a topic. The reason why the price is high is that the CAR-T cell therapy product is a highly customized drug. Its entire treatment process includes collecting the patient’s peripheral blood mononuclear cells, T cell isolation and activation, in vitro genetic modification of T cells, and CAR- The price includes the six main steps of in vitro expansion of T cells, quality monitoring of CAR-T cells, and reinfusion of CAR-T cells into the patient’s body. The price also includes the total cost of operations, research and development, logistics, etc.

Previously, according to reports from Xinhua Finance and other media, the unit prices of Fosun Kite and WuXi Junuo’s CAR-T products were 1.2 million yuan and 1.29 million yuan respectively. In August this year, according to a report by the big health industry media Yigu, the price of Reindeer Biotech’s CAR-T product Ichiolense Injection was 1.166 million yuan. It can be seen that compared with the first three approved products, the price of Heyuan Biotech’s CAR-T has dropped below one million CNY.