Gamers continue to pour into the CAR-T cell industry.
On March 1, CARsgen (02171HK) announced that its CAR-T cell product, Zewogene autoleucel injection (trade name: Saikaize), has been approved for marketing by the China Food and Drug Administration.
This is the fifth CAR-T cell product approved for marketing in China. In terms of target, this is the second BCMA (B cell maturation antigen) targeted CAR-T cell product approved for marketing in China.
The indication approved by Saikaze this time is for patients with *** or refractory multiple myeloma**, who have progressed after at least 3 lines** (at least one proteasome inhibitor and immunomodulator have been used), which is consistent with another BCMA-targeted CAR-T previously approved for marketing in China, that is, Igeuleucel injection (trade name: Fokesu) of IASO Biologics.
Multiple myeloma is a refractory malignant plasma cell disease that accounts for about 10% of all hematologic cancers. With the acceleration of China's aging population and the increase in the average life expectancy of the population, the number of people with multiple myeloma will continue to increase, and according to Frost and Sullivan's estimates, the number of people with multiple myeloma in China will be about 15 in 202330,000 people, with 2 new cases320,000 people, and the number of people with multiple myeloma in China is expected to increase to 26 by 2030630,000 people.
There are two main factors restricting the commercialization of CAR-T products: first, safety; The second is **.
Recently, there has been a lot of attention about the safety of CAR-T products.
On January 19 this year, the U.S. FDA required six CAR-T cells** marketed in the U.S. to be marked with a black box warning on the prescription instructions, reminding patients of the risk of T lymphocytic malignancy after autologous CAR-T cell immunity** targeting BCMA or CD19. Earlier, on November 28, 2023, the U.S. FDA said that it had reported on patients receiving autologous CAR-T cell immunity targeting BCMA or CD19 ** T-cell tumors.
On February 7 this year, the China Food and Drug Administration also responded that considering the characteristics of chimeric antigen receptor (CAR)-T cell immunity** products (hereinafter referred to as "CAR-T products"), when China approved the listing of four CAR-T products, they had already indicated in the "precautions" of the instructions that there was a possibility of secondary malignant tumors after the use of this product**, and suggested that patients need to be monitored for secondary malignant tumors for life. Contact the relevant marketing authorization holder when secondary T cell-related malignancies are identified for guidance on sample collection and testing.
CARsgen also responded in November 2023 that as of November 30, 2023, the company has more than 500 patients in clinical trials of CAR-T products under development, including more than 250 cases targeting BCMA CAR-T products, and no T-cell tumor cases have been observed.
At the time of the approval of Sakaize, CARsgen also said that the approval of the company's CAR-T** was based on an open-label, single-arm, multi-center phase II clinical trial conducted in China. According to the results of the trial published by the American Society of Hematology in 2022, the product showed encouraging efficacy and a good safety profile.
A hematologist told the first financial reporter that to evaluate the safety of CAR-T**, it is necessary to weigh the relationship between risks and benefits. From the current point of view, the degree of benefit brought to patients by CAR-T cells** is still higher than the degree of risk.
Prior to the approval of the company, the other four CAR-T cells approved in China were generally expensive, close to one million yuan or more than one million yuan. Expensive** limits the popularity of related products to a certain extent.
The first financial reporter asked CARsgen about the pricing of Saikaize, and the other party said that "it has not come out yet".
The commercialization of Saikaize was handed over to Huadong Pharmaceutical (000963), an A-share companySZ) is responsible. In January 2023, Huadong Pharmaceutical (Hangzhou), a wholly-owned subsidiary of Huadong Pharmaceutical, signed an exclusive commercialization cooperation agreement with Kaixing Life Science (Shanghai)**, a wholly-owned subsidiary of CARsgen, and Huadong Pharmaceutical (Hangzhou) has the exclusive commercialization rights and interests of Saikaize in Chinese mainland.
Huadong Medicine told the first financial reporter that this is an important milestone in the company's layout of the cell industry chain, and an important move for the company to enter the CAR-T field, which is expected to continue to enhance the company's market competitiveness in the field of tumors. Saikaize is expected to leverage Huadong Pharmaceutical's commercialization capabilities to accelerate the implementation of innovative products in China.