According to the official website of China’s National Food and Drug Administration, Fosun Kate’s application for axicabtagene ciloleucel targeting CD19 auto-chimeric antigen receptor (CAR) T-cell therapy in China is in the “under review” stage and is expected to Recently approved by NMPA for listing, it will be the first CAR-T therapy approved for marketing in China.

Akirensai injection is a genetically modified autologous CAR-T cell injection targeting CD19 developed by Gilead/Kite Pharmaceuticals. That is, T cells are extracted from the blood of patients, and these cells are genetically modified in vitro, and they are equipped with "chimeric antigen receptors" (CAR) that recognize the CD19 antigen on the surface of cancer cells, so that these cells can target tumors. Highly expressed CD19 antigen on the cell surface. Then, these modified cells are expanded in large quantities and then infused back into the patient's body, thereby increasing the survival rate of CAR-T cells in the body. Once CAR-T cells survive in the patient's body, they will continue to multiply and eventually attack cancer cells.

In October 2017, Akirensai injection was approved by the FDA (trade name: Yescarta) for relapsed or refractory large B-cell lymphomas that have received two or more lines of systemic treatment, including: diffuse large B-cell lymphoma (DLBCL) non-specific, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and follicular lymphoma transformed DLBCL patients. Yescarta is the second CAR-T therapy approved by the FDA and the first CAR-T therapy for non-Hodgkin's lymphoma.

In August 2018, Yescarta was approved for listing in the European Union. In March 2021, Yescarta received accelerated approval from the US FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who had previously received second-line and above systemic therapy.

Fosun Kate introduced Yescarta from KitePharma in the United States in early 2017, obtained all technology licenses, and owned its commercialization rights in China including Hong Kong and Macau, and localized production in China (excluding Hong Kong, Macau and Taiwan).

After completing the bridging clinical trial in China for the treatment of adult relapsed and refractory large B-cell lymphoma, in February 2020, Fosun Kate submitted a domestic market application for Akirensai injection for the treatment of relapsed and refractory adult Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) unspecified type, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and follicular lymphoma transformed DLBCL, and in It was included in the priority review by CDE on March 13.

At present, 5 CAR-T therapies have been approved for marketing globally, 4 targeting CD19 and 1 targeting BCMA, namely Novartis’ Kymriah (approved in August 2017), Gilead’s Yescarta and Tecartus (October 2017) , Approved in July 2020), Breyanzi and Abecma of Bristol-Myers Squibb (approved in February 2021, March 2021).