The first CAR-T therapy in China!

Author: Shi Bei

According to the official website of the State Food and Drug Administration, Fosun Kate’s application for axicabtagene ciloleucel targeting CD19 auto-chimeric antigen receptor (CAR) T cell therapy in China (acceptance number: CXSS2000006) is under approval.

Akirensai injection is a genetically modified autologous CAR-T cell injection targeting CD19 developed by Gilead/Kite Pharmaceuticals

In October 2017, Akirensai injection was approved by the FDA (trade name: Yescarta) for relapsed or refractory large B-cell lymphoma that has received two lines or more 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

In August 2018, Yescarta was approved for listing in the European Union

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 worldwide, 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)

In 2020, the global sales of Tecartus, Yescarta, and Kymriah will be US$44 million, US$563 million, and US$474 million, respectively

In China, there are as many as 36 CAR-T therapies that have entered the clinical stage.

From the point of view of targets, the number of CAR-T products targeting CD19 being developed in China is the largest, reaching 23, followed by BCMA targets, with a total of 5 models