China's First CAR-T Therapy: Fosun Kite's Axicabtagene Ciloleucel (FKC876) Nears Approval

On January 12, the NMPA website indicated that the marketing application (Acceptance Number: CXSS2000006) for Fosun Kite’s CAR-T product “Axicabtagene Ciloleucel Injection” had entered the administrative approval stage, with approval expected in the near future. This means that the first CAR-T therapy product in China is poised for imminent market approval!

From the NMPA Official Website

Axicabtagene Ciloleucel Injection (code: FKC876) is a CD19-targeted autologous CAR-T cell therapy product, locally manufactured in China under license by Fosun Kite Biotechnology Co., Ltd., which introduced the YESCARTA® (axicabtagene ciloleucel) technology from Kite Pharma (USA). On October 18, 2017, Yescarta received FDA approval for the treatment of patients with relapsed or refractory large B-cell lymphoma, becoming the first CAR-T cell therapy approved by the U.S. FDA for a specific type of non-Hodgkin lymphoma. On August 27, 2018, it was approved for marketing in Europe for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL).

There are currently three CAR-T cell immunotherapy products approved for marketing worldwide, including Kite Pharma’s Yescarta and Tecartus, as well as Novartis’ Kymriah, all of which target CD19. The approval dates and indications for these products are detailed in the figure below:

According to the published financial reports of Gilead and Novartis, in 2019, the global sales of Yescarta and Kymriah were approximately $456 million and $278 million, respectively.

In early 2017, Fosun Kite introduced Yescarta from Kite Pharma in the United States, obtaining the technical and commercialization rights for mainland China, the Hong Kong Special Administrative Region, and the Macao Special Administrative Region, with plans to localize production within China. In August 2018, the Center for Drug Evaluation (CDE) approved its Investigational New Drug (IND) application. In February 2020, Fosun Kite submitted a marketing authorization application, completing the process in just over one year.

On February 21, 2020, the marketing application for Fosun Kite’s axicabtagene ciloleucel injection was accepted by the National Medical Products Administration (NMPA). This marketing application is based on a single-arm, open-label, multicenter bridging clinical trial (FKC876-2018-001) conducted in China, which evaluated the safety and efficacy of the product in Chinese patients with refractory aggressive non-Hodgkin lymphoma (NHL), specifically large B-cell lymphoma.

On March 10, 2020, the marketing application was officially included in the priority review and approval program by the Center for Drug Evaluation (CDE). Today, the drug has entered the administrative approval stage. From the submission of the marketing application to its imminent approval, less than one year has elapsed.

Axicabtagene Ciloleucel Injection · Review Timeline ▼

From the Insight database (http://db.dxy.cn/v5/home/)

Insight database shows that, currently, apart from Fosun Kite, only JW Therapeutics’ CAR-T product, rilocabtagene autoleucel, has been submitted for marketing approval. Among CAR-T products in clinical development, Novartis’ Kymriah^®(tisagenlecleucel) has progressed most rapidly, with Phase III clinical trials already initiated; additionally, seven domestically produced CAR-T products have entered Phase II clinical trials. Notably, Legend Biotech’s BCMA-targeted CAR-T therapy was included in the Breakthrough Therapy Program by the Center for Drug Evaluation (CDE) in August 2020.

From the Insight Database (http://db.dxy.cn/v5/home/)