China's First CAR-T Therapy FKC876 (Axicabtagene Ciloleucel) by Fosun Kite Receives NMPA Approval

According to the latest public notice from China's National Medical Products Administration (NMPA), Fosun Kite Biotechnology Co., Ltd.'s CAR-T cell therapy product, axicabtagene ciloleucel injection (also known as Yikaililuncesai injection, code: FKC876), has been officially approved. This marks the approval and commercial launch of China's first CAR-T cell therapy product.

Source: NMPA Official Website

Axicabtagene ciloleucel injection is locally manufactured through technology transfer based on Yescarta®, a CAR-T product from Kite Company in the United States. Yescarta® received marketing approval in the United States in October 2017 and was approved for marketing in Europe in August 2018. In March 2021, Yescarta® was approved by the U.S. FDA for the treatment of indolent non-Hodgkin lymphoma for marketing in the United States.

A CD19-targeted autologous CAR-T cell therapy product, for which Fosun Kite licensed the Yescarta technology from Kite Pharma in 2017 and obtained authorization for localized manufacturing in China.

The approved indication is: for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after second-line or later systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma.

Additionally, a new indication for axicabtagene ciloleucel injection was recently approved for clinical trials, intended for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma (r/r iNHL) following two or more prior lines of systemic therapy, including follicular lymphoma (FL) and marginal zone lymphoma (MZL).

Currently, five CAR-T therapies have been approved for marketing globally, with four targeting CD19 and one targeting BCMA. They are Novartis's Kymriah (approved in August 2017), Gilead's Yescarta and Tecartus (approved in October 2017 and July 2020, respectively), and Bristol Myers Squibb's Breyanzi and Abecma (approved in February 2021 and March 2021, respectively).

In China, dozens of CAR-T therapies have entered clinical trials. In addition to Yescarta, which is nearing market approval, JW Therapeutics' CD19-targeted CAR-T therapy, relcabtagene autoleucel, submitted its marketing application on June 29, 2020, and is currently under regulatory review. Novartis' Kymriah is currently in Phase III clinical trials, while Legend Biotech's BCMA-targeted CAR-T therapy is in Phase II clinical trials.

Editor: Liuli

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