Fosun Pharma's Anti-Lymphoma Drug Yescarta Receives IND Approval in China for Relapsed/Refractory Large B-Cell Lymphoma

FosunPharmaceuticalsAnnouncement: Fosun Kite Biotechnology Co., Ltd., a company invested in by the Company, has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials of Yikiliruncei (provisional name) for the treatment of relapsed or refractory large B-cell lymphoma. Fosun Kite plans to initiate Phase I clinical trials of this product in the near future once the necessary conditions are met.

The announcement indicates that the product is the anti-human CD19 CAR-T cell injection (brand name Yescarta) from Kite Pharma, Inc. in the United States. Yescarta was approved by the U.S. FDA for marketing in the United States in October 2017 and received approval from the European EMA for marketing in Europe in August 2018.

This product, introduced by Fosun Kite from Kite Pharma, is used for the treatment of relapsed or refractory large B-cell lymphoma in adults, including diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.

Currently, there are no similar drugs with the same target as this product marketed within China (excluding Hong Kong, Macao, and Taiwan regions, hereinafter referred to as the same).

In May 2018, Fosun Kite Biotechnology Co., Ltd. received acceptance from the China Food and Drug Administration for the clinical trial registration review of this product for the treatment of relapsed or refractory large B-cell lymphoma.

Source: Shanghai Securities News