Fosun Kite's CAR-T Therapy FKC876 Granted IND Approval in China for Relapsed/Refractory Large B-Cell Lymphoma

Recently, Fosun Kite Biotechnology Co., Ltd. (hereinafter referred to as “Fosun Kite”) received formal approval from the National Medical Products Administration for the clinical trial of its CAR-T cell therapy product FKC876 (Yijililunsai (proposed), acceptance number CXSL1800059).

This product is being developed for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of 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.

FKC876 (marketed in the United States as Yescarta) is a CAR-T cell immunotherapy product introduced by Fosun Kite from Kite Pharma (USA) in early 2017. Fosun Kite obtained full technology licensing for this product from Kite and holds commercialization rights in China, including Hong Kong and Macau. On October 18, 2017, Yescarta received approval from the U.S. FDA 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, Yescarta became one of the first CAR-T cell therapies approved for marketing in Europe, indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL).

Dr. Wang Liqun, CEO of Fosun Kite Biotechnology Co., Ltd., stated, “For this IND review, the CDE took less than 70 working days from formal acceptance to completion of the technical review, demonstrating the significant effectiveness of national efforts to optimize drug review and approval reforms. This also reflects the CDE’s recognition and affirmation of the quality of our submission materials, providing impetus for the rapid introduction of world-class CAR-T products in China and bringing new hope to patients with refractory aggressive lymphoma in the country. We will promptly initiate and complete clinical trials according to the submitted protocol to prepare for the product’s marketing application in China.”

The results of the pivotal Phase II ZUMA-1 clinical study, used for Yescarta’s drug registration application, showed that among 101 patients with refractory large B-cell lymphoma who received Yescarta and were eligible for 12-month follow-up, the overall response rate was 83%, and the complete response rate reached 58%. With a median follow-up of 15.4 months, 42% of subjects maintained remission, including 40% who maintained complete remission, and the median duration of response was 11.1 months.

Source: Announcement of Listed Company

Source: Menet