About Fosun Kite

As a joint venture of Shanghai Fosun Pharmaceutical (Group) Co., Ltd and U.S. Kite Pharma, Fosun Kite Biotechnology Co., Ltd. (hereinafter referred as "Fosun Kite") was established in April 2017 in Shanghai China. Taking a combined approach of internal R&D and external partnering/technology transfer, Fosun Kite is dedicated to the advancement of innovative cell therapy and its industrialization in China to benefit patients.

In early 2017, Fosun Kite brought in the world’s first approved CAR-T therapy for NHL Axicabtagene ciloleucel (US trade name Yescarta) from Kite Pharma (project name FKC876). Having obtained the comprehensive technology transfer and commercial license, the company has built a class B+A clean cell preparation base which is up to the latest GMP standards and in line with Kite’s commercial production standards and plant design concept. In August 2018, FKC876 officially obtained the Investigational New Drug (IND) approval from National Medical Products Administration (NMPA) in China, and now is carrying out registrational clinical trials strictly following GCP and other regulatory requirements in China to provide evidence in support of its successful registration. In January 2019, a commercial manufacture base of approx.10,000sqm settled in South Zhangjiang, for commercial production of CAR-T therapies including FKC876 following registration.

Besides Yescarta, Fosun Kite also collaborates with leading immunotherapy R&D organizations at home and abroad to build a rich and independent R&D pipeline.

Technology Acquisition and independent R&D

Fosun Kite’s investigational product FKC876 (US trade name Yescarta) has obtained the IND approval from NMPA for registrational clinical trials in China. It will be developed for the treatment of relapsed or refractory large B-cell lymphoma after line 2 or more systemic treatment, including diffuse large B-cell lymphoma (DLBCL) of non-specific type, primary mediastinal B-cell lymphoma (PMBCL), B-cell lymphoma of high-grade and DLBCL transformed from follicular lymphoma.

Yescarta is the world's first approved CAR-T cell therapy for adult patients with certain types of non-Hodgkin lymphoma (NHL). FDA approved Yescarca for the US market in October, 2017, followed by EMA for EU markets in August, 2018. According to the ZUMA-1 clinical results released by Kite Pharma, among 101 patients with refractory large B-cell lymphoma, at two years after being treated with Yescarta, the best objective response showed an overall response rate of 83%, with 58% of patients having achieved a complete response. At a median of 15.1 months post-infusion, 42% of patients remained in response, including 40% in complete remission. At a median of 27.1 months post-infusion, 39% of patients remained in response, including 37% in complete remission.

Meantime, by building independent R&D capability, Fosun Kite is committed to developing more innovative immunotherapy products to enrich the company's pipeline and open up for more therapeutic areas.