Fosun Kite’s New Drug Application (NDA) Filing for Axicabtagene Ciloleucel Accepted for Review by China NMPA

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2020-02

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Today, Fosun Kite Biotechnology based in Shanghai announced its New Drug Application (NDA) filing for CD19-directed CAR-T cell therapy Axicabtagene Ciloleucel (FKC876) has been accepted for review by China National Medical Products Administration (NMPA) for the treatment of adult patients with 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 large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.


Axicabtagene Ciloleucel, FKC876, is an autologous CD19-directed CAR-T cell therapy manufactured in China with the technology of YESCARTA® (Axicabtagene Ciloleucel) transferred from Kite Pharma, a Gilead Company.


The principle of autologous CAR-T cell therapy is to genetically modify patient’s T-cells to express a chimeric antigen receptor (CAR) that will activate T-cells upon engaging cells carrying the specific antigen on the surface and conduct killing. FKC876 targets the B-cell specific antigen CD19 for treating B-cell malignancies. This NDA filing is based on results of a single-arm, open label, multi-center bridging trial (FKC876-2018-001) which has evaluated the efficacy and safety of FKC876 in the treatment of Chinese patients with refractory intermediate invasive non-Hodgkin's lymphoma (NHL)/ large B-cell lymphoma in China.


William Wu, President and CEO of Fosun Pharma, President of Fosun Kite, said, “FKC876 is Fosun Kite’s first CAR-T cell therapy product to be commercialized in China; it’s also the first NDA filing accepted for any CAR-T product in China so far. As a breakthrough cancer treatment, FKC876 brings hope and chance to live to patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy in China. This acceptance also gives us confidence to bring more world-leading cell therapies to China and further invest in innovation.”


Richard Wang, CEO of Fosun Kite, commented, “We really appreciate the openness and innovation of NMPA in regulating CAR-T cell therapies. This acceptance means a preliminary recognition of our manufacturing process, quality control and clinical efficacy of FKC876. As a leader for immune cell therapy commercialization in China, we believe once approved FKC876 will change the way lymphoma patients are treated in China. Meanwhile, we look forward to working closely with government agencies, hospitals, charity foundations and commercial insurances to explore new approaches of patient assistance programs and payment models to ease patient financial burden, thus benefiting more lymphoma patients in China.”


About Large B-cell Lymphoma

Lymphoma refers to a class of heterogeneous cancers that are specific to the lymphatic system. It is divided into two categories based on cell type: Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL), and the latter is much more common. Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of NHL among adult lymphoma patients, and it’s a type of malignant cancers with heterogeneity in clinical manifestation, prognosis and other aspects; DLBCL incidence among NHL is 31%to 34%, while over 40% in Asian countries1. According to a study of 10002 patients from 24 sites carried out in China in 2011, DLBCL takes up to 45.8%among NHL, and 40.1% among all lymphoma1. Epidemiology estimates 88090 newly diagnosed NHL patients in China in 20182. Results from an international SCHOLAR-1 study indicates that 20% to 50% of the patients with DLBCL would become refractory or relapsed after first line treatments3.


Sources:

1. China guidelines for diagnosis and treatment of diffuse large B-cell lymphoma(2013)

2. Globocan 2018

3. Michael Crump, et al., Outcomes in Refractory Diffuse Large B-cell Lymphoma: Results from the International SCHOLAR-1 Study. Blood, 130, 1800-1808


About FKC876

In 2017 Fosun Kite initiated the technology transfer of the world’s first approved CAR-T cell therapy for adult NHL - YESCARTA®(Axicabtagene Ciloleucel) from Kite Pharma, named FKC876 in China, and obtained full technical and commercial rights in mainland China, Hong Kong SAR and Macau SAR. In August 2018, FKC876 obtained the Investigational New Drug (IND) approval from China NMPA, and completed a bridging clinical trial in September 2019 in support of its marketing registration in China. In December 2019, Fosun Kite opened an approx. 10,000 sqm commercial manufacturing facility in the Zhangjiang Innovative Medicine Industrialization Park in preparation for commercial production of FKC876 upon approval.


About YESCARTA® (Axicabtagene Ciloleucel)

YESCARTA® is the world's first approved CAR-T cell therapy for adult patients with certain types of non-Hodgkin lymphoma (NHL). It was approved for the US market on October 18, 2017 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with 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 large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. On August 27, 2018 YESCARTA® was also approved by the European Medicines Agency’s (EMA) Committee for EU markets as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.


According to the ZUMA-1 pivotal study carried out by Kite Pharma evaluating efficacy and safety of YESCARTA® (Axicabtagene Ciloleucel) in 101 adult patients with refractory large B-cell lymphoma (DLBCL): 1-year follow-up results released in December 2017 showed the best objective response rate of 82%, with 54% of patients achieved a complete remission. The 2-year follow-up results released in December 2018 indicated that at a median follow-up of 27.1 months post-infusion, 39% of patients remained in response, including 37% in complete remission. The 3-year follow-up results released in December 2019 indicated that at a median follow-up of 39.1 months, 47% of patients were alive, and the median overall survival (OS) was 25.8 months. Please visit www.yescarta.com for more detailed safety and efficacy data of YESCARTA®.


About Fosun Kite

As a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd and Kite Pharma (a Gilead company) in the U.S., Fosun Kite is dedicated to the advancement and commercialization of innovative immune cell therapies in China to benefit patients. Since establishment in 2017, Fosun Kite has brought in the technology of YESCARTA® (Axicabtagene Ciloleucel), the world’s first approved CAR-T cell therapy for NHL, from Kite Pharma for development in China (named FKC876), built a GMP manufacturing site for clinical studies, obtained the Investigational New Drug (IND) approval and completed its registrational clinical studies in China. Headquartered in Zhangjiang Hi-tech Park of Shanghai, Fosun Kite opened an approx. 10,000 sqm commercial manufacturing facility in Zhangjiang Innovative Medicine Industrialization Park in December 2019. Meanwhile, Fosun Kite has also built a 2000 sqm R&D center and a professionally talented and experienced R&D team, taking a combined approach of internal R&D effort and external partnering to build a sustainable pipeline including CAR-T/TCR-T programs in both discovery and clinical stages.

For more information, please visit www.fosunkitebio.com.