The first* CAR-T cell therapy approved by NMPA: opening a new era of cell therapy in China

Individualized living-cell-based medicine: genetically modify patient's T-cells to expresses a chimeric antigen receptor (CAR) that will activate T-cells upon engaging cells carrying the specific antigen and conduct targeting

The bridging trial results has demonstrated remarkable similarity between Axicabtagene Ciloleucel (FKC876) and Yescarta® in terms of efficacy and safety both in U.S. clinical and real-world setting[1]

SHANGHAI, June 24, 2021-- On June 23, 2021, Fosun Kite Biotechnology announced its autologous CD19-directed CAR-T cell therapy Axicabtagene Ciloleucel (FKC876) (axicabtagene ciloleucel) has been approved by China National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) 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[1].

Axicabtagene Ciloleucel (FKC876) is an autologous CD19-directed CAR-T cell therapy manufactured in China pursuant to a license from Kite, a Gilead Company ("Kite") of Kite's Yescarta (axicabtagene ciloleucel), which is the world's first approved CAR-T cell therapy for adult patients with certain types of NHL. This NDA approval is based on results of a single-arm, open label, multi-center bridging trial which has evaluated and proven the efficacy and safety of Axicabtagene Ciloleucel (FKC876) in the treatment of Chinese patients with refractory intermediate invasive DLBCL.

WU Yifang, Chairman and CEO of Fosun Pharma, says, "CAR-T cell therapy is one of the significant cancer treatment breakthroughs in recent years. It is a great pleasure to work with Kite, a world-leading partner, to bring Axicabtagene Ciloleucel (FKC876) in China together, which is also an important milestone for Fosun Pharma's global innovation and R&D cooperation. Thanks to NMPA for the rigorous review and recognition of China's first CAR-T cell therapy. Focusing on unmet clinical needs, Fosun Pharma will continue to take innovative R&D as the core driving force and strive to provide patients with more high-quality, accessible and innovative medicines and treatment options."

MEI Jingping, Chairwoman of Fosun Kite, says, "As the first commercialized product of Fosun Kite, the approval of Axicabtagene Ciloleucel (FKC876) brings a revolutionary treatment option to cancer patients in China. We will continue to guard this innovative vein-to-vein treatment circle with high-quality and rigorous service chains to benefit more cancer patients."

Terence O'Sullivan, Vice President, International Region at Kite comments: "As the world's first approved CAR-T cell therapy for NHL, Kite's Yescarta® (axicabtagene ciloleucel) has been used in thousands of patients around the world. Thank you to the dedicated healthcare professionals, patients and caregivers who worked with the team at Fosun Kite to make this fast and reliably manufactured treatment option, with the potential of survival for patients facing these challenging and aggressive cancers available in China."

Dr. MA Jun, Director of the Harbin Institute of Hematology & Oncology, Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology, "Thanks to the reform of national medicines review and approval system in recent years, China's lymphoma diagnosis and treatment level has progressed rapidly, and CAR-T cell therapies have seen even more significant changes. As China's first CAR-T product approved by NMPA, Axicabtagene Ciloleucel (FKC876)'s approval for marketing. shows China's innovation to establish new review guidelines and standards for cell therapies, and determination to bring in world-leading technologies and medicines to benefit cancer patients in China."

Dr. WU De-pei, Chair of the Department of Hematology at the First Affiliated Hospital of Soochow University, Co-Lead Investigator of Axicabtagene Ciloleucel (FKC876) clinical trial, "As a type of malignant cancer with heterogeneity in clinical manifestation, prognosis and other aspects, DLBCL is still facing a large number of unmet medical needs in China. As the first regulatory approved and commercially available CAR-T, the approval of Axicabtagene Ciloleucel (FKC876) provides oncologists with one more option and hope of long term survival to a patient population that previously exhausted all viable treatment options."

Dr. ZHAO Wei-li, Vice Chair of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Lead Investigator of Axicabtagene Ciloleucel (FKC876) clinical trial, comments, "The bridging trial results has demonstrated remarkable similarity between Axicabtagene Ciloleucel (FKC876) and Yescarta® in terms of efficacy and safety in the treatment of Chinese adult patients with r/r LBCL. In the bridging trial, 79.2% of patients had achieved a response after a single infusion[1]; Zuma-1 data showed the best objective response rate was 83%, with 58% in complete remission[2]. Overall, Axicabtagene Ciloleucel (FKC876) has demonstrated durable response and survival rate with a manageable safety profile."

HUANG Hai, CEO of Fosun Kite, says, "We really appreciate NMPA's recognition of Axicabtagene Ciloleucel (FKC876) manufacturing process, quality control and clinical efficacy. We will continue to fulfill our mission "focus on cancer cure". A big thanks to Professor ZHAO Wei-li's team from Ruijin Hospital Affiliated to Shanghai Jiao Tong University as the Lead Investigator, together with Professor WU De-pei's team from the First Affiliated Hospital of Soochow University, Professor Hu Yu's team from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Professor . Zhang Hui-lai's team from Tianjin Cancer Hospital, their trust and efforts in the registered clinical trials have promoted successful approval of Axicabtagene Ciloleucel (FKC876) in China. With patients at the center of what we do, Fosun Kite is working hard to make this revolutionary cancer treatment accessible to benefit patients in China as soon as possible."

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. Epidemiology estimates 88,090 newly diagnosed NHL patients in China in 2018[4]. LBCL is the most common subtype of NHL among adult lymphoma patients, and it is a type of malignant cancer with heterogeneity in clinical manifestation, prognosis and other aspects; DLBCL incidence is approximately one-third of all NHL in China[5]. Studies have shown 40%-50% of DLBCL patients would become relapsed or refractory after first line treatments[6,7], 73% r/r DLBCL patients would not respond to two or more lines of treatments[8]. A study of 603 patients with r/r DLBCL showed median overall survival of only 6.3 months[8] indicating the limitations with current standard of care, associated with poor outcomes and creating a high unmet need.

About Yescarta®

Yescarta® is an autologous CD19-directed CAR-T cell therapy of Kite, approved for the U.S. market on October 18, 2017 by FDA for the treatment of adult patients with r/r LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. According to an ongoing single-arm, multi-center, open-label clinical study (ZUMA-1) carried out by Kite evaluating efficacy and safety of axicabtagene ciloleucel in 101 adult patients with r/r LBCL, 1-year follow-up results showed the best objective response rate of 82%, with 54% of patients achieved a complete remission[9]; at a median follow-up of 27.1 months post-infusion, the best objective response rate was 83%, with 58% in complete remission and 39% remain in complete remission[2]; at a median follow-up of 51.1 months, 44% of patients were alive and the median overall survival was 25.8 months[3], confirming that axicabtagene ciloleucel can bring long-term survival benefits to patients.

About Fosun Kite

As a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd and Kite Pharma, Inc., Fosun Kite is dedicated to the advancement and commercialization of innovative cell therapies in China to benefit patients. Headquartered in Zhangjiang Hi-tech Park of Shanghai, Fosun Kite has a commercial manufacturing facility of approximately 10,000 m2 in Zhangjiang Innovative Medicine Industry Park. Fosun Kite has also built a 2,000 m2 R&D center with a professionally 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

*As of the approval date 2021/06/22
Kite, the Kite logo, Yescarta, Axi-Cel and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies.

Reference:
1. Axicabtagene Ciloleucel (FKC876) 获批说明书
2. Locke et al. Lancet Oncol. 2019 Jan;20(1):31-42
3. Caron Jacobson, MD. 2020 ASH Poster abs 1187
4. Globocan 2018
5. 中国弥漫大B细胞淋巴瘤诊断与治疗指南（2013年2月修订版）
6. Coiffier B, Sarkozy C. 2016;2016(1):366-378
7. Sehn LH, Gascoyne RD.Blood. 2015;125(1):22-32
8. Crump M, et al. Blood. 2017;130(16):1800-1808
9. Neelapu SS, et al. N Engl J Med 2017;377(26):2531-2544