[Shanghai, China] Fosun Kite Biotechnology Co., Ltd. announced today that the National Medical Products Administration (NMPA) has officially approved the IND application [Acceptance No.CXSL2100098] for the registration of a new indication of Axicabtagene Ciloleucel (FKC876), a CD19-targeted autologous CAR-T cell therapy product of Fosun Kite for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma (r/r iNHL) after two or more lines of systemic therapy.。

Mr. Huang Hai, CEO of Fosun Kite, said: "On March 5, 2021, Yescarta (Axicabtagene Ciloleucel) was granted accelerated approval by the US FDA for the treatment of adult patients with r/r follicular lymphoma (r/r FL), and we are pleased to see that the IND application for this new indication of FKC876 (Axicabtagene Ciloleucel) in China has also been approved by the NMPA. This means that the second indication of Fosun Kite's CAR-T cell therapy product is in the clinical phase. We are very grateful to the regulatory authorities for their encouragement and support for innovative therapies. We are looking forward to working with Chinese clinical experts to carry out relevant trials, so as to provide an important basis for the registration and marketing of the new indication of this product in China, and bring new hope and opportunities for more NHL patients in China as soon as possible.

About iNHL
Indolent non-Hodgkin lymphoma (iNHL) is a malignancy that progresses slowly but becomes more aggressive over time. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are both common subtypes. FL is also the second most common type of lymphoma worldwide, accounting for approximately 22% of confirmed cases of NHL worldwide. MZL is the third most common lymphoma, accounting for approximately 8% to 12% of all B-cell NHL 1. Although the long-term survival of FL patients has been considerably improved with advances in disease management, there are great differences in prognosis. At present, there is no standard treatment for r/r FL patients after two or more lines of therapy, and treatment options for r/r MZL patients are also very limited.

About FKC876
FKC876 is a CAR-T cell therapy product manufactured in China and introduced by Fosun Kite pursuant to a license from Kite (a Gilead Company) of its Yescarta (Axicabtagene Ciloleucel) in early 2017. Its NDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma - not otherwise specified (DLBCL-NOS), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma) after two or more lines of prior systemic therapy has been included in the Priority Review by NMPA in March 2020.

About Yescarta
Yescarta has been approved by the US FDA on October 18, 2017 for the treatment of adult patients with r/r LBCL, including DLBCL-NOS, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma, and is the first CAR-T cell therapy product approved by the US FDA for specific non-Hodgkin lymphoma.

On March 5, 2020, its application for an expanded indication for the treatment of adult patients with r/r FL was granted accelerated approval by the US FDA and became the world's first CAR-T cell therapy product approved for marketing for FL. Based on the results of the ZUMA-5 single-arm, open-label, multicenter trial, 92% of patients with r/r iNHL (n = 104) responded to Yescarta, 76% achieved a complete response at a median follow-up of 17.5 months; median DOR, PFS, and OS had not yet been reached, and 64% of FL patients remained in response 2.

About Fosun Kite
As a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Kite Pharma, Inc. (a subsidiary of Gilead Sciences), Fosun Kite Biotechnology Co., Ltd. (hereinafter referred to as "Fosun Kite") is dedicated to the R&D, industrialization and standardization of immune cell therapy products for tumors to benefit Chinese patients. Headquartered in Zhangjiang Hi-tech Park of Shanghai, Fosun Kite has a 10,000 m2 CAR-T commercial manufacturing facility which has been completed and put into use in Zhangjiang Biotech and Pharmaceutical Industrial Base. Moreover, Fosun Kite has also built a 2,000 m2 cell therapy 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 innovative R&D pipeline focusing on CAR-T/TCR-T programs in both early R&D and clinical evidence-based stages.
For more information about Fosun Kite, please visit www.fosunkitebio.com

Data source：
1. NCCN Guideline V1. 2020 B-cell Lymphomas

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