NDA for New Second-Line Indication of CAR T-Cell Therapy Product YIKAIDA (Axicabtagene Ciloleucel Injection) Approved for CDE Review

NDA for New Second-Line Indication of CAR T-Cell Therapy Product YIKAIDA (Axicabtagene Ciloleucel Injection) Approved for CDE Review

Fosun Kite to Participate in the Fifth CIIE to Showcase New Options in Cell Therapy

SHANGHAI, Oct. 28, 2022 /PRNewswire/ — October 24 brought good news from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) that the NDA for new second-line indication of YIKAIDA submitted by Fosun Kite Biotechnology Co., Ltd. (hereinafter referred to as Fosun Kite) was approved for review and included in the list for priority review. Consequently, adult patients suffering from large B cell lymphoma and not responding to first-line immunochemo therapy or relapsing within 12 months after first-line immunochemo therapy are expected to enjoy such benefits earlier.

“The NDA for new second-line indication of YIKAIDA was recently approved by the CDE of NMPA for review, which inspired the staff at Fosun Kite.” Huang Hai, CEO of Fosun Kite, said, “As a high-tech biomedical enterprise, we will strive to benefit more patients through our practical pioneering and innovation.”

In recent years, lymphoma has increased in China from year to year to become the malignant tumor with the fastest growth rate. Patients from all walks of life and the community at large have shown great concerns over how to improve the prognosis for lymphoma and improve the clinical cure rate. To this end, Fosun Kite has long been committed to the R&D of CAR T-cell therapy for lymphoma and received approval to market China’s first CAR-T cell therapy product -YIKAIDA (axicabtagene ciloleucel injection) in June 2021. It is an autologous CD19-targeted CAR T-cell therapy that was authorized to be locally produced in China using Yescarta® technology from Kite Pharma, Inc. It is an individualized, custom-made, one-time therapy that brings hope to patients with lymphoma. Up to now, it has been applied in more than 200 patients with relapsed/refractory large B cell lymphoma in China. In April and October this year, Yescarta® new second-line indication was approved for marketing by FDA and EMA, respectively.

Thanks to the strong support shown by the Party and the government to the development of the biomedical industry, and innovator drugs in particular, Fosun Kite has embarked on a fast track of development since its establishment. Fosun Kite has reaped the benefits of Shanghai’s good entrepreneurial and innovative business environment, and that of the country as a whole, for development ranging from clinical trial projects, industrialization, commercial operation, and innovative payment. Thanks to support from the community at large, Fosun Kite has had the opportunity to work together with 111 hospitals in 25 provinces and cities in China to establish the Axicabtagene Ciloleucel Cell Therapy Center and has promoted the inclusion of YIKAIDA in the urban Huiminbao insurance initiatives in more than 50 provinces and cities and more than 60 commercial insurance catalogs, sparing no effort to make CAR T-cell therapies available and affordable for more patients with lymphoma.

Currently, Fosun Kite is actively expanding more indications of YIKAIDA, developing new targets and technologies, and accelerating the R&D process in the field of solid tumors, with an aim to launch at least one new product/product with new indication every year to better serve the vast number of patients with tumors. At the upcoming Fifth CIIE, Fosun Kite will also be showcasing new options in cell therapy to the community at large.

The road ahead is long; striving is the only way forward. In the future, following the Party and the Government’s call, keeping abreast of international medical advances, and adhering to the principle of being patient-centered, Fosun Kite aims to lead the way in cell and gene therapy by increasing its investment in R&D, sparing no effort in drug quality, making products more accessible, and promoting the transformation and upgrading of the biomedical industry with more cutting-edge technologies and high-quality products. Fosun Kite will contribute its wisdom and strength to stepping up the full efforts of the Party and Government to build a “Healthy China”.

CONTACT: Monica Li, [email protected]

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