Fosun Kite Recognized as Shanghai 'Quality Benchmark' Enterprise for CAR-T Therapy Quality Management Excellence

On July 2, the Shanghai Municipal Commission of Economy and Informatization officially announced the list of Shanghai's "Quality Benchmark" (2023-2024). Fosun Kite Biotechnology Co., Ltd. was included."Experience in Implementing a CAR-T Cell Therapy Drug Quality Management System Centered on Chain of Custody/Chain of Control"Awarded as one of the "Quality Benchmarks" (2023-2024) enterprises in Shanghai, becoming one of the four selected biopharmaceutical companies. This successful inclusion fully recognizes and highly affirms Fosun Kite's comprehensive quality management, promotion of quality technology innovation and application, enhancement of quality management efficiency, and creation of excellent quality standards in the CAR-T cell therapy product field since its establishment.

In recent years, in order to thoroughly implement the strategies of a manufacturing powerhouse and a quality powerhouse, the Shanghai Municipal Commission of Economy and Informatization has continuously organized the "Quality Benchmark" selection activity, choosing a group of benchmark enterprises with advanced quality management experience and high-level quality management capabilities. Since its establishment in 2017, Fosun Kite Biotechnology Co., Ltd. has been dedicated to..."Quality from Start to Finish: Integrating Quality into Every Cell"For the quality strategy, establish a standardized, innovative, and high-standard CAR-T system that covers the manufacturing end, logistics end, and hospital end.Process Quality Management and Guardian System.

Manufacturing end,Implement advanced international quality control standards and strengthen quality capability construction in multiple dimensions, pursuing an excellent quality culture where all employees "understand quality, value quality, and improve quality."Logistics end,Actively promote the digitalization and intelligentization of quality management, and establish a full-process bidirectional traceability quality supervision system in China for the first time, covering the entire process from apheresis blood collection, blood sample transportation, centralized production, final product transportation, to final product re-melting and reinfusion — namely, the Chain of Identity (COI) and Chain of Custody (COC). This system enables real-time data collection and full life-cycle management throughout the production, transportation, and usage of autologous CAR-T cell therapies.Hospital End,Take the lead in establishing a strict CAR-T treatment center access management and dynamic adjustment mechanism to further standardize the collection, reconstitution, and infusion processes of CAR-T drugs.

This time, being honored as a "quality benchmark" enterprise will further motivate Fosun Kite to continuously promote the comprehensive quality management system and quality management capability construction for CAR-T cell therapy products. The company will keep introducing new concepts, technologies, and methods, further accelerating the digital application of CAR-T drug quality management, continuously upgrading quality management capabilities, and truly practicing to become an innovator, demonstrator, and leader in the field of cell therapy as a "quality benchmark."