Pudong Hospital-Fosun Kite Yescarta® Authorized Treatment Center Officially Launched

On September 27, the Pudong Hospital Fosun Kite Yikaida® Authorized Treatment Center was inaugurated. The New District Health Commission stated that this is an exemplary case of the integration of medical and industrial sectors in the New District, and also marks a solid step forward for Pudong in the field of cellular immunotherapy.

On June 21, 2021, the first CAR-T cell immunotherapy product in China, Fosun Kite's Yikaida (Axicabtagene Ciloleucel Injection), was approved for marketing. It is approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who have received two or more lines of systemic therapy.

CAR-T Cell Immunotherapy: Chimeric Antigen Receptor T-Cell ImmunotherapyCAR-T cell immunotherapy is a personalized technology based on cells. It involves collecting and isolating the patient's own T cells, which are then genetically engineered in the laboratory to produce CAR-T cells. These CAR-T cells have the ability to recognize antigens (or markers) on the surface of cancer cells and activate T cells to kill these cancer cells. Once reinfused into the patient’s body, CAR-T cells can precisely identify and eliminate cancer cells, thereby treating cancer.

On June 26, 2023, the new indication application for Yikaida was officially approved, expanding its indications to include adult patients with large B-cell lymphoma who are either unresponsive to first-line immunochemotherapy or relapse within 12 months after first-line immunochemotherapy. This also brings hope to more patients who are unresponsive to or relapse after first-line immunochemotherapy.

Huang Hai, CEO of Fosun Kite, revealed that the treatment process of CAR-T cell immunotherapy is complex, including cell collection, pretreatment, cell reinfusion, and adverse reaction management. Therefore, Fosun Kite is very cautious about authorizing Yikaida cell immunotherapy centers. It is reported that Pudong Hospital underwent multiple rounds of inspections and was submitted to the National Center for Drug Evaluation (CDE) for review and filing, eventually obtaining the "Authorization Certificate" on August 27, 2023.

Huang Hai said that a large number of clinical applications have shown that the efficacy of CAR-T cell immunotherapy in China is better than the global average. "Our current goal is 'not only to make it work well, but also to make it affordable.' By cooperating with hospitals, we will accelerate clinical transformation and gradually make it more accessible and localized to benefit more patients," said Dr. Shen Hao, Chief Scientist of Fosun Kite Biotechnology Co., Ltd. "We hope to place cell collection, pretreatment, cell infusion, and so on in the hospital, completing all procedures at the patient's bedside to achieve 'bedside treatment.'"

Since the beginning of this year, the Health Commission of Pudong New Area has been focusing on promoting the integration of medical and industrial work to boost the development of the biopharmaceutical industry. In collaboration with relevant departments, they have introduced a series of policy measures, established the "Clinical Research and Application Alliance," and developed the "Medical-Industrial Integration Innovation Platform." They are actively building communication platforms between the medical and industrial sectors to help medical institutions and biopharmaceutical companies achieve precise resource, information, and project alignment. At the same time, they support and guide medical institutions to focus on difficult and complicated diseases, cutting-edge technologies, and scientific innovation by carrying out hospital-enterprise and hospital-university cooperation, comprehensively enhancing the capabilities and intrinsic quality of medical services.

It is reported that as an affiliated hospital of Fudan University, the Clinical Research Center for Cell Immunotherapy of Fudan University is located within Pudong Hospital. The hospital revealed that it will cooperate with Fosun Kite in the treatment of solid tumors. Yu Minghua, vice president of Pudong Hospital, stated that Pudong Hospital has established partnerships with multiple pharmaceutical enterprises in Zhangjiang to promote the integration of medical and industrial resources, accelerating the entry of innovative drugs and medical devices, guided by clinical value and needs, into clinical trials or applications.

Zhu Wei, Deputy Director of the Pudong New Area Health Commission, stated that he hopes to use the Fosun Kite Yikaida Authorized Treatment Center at Pudong Hospital as a starting point to continuously explore new areas of cooperation, develop new targets and technologies, accelerate the R&D process for solid tumor treatments, build a new highland for cellular immunotherapy, and bring hope to more patients.