Fosun Kite Participates in Launching China's First Service Standard for Retail Pharmacies Handling Autologous CAR-T Therapy Products

ShanghaiJune 12, 2023PR Newswire -- Recently, the first standard in China for "Service Specifications for Retail Pharmacies Operating Autologous Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Drugs" (T/CAPC 011—2023), in which Fosun Kite participated in the compilation, was officially released. This provides a service standard for retail pharmacies operating CAR-T drugs, filling an industry gap and better serving patients with pharmaceutical services. The standard was jointly developed by experts from drug marketing authorization holders, regulatory agencies, medical institutions, research organizations, and pharmaceutical retail pharmacy technicians organized by the China Pharmaceutical Commerce Association. It was drafted and compiled by the China Pharmaceutical Commerce Association, Shanghai Municipal Drug Administration, Fudan University Cancer Hospital, Minhang Branch of Fudan University Cancer Hospital, School of Basic Medicine and Clinical Pharmacy at China Pharmaceutical University, Shanghai Pharma Health E-Medicine Pharmaceutical Co., Ltd., Sinopharm Holding Chongqing Taimin Pharmaceutical Co., Ltd., Sinopharm Specialty Pharmacy (Beijing) Co., Ltd., Beijing Yuanxin Technology Group Co., Ltd., and Fosun Kite Biotechnology Co., Ltd.

CAR-T therapy is a globally leading innovative technology in the field of cancer treatment. It enhances the ability of patients' own T cells to attack tumor cells by modifying them, thereby achieving the effect of treating cancer. In June 2021, Fosun Kite Biotechnology Co., Ltd. launched Yikaida, the first CAR-T cell therapy product in China.^®(The Axicel Injection) has been approved for marketing, bringing a revolutionary innovative breakthrough in China's oncology treatment field. It has successfully treated more than 400 patients with relapsed/refractory large B-cell lymphoma. Compared with traditional drugs, autologous CAR-T therapy is a highly personalized "vein-to-vein" treatment. It requires coordinated efforts from hospitals, logistics, and enterprises to establish a high-standard, full-process CAR-T quality management system, in which the operation and circulation management of retail pharmacies plays a crucial role. Therefore, it is urgent to formulate a unified national service standard for CAR-T drugs in retail pharmacies.

Specialized Pharmacies Continue to Conduct On-site Training and Certification for Yikaida Operations

The release of this standard fully reflects the patient-centered concept, which will better promote the supply and service guarantee of cell therapy drugs in retail pharmacies. It meets the customized and specialized service needs of cell therapy drugs in the supply chain, operation, and pharmaceutical services, enabling cancer patients undergoing cell therapy to obtain qualified drugs on demand while receiving standardized and consistent pharmaceutical services. This fully leverages the role of retail pharmacies in meeting patients' accessibility and safety needs for special treatment products.

This standard provides a series of professional pharmaceutical management services for retail pharmacies operating autologous chimeric antigen receptor T-cell (CAR-T) therapy drugs, including supply chain management, operational services, and pharmaceutical services. It covers the entire process, including training for relevant personnel, operational service environment and facilities, CAR-T drug supply chain and operational services, pharmaceutical services for cell therapy drugs, handling special situations, quality control, and continuous improvement, which will help promote the standardized and standardized application of CAR-T drugs in China's pharmaceutical distribution sector.

Huang Hai, CEO of Fosun Kite, stated: "As one of the drafting organizations, Fosun Kite will strictly adhere to the standard requirements, collaborate closely with distribution partners, and jointly ensure product supply and service for every patient. As a customized autologous CAR-T drug, Yikaida..."^®With a strict production quality management system and a traceability system to prevent confusion and errors, Fosun Kite Biotechnology Co., Ltd. ensures a consistently high success rate in drug manufacturing and preparation, as well as the reliable use of Yikaida.^®Patients can receive safe reinfusion. We will work with regulatory authorities and industry organizations to establish more and more standardized industry standards, leading the industry forward."

As a high-tech biopharmaceutical enterprise deeply engaged in the field of tumor immunotherapy and cellular treatment, particularly known for advancing the first CAR-T cell therapy product in China to market, Fosun Kite Biotechnology Co., Ltd. has been committed to being an industry leader in commercialization, industrialization, and standardization since its establishment in 2017, exploring more attempts and breakthroughs for the development of China's cell therapy industry. Its participation as a main drafting entity in formulating China’s first "Service Specifications for Retail Pharmacies Operating Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Drugs" marks another significant step by Fosun Kite in accelerating the standardization, regulation, and high-quality development of the cell therapy industry.

In the future, Fosun Kite Biotechnology Co., Ltd. will seize the opportunities brought by industrial transformation as a pioneer in the industry. It will increase R&D investment, strictly control product quality, and improve drug efficacy, striving to develop more high-quality, cutting-edge innovative drugs. At the same time, Fosun Kite will also actively collaborate with the government, academia, institutions, pharmacies, and other parties to fully promote the high-quality development of China's cell therapy industry.