Developer of Tumor Immune Cell Therapy Technologies and Products
From Start to Finish, Integrate Quality into Every Cell
ShanghaiFebruary 17, 2023PR Newswire -- Recently, Fosun Kite Biotechnology Co., Ltd. received a notification that, according to the requirements of the 2022 credit rating assessment for pharmaceutical manufacturers in Shanghai by the Shanghai Municipal Drug Administration, and based on the "Shanghai Pharmaceutical Manufacturers Credit Rating Assessment Index System (2022 Revised Edition)," through the review of participating applications, data statistical analysis, and model evaluation conducted by third-party credit assessment agencies, and after expert review by the Shanghai Pharmaceutical Quality Association and confirmation by relevant departments of the Shanghai Drug Administration, Fosun Kite was awarded the highest credit rating of A level in the 2022 credit assessment of pharmaceutical manufacturers in Shanghai.This is Fosun Kite Biotechnology Co., Ltd. sinceIn June 2021, the first CAR-T drug in China, Yikaida, was produced.®Participated in the credit rating evaluation of Shanghai pharmaceutical manufacturing enterprises for the first time since, achieving a successful rating on the first attempt.Grade A excellent results.
Since 2014, the Shanghai Drug Administration has entrusted the Shanghai Pharmaceutical Quality Association with the research work on the project "Credit Rating Evaluation Standards and Evaluation Report for Pharmaceutical Manufacturing Enterprises in Shanghai." The newly revised 2022 credit rating evaluation standards for pharmaceutical manufacturing enterprises align with the requirements of the new Drug Administration Law. Adjustments have been made to the indicators for different categories of pharmaceutical manufacturing enterprises. A comprehensive assessment was conducted on all 162 participating enterprises based on four primary indicators: records of dishonest and non-compliant behavior in drug production and sales, risk management capabilities, social credit evaluation, and market competitiveness. Fosun Kite Biotechnology Co., Ltd. achieved the highest evaluation grade of A."Production and Sales Dishonesty Violation Records" and "Risk Management Capability" Both Receive Full Marks。
Autologous CAR-T cell therapy drugs are personalized, customized products that follow a "vein-to-vein" process. The quality of these drugs is directly tied to patients' lives, the growth of enterprises, and societal progress. In the future, Fosun Kite Biotechnology Co., Ltd. will adhere to the principle that "drug quality is the life of an enterprise" by establishing the strictest quality management system. With cutting-edge technology, superior products, and more reliable therapeutic outcomes, the company strives to become the most valuable leader in cell and gene therapies, ultimately benefiting a wide range of lymphoma patients through a steadfast commitment to quality from start to finish.