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Jiye Bio successfully passed the RAPT customer audit, taking international cooperation to a new level
2025.02.22
On December 23, 2024, Jiyu Pharmaceutical and RAPT Therapeutics (referred to as "RAPT") successfully signed an exclusive license agreement. According to the agreement, Jiyu Pharmaceutical exclusively grants RAPT the global development and commercialization rights for its independently developed novel long-acting IgE antibody JYB1904 outside of Greater China. Jiyu Pharmaceutical's subsidiary, Jiangsu Jiye Biopharmaceutical Co., Ltd., will supply RAPT with samples required for clinical trials. In this cooperation, Jiyu Pharmaceutical not only received a prepayment of 35 million US dollars, but also hopes to achieve milestone payments of up to 672.5 million US dollars, as well as considerable gradient sales commissions in the future.
On February 20-21, 2025, the RAPT special inspection team conducted an on-site inspection of Jiangsu Jiye Biopharmaceutical Co., Ltd. The focus of this inspection is on the production process of the JYB1904 project's raw liquid, aiming to comprehensively evaluate its production and quality management system. The inspection strictly followed the FDA 21CFR Part 11, 210, 211, 600, and 610 standards, and after two days, a detailed review was conducted on key aspects such as the quality management system, raw material production workshop, quality control laboratory, and public systems.
To ensure the smooth passing of this inspection, Jiyu Pharmaceutical Manufacturing Center has led the development of a detailed inspection plan and response strategy, comprehensively reviewed the production quality management system, and identified and supplemented deficiencies. At the same time, fine division of labor and specialized training were provided to the inspection personnel to prepare adequately for the audit at all levels. In the end, Jiye Bio successfully passed the factory audit, and its professional production capacity and excellent quality management level have won high praise from experts at home and abroad.
This time, Jiye Bio successfully passed the on-site inspection, becoming an important milestone in Jiyu Pharmaceutical's international cooperation journey. This not only lays a solid foundation for the global development of the JYB1904 project, but also creates new opportunities for both parties to engage in deeper cooperation in a wider range of fields in the future.
