CIRC (01763): China Isotope & Radiation Corporation's subsidiary CNNC High Tech's Lu-177 DMF successfully passed U.S. FDA filing.

CIRC (01763) announced that recently, Chengdu CNNC High Tech Isotope Co., Ltd. (CNNC High Tech), a subsidiary of CIRC, received a confirmation letter from the U.S. Food and Drug Administration (FDA). The previously submitted DMF for Lu-177 API successfully passed review, marking that CNNC High Tech's Lu-177 API DMF has been recognized by the FDA and the DMF number has been successfully activated, qualifying it to be referenced by downstream formulation manufacturers. This is an important step for CNNC High Tech in advancing its international layout in the field of key raw materials for nuclear medicine. The approval and activation of the Lu-177 DMF means that when formulation manufacturers submit applications to the FDA for radiopharmaceuticals containing Lu-177, they can directly reference this DMF number without separately providing API-related materials, effectively simplifying the registration pathway, shortening the review cycle, and reducing application costs. For downstream partners, this provides a more convenient and efficient compliant source of API, helping to accelerate the clinical research and commercialization process of Lu-177-based radiopharmaceuticals. The successful filing this time will enhance the confidence of existing and potential customers in cooperation, promote the negotiation and implementation of related cooperation projects, and inject new momentum into CNNC High Tech's business expansion.