China Tongshi (01763): CNNC Qualcomm Lu-177 DMF successfully passed the US FDA registration

Zhitongcaijing · 23h ago

Zhitong Finance App News, China Tongshi (01763) issued an announcement. Recently, China Tongfu's subsidiary Chengdu Qualcomm Isotope Co., Ltd. (CNNC Qualcomm) received a confirmation letter from the US Food and Drug Administration (FDA). The DMF file for the Lu-177 API submitted earlier has successfully passed the review, marking that the DMF file for CNNC Qualcomm Lu-177 API has been approved by the FDA. The DMF has been successfully launched and qualified for use by downstream formulation manufacturers. An important step.

The Lu-177 DMF file has been reviewed and launched, which means that formulation manufacturers can directly cite the DMF number when declaring radiopharmaceuticals containing Lu-177 to the FDA. There is no need to separately provide data related to the API, which can effectively simplify the registration process, shorten the review cycle, and reduce the filing cost. For downstream partners, this provides a more convenient and efficient source of API compliance and helps accelerate clinical research and commercialization of Lu-177 radiopharmaceuticals.

The successful filing will enhance the cooperation confidence of existing and potential customers, promote the negotiation and implementation of related cooperation projects, and inject new impetus into CNNC Qualcomm's business development.