CIRC (01763.HK): Subsidiary CNGT's Lu-177 API DMF Clears U.S. FDA Review
- CNGT, short for Chengdu Gaotong Isotope Co., Ltd. (CNNC), is a subsidiary of China Isotope & Radiation; the FDA confirmation letter verifies that its Lu-177 APIs DMF cleared review and qualifies for citation by formulation manufacturers.
- Downstream manufacturers may directly cite the DMF number in FDA filings for Lu-177-based radiopharmaceuticals without separate API documentation, streamlining registration, shortening review and cutting application costs.
NewTimeSpace News: On 22 September 2026, China Isotope & Radiation Corporation (stock code: 01763.HK) announced that Chengdu Gaotong Isotope Co., Ltd. (CNNC) ("CNGT"), a subsidiary of the Company, recently received a confirmation letter from the U.S. Food and Drug Administration (FDA). The Lu-177 APIs DMF previously submitted by CNGT successfully passed the FDA review, with its DMF number activated, qualifying it for citation by downstream pharmaceutical formulation manufacturers.
The approval and activation of the Lu-177 DMF means that downstream formulation manufacturers may directly cite the DMF number when submitting applications to the FDA for Lu-177-based radiopharmaceuticals, without separately providing API documentation. This streamlines the drug registration process, shortens regulatory review timelines and reduces application costs, and helps accelerate clinical research and commercialisation of Lu-177-based radiopharmaceuticals.
The Company said the successful filing will bolster the confidence of existing and prospective customers and drive the negotiation and implementation of relevant cooperation projects, marking a crucial step in CNGT's internationalisation in the core raw material sector of nuclear medicines.
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