CIRC(01763): Atomic High-tech Research and Development's innovative drug for melanoma imaging, Class 1, has been approved for clinical trial notification.

CIRC (01763) announced that on December 24, 2024, the affiliated company, Atomic High-Tech Co., Ltd. (hereinafter referred to as "Atomic High-Tech"), successfully passed the review for the innovative drug class 1 "Fluorine [18F] Pipecolinamide Injection" developed by the company, and officially obtained the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA) for conducting clinical trials. In December 2022, Atomic High-Tech introduced the patent for the fluorine [18F] pipecolinamide compound from Tongji Medical College affiliated to Union Hospital of Huazhong University of Science and Technology, and rapidly carried out the product transformation work. With the strong support from the National Defense Industry Bureau, China National Nuclear Corporation, Beijing Municipal Science and Technology Commission, and Beijing Centergate Technologies Science Park Management Committee, Atomic High-Tech successfully completed preclinical research such as chemical precursors and formulations, submitted a clinical trial application to the NMPA, and obtained approval to conduct clinical trials. Fluorine [18F] Pipecolinamide Injection is a positron emission tomography (PET) imaging agent that can rapidly bind to melanoma in the body, with good specificity and high sensitivity, significantly improving the accuracy of melanoma diagnosis and staging, providing precise basis for clinical treatment decisions. Melanoma is a malignant tumor derived from neural crest melanocytes, commonly found in the extremities such as the soles of the feet, toes, fingertips, and under the nails. Melanoma is a highly malignant tumor with a high mortality rate, and statistics show that the incidence has been increasing year by year in recent years, making timely and accurate diagnosis crucial for melanoma treatment. Atomic High-Tech will strictly follow the requirements notified by the NMPA, accelerate and successfully complete the clinical research work of Fluorine [18F] Pipecolinamide Injection, and promote its early market launch. After the product is launched, it will significantly increase the accuracy of melanoma diagnosis, enrich the Atomic High-Tech radiopharmaceutical pipeline, serve the "Healthy China" strategy, and actively benefit the vast number of patients.