Tongfu, China (01763): Fluorine [¹F] sitamine injection for prostate cancer diagnosis successfully completed the enrollment and data management of participants in two phase III clinical trials

Zhitong Finance App News, China Tongbo (01763) issued an announcement. Recently, Atomic Hi-Tech Co., Ltd. has made important research and development progress. The fluorine [¹F] sitamine injection independently developed by the company has successfully completed the enrollment and data management of participants in two phase III clinical trials. This landmark development lays a solid foundation for subsequent product registration and clinical application, and will provide a new solution for accurate diagnosis and treatment of prostate cancer in China.

Fluorine [¹F] sitamine injection is an innovative nuclear medicine imaging drug targeting prostate-specific membrane antigen (PSMA) and can specifically bind to prostate cancer cells. Through positron emission tomography/X-ray computed tomography (PET/CT) imaging, it is possible to clearly display the location, size and distribution range of lesions, effectively improve the detection rate of small lesions and hidden metastases, accurately assist clinical trials to complete tumor staging and recurrence risk assessments, provide a reliable imaging basis for individualized diagnosis and treatment plan formulation, and effectively optimize the full diagnosis and treatment of prostate cancer and improve patient prognosis.

These two multi-center phase III clinical trials have comprehensively verified the clinical diagnostic efficacy and safety of fluorine [¹F] sitamine injections for two core patients with moderate‐risk primary treatment and suspected recurrent prostate cancer, respectively. The experimental design is scientific, conforms to domestic clinical reality, and the high-quality clinical data obtained will improve China's PSMA targeted imaging drug evidence-based system, fill the gap in accurate diagnosis of domestic drugs for high-end prostate cancer, and help break the pattern of dependence on imports of similar drugs.

The clinical trial was led by Sun Yat-sen University Tumor Prevention Center and Peking University First Hospital, and was jointly carried out by several authoritative clinical research centers within the United Nations. Standardized quality control was implemented throughout the project to ensure that the test data was true, accurate and reliable, and provided strong support for subsequent product marketing declarations and standardized clinical application.

In the next step, Atom Hi-Tech will accelerate the registration process for fluorine [¹] sitamine injections, promote early approval for the product to be marketed, serve clinical patients, and help build a healthy China. In the future, the company will continue to deeply cultivate cutting-edge fields of nuclear medicine, focus on unmet clinical needs, continue to attack core radiopharmaceutical technology, promote high-quality development of the industry with more domestic innovations, and protect people's lives and health.