On September 30, 2020, a meeting for phase III clinical trial researchers for 18F-NaF injection was held successfully. The meeting is organized by Quarkmed  and presided over by Huo Li, director of Nuclear Medicine Department, Peking Union Medical College Hospital. The injection is researched and developed by CNNC HTA Co., Ltd.

Many distinguished guests from Peking Union Medical College Hospital, Peking University First Hospital, Peking University Cancer Hospital, Beijing Friendship Hospital, Capital Medical University, Peking University Third Hospital, Beijing Tongren Hospital, Capital Medical University, Xuanwu Hospital Capital Medical University, Fifth Medical Center of Chinese PLA General Hospital and others, were present at the meeting.

On the meeting, researchers from clinical institutions made an in-depth discussion with the experts and professors from nuclear medicine departments on the clinical trial program design, medical statistics, subject protection and other issues, and determined a workable and feasible plan. Professor Yao Chen from Peking University First Hospital, and director Wang Huanling from the clinical institution of Peking Union Medical College Hospital gave guidance specific to the statistical issue in the program design and the subject protection during the trial.

As a bone imaging agent, 18F-NaF injection is used for PET/CT bone imaging examination which may improve the accuracy of diagnosis of osseous metastasis of malignant tumor, and have significant clinical value for clinical classification, disease progression determination, therapeutic confirmation, therapeutic schedule selection and others. Both experts and professors present at the meeting agreed that the clinical trial should be accelerated to promote the registration and marketing of 18F-NaF injection.

About osseous metastasis of malignant tumor

More than14 million malignant tumor patients are increased worldwide a year. WHO defines the malignant tumor as a controllable chronic disease. Revealing early osseous metastasis by imageological examination is of significance for clinical classification, therapeutic schedule determination, therapeutic effect evaluation, prognostic judgment, osseous metastasis state and survival quality improvement.

About 18F-NaF PET/CT

18F-NaF PET/CT is used for the diagnosis of niduses of enhanced osteogenic activity including osseous metastasis of malignant tumor. Compared to existing bone imaging examination, the diagnosis of osseous metastasis of malignant tumor by using 18F-NaF injection as bone imaging agent, is more accurate with early tiny niduses being found and significant clinical value for the diagnosis of osseous metastasis of malignant tumor, and is also applicable to the diagnosis of nonneoplastic osteogenic activity niduses.

HTA Co., Ltd.

HTA Co., Ltd. (hereinafter referred to as “HTA”) is an affiliate of China National Nuclear Corporation and a subsidiary of China Isotope and Radiation Corporation.

HTA commits itself to the industrialization of nuclear technology application. It is mainly engaged in the R&D, production, sales and service of nuclear technology application products. HTA has successfully passed the qualification certificates such as GMP, QES, etc. Its products cover multiple fields including radiopharmaceuticals, radioactive sources, radioactive medical devices, radiolabeled compounds, radioactive tracers, and nuclear medicine services.

HTA practices “Responsibility, Security, Innovation, Synergy” core values. With the mission of “strengthening nuclear industry to build a strong country and benefit the mankind”, and vision of “to become the leading player in the development of international nuclear science and technology”, HTA will constantly reform and innovate, enhance the core competitiveness, and work tirelessly to strengthen, optimize and expand the radiopharmaceutical industry.

Quarkmed

Quarkmed is to provide CRO service for overseas and domestic pharmaceutical research, development and producing organizations. Since establishment, Quarkmed has completed almost 100 clinical projects of phases I-IV, facilitating the research and development goal attainment of the partner. Meanwhile, Quarkmed has built our service network nationwide, entered into good relationship with more than 100 clinical institutions and established a network of experts involving various clinical specialities, forming a distinctive competence in the clinical trial related to imaging endpoint.

Quarkmed is to provide HTA with CRO service of phase III clinical trial for 18F-NaF injection, which may further enhance our CRO service capability in the fields of radiodiagnosis and therapeutic drugs, particularly the nuclear medicine diagnosis and therapy.