Good News丨Congratulations on the IND approval of[¹⁸F]BF₃-BPA Injection of BoomRay
On August 29,2023, BoomRay Pharmaceuticals (hereinafter referred to as "BoomRay") , the registered partner of Yeedo, received a notice from the CDE that [¹⁸ F] BF ₃ -BPA injection (BR-02) developed by BoomRay obtained IND approval. Yeedo warmly congratulates BoomRay!
BR-02 is a positron emission computed tomography (PET) tracer used in the diagnosis of primary and metastatic brain tumors. As a novel amino acid analogous molecule, BR-02 is expected to make up for the shortcomings of glucose PET tracer in the diagnosis and evaluation of brain tumors, and play a role in different clinical application scenarios such as the diagnosis of primary and metastatic brain tumors, evaluation of therapeutic effect, differentiation of tumor progression, and inflammatory or false-positive lesions after treatment. In the future, BoomRay also plans to expand BR-02 as a companion diagnostic drug for boron neutron capture therapy (BNCT).
During the IND application of BR-02, Yeedo cooperated closely with BoomRay , according to the characteristics of BR-02, we formulated the registration strategy of directly submitting the IND application without the pre-IND meeting. Both parties jointly checked the research work and application materials, so that the IND application could be accepted at one time and successfully approved for clinical trial. So far, the high quality registration services provided by Yeedo has assisted four nuclear drug projects including this project successfully obtain approval.
About Yeedo
Since its establishment 13 years ago, Yeedozencom has provided more than 650 drug registration and clinical and other related services for more than 350 domestic and foreign pharmaceutical enterprises, covering phase I-IV clinical trials and clinical pharmacological trials such as mass balance / DDI / PK for special populations, and helped more than 10 innovative drugs and 100+ generic drugs to successfully market.
About BoomRay
BoomRay focuses on the development of targeted radionuclide drugs, concentrating on accurate tumor diagnosis and treatment. BoomRay has a number of diagnostic and therapeutic radionuclide drug research projects with independent intellectual property rights, and has built a self-research, development and transformation technology platform for drug innovation. BoomRay is headquartered in Suzhou, and has New Drug Discovery, Clinical Transformation, Regulatory Affairs and other business departments in Beijing and Shanghai. BoomRay has a management team led by overseas high-level talents with nuclear medicine industry background and drug design and transformation work experience. Relying on the technology platform and basic research of Peking University, and cooperation with a number of clinical hospitals in China, BoomRay strives to build the company into a first-class nuclear drug enterprise with source innovation ability and efficient industrial transformation ability.
