Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with Phase III clinical studies for its gallium [68Ga] edotreotide injection and gallium [68Ga] edotreotide injection preparation kit.
Gallium [68Ga] Edotreotide Injection for PET Imaging
The gallium [68Ga] edotreotide injection is indicated for positron emission tomography (PET) imaging in adult patients with confirmed or suspected highly differentiated gastrointestinal and pancreatic neuroendocrine tumors (GEP-NET). The injection aids in locating the primary tumor with overexpression of somatostatin receptor and its metastasis, providing critical information for clinical diagnosis and treatment planning.
Preparation Kit for Radiolabeling
The gallium [68Ga] edotreotide injection preparation kit is designed to be radiolabeled with gallium trichloride [68Ga] for the production of gallium [68Ga] edotreotide injection for clinical administration. This process is essential for the preparation of the diagnostic agent used in PET imaging.
Market Potential and Development Investment
The originator product, Somakit TOC, a 68Ga DOTATOC diagnostic reagent for somatostatin receptor positive NET by PET, was developed by France-based Advanced Accelerator Applications and was approved for marketing in the EU in 2016. Currently, neither the originator nor any similar product is registered in China, presenting a significant market opportunity. Hengrui Pharmaceuticals has invested RMB 28.78 million in the development of this product, highlighting the company’s commitment to advancing diagnostic options for neuroendocrine tumor patients in China.-Fineline Info & Tech
