Radiopharmaceuticals in Phase III of Commercial Clinical Development or Market Approval Process in China
| Drug | Company | Indication |
|---|---|---|
| 18F-alfatide injection | Jiangsu Shimeikang Pharmaceutical Co., Ltd. | Tumor diagnosis |
| 18F-APN-1607 injection | Suzhou Xinxu Pharmaceutical Co., Ltd. | Diagnosis and evaluation of neurodegenerative diseases, including Alzheimer disease and cognitive impairment related to tau protein pathology |
| 18F-florbetaben injection | Tianjin HTA Isotope Medicine Co., Ltd. | Diagnosis of Alzheimer disease related to β-amyloid neuritic plaques |
| 18F-sodium fluoride injection | Nanjing Jiangyuan AMS Positron Research and Development Co., Ltd.; HTA Co., Ltd. | Diagnosis of bone metastasis of malignant tumor |
| 6-18F-fluoro-l-dopa injection | Jiangsu Huayi Technology Co., Ltd.; HTA Co., Ltd. | Imaging to visualize dopaminergic nerve terminals in striatum for evaluation of suspected Parkinson disease in adult patients |
| 18F-flortaucipir injection | Beijing Xinhe Pharmaceutical Technology Co., Ltd. | Diagnosis and evaluation of neurodegenerative diseases, including Alzheimer disease and cognitive impairment related to tau protein pathology |
| Kit for preparation of 68Ga-PSMA-11 | Novartis Pharma AG/Advanced Accelerator Applications USA, Inc., Novartis Co. | Diagnosis of PSMA-positive lesions in prostate cancer patients |
| 68Ga-PSMA-11 injection | Telix Pharmaceuticals Inc., US | |
| Kit for preparation of 68Ga-DOTATATE | HTA Co., Ltd. | Diagnosis of somatostatin receptor–positive NETs in adults and children |
| 68Ga-DOTATATE injection | HTA Co., Ltd. | |
| Kit for preparation of 68Ga-edotreotide | Tianjin Hengrui Pharmaceuticals Co., Ltd. | Diagnosis of somatostatin receptor–positive NETs in adults and children |
| 68Ga-edotreotide injection | Tianjin Hengrui Pharmaceuticals Co., Ltd. | |
| 99mTc-3PRGD2 injection | Foshan Ruidiao Pharmaceutical Co., Ltd. | Diagnosis of benign and malignant lung tumors and lung lymph node metastasis |
| 99mTc-GSA injection | Beijing Shihong Drug Development Center | Diagnosis of function and morphology of liver |
| 99mTc-technetiumsulfur colloid injection | HTA Co., Ltd. | Diagnosis of primary tumor drainage area lymph nodes in adult breast cancer patients |
| 123I-ioflupane injection | GE Pharmaceutical Co., Ltd., Shanghai | Diagnosis of Parkinson disease |
| 90Y-glass microspheres | Fangen Pharmaceutical Development Co., Ltd., Tianjin | Therapy for unresectable primary liver cancer |
| 131I-MIBG injection | HTA Co., Ltd. | Diagnosis of neuroblastoma and pheochromocytoma |
| 177Lu-DOTATATE injection | Advanced Accelerator Applications S.A.; Jingding Pharmaceutical Research and Development Co., Ltd., Shanghai | Therapy for neuroendocrine tumor |
| 177Lu-DOTATATE injection | HTA Co., Ltd. | Therapy for neuroendocrine tumor |
| 177Lu-DOTATATE injection | Sinotau Pharmaceuticals Co., Ltd. | Therapy for neuroendocrine tumor |
| 177Lu-DOTATATE injection | Tianjin Hengrui Pharmaceuticals Co., Ltd. | Therapy for neuroendocrine tumor |
| 177Lu-DOTATOC injection | ITM Solucin GmbH | Therapy for neuroendocrine tumor |
APN = florzolotau; NETs = neuroendocrine tumors; GSA = galactosyl-human serum albumin; MIBG = metaiodobenzylguanidine.