New China Clinical Trials with HGR Filing
On May 8, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from April 14, 2020 to April 27, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction.
Link:http://www.cncbd.org.cn/Notice/Detail/9257
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0235 | Clinical trial of placental growth factor detection kit (magnetic particle chemiluminescence method) | Xinjiang Uygur Autonomous Region Maternal and Child Health Hospital | Suzhou Sym-Bio Life Science Co.,Ltd. | 2020.05 |
| 2 | 2020BAL0241 | Soluble fms-like tyrosine kinase-1 detection kit (magnetic particle chemiluminescence method) | Xinjiang Uygur Autonomous Region Maternal and Child Health Hospital | Suzhou Sym-Bio Life Science Co.,Ltd. | 2020.05 |
| 3 | 2020BAL0246 | A multicenter, prospective clinical study of CT noninvasive flow reserve fraction measurement system | Zhongshan Hospital | Hangzhou Atri Technology co. LTD | 2020.05 |
| 4 | 2020BAL0252 | Evaluation of the effectiveness and safety of single-arm, open, single-center and phase II clinical studies for the treatment of HER2-negative late-local or metastatic urinary maltosin patients with recombinant humanized anti-HER2 mono-anti-MMAE conjugate agent. | Beijing Cancer Hospital | RC Biotechnologies Ltd. | 2020.05 |
| 5 | 2020BAL0262 | Clinical trials of a disposable cutter head for an ultrasonic cutting hemostatic knife system and an ultrasonic cutting hemostatic knife system | Lishui Municipal Hospital | Kangji Medical | 2020.05 |
| 6 | 2020BAL0263 | Study on human bioequivalence of statitin-loccitin intestinal capsules | Changsha Central Hospital | Lansson Pharma | 2020.05 |
| 7 | 2020BAL0272 | Phase Ib clinical study for the treatment of recurrent and/or refractory B-cell malignant blood tumors with “YY-20394” | Hospital of hematology, Chinese Academy of Medical Sciences | YL-Pharma | 2020.05 |
| 8 | 2020BAL0274 | Clinical studies that multi-center single-blind, randomly and parallelly verify the safety and effectiveness of intervertebral fusion devices | Zhongshan Hospital, Xiamen University | Double Medical Technology Inc. | 2020.05 |
| 9 | 2020BAL0276 | A prospective, multicenter, single-group clinical study to evaluate the safety and effectiveness of disposable pulmonary surgical markers for pulmonary nodule localization | Cancer Hospital, Chinese Academy of Medical Sciences | Broncus | 2020.05 |
| 10 | 2020BAL0277 | A comparative assessment of Therapyv GS-5734 ™ with standard nursing therapy for the treatment of moderate COVID-19 study participants in the randomization of 3 studies of safety and antiviral activity | The First Affiliated Hospital Of Guangzhou Medical University | Gilead Sciences, Inc. | 2020.05 |
| 11 | 2020BAL0278 | Phase II clinical trial of recombinant human B lymphocyte stimulating factor receptor-antibody fusion protein for injection in patients with IgA nephropathy |
Peking University First Hospital |
RC Biotechnologies Ltd. | 2020.05 |
| 12 | 2020BAL0279 | A clinical trial was conducted to evaluate the safety and effectiveness of radiation therapy for tumor by medical electron linear accelerator | Tianjin Medical University Center Institute & Hospital | LineTech | 2020.05 |
