New China Clinical Trials with HGR Filing
On April 22, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from March 31, 2020 to April 13, 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/9245
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0190 | Clinical Trial for 2019-nCoV IgM antibody detection reagent (Magnetic particle chemiluminescence) | Zhongshan Hospital of Wuhan University | Autobio | 2020.04 |
| 2 | 2020BAL0191 | Clinical Trial for 2019-nCoV IgG antibody detection reagent (Magnetic particle chemiluminescence) | Zhongshan Hospital of Wuhan University | Autobio | 2020.04 |
| 3 | 2020BAL0192 | Clinical Trial for 2019-nCoV antibody detection reagent (colloidal gold method) | Zhongshan Hospital of Wuhan University | Autobio | 2020.04 |
| 4 | 2020BAL0193 | Phase I clinical trial of hepatitis a/b combination vaccine (child size) | Shanxi Provincial Centre for Disease Control and Prevention | SINOVAC BIOTECH CO.,LTD. | 2020.04 |
| 5 | 2020BAL0194 | Phase I clinical trial of hepatitis a/b combination vaccine | Shanxi Provincial Centre for Disease Control and Prevention | SINOVAC BIOTECH CO.,LTD. | 2020.04 |
| 6 | 2020BAL0206 | To evaluate the efficacy and safety of recombinant humanized anti-her2 monoclonal antibody -MMAE conjugation agent (rc48-adc) for injection in the treatment of advanced non-small cell lung cancer with HER2 overexpression or HER2 mutation. | Shanghai Pulmonary Hospital | RC Biotechnologies Ltd. | 2020.04 |
| 7 | 2020BAL0225 | Open, random, single oral administration, two-cycle crossover design to evaluate the bioavailability of valsartan hydrochlorothiazide tablets (金缬克®, Changzhou Siyao Pharmaceuticals Co.,Ltd.) and the reference product (复代文®, Novartis China) in healthy subjects in China on an fasting and post-meal basis | Shanghai Xuhui Central Hospital | Changzhou Siyao Pharmaceuticals Co.,Ltd. | 2020.04 |
