New China Clinical Trials with HGR Filing
On September 8, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from August 4, 2020 to August 17, 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/9456
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0413 | An extended clinical study to evaluate the safety and efficacy of aortic valve replacement in patients with aortic stenosis using Venus A-plus of Venus MedTech | The Second Affiliated Hospital of Zhejiang University School of Medical | Venus Medtech (Hangzhou) Inc. | 2020.08 |
| 2 | 2020BAL0414 | The bioequivalence test of donepezil hydrochloride orally disintegrated tablets in healthy subjects under fasting and postpranational conditions was conducted in a randomized, open, two-agent, two-cycle, double-cross situation | The First Affiliated Hospital of Shantou University Medical College | Golden Sun Pharmaceutical(China)Co.,Ltd. | 2020.08 |
| 3 | 2020BAL0415 | Detection reagent for Helicobacter pylori antigen (Latex method) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | New Horizon Health | 2020.08 |
| 4 | 2020BAL0416 | A phase I clinical study of BPI-27336 tablets in patients with advanced solid tumors | Beijing Cancer Hospital | Betta Pharmaceuticals Co.,Ltd | 2020.08 |
| 5
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2020BAL0418 | Clinical trial of the Autoantibody Detection Kit for autoimmune liver disease (Magnetic barcode immunofluorescence method) | Beijing Tongren Hospital, Capital Medical University | Zhuhai Livzon Diagnostics Inc. | 2020.08 |
| 6 | 2020BAL0419 | Clinical trial of liver fluke IgG Antibody Detection Kit (enzyme-linked immunoassay) | Jiangmen Wuyi Hospital of Traditional Chinese Medicine | Shenzhen Huakang Biological Medicine Engineering Co.,Ltd. | 2020.08 |
| 7 | 2020BAL0420 | A randomized, open, single-dose, tri-cycle, tri-cross pre-test bioequivalence test for erythromycin ethylsuccinate tablets (0.25g) were designed in healthy Chinese subjects under fasting and postpranational conditions | Anhui Jimin Cancer Hospital | Xi’an Lijun Pharmaceutical Co., Ltd | 2020.08 |
| 8 | 2020BAL0421 | TQB3303 tablets Phase I tolerance and pharmacokinetics clinical trial | Cancer Hospital Chinese Academy of Medical Science | CTTQ | 2020.08 |
| 9 | 2020BAL0422 | Clinical trial of fetal chromosome Aneuploidy (T21, T18, T13) Detection Kit (probe hybridization) | Women’s Hospital, School of Medicine, Zhejiang University (WHZJU) | Suzhou Sym-Bio Life Science Co.,Ltd. | 2020.08 |
| 10 | 2020BAL0423 | Elecsys Anti-SARS-CoV-2 Clinical Trial | Shanghai Public Health Clinical Center | Roche Diagnostics(Shanghai)Limited. | 2020.08 |
| 11 | 2020BAL0424 | A randomized, open, two-cycle, two-cross bioequivalence official test of propofol fumarate tenofovir tablets (25 mg) in healthy subjects in single fasting conditions | The First Affiliated Hospital of Shantou University Medical College | Simcere | 2020.08 |
| 12 | 2020BAL0425 | Clinical trial to evaluate the efficacy and safety of hemodialyzer | Shulan Health | Dreifu (Chongqing) Medical Equipment Co. LTD | 2020.08 |
| 13 | 2020BAL0426 | Clinical trial to evaluate the efficacy and safety of hemodialyzer | Shulan Health | Dreifu (Chongqing) Medical Equipment Co. LTD | 2020.08 |
| 14 | 2020BAL0427 | Trypsin 1 detection Kit (enzyme-linked immunoassay) | Changhai Hospital | BIOHIT Healthcare (Hefei) Co., Ltd. | 2020.08 |
| 15 | 2020BAL0428 | Clinical trial of PCA3 gene Detection Kit (PCR fluorescent probe method) | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Raybiotech | 2020.08 |
| 16 | 2020BAL0429 | Clinical trial of disposable vacuum blood collection vessel | First Affiliated Hospital of Sun yat-sen university | Roche Diagnostics(Shanghai)Limited. | 2020.08 |
| 17 | 2020BAL0430 | Clinical validation of influenza A/B virus antigen Detection Kit (Colloidal gold method) | Beijing Tongren Hospital, Capital Medical University | Fujifilm(China)Investment Co.,Ltd. | 2020.08 |
| 18 | 2020BAL0431 | Clinical trial of CD20 detection Kit for leukocyte differentiation antigen (flow cytometry) | Peking University People’s Hospital | Beckman Coulter Commercial Enterprise(China)Co.,Ltd. | 2020.08 |
| 19 | 2020BAL0432 | Detection kit of Carbohydrate Antigen 72-4 (Chemiluminescent microparticle Immunoassay) | Zhejiang Cancer Hospital (ZJCH) | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.08 |
