New China Clinical Trials with HGR Filing
On August 27, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from July 21, 2020 to August 3, 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/9440
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0368 | A single-arm, open, randomized, Phase Ib/IIa study evaluating the safety and preliminary efficacy of AL8326 in the treatment of small cell lung cancer | The Affiliated Hospital of Qingdao University | Advenchen Laboratories Nanjing Ltd. | 2020.08 |
| 2 | 2020BAL0369 | A prospective, multicenter, single-blind, parallel, randomized controlled clinical trial to evaluate the efficacy and safety of real-time near-infrared fluorescence imaging provided by an endoscope LED light source system. (ENV) | Beijing Friendship Hospital, Capital Medical University | Stryker (Beijing) Healthcare Products Co.,Ltd. | 2020.08 |
| 3 | 2020BAL0370 | A prospective, multicenter, single-group study to evaluate the efficacy and safety of the intragastric balloon system for weight loss in adults | Beijing Friendship Hospital, Capital Medical University | Changzhou Panda Medical Co., Ltd. | 2020.08 |
| 4 | 2020BAL0371 | A multicenter, randomized, double-blind, positie parallel control drug clinical study on the safety and efficacy of Type A botulinum toxin injection for the treatment of moderate and severe brow furrows | Shanghai Ninth People’s Hospital | Daewoong Pharmaceutical Co., Ltd. | 2020.08 |
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2020BAL0372 | Study on the precision of interpretation of non-small cell lung cancer specimens using rabbit monoclonal antibody reagents (immunohistochemistry) against PD-L1(SP263) | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Roche Diagnostics(Shanghai)Limited. | 2020.08 |
| 6 | 2020BAL0373 | A prospective, multicenter, randomized, parallel controlled, blind, noninferiority clinical study to evaluate the absorbable hemostatic fluid gelatin used for intraoperative hemostasis | China-Japan Friendship Hospital | Borayer | 2020.08 |
| 7 | 2020BAL0374 | Phase I clinical trial of TQB3728 tablets for tolerability and pharmacokinetics | Sun Yat-sen University Cancer Center (SYSUCC) | CTTQ | 2020.08 |
| 8 | 2020BAL0375 | 2019-nCoV IgG Antibody Detection Kit (Enzyme-linked immunoassay) Clinical Trial | Shanghai Public Health Clinical Center | Zhuhai Livzon Diagnostics Inc. | 2020.08 |
| 9 | 2020BAL0376 | 2019-nCoV IgM Antibody Detection Kit (Enzyme-linked immunoassay) Clinical Trial | Shanghai Public Health Clinical Center | Zhuhai Livzon Diagnostics Inc. | 2020.08 |
| 10 | 2020BAL0377 | Clinical trial of Hepatitis B Virus Core Antibody (Anti-HBC) Detection Kit (magnetic particle chemiluminescence) | The First Affiliated Hospital of Bengbu Medical College | Shanghai Ailex Technology Co.,Ltd. | 2020.08 |
| 11 | 2020BAL0378 | Clinical trial of Hepatitis B Virus E Antibody (Anti-HBe) Detection Kit (magnetic particle chemiluminescence) | The First Affiliated Hospital of Bengbu Medical College | Shanghai Ailex Technology Co.,Ltd. | 2020.08 |
| 12 | 2020BAL0379 | Clinical trial of Hepatitis B Virus E Antigen (HBeAg) Detection Kit (magnetic particle chemiluminescence) | The First Affiliated Hospital of Bengbu Medical College | Shanghai Ailex Technology Co.,Ltd. | 2020.08 |
| 13 | 2020BAL0380 | Hepatitis B Virus Surface Antibody Detection Kit (magnetic particle chemiluminescence) | The First Affiliated Hospital of Bengbu Medical College | Shanghai Ailex Technology Co.,Ltd. | 2020.08 |
| 14 | 2020BAL0381 | Hepatitis B Virus Surface Antigen Detection Kit (magnetic particle chemiluminescence) | The First Affiliated Hospital of Bengbu Medical College | Shanghai Ailex Technology Co.,Ltd. | 2020.08 |
| 15 | 2020BAL0382 | Hepatitis C Virus (HCV) Antibody Detection Kit (magnetic particle chemiluminescence) | The First Affiliated Hospital of Bengbu Medical College | Shanghai Ailex Technology Co.,Ltd. | 2020.08 |
| 16 | 2020BAL0383 | Treponema Pallidum Antibody Detection Kit (magnetic particle chemiluminescence) | The First Affiliated Hospital of Bengbu Medical College | Shanghai Ailex Technology Co.,Ltd. | 2020.08 |
| 17 | 2020BAL0384 | Single-arm, open, multicenter phase 1b/2 clinical trial of YY-20394 combined with GEMOX in patients with relapsed and/or refractory diffuse large B-cell lymphoma | Sun Yat-sen University Cancer Center (SYSUCC) | Shanghai Yingli Pharmaceutical Co., Ltd. | 2020.08 |
| 18 | 2020BAL0385 | 2019-nCoV IgM/IgG Antibody Test Paper (colloidal gold method) | Hwa Mei Hospital, University of China Academy of Science | Zhejiang Orient Gene Biotech Co., Ltd. | 2020.08 |
| 19 | 2020BAL0387 | A clinical trial to verify the safety and efficacy of lung CT image-assisted diagnostic software | Tianjin Cancer Hospital | SenseTime | 2020.08 |
| 20 | 2020BAL0388 | Evaluation of the safety, efficacy, and usability of a hybrid closed-loop (HCL) system in a Chinese population of adult and adolescent subjects with type 1 diabetes | The General Hospital of the People’s Liberation Army (PLAGH) | Medtronic (Shanghai)Management Co.,Ltd. | 2020.08 |
| 21 | 2020BAL0389 | Clinical trial on safety and efficacy of rigid gas permeable contact lenses for orthokeratology (MODEL: DRL Night) | Eye Hospital, WMU Zhejiang Eye Hospital | Precilens | 2020.08 |
| 22 | 2020BAL0390 | Single-arm, open, single-center phase II clinical study to evaluate the efficacy and safety of injectable recombinant humanized anti-HER2 monoclonal antiher2-mMAE couplers in the treatment of HER2-negative patients with locally advanced or metastatic uepithelial carcinoma | Beijing Cancer Hospital | RemeGen, Ltd. | 2020.08 |
| 23 | 2020BAL0391 | Evaluation test of tacrolimus assay kit methodology | First Affiliated Hospital of Zhengzhou University | Suzhou Pharmaceutical Mingzekang Biological Technology Co. LTD | 2020.08 |
| 24 | 2020BAL0392 | Elecsys Anti-P53 Antibody Detection Kit (Electrochemical Luminescence method) Clinical Trial | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Roche Diagnostics(Shanghai)Limited. | 2020.08 |
| 25 | 2020BAL0393 | A randomized controlled clinical trial on the safety and efficacy of intraocular lens implantation in aphakic eyes after cataract surgery | Beijing Tongren Hospital, Capital Medical University | KOWA Group | 2020.08 |
| 26 | 2020BAL0394 | High sensitivity troponin I assay Kit (chemiluminescence) | Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University | Siemens | 2020.08 |
| 27 | 2020BAL0395 | Human Immunodeficiency Virus (HIV 1/2) Antibody Detection Kit (Latex method) | Shanghai Public Health Clinical Center | Abon Biopharm(Hangzhou)Co.,Ltd. | 2020.08 |
| 28 | 2020BAL0396 | Human Immunodeficiency Virus (HIV 1/2) Antibody Detection Kit (Latex method) | Shanghai Public Health Clinical Center | Abon Biopharm(Hangzhou)Co.,Ltd. | 2020.08 |
| 29 | 2020BAL0397 | ACC006 combined with albumin-bound paclitaxel and carboplatin (nab-PC) in the treatment of advanced squamous non-small cell lung cancer: a multicenter, randomized, double-blind, parallel controlled, dose-exploration phase II trial of the nab-PC regimen | Sun Yat-sen University Cancer Center (SYSUCC) | Jiangsu Aidea Pharmaceutical Co.,Ltd. | 2020.08 |
| 30 | 2020BAL0398 | 2019-nCoV (SARS-CoV-2) IgG/IgM antibody detection reagent (colloidal gold method) clinical trial | Shanghai Public Health Clinical Center | Aikang Bio-Technology Hangzhou Co.,Ltd. | 2020.08 |
| 31 | 2020BAL0399 | 2019-nCoV (SARS-COV-2) IgG Antibody Detection Kit (enzyme-linked immunoassay) clinical trial | Shanghai Public Health Clinical Center | Aikang Bio-Technology Hangzhou Co.,Ltd. | 2020.08 |
| 32 | 2020BAL0400 | 2019-nCoV (SARS-CoV-2) IgM Antibody Detection Kit (enzyme-linked immunoassay) clinical trial | Shanghai Public Health Clinical Center | Aikang Bio-Technology Hangzhou Co.,Ltd. | 2020.08 |
| 33 | 2020BAL0401 | 2019-nCoV (SARS-COV-2) nucleic acid detection kit (PCR-FLUORESCENT probe) clinical trial | Shanghai Public Health Clinical Center | Aikang Bio-Technology Hangzhou Co.,Ltd. | 2020.08 |
| 34 | 2020BAL0402 | 2019-nCoV (SARS-CoV-2) IgM/IgG antibody detection reagent (colloidal gold method) clinical trial | Shanghai Municipal Center For Disease Control & Prevention | BIOHIT Healthcare (Hefei) Co., Ltd. | 2020.08 |
| 35 | 2020BAL0403 | Clinical trial on disposable hysteroscopy | First Affiliated Hospital of Zhengzhou University | Zhejiang Reed Medical Technology Co. Ltd. | 2020.08 |
| 36 | 2020BAL0404 | Clinical trial of safety and efficacy of ultrasonic soft tissue cutting hemostasis system for soft tissue cutting and hemostasis | Beijing Cancer Hospital | Shenzhen Purwell Medical Technology Co., Ltd. | 2020.08 |
| 37 | 2020BAL0405 | Clinical trial of human immunodeficiency virus antibody oral mucosal exudate detection kit (colloidal gold immunochromatography) | Beijing Tongren Hospital, Capital Medical University | W.H.P.M.Bioresearch and Technology Co.,Ltd. | 2020.08 |
| 38 | 2020BAL0406 | Influenza A/B virus antigen detection kit (fluorescence immunochromatography) | First Affiliated Hospital of Sun yat-sen university | Zhuhai Livzon Diagnostics Inc. | 2020.08 |
| 39 | 2020BAL0407 | Clinical trial of FMR1 gene detection kit (PCR microfluidic chip capillary electrophoresis) | Women’s Hospital School of Medicine,Zhejiang University, Zhejiang Women’s Hospital, Zhejiang Women’s Health Care Hospital | Suzhou Sym-Bio Life Science Co.,Ltd. | 2020.08 |
| 40 | 2020BAL0408 | A prospective, multicentre, randomized controlled, non-inferiority clinical study to evaluate the vascular stapler system for the sutures at the percutaneous common femoral artery puncture site | The Second Affiliated Hospital of Zhejiang University School of Medical | Zhejiang Guichuang Medical Devices Co.,Ltd. | 2020.08 |
| 41 | 2020BAL0409 | A multicenter, randomized, double-blind Ⅲ period clinical study to evaluate the curative efficacy and safety of the EVT201 capsule compared to placebo in patients with insomnia disorders | Xuanwu Hospital Capital Medical University | Zhejiang Jingxin Pharmaceutical Co.,Ltd. | 2020.08 |
| 42 | 2020BAL0410 | Clinical trial of helicobacter pylori antigen detection kit (latex immunochromatography) | Beijing Tongren Hospital, Capital Medical University | W.H.P.M.Bioresearch and Technology Co.,Ltd. | 2020.08 |
| 43 | 2020BAL0411 | A multicentre, randomized, single-blind, positie, and placebo-controlled clinical study on flurbiprofen patch for pain relief in knee osteoarthritis | Peking University Third Hospital | Beijing Tide Pharmaceutical Co., Ltd | 2020.08 |
| 44 | 2020BAL0412 | Study on the precision of interpretation of triple negative breast cancer (TNBC) specimens using rabbit monoclonal antibody reagents (immunohistochemistry) against PD-L1(SP142) | Fudan University Shanghai Cancer Hospital | Roche Diagnostics (Shanghai)Limited. | 2020.08 |
