New China Clinical Trials with HGR Filing
On November 23, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from September 7, 2020 to October 29, 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/9569
http://www.cncbd.org.cn/Notice/Detail/9566
http://www.cncbd.org.cn/Notice/Detail/9564
http://www.cncbd.org.cn/Notice/Detail/9562
http://www.cncbd.org.cn/Notice/Detail/9560
http://www.cncbd.org.cn/Notice/Detail/9558
If you want to know more about your device category, clinical pathways, predicate information and other related to your China business, please do not hesitate to contact us info@inspirativemed.com.
New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0465 | C – peptide detection Kit (chemiluminescence) clinical trial | Wuxi People’s Hospital | Beckman Coulter Laboratory Systems(Suzhou)Co.,Ltd. | 2020.09 |
| 2 | 2020BAL0466 | Clinical trial of a nonderivative screening kit (tandem mass spectrometry) for a variety of neonatal genetic metabolic diseases | The Children’s Hospital of Zhejiang University School of Medicine | Suzhou Sym-Bio Life Science Co.,Ltd. | 2020.09 |
| 3 | 2020BAL0467 | To evaluate phase I clinical trials of ASC41 tablets in healthy subjects in a randomized, double-blind, placebo-controlled multi-dose, single-dose, multiple-dose, multiple-dose, safety, pharmacokinetic, and efficacy biomarkers | Henan Provincial People’s Hospital | Ganlai Pharmaceutical Co. LTD | 2020.09 |
| 4 | 2020BAL0468 | To evaluate a prospective, randomized, open, positive parallel control, multicenter clinical study of the efficacy and safety of absorbable threaded anchorage systems | Lanzhou University Second Hospital | Wegortho | 2020.09 |
| 5 | 2020BAL0469 | CD20 antibody reagent (Immunohistochemical method) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Gene Tech | 2020.09 |
| 6 | 2020BAL0470 | CD117 antibody reagent (Immunohistochemical method) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Gene Tech | 2020.09 |
| 7 | 2020BAL0471 | HER2 antibody reagent (Immunohistochemical method) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Gene Tech | 2020.09 |
| 8 | 2020BAL0472 | Lupus Anticoagulant Detection Kit (coagulation method) | Hangzhou First People’s Hospital | Sekisui Medical Technology（China）LTD. | 2020.09 |
| 9 | 2020BAL0473 | Clinical Trial of Glucose Test Strip (Glucose dehydrogenase method) (Model: OGS-211) | Hangzhou First People’s Hospital | Aikang Bio-Technology Hangzhou Co.,Ltd. | 2020.09 |
| 10 | 2020BAL0474 | Clinical Trial of Glucose Test Strip (Glucose dehydrogenase method) (Model: OGS-251) | Hangzhou First People’s Hospital | Aikang Bio-Technology Hangzhou Co.,Ltd. | 2020.09 |
| 11 | 2020BAL0475 | Uric acid test bar (dry chemical method) clinical trial | Hangzhou First People’s Hospital | Aikang Bio-Technology Hangzhou Co.,Ltd. | 2020.09 |
| 12 | 2020BAL0476 | A prospective, multicentre, randomized, blind, parallel positive controlled clinical trial of biological mesh for alveolar ridge preservation | Beijing Ditan Hospital, Capital Medical University | Beijing Ruijian High-Tech Biological Technology Co.,Ltd. | 2020.09 |
| 13 | 2020BAL0477 | Single-target and multi-center clinical trials validated the efficacy and safety of universal spinal internal fixators for posterior spinal internal fixation at different segments of the spine | The Third Hospital of Hebei Medical University | Double Medical Technology Inc. | 2020.09 |
| 14 | 2020BAL0478 | Clinical evaluation of homocysteine assay kit | Zhejiang Provincial People’s Hospital | Suzhou Pharmaceutical Mingzekang Biological Technology Co. LTD | 2020.09 |
| 15 | 2020BAL0479 | Aspheric trifocal astigmatism corrects intraocular lens | Eye Hospital, WMU Zhejiang Eye Hospital | Eyebright | 2020.09 |
| 16 | 2020BAL0480 | Clinical trial of hepatitis B virus surface antigen Confirmation kit (neutralization assay) | Beijing Ditan Hospital, Capital Medical University | Autobio | 2020.09 |
| 17 | 2020BAL0481 | A prospective, randomized controlled, multicenter clinical trial of the safety and efficacy of an absorbable gradient layer repair membrane for periodontal soft tissue increment | Nanjing Stomatological Hospital | Nuoyimer (Suzhou) Medical Technology Co., LTD | 2020.09 |
| 18 | 2020BAL0482 | Thyroglobulin Antibody Assay Kit (Chemiluminescent microparticle immunoassay) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.09 |
| 19 | 2020BAL0483 | Thyroid peroxidase Antibody Assay Kit (Chemiluminescent microparticle immunoassay) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.09 |
| 20 | 2020BAL0484 | Thyroglobulin assay Kit (Chemiluminescent microparticle immunoassay) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.09 |
| 21 | 2020BAL0485 | Thyrotrophin receptor Antibody assay Kit (Chemiluminescent microparticle immunoassay) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.09 |
| 22 | 2020BAL0486 | Prospective, multicenter, non-inferiority, randomized, open, parallel controlled trial to evaluate the efficacy and safety of foldable, monofocal, aspheric hydrophobic acrylate intraocular lens for acaphakia vision correction after phacoemulsification of cataract | Zhongshan Ophthalmic Center, Sun Yat-sen University | Henan Saimeishi Biological Technology Co. LTD | 2020.09 |
| 23 | 2020BAL0487 | TRPC6 NUCLEic acid amplification detection Kit (FLUORESCENCE PCR) clinical trial | Zhongshan Hospital | Wuhu Geronzhi Biotechnology Co., LTD | 2020.09 |
| 24 | 2020BAL0489 | Active Vitamin B12 Determination Kit (Chemiluminescence) | Renmin Hospital of Wuhan University | Siemens | 2020.09 |
| 25 | 2020BAL0490 | Phase IIa clinical trial of Annatriol injection for acute ischemic stroke – a prospective, multicenter, randomized, double-blind, placebo-controlled study | Beijing Ditan Hospital, Capital Medical University | CellProTech | 2020.09 |
| 26 | 2020BAL0490 | High-fat diet affects the pharmacokinetics of TQ-B3525 tablets in a randomized, single-center, two-cycle, two-cross phase I clinical trial in healthy adult subjects | The First Hospital of Jilin University | CTTQ | 2020.10 |
| 27 | 2020BAL0491 | Clinical evaluation of procalcitonin assay kit (chemiluminescence) | Wuxi People’s Hospital | SYSMEX | 2020.10 |
| 28 | 2020BAL0492 | Clinical evaluation of creatine kinase isoenzyme detection kit (chemiluminescence) | Wuxi People’s Hospital | SYSMEX | 2020.10 |
| 29 | 2020BAL0493 | Clinical evaluation of myoglobin detection kit (chemiluminescence) | Wuxi People’s Hospital | SYSMEX | 2020.10 |
| 30 | 2020BAL0494 | A Phase Ib/II trial of Gimatecan (ST1481) for small-cell lung cancer in which first-line standard platinum-containing chemotherapy fails | The Fifth Medical Center of general Hospital of the Chinese People’s Liberation Army | Zhaoke (Guangzhou) Oncology Pharmaceutical Limited | 2020.10 |
| 31 | 2020BAL0495 | A prospective, multicenter, single-group, target-value clinical trial to evaluate the efficacy and safety of cryoablation in the treatment of paroxysmal atrial fibrillation | Beijing Ditan Hospital, Capital Medical University | Artechmed | 2020.10 |
| 32 | 2020BAL0496 | Study on human Bioequivalence of Bunanserin Tablets (postpranational test) | The Second Nanning People’s Hospital | Shijiazhuang No. 4 Pharmaceutical Co., Ltd. | 2020.10 |
| 33 | 2020BAL0497 | Study on human Bioequivalence of Bunanserin Tablets (Fasting test) | The Second Nanning People’s Hospital | Shijiazhuang No. 4 Pharmaceutical Co., Ltd. | 2020.10 |
| 34 | 2020BAL0498 | A key clinical study of LeukoStrat® CDx FLT3 mutation assay comparing ITD and TKD reference methods | Hospital of hematology, Chinese Academy of Medical Sciences | Rayco(Shanghai)Medical Products Company Limited | 2020.10 |
| 35 | 2020BAL0499 | To evaluate the pharmacokinetic clinical studies of ASC09F tablets administered multiple times in healthy subjects | Beijing Ditan Hospital, Capital Medical University | Ascletis Pharma Inc. | 2020.10 |
| 36 | 2020BAL0500 | Novel Coronavirus (2019-NCOV) Nucleic acid detection kit (FLUORESCENCE PCR) Clinical Trial | Tongji Hospital | Suzhou Tianlong Biological Technology Co. LTD | 2020.10 |
| 37 | 2020BAL0501 | Clinical trial of human Immunodeficiency virus (HIV-1) nucleic acid Detection Kit (FLUORESCENCE PCR method) | The Second Hospital of Nanjing | Suzhou Tianlong Biological Technology Co. LTD | 2020.10 |
| 38 | 2020BAL0502 | A preliminary assessment of the safety and efficacy of olaparil tablets in patients with breast cancer was performed using the results of the human BRCA1 and BRCA2 gene mutation detection kit (reversible end-termination sequencing) | Tianjin Medical University Second Hospital | Amoydx | 2020.10 |
| 39 | 2020BAL0503 | A randomized, double-blind, double-simulated, multicenter, active drug control phase III study comparing the efficacy and safety of nebirol and bisoprolol in Chinese patients with mild to moderate essential hypertension | Ruijin Hospital affiliated to Shanghai Jiao Tong University Medical College | Menarini | 2020.10 |
| 40 | 2020BAL0504 | Clinical trial to evaluate the efficacy and safety of hemodialyzer | Shulan Health | Dreifu (Chongqing) Medical Equipment Co. LTD | 2020.10 |
| 41 | 2020BAL0505 | Clinical verification of safety and efficacy of electric endoscopic cutting stapler | Peking University Third Hospital | B.J.Zh.F.Panther Medical Equipment Co., Ltd. | 2020.10 |
| 42 | 2020BAL0506 | LW402 piece in Chinese healthy male subjects safety, tolerability and pharmacokinetics characteristics of Ⅰ period clinical research | Shanghai Xuhui Central Hospital | Longwood Biopharmaceuticals Co., Ltd | 2020.10 |
| 43 | 2020BAL0507 | Treponema Pallidum Antibody Detection Kit (Chemiluminescent microparticle immunoassay) | Beijing Ditan Hospital, Capital Medical University | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.10 |
| 44 | 2020BAL0508 | Novel Coronavirus (SARS-COV-2) IgM/IgG Antibody Detection Kit (Lateral immunochromatography) | Wuhan Jinyintan Hospital | Zhuhai Livzon Diagnostics Inc. | 2020.10 |
| 45 | 2020BAL0509 | The efficacy and safety of partial knee prostheses for primary replacement of partial knee joints were verified by single-group target value and multi-center clinical trial | The Third Hospital of Hebei Medical University | 大博医疗科技股份有限公司 | 2020.10 |
| 46 | 2020BAL0510 | A multicenter randomized controlled open non-inferiority trial to evaluate the safety and efficacy of biologic dura mater patch for repair of dura mater defect | Beijing Ditan Hospital, Capital Medical University | Yantai Zhenghai Bio-tech Co., Ltd. | 2020.10 |
| 47 | 2020BAL0511 | A single blind, randomized, parallel controlled, multicenter clinical trial validated the efficacy and safety of spinal intervertebral fusion apparatus for internal fixation with intervertebral bone graft fusion | The Third Hospital of Hebei Medical University | Double Medical Technology Inc. | 2020.10 |
| 48 | 2020BAL0512 | Clinical evaluation of Abbott bedside diagnostic products | Tongji Hospital | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.10 |
| 49 | 2020BAL0513 | A randomized, open bioequivalence study of ritonavir tablets taken orally after meals in healthy Chinese subjects | Hunan Prevention and Treatment Institute for Occupational Diseases | Ascletis Pharma Inc. | 2020.10 |
| 50 | 2020BAL0514 | A prospective, multicentric, randomized controlled clinical trial to evaluate the safety and efficacy of rotator cuff Functional reconstruction in the treatment of Irreparable rotator cuff tears (CHEER-I) | Shanghai 6th People’s Hospital | Shanghai Jingjie Medical Technology Co., LTD | 2020.10 |
| 51 | 2020BAL0515 | Clinical trial to evaluate the efficacy and safety of hemodialyzer | Shulan Health | Dreifu (Chongqing) Medical Equipment Co. LTD | 2020.10 |
| 52 | 2020BAL0516 | A multicenter, randomized, double-blind, double-simulation, positive-drug parallel control phase III clinical study to evaluate the efficacy and safety of mometasone formoterol inhaled aerosol in the treatment of chronic persistent asthma in adults | Shenzhen People’s Hospital | Shanghai Oumini Medicine Technology Co.,Ltd.Suzhou Oumini Medicine Co.,Ltd. | 2020.10 |
| 53 | 2020BAL0517 | A prospective, multicenter, randomized, open, parallel controlled, non-inferiority clinical trial of the multifunctional nursing solution of rigid corneal contact lens for clinical efficacy and safety | Henan Provincial People’s Hospital | Yongsheng Optical Co. LTD, Hai Chang Contact Lens Co.,Ltd | 2020.10 |
| 54 | 2020BAL0519 | A prospective, single-group, multicenter clinical study was conducted to evaluate the safety and efficacy of sterile transcatheter pulmonary valve and delivery system | Shanghai Children’s Medical Center affiliated to Shanghai Jiao Tong University Medical College | Beijing Med Zenith Medical Scientific Co., Ltd. | 2020.10 |
| 55 | 2020BAL0520 | Study on bioequivalence of Lacosamine tablets in human | Huaihua First People’s Hospital | Alembic Pharmaceuticals Limited | 2020.10 |
| 56 | 2020BAL0521 | Kit for nucleic Acid Detection of Chlamydia trachomatis (CT) and Gonococcus Gonorrhoeae (NG) (Constant temperature amplification real-time fluorescence method) | Zhejiang Provincial People’s Hospital | Ustar Biotechnologies (Hangzhou) Ltd. | 2020.10 |
| 57 | 2020BAL0523 | Efficacy and safety of rigid breathable contact lenses for temporary correction of myopia in keratoplasty: a multicenter, randomized, open, positive parallel control, non-inferior clinical trial | Eye Hospital, WMU Zhejiang Eye Hospital | Shanghai Vision X Medical Technology Co., Ltd. | 2020.11 |
| 58 | 2020BAL0524 | A loss-of-function assay kit (feSIL Free Protein S) was designed to determine the concentration of Free Protein S in human citrate anticoagulant plasma samples | Tianjin Medical University Second Hospital | Roche Diagnostics(Shanghai)Limited. | 2020.11 |
| 59 | 2020BAL0525 | Clinical trial of D-dimer Detection Kit (Latex enhanced immunoturbidimetry) | Heze Hospital of Traditional Chinese Medicine | Suzhou Sym-Bio Life Science Co.,Ltd. | 2020.11 |
| 60 | 2020BAL0526 | Clinical trial of fibrinogen degradation Product Detection Kit (Latex enhanced immunoturbidimetry) | Heze Hospital of Traditional Chinese Medicine | Suzhou Sym-Bio Life Science Co.,Ltd. | 2020.11 |
| 61 | 2020BAL0527 | TRPC6 NUCLEic acid amplification detection Kit (FLUORESCENCE PCR) clinical trial | Zhongshan Hospital | Wuhu Geronzhi Biotechnology Co., LTD | 2020.11 |
| 62 | 2020BAL0528 | A prospective multicenter randomized controlled non-inferiority clinical trial to evaluate the safety and efficacy of artificial vascular CIRCULINE | Longhua Hospital Shanghai University of Traditional Chinese Medicine | Shanghai Jingjie Medical Technology Co., LTD | 2020.11 |
| 63 | 2020BAL0529 | A prospective, multicenter, single-group clinical study to evaluate the safety and efficacy of transcatheter aortic valve system in the treatment of severe aortic stenosis | West China Hospital，Sichuan University | KingstronBio | 2020.11 |
| 64 | 2020BAL0530 | Study on bioequivalence of Venlafaxine Hydrochloride Sustained-release Capsules in human (pre-test after meal) | Huaihua First People’s Hospital | Alembic Pharmaceuticals Limited | 2020.11 |
| 65 | 2020BAL0531 | Clinical trial of treponema Pallidum antibody detection reagent (Colloidal gold method) | Beijing Ditan Hospital, Capital Medical University | Zhuhai Livzon Diagnostics Inc. | 2020.11 |
| 66 | 2020BAL0532 | Randomized, blind, self-controlled, double-center study on the Safety and Efficacy of Nd: YAG Picosecond Laser therapy in the treatment of benign epidermal pigmentation diseases (Picoway-730) | Hospital of hematology, Chinese Academy of Medical Sciences | syneron-candela | 2020.11 |
