[exclusive] out of the shadow of the clinical verification tragedy, 2018 clinical trial ushered in the outbreak, the first half of the year

Highlights: 1 The trend of clinical trial registration in the first half of 2018: China clinical trial registration center increased by 81.63% year on year, and CDE clinical trial registration increased by 45.45% year on year 2 The third phase of propofol sodium in humanwell medicine is over, which is expected to fill the gap in clinical use in China 3 The most popular varieties for be record: Amlodipine Besylate tablets, metformin hydrochloride tablets, Amoxicillin Capsules 4 The enterprise with the most be records: Yangzijiang Pharmaceutical Group Co., Ltd Drug clinical trials provide regulatory application materials for new drug review and registration, provide the basis for enterprises to make new drug and market development decisions, and also provide the basis for doctors and patients to use new drugs correctly It is of great significance as the necessary research for new drug listing More than half of the clinical trials have been conducted in 2018 What is the general situation of clinical trials in China? And let the editor do a brief analysis for you The drug intelligence clinical trial database collects the clinical trial information of national new drug evaluation center, West China clinical trial center and other scientific research institutions It is the most authoritative clinical trial database with the largest amount of information in China at present Based on the data of China clinical trial database of Yaozhi, the following small compilation briefly summarizes the data of China Clinical Trial Registration Center (ChiCTR), CDE clinical trial of drugs (CTR) and be filing platform (be) in the first half of this year 1、 According to statistics of China Clinical Trial Registration Center (ChiCTR), in the first half of this year (January 1, 2018 June 30, 2018), China clinical trial registration center has 2739 clinical trial registration data (by registration number, the same below), an increase of 81.63% over the first half of last year Among them, 103 phase-1 clinical trials, 56 phase-2 clinical trials, 40 phase-3 clinical trials and 50 phase-4 clinical trials; 2490 data were registered in post market drug, pre-trial trial, clinical trial of new treatment technology, clinical trial of diagnostic test technology, retrospective study, phase-1 + phase-2, basic science research, health service research and other clinical trials, as shown in the figure below It is worth mentioning that among the 40 3-phase clinical trial registration numbers, 20 are in progress; 13 have not yet started; 7 have already ended, which are 6 intervention studies and 1 observation study Among them, isoglycyrrhizic acid magnesium injection for drug-induced liver injury is a fist product of Zhengda Tianqing and propofol disodium for injection for anesthesia and analgesia is a new drug of humanwell medicine Details As shown in Table 1 Table 1 details of the 3-phase clinical trials that have been registered by China clinical trial registration center Zhengda Tianqing magnesium isoglycate injection (Tianqing Ganmei) is a kind of hepatocyte protective agent, which is suitable for chronic viral hepatitis and improvement of liver function abnormality It is reported that the annual sales of Tianqing Ganmei in 2017 was 1.925 billion The clinical phase 3 intervention study of Magnesium Isoglycyrrhizinate Injection belongs to supplementary registration, aiming to evaluate the efficacy and safety of Magnesium Isoglycyrrhizinate Injection in the treatment of acute drug-induced liver injury compared with the positive drug Tiopronin Injection Propofol sodium of humanwell medicine is a kind of water-soluble propofol prodrug jointly developed by humanwell Yichang and Huaxi Hospital of Sichuan University It is a new type of short effect intravenous general anaesthetic with fast onset and recovery According to the registration and acceptance database of smart drugs, propofol sodium for injection of yixuanrenfu was approved for clinical use in January 2015 Now the phase 3 clinical practice is over, and it is believed that the application for listing will be carried out soon If it is successfully listed, it will fill the gap in clinical use of the drug in China and gradually narrow the gap in drug use between China and the United States and other developed countries; moreover, humanwell pharmaceutical is the leading enterprise in the field of narcotic drugs in China, with the market share of narcotic drugs ranking first in China The research and development of the product will enrich the company's product line, and further consolidate the company's dominance in the field of anesthesia and analgesia Dominance Table 2 details of application and registration of humanwell pharmaceutical propofol sodium II List of clinical trial registration data of CDE drugs (CTR) According to statistics, 880 clinical trials of CDE drugs were registered in the first half of 2018, an increase of 45.45% over the first half of 2017 Among them, there are 186 clinical trials in phase 1, 69 in phase 2, 130 in phase 3, 18 in phase 4 and 477 in other phases There are 699 chemical drugs, 154 biological products and 26 traditional Chinese medicine / natural drugs involved Three phase clinical trials have been completed, namely, influenza virus split vaccine (tetravalent) of Changchun Changsheng Biotechnology Co., Ltd to prevent influenza virus and intravenous induction hx0507 of humanwell medicine to be used in general anesthesia, namely, propofol sodium for injection (2 registration numbers) Table 4: CDE clinical trial registration platform has completed three phases of clinical trials According to the database of registration and acceptance of intelligent drugs, there are 29 acceptance numbers of application for registration of tetravalent influenza virus split vaccine, including 26 clinical applications and 3 production applications It is worth mentioning that Hualan biology and Changchun Changsheng Biotechnology Co., Ltd have obtained the production approval document on June 15 this year, becoming the first approved influenza vaccine in China Table V details of application and registration of influenza virus split vaccine III list of registration data of be filing platform (be) up to now, the be filing platform has received 808 filing records, of which 291 in the first half of 2018, accounting for 36.01% Among them, amlodipine besylate tablets are the most frequently recorded, followed by metformin hydrochloride tablets, with details as shown in Table 6; Yangzijiang Pharmaceutical Group Co., Ltd is the most recorded company, with 22 enterprises, and the top 5 enterprises of be record number are shown in Table 7 Table 6 be record quantity and variety ranking top 10 table 7 be record quantity and enterprise ranking top 5 more details, please click here to enter the database of Chinese clinical trials of Yaozhi~