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    Home > Medical News > Medical Research Articles > Four pharmaceutical companies obtained the clinical approval document of heavyweight new drugs on the same day

    Four pharmaceutical companies obtained the clinical approval document of heavyweight new drugs on the same day

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    Haizheng pharmaceutical's second-generation insulin has been approved by the State Administration of drug administration According to the latest data, Haizheng pharmaceutical's new recombinant human insulin injection biological product (acceptance No cxsl1200022 Zhejiang) has been approved by the clinic, and the processing status has changed to "certificate preparation completed - pending approval document" It is understood that Haizheng pharmaceutical has been distributing insulin products since 2009 Up to now, five varieties have been distributed in this field, all of which are for clinical application, including 30 / 70 mixed recombinant human insulin injection, recombinant human insulin injection, recombinant human insulin injection, recombinant insulin glargine injection and recombinant insulin asparagus injection accepted in June this year The first three varieties were second-generation insulin and the last two were third-generation insulin The second-generation insulin product, recombinant human insulin injection, was approved this time Analysts pointed out that the second-generation insulin market has matured in China, and the relevant varieties have been produced by many enterprises, with fierce competition In contrast, three generations of insulin products are rare in China, among which, insulin glargine is only produced by Sanofi, the original research pharmaceutical enterprise, and Ganli pharmaceutical, the domestic pharmaceutical enterprise It is worth mentioning that in June this year, Haizheng pharmaceutical applied for clinical application of the third generation insulin recombinant aspart insulin API and preparation recombinant aspart insulin injection, which was accepted by the State Food and drug administration, became the fifth insulin product in the company's layout It is reported that currently, only the imported drugs of Novo Nordisk are on sale At the same time, two new contraceptive drugs were approved The approved varieties are ulinastate acetate (acceptance No cxhl1000643) and ulinastate acetate tablets (acceptance No cxhl1000644) The type of application is class 3.1 clinical chemical new drug At present, the status is changed to "certificate preparation completed - pending approval" The company can carry out the clinical application of the drug with the approval The data showed that ulinastate acetate was the first progesterone receptor modulator approved for emergency contraception within 0-120h (5 days) after unprotected sexual intercourse The emergency contraception effect of ulinastate acetate 30mg tablet was at least 1.5mg lower than that of levonorgestrel, with good tolerance The overall safety characteristics were similar to levonorgestrel In May 2009, the European Union approved, for the first time, the 30mg tablet of oral ulinastate acetate from Laboratoire HRA Pharma in France for emergency contraception within 120h (5 days) after unprotected sexual intercourse or contraceptive failure It is reported that at the beginning of June this year, China Resources Zizhu Pharmaceutical Co., Ltd has started the bidding work of outsourcing the clinical trial project of "julist acetate tablets (30mg) for 0-120 hours of emergency contraception" This time, the company has been approved for clinical application, and will also accelerate the company's clinical research on the product It is also noteworthy that a new chemical drug of Huabang Pharmaceutical (acceptance No cxhl1200302 Yu) has been approved for clinical application At present, the registration progress of Huabang pharmaceutical in CFDA is "certificate preparation completed - pending approval" According to the investigation, the approved variety is the asthma drug rofluoristone tablet Data show that rofluorostat is a new oral drug developed by Nycomed company, which is expected to be used in the treatment of asthma and COPD Some market analysts said that in the European Union, sales of RoF theluost in the year of listing were 7 million euros, and could rise to 150 million euros by 2015 It is reported that rofluorostat has compound patent "fluoroalkoxy substituted benzamide and its preparation method and application" (wo09501338, cn94192659) in China The patent was applied on July 2, 1994 and authorized on December 1, 1999 It protects the compound, preparation method and application in the treatment of airway disease or skin disease It is worth mentioning that the patent expired on July 2 this year In addition, Tiantan Biological meningitis vaccine was approved for clinical use A new biological product of Tiantan Biological was approved for clinical use (acceptance No.: cxsl1100076 Beijing) According to the investigation, the drug is acyw135 group meningococcal polysaccharide vaccine, which belongs to the new biological product for prevention At present, the handling status in the State Administration of drug administration is "certificate preparation completed - to be approved" It is understood that the vaccinated targets of meningococcal polysaccharide in acyw135 group are mainly high-risk groups of children over 2 years old and adults: those who travel to or live in high-risk areas, such as sub Saharan Africa (a, C, y and Neisseria meningitidis epidemic area in W135 group); those who engage in laboratory or vaccine production can be exposed to a, C, y and W135 from the air Group Neisseria meningitidis; and according to the epidemiological survey, the Ministry of health and the Centers for disease control predict the high-risk population in the Y and W135 group Neisseria meningitidis outbreak area The product is only used to prevent epidemic cerebrospinal meningitis caused by Neisseria meningitidis in groups a, C, y and W135 It is also worth mentioning that Watson biological AC polysaccharide and acyw135 tetravalent meningitis vaccine are expected to obtain GMP certificate in September, and the product is expected to be available at the end of the year  
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