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    Home > Medical News > Latest Medical News > Zhengda Qing 2 first imitation injection agent products failed the consistency evaluation.

    Zhengda Qing 2 first imitation injection agent products failed the consistency evaluation.

    • Last Update: 2020-07-20
    • Source: Internet
    • Author: User
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    On June 19th, the application for consistency evaluation of the two injection products submitted by Zhengda Tianqing (disodium dissodium dissodium injection and palonosioscoe injection hydrochloride) was completed and the consistency evaluation was not approvedsource: PharmaGodicodium dsodium pyreiton acid injectionxanthan acid dsodium injection is the first contrast agent product developed by Zhengda Qingqing, is also the first imitation in China, in June 2019 by the State Drug Administration approved the listing, the commodity name is xingairesearch and development by Bayer, is a liver-specific magnetic resonance contrast agent, can show the structure and smoothness of the bile duct system inside and outside the liver, understand liver cell function, qualitative and different types of liver damageThis product facilitates the detection of liver lesions, especially to improve the detection rate of small liver tumors, thus contributing to the early diagnosis and treatment of liver lesionsaccording to pharmaGo,Pharmaceutical Rubik's Cube database, Collum Pharmaceuticals submitted a listing application for the new 4-category disodium disodium pyrethroid injection in September 2018 and is currently in the "review" phaseZhengda Tianqing this time was not approved, Collum Pharmaceuticals is expected to become the first domestic manufacturer of the producthydrochloric acid Paronocin injectionhydrochloric acid Palonosan injection is one of the fist products that is very clear, clinically used mainly for chemotherapy-induced vomitingThe drug was approved for listing in 2009 as the first imitation in China, the name of the commodity so farhydrochloric acid Palonosau belongs to the second generation of 5-HT3 receptor antagonists, compared with the first generation of products, has the advantages of high receptor affinity, long half-life, small toxic side effects, small dose of the drugDeveloped by Helssin Healthcare SA in Switzerland, it was launched in the United States in 2003 under the name Aloxirdomestic in addition to the original research products, there have been 13 enterprises listed to sell hydrochloric acid Palonosjoan injections, including Hengrui, Osaikang and Qilu Pharmaceuticals, etc., has not yet been approved by the enterprise consistency evaluationPharmaGo pharmaceutical Rubik's Cube database shows that the current / as the application for hydrochloric acid Palonosjoan injection consistency evaluation of the manufacturers have 8, this time the day clear did not pass the consistency evaluation, according to the CDE contractor time calculation, it is expected that the first evaluation enterprises will be produced from Hengrui or Osekangaccording to statistics, the size of China's chemical drug market in 2019 is about 642.3 billion yuan, of which injections occupy the main position, 57%From a policy perspective, the injection consistency evaluation has been officially launched since the 2017 draft was issued for commentsthe number of injectable products being applied for/treated as consistent evaluation has reached 729 (1144 acceptance numbers)However, from the evaluation of the situation is not ideal, so far, only 42 drugs (54 acceptance numbers) through the consistency evaluation, in addition to Puli Pharmaceutical injection azithromycin, the rest are at home and abroad co-line or according to the new registration classification of declared varietiesAccording to pharmaGo, apharmaceutical Rubik's Cube database, the 20 injections that have not been approved (65 received consistency evaluations, 55% (36) of supplementary applications, including Hengrui's injections of capofen and hydrochloric acid, etc.
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