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    Home > Medical News > Latest Medical News > Within a week, three first generic drugs were approved by China Biopharmaceuticals half a year "grab" the next 5 counterfeit drugs.

    Within a week, three first generic drugs were approved by China Biopharmaceuticals half a year "grab" the next 5 counterfeit drugs.

    • Last Update: 2020-07-29
    • Source: Internet
    • Author: User
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    Since October 2019, the State Health and Care Commission jointly with the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the State Drug Administration, the State Intellectual Property Office and other departments issued the "first batch of encouraging generic drugs catalog", the "fast-forward key" for the development of generic drugs in China was pressedAccording to incomplete statistics, the number of generic drugs approved for listing in China in the first half of 2020 is 234, and with the continuous improvement of national collection and consistency evaluation policies, generic drug market may be further "slim."From January to July, 20 first generic drugs were approved into July, and three drugs were approved for domestic first generic market in one weekOn July 13, Dongsun 4 generic drug Liglitin tablets were approved by the State Drug Administration for listing, the first imitation in ChinaLiglitin is a DPP-4 inhibitor, originally developed by Bollinger Ingham and Lilly, and is a highly selective, powerful DPP-4 inhibitor class oral anti-sugar drug used in a single drug or in combination with metformin or in combination with metformin and sulfonate to treat type 2 diabetesAt present, a total of 5 DPP-4 inhibitors approved for listing in ChinaAmong them, Sigretin, Sagretin, Viglitin and Agretin have previously been approved for the market of generic drugsAfter the first imitation of Liglitin was approved, these five DPP-4 sugar-lowering drugs are original research drugs and generic drugs in China's market salesAlso on July 13, Nanjing Hang Seng Pharmaceuticals 4 generic drugs carbonate Sweram tablets approved by the State Drug Administration for listing, the first imitation in ChinaCarbonated Viram tablets are used to control hyperphosphate in adult patients with chronic kidney disease (CKD) who are being treated on dialysisThe drug, originally developed by Sanofi and approved for entry into China in June 2013, has been included in the national health insurance, with a median bid of 8.10 yuan per tabletIn 2019, Sanofis Viram had sales of 311 million eurosHyperphosphateemia is a common complication of chronic kidney disease, the prevalence of chronic kidney disease in adults in China is currently 10.8%, a total of 120 million people, of which about 2 million people are suffering from end-stage nephropathyOn July 8, Jiangxi Shanxiang Pharmaceutical s4 generic drug Aiomeprazole magnesium intestinal tablets were approved by the State Drug Administration for listing, the first imitation in China, approved as the same as through the consistency evaluationEsomeprazole (Essomeprazole) is a single isomer of omeprazole, clinically used for the treatment of gastroesophageal reflux disease, corrosive reflux esophagitis, etcAsomepeight, a former research company, had sales of $1.483 billion in 2019 and domestic sales of about $2.3 billionAccording to the PharmaGo database, the number of generic drugs approved for sale in China in January-June 2020 was 234, and at least 17 counterfeit drugs were approved in January-June 2020Compared with ordinary generic drugs, the first generic drug needs a stronger research and development technology, to obtain the first imitation for pharmaceutical companies also have the advantage of taking the lead in the market From this year's approved first generic drug species, covering anti-tumor, antiviral, diabetes, hypertension and other diseases Among them, China Biopharmaceutical in the first half of the year a total of 5 counterfeit drugs were approved for market, the first half of 2020 as the "biggest winner", involving respiratory, endocrine, cardiovascular, anti-infection and other fields, respectively, positive day-to-day inhalation with budined suspension, phosphate sigressin tablets, dabbiga group ester capsules and Entabinte Nofove tablets and Zhengda Fenghai's sodium chloride injections Howson Pharmaceuticals also has two first generic drugs approved in the field of central nervous system and tumor, namely: paliquinone slow release tablets, Malay acid afatini tablets, and East Sunshine medicine's Esomeprazole magnesium intestinal capsules were also approved for the first imitation Several other first generic drugs from The compreteo Pharmaceuticals, Renfu Pharmaceuticals, Huilun Pharmaceuticals and other companies has been rated as the key to the development of generic drugs In recent years, China's generic drug market continued to change In addition to the "first-in-class imitation", for generic supping enterprises, whether to successfully pass the consistency evaluation has also become a further occupation of the market needs to cross the threshold By the end of 2019 data, Qilu, Zhengda Qing, Howson, Hengrui and other generic drugs "big households" are also domestic consistent evaluation through the number of high-class enterprises Since 2016, when the General Office of the State Council issued the Opinions on the Evaluation of The Quality and Efficacy of Generic Drugs, it has become an important task to improve the quality of generic drugs after more than 3 production enterprises through consistency evaluation and no longer choose varieties that have not passed the consistency evaluation in terms of centralized drug procurement With the continuous promotion of band procurement, it is necessary for generic drugs to enter the collection through consistency evaluation In the process of implementing the national collection and provincial-level volume procurement, various places have announced the corresponding drug suspension network notice, there are now Beijing, Shanghai, Jiangsu, Zhejiang, Guangdong, Shandong, Jiangxi, Hubei, Heilongjiang and other provinces and cities, began to implement the same name over-consistency evaluation of pharmaceutical enterprises up to 3, no longer purchase the policy of not over-consistent evaluation of varieties In May this year, the State Drug Administration issued a "announcement on the evaluation of the quality and efficacy of generic drugs for chemical injections", marking the official start of the evaluation of injection consistency, and the National Drug Review Center also issued the technical requirements for the evaluation of the quality and efficacy of generic drugs for chemical injections "Chemical injection generic drug quality and efficacy consistency evaluation reporting requirements" "Chemical injection (special injection) generic drug quality and efficacy consistency evaluation technical requirements" three documents, injection consistency evaluation may become the focus of the consistency evaluation work in the next period of time Industry analysts pointed out that with the continuous promotion of national drug collection and consistency evaluation, especially after the comprehensive evaluation of the consistency of chemical injections, the quality of the generic drug market is expected to improve significantly, not through the consistency evaluation of generic drugs, is bound to be eliminated first Original title: 3 first generic drugs approved in a week! China Biopharmaceutical half a year "grab" the next 5 counterfeit drugs, Howson, Dongsun followed closely behind.
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