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    Home > Medical News > Latest Medical News > [Yao Kejun] xinlitai's first biological product is on the market; 5 billion anti epileptic market welcomes the Challenger; Wang Zhengda Tianqing, the first imitator, makes another 2-pound product

    [Yao Kejun] xinlitai's first biological product is on the market; 5 billion anti epileptic market welcomes the Challenger; Wang Zhengda Tianqing, the first imitator, makes another 2-pound product

    • Last Update: 2019-10-21
    • Source: Internet
    • Author: User
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    Highlights: to fill the gap in orthopaedic field, xinlitai's first biological product was approved; Weicai PiRen panai entered the Bureau strongly, which will break the trend of the three pillars of anti epileptic drugs; hausen's first imitated product added a strong will; the first imitated product came, and many varieties were filed; the first imitated king, Zhengda Tianqing has another two drugs reported for production; clinical urgent need, Qilu pharmaceutical challenged Parkinson's drugs This week, 4 new developments of review and approval have been reported to the production drug for approval, and the drug registration approval document, 1 new drug, 1 imported drug and 2 generic drugs have been obtained The details are as follows: trypatide for injection As a kind of recombinant human parathyroid hormone analogue, trypatide for injection is a drug for the treatment of osteoporosis It is suitable for the treatment of osteoporosis in postmenopausal women with high risk of fracture It is the only drug that can regulate new bone synthesis to increase bone mass and improve bone structure, and it is recognized as one of the ideal drugs for the treatment of osteoporosis The original research enterprise is Lilly In 2002, the drug was first listed in the United States In 2003, it was approved by the European EMA In 2010, it was approved by the Japanese PMDA In 2011, it was approved to be sold in China The commodity names are Forteo ® and forsteo ® In 2017, the global sales of Lilly reached 11.77 billion yuan In 2018, the global sales were 10.02 billion yuan, down 14.89% year on year Source of figures: according to the national large-scale epidemiological survey of the global best selling drug database of Yaozhi, the total prevalence of osteoporosis in China is 12.4%, and the total number of people has exceeded 160 million It is estimated that by 2020, the number of osteoporosis and low bone mass patients in China will increase to 280 million With the aging of the population, the gradual improvement of the coverage of the medical insurance system and the improvement of the residents' ability to pay, it will bring a vast space for the growth of the osteoporosis drug market According to the data of pharmaceutical intelligence, at present, there are only two domestic trypatide companies, including Jinmeng biological company, a subsidiary of xinlitai, which was approved this week The other company is Shanghai United cell bioengineering Co., Ltd It remains to be seen whether the sales volume will be affected again if Lilly wins the competition again In addition, it is worth mentioning that tripatide is the first biological product approved to be listed by xinlitai 。 Pirampanide is a highly selective and noncompetitive AMPA receptor antagonist, an innovative antiepileptic drug It is used for the treatment of partial seizures (with or without secondary generalized seizures) in adults and children over 12 years old As one of the four main products of Weicai, piranpanel was listed in 2012 and has been approved to be listed in more than 60 countries It is estimated that there are 9 million epileptics in China Among them, about 30% of patients can not control epilepsy through existing drugs, and the demand for new drugs is very large In addition, according to the data of wind sample hospitals, the market of antiepileptic drugs in domestic sample hospitals in 2018 was 1.406 billion yuan, an increase of 8.33% year on year It is estimated that the market of anti epileptic drugs in public medical institutions and drugstores in 2018 will be close to 5 billion yuan In addition, about 60% of the domestic anti epileptic market is dominated by levetiracetam, valproate and oxcarbazepine Three drugs have formed a tripartite confrontation in China, and three drugs have been approved for marketing for many years in China This time, when the medicine of Weicai enters China, it is bound to break the tripartite confrontation, join the battle for market cake, and meet the diversified needs of epileptics Fosartan and meglumine for injection fosartan and meglumine for injection were used to prevent acute and delayed nausea and vomiting caused by chemotherapy It was developed by MSD, approved by FDA in January 2008, and approved by EMA in November of the same year It is reported that in 2018, the global sales of the original bismeglumine for injection product reached 522 million yuan However, the original manufacturer has not yet been listed in the domestic market Howson is its first imitator It is worth noting that bismeglumine is an urgent clinical drug in China In the first list of encouraged generic drugs just released by the national health and Health Commission, bismeglumine is on the list In addition, the variety was approved with the new registration of chemical medicine category 3.1, which is deemed to have passed the consistency evaluation (for more content related to the consistency evaluation, please refer to the "good medicine record" Zhengda Tianqing and hausen another heavyweight product review; the injection was "ignited" and 12 varieties have been reviewed) sodium acetate ringer injection Sodium acetate ringer injection is used to supplement body fluid, regulate electrolyte balance and correct acidosis The original research enterprise is Riyan Chemical Co., Ltd (acquired by Xinghe (Zhuzhou) in 2006), which was approved for listing in 1993 According to the domestic database of pharmaceutical intelligence drugs, there are 5 domestic enterprises of this variety, including Kelun pharmaceutical, Shijiazhuang No.4 pharmaceutical, and Baiyu, etc According to PDB database, the domestic sales volume of sodium acetate ringer injection in 2018 is about 194.35 million yuan This week, Zhejiang sharplove Pharmaceutical Co., Ltd approved the production of this variety, and its competitors added another one There are 25 new acceptance numbers (19 varieties) reported by CDE in this week, including 1 new drug, 1 imported drug and 17 generic drugs It is worth noting that the first generic drugs are piled up this week At present, no domestic generic drugs have been approved for listing, only the original research approved for import They are risajilan mesylate tablets of Qilu pharmaceutical, millabelon sustained release tablets of Huayi pharmaceutical, propofol tenofovir fumarate tablets and cigliptin phosphate tablets of dongyangyao, voltacetin hydrobromide tablets of Zhengda Tianqing and arepitan capsules This week's report focuses on the new production acceptance details of risajilan mesylate tablets of Qilu pharmaceutical, voltacetin hydrobromide tablets of Zhengda Tianqing and arepitan capsules Rasagilan mesylate tablet is the second generation of monoamine oxidase B inhibitor Developed jointly by lundbeck company of Denmark and Teva company of Israel to treat Parkinson's disease, the drug was approved by Israel and the European Union in 2005; approved by FDA in 2006, it is used for single drug treatment of early Parkinson's disease, and can be combined with levodopa to treat middle and late Parkinson's disease; approved for import in 2017, the drug has been listed in more than 50 countries and regions around the world It is the most prescribed new drug for Parkinson's disease in many countries According to the data published on the Internet, there are about 2.5 million patients with Parkinson's disease in China With the increasing aging, the number of patients will increase sharply, and the number of patients may account for more than half of the world It can be seen that the market of Parkinson's medicine has unlimited potential According to the database of pharmaceutical intelligent drugs and registration acceptance, at present, in addition to Qilu pharmaceutical, the domestic enterprises applying for the listing of the drug also include Huasen pharmaceutical, Changzhou No.4 pharmaceutical and Shanghai Sinopharm In 2016, all of them were withdrawn due to the self-examination and verification of drug clinical trial data After two years, Qilu pharmaceutical was accepted again Whether it won the first imitation at one stroke remains to be seen The new antidepressant of vothixetine hydrobromide is used in the treatment of adult depression The original research enterprise is Lingbei pharmaceutical, which was approved to be listed by FDA in 2013 and approved to be imported by China in 2017 At present, the drug has been listed in more than 70 countries and regions around the world According to the pharmaceutical intelligence data, at present, in addition to the original research enterprise's approval for import, only the generic drugs of Zhengda Tianqing and Yangzijiang pharmaceutical industry have been applied for listing However, Yangzijiang is still in the approval clinical stage If Zhengda Tianqing works together this time, it is expected to win the first generic qualification of fosixidine hydrobromide tablets It is reported that the market scale of antidepressants in China is the fifth in the world, accounting for about 5% of the global market From 2010 to 2016, the market scale of antidepressants in China increased by an average of 19% annually, reaching about 4.4 billion yuan in 2016 Although there are many antidepressants on the market, new drugs can bring innovative treatment to patients Aripitan capsule is the first highly selective NK-1 receptor antagonist in the world It is used to prevent the acute and delayed nausea and vomiting caused by chemotherapy or to prevent and control the nausea and vomiting caused by chemotherapy with steroids and 5-HT3 receptor antagonists The original research enterprise is Merck's Yimei, which was approved to be listed by FDA in 2003 and approved to be listed in China in 2014 According to IMS data, the global sales volume of aripitan capsule in 2017 is about US $275 million In addition, according to PDB data, the sales volume of sample hospitals in 22 cities of aripitan capsule in 2018 was about 75 million yuan At present, there are only original research and import products in China, but no domestic products According to the registration and acceptance data of smart drugs, at present, there are six enterprises in China that have reported production layout Except Zhengda Tianqing and Qilu pharmaceutical, other enterprises are in the approved clinical stage If Zhengda Tianqing goes on the market successfully, the first imitated product will be added to consolidate its title of "king of first imitated product" Data source: drug intelligence data, enterprise announcement and other network public data information sources: drug intelligence network, enterprise announcement and other network public information With high integration, in-depth analysis and intelligent intelligence of pharmaceutical intelligence data, the intelligent tool platform for pharmaceutical data has been specially built for VIP enterprise customers, covering core data such as drug registration, hospital sales, drug reports, enterprise reports, clinical trials, drug listing, drug bid winning, device listing, drug sales, etc., and providing all-round access to enterprise users from production, research and development, sales, and use And other information channels in various links to help enterprises in R & D and decision-making Welcome to click "https://vip.yaozh.com/introduction" to enter the pharmaceutical intelligence data Enterprise Edition ~ statement: this point of view only represents the author, not the pharmaceutical intelligence network position, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.
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