Can levetiracetam take the lead in the 4 billion antiepileptic terminal market and pass the consistency evaluation?

Wonderful content: previously, due to the lack of consistency evaluation mechanism, some generic drugs in China have been far behind the original drugs for a long time Especially for the elderly, the decrease of drug release level and weak absorption function lead to the difference of the efficacy between the original research drug and the generic drug Therefore, carrying out the consistency evaluation of the generic drug will effectively promote the effectiveness of the generic drug to ensure the consistency with the original research drug, ensure the safety of drug use, and improve the overall level of the pharmaceutical industry in China Recently, 13 varieties of about 9 pharmaceutical enterprises in the first six provinces involved in the on-site inspection of CFDI of the State Food and drug administration are currently in the state of application and approval The antiepileptic drug levetiracetam of Jingxin Pharmaceutical Co., Ltd in Zhejiang Province is one of them So, what's the status of the drug market in levetiracetam? Today, let's take a look at none = "shifumousedownstyle ('shifu bus_002 ')" style = "margin: 1em Auto; padding: 0px; max width: 100%; color: rgb (62, 62, 62); font family:" hiragino sans GB "," Microsoft YaHei ", Arial, sans serif; font size: 16px; line height: 25.6px; width: 1 Border style: none solid; text align: Center; border bottom width: 1px; border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> ancient epilepsy puzzles social epilepsy (EPD) is one of the three major diseases of human central nervous system It is also one of the ancient and typical diseases in human history The difference of the initial location and transmission of abnormal discharge in the central nervous system of EPD patients leads to the complex and diversified seizure, showing abnormal paroxysmal movement, non autonomic nerve, consciousness and mental disorders The controlled rate of drug treatment for epilepsy is 70% After long-term drug treatment, more than half of the patients can recover and live a normal life According to the report of the World Health Organization, the global active epilepsy patients account for about 8.2 ‰ of human beings, and the total number of EPD patients in the world is about 50 million Under the influence of population growth, genetic factors and environmental factors, up to 2 million new epileptic patients are added every year The incidence rate of epilepsy is slightly lower in China, with a total prevalence rate of about 7 per thousand Under the huge population base, there are nearly 10 million epileptic patients who need reasonable treatment, of which more than 6 million are patients with seizure history And every year, the number of new epileptics still reaches more than 400000 It is still an eternal task to strengthen the management of antiepileptic diseases Entrusted by the national health and Family Planning Commission, China Anti Epilepsy Association revised and issued the 2015 edition of China Anti epilepsy diagnosis and treatment guide, which is a guiding basis for the diagnosis and treatment of epilepsy in neurology, neurosurgery, pediatrics and psychiatry In February 2017, the Hong Kong Epilepsy Society updated the guidelines for the use of antiepileptic drugs It provides guidance for the use of levetiracetam, oxcarbazepine, laconamide and pregabalin, and emphasizes the important role of new AEDs in clinical practice
none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; Border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> 13 anti epileptic (EPD) drugs are included in 2017 national medical insurance drug catalog of anti epileptic data of key cities in China It includes traditional AEDs drugs, and 5 new AEDs drugs, such as levetiracetam (Lev), OXC, gabapentin (GBP), lamotrigine (LTG), topiramate (TPM), are also included According to data from minenet, the market of antiepileptic drugs in public medical institutions in China reached 3.522 billion yuan in 2016, an increase of 16.82% over the previous year According to the statistical data released in the first half of 2017, it is predicted that the market scale of antiepileptic drug terminals in public medical institutions will exceed 4 billion in the whole year Levetiracetam is the pillar variety in this field, accounting for nearly 30% of the shares in public hospitals in key cities
none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; Border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> levetiracetam leads the EPD market It is well known that the domestic epilepsy (EPD) market has long-term use of traditional drugs, and there is a certain gap with foreign countries Although imported drugs have entered the domestic market, the high price limits the long-term use of drugs by some people With the expiration of the original research patent, the listing of domestic generic drugs has changed the management and market pattern of epilepsy treatment, as has the category of levetiracetam According to the data on CFDA official website, Keppra (Kaplan) is the tablet of UCB Pharma S.A, the oral solution produced by nextpharma SAS in France, and the injection concentrated solution produced by patheon Italia in Italy approved on July 25, 2017 So far, only four tablet products have been approved in China, namely xintong'an of Shenzhen xinlitai Pharmaceutical Co., Ltd., jiyike of Zhejiang Jingxin Pharmaceutical Co., Ltd., shenghuaxi Pharmaceutical Co., Ltd of Chongqing and zuoetiracetam of Zhuhai United Pharmaceutical Co., Ltd In addition, the research and development of levetiracetam granules and injection are in the process of application According to the data of minenet, in 2016, the drug market of public hospitals in key cities exceeded 200 million, an increase of 16.63% year on year Professional companies predict that the scale will reach 250 million yuan in 2017 In the first half of 2017, 99.38% of the original tablets and kaipram oral liquid, 0.44% of Zhejiang Jingxin Pharmaceutical Co., Ltd., and 0.18% of Chongqing Shenghua Xi pharmaceutical Co., Ltd were zuoetiracetam tablets At present, the main dosage forms of levetiracetam are tablets and oral liquid In 2016, the proportion of levetiracetam tablets and oral solutions in public hospitals in key cities was 92.8% and 7.2% respectively According to the 2017 national medical insurance drug catalogue, the oral solution is only used for children with epilepsy, and the market of patheon Italia will be reshuffled next year by injecting the concentrated solution of levetiracetam
none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; Border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> consistency evaluation to promote the development of levetiracetam is the only antiepileptic drug with the ability to prevent epilepsy, which has the potential of large varieties and has a broad market prospect in China Hainan Puli Pharmaceutical Co., Ltd., Beijing Dezhong Wanquan Pharmaceutical Technology Co., Ltd., Jilin Boda Pharmaceutical Co., Ltd., Kaifeng Pharmaceutical Co., Ltd., Beijing Sihuan Pharmaceutical Co., Ltd., Shenzhen xinlitai Pharmaceutical Co., Ltd and many other enterprises have focused on this product According to Dongfang securities, Jingxin pharmaceutical is one of the fastest growing enterprises in China in terms of consistency evaluation of quality and efficacy of generic drugs The reason is very simple Levetiracetam is the first-line antiepileptic drug, and there are more than 20 CFDA registered for approval It has been widely recognized as the "gold standard" for the treatment of epilepsy in the world In recent two years, the sales of zuelacetan tablets in Beijing new pharmaceutical industry has made great strides In 2016, the sales of zuelacetan tablets in domestic public medical institutions increased by 531% compared with the previous year From the data of the first half of 2017, the sales of zuelacetan tablets in 2017 will increase by 188.89% compared with the previous year Passing the domestic consistency evaluation is equivalent to obtaining the golden signboard Levetiracetam has great potential Once it passes the evaluation, the competitiveness of related companies in the field of psychotropic drugs will be further enhanced From the current market competition pattern of levetiracetam, the market share of the original research drug Kaplan is relatively large, accounting for more than 90% of China's public medical institutions, and Beijing new pharmaceutical industry ranks second If its levetiracetam can successfully pass the consistency evaluation, its position cannot be shaken With the development, there is a huge market space to replace the imported products in the future In addition, with the gradual growth of levetiracetam, it is expected to further increase the competitiveness of Jingxin in the fields of sertraline, bupropion and other neuropsychiatric drugs, and become a new growth point of its performance