With an annual growth of more than 1 billion yuan and potential of first-line epilepsy drugs, the first imitation will be launched soon!

On March 21, Sihuan pharmaceutical announced that the application for the production approval of its epilepsy drug "escalicarpine acetate tablets" has been accepted by the State Food and Drug Administration with the acceptance number of cyhs1900082 At present, the drug has not been approved for listing in domestic enterprises If the chemical drugs of Category 3 declared by Sihuan Pharmaceutical (the drugs that are imitated from overseas but not listed in China) can be successfully listed, it will become the first one in China On the same day, the drug audit center plans to give priority to the evaluation of varieties in the column of publicity, adding 5 records, including siliquacept acetate tablets of Sihuan medicine After entering the priority review, the review speed of the drug will be further accelerated, and the drug will be on the market soon Escalicarbine acetate, with an annual growth of more than 1 billion, is a relatively new antiepileptic drug It can inhibit the repeated abnormal discharge of brain neurons and control epileptic seizures by blocking the conduction of action potential The drug was jointly developed by bial Portela, Eisai and dainipponsumitomo It was first approved for marketing in Europe in 2009, and then approved by the US FDA for adjuvant treatment of focal epilepsy in 2013 In 2015, it was extended to a single drug treatment of focal epilepsy According to the data of pharmaceutical intelligence, it is sold by Weicai company in Germany and Austria, with the commodity name of zebinix, and sunnovionpharms company in the United States, with the commodity name of aptiom From the perspective of the overall market performance in 2014-2017, the sales volume of escalicarpine acetate has a breakthrough growth: from 220 million yuan in 2016 to 1.3 billion yuan in 2017, with an increase of more than 1 billion yuan (details are as follows) At present, in addition to the acceptance number of one class 3 chemical drug report of Sihuan Pharmaceutical Co., Ltd., there are also 17 class 3.1 chemical drug report clinical acceptance numbers (including 7 API acceptance numbers) in China In terms of time, since 2012, there have been enterprises applying for clinical acceptance, and by 2015, the application has reached its peak, with a total of 8 acceptance numbers After 2015, there have been no acceptance records for three years (2016-2018) (see the figure below for details) This time, four ring pharmaceutical's esmicarpine acetate tablet broke the deadlock, and its listing application was accepted, and it was included in the priority review, ranking first among all enterprises The clinical acceptance numbers of 17 individual reports were approved in 2015-2016, including 8 Application Enterprises: Shanghai Pharmaceutical Group Co., Ltd., Xi'an Xintong Pharmaceutical Research Co., Ltd., Tianjin hankang Pharmaceutical Biotechnology Co., Ltd., Hefei Tuorui Biotechnology Co., Ltd., Anhui Xinxing Pharmaceutical Development Co., Ltd., etc Epilepsy is expected to become one of the three major diseases of the human central nervous system According to the World Health Organization (who) report, the global active epilepsy patients account for about 8.2% of the world's total population, with a total of more than 50 million people At present, there are about 9 million epileptics in China, accounting for about one fifth of the global epileptic patients, and the number of new epileptic patients each year reaches more than 400000 According to IMS data statistics, China's anti epileptic drug market reached 2.4 billion yuan in 2017, an increase of 20.37% over the previous year At present, the top five antiepileptic drugs in China are valproate, levetiracetam, oxcarbazepine, lamotrigine and topiramate Some of the drugs have been on the market for a long time Escalicarbazepine acetate mainly plays an antiepileptic role by blocking voltage-gated sodium channels It is well tolerated for long-term patients with higher efficacy and safety In addition to its breakthrough market performance in the past two years, this drug is expected to become the first-line clinical drug in China in the future Data source: drug intelligence data content source: drug Audit Center, drug intelligence network, Sihuan pharmaceutical announcement