Another big wave of varieties apply for protection of traditional Chinese medicine! Tianshili, Kangyuan, Zhengda Tianqing and Cr double review crane are listed

On May 16, the National Committee for the protection and review of traditional Chinese medicine varieties issued several lists of traditional Chinese medicine protection data receiving varieties and supplementary information 　　 According to the variety receiving list published on the official website from February 2018 to may 2018, the varieties such as Yangxue Qingnao pill of Tianshili Pharmaceutical Group Co., Ltd applied for extending the protection period; Guibai Huayu capsule of Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd., Longxue Tongluo capsule and Cistanche total glycoside capsule of Jiangsu Kangyuan Pharmaceutical Co., Ltd and sinorun Shuanghe Pharmaceutical Co., Ltd Compound duzhongjiangu granules and other varieties applied for initial protection (click on the picture to enlarge) the reporter noted that on May 15, the official website also released a notice on the application of the 69th batch of national protected varieties of traditional Chinese medicine to extend the protection period According to the notice, the 69th batch of national traditional Chinese medicine protection varieties (the end date of the initial protection period is March 19, 2019) involve Shengxuening tablet, etc The deadline for accepting the application for extension of the protection period of these national traditional Chinese medicine varieties is September 19, 2018 According to the regulations on the protection of traditional Chinese medicine varieties and the guiding principles for the protection of traditional Chinese medicine varieties, the production enterprises applying for the extension of the protection period shall, six months before the expiration of the protection period of the varieties, submit an application to the former Center for administrative matters acceptance service and complaint reporting of the State Food and Drug Administration (temporarily) and submit complete information As an administrative protection, the original intention is to improve the quality of traditional Chinese medicine varieties, rectify the competition order of traditional Chinese medicine market, effectively allocate traditional Chinese medicine resources, and protect the legitimate rights and interests of traditional Chinese medicine enterprises The protected varieties of traditional Chinese medicine will be awarded the certificate of variety protection of traditional Chinese medicine, and the relevant enterprises will also be granted a certain period of variety production right by the drug supervision and administration department, which effectively solves the problems of over imitation of traditional Chinese medicine varieties, disordered market competition, and uneven quality of traditional Chinese medicine varieties In fact, the protection system of traditional Chinese medicine varieties has also accelerated the structural adjustment of traditional Chinese medicine products, and cultivated a large number of large varieties of traditional Chinese medicine, such as compound Danshen dropping pill, Yunnan Baiyao, 999 Ganmaoling granules, Liushen pills, Yangxue Qingnao Granules, etc., including hundreds of millions of yuan level varieties From a positive point of view, the continuous reduction of the number of protected varieties of traditional Chinese medicine and the improvement of the technical threshold for application for protection will increase the gold content of the protected varieties of traditional Chinese medicine, so as to win a greater market advantage in the new round of market competition According to the 2017 annual report of food and drug supervision statistics, as of the end of November 2017, there were 237 certificates of protected varieties of traditional Chinese medicine, including 110 first declared varieties, 12 same varieties and 115 extended protection periods With the strict review and approval, the number of TCM protected varieties accepted and approved has a downward trend At present, China has approved about 265 applications for protected varieties of traditional Chinese medicine, involving 226 varieties from 195 manufacturers, according to the previous review of pharmaceutical economic news Among them, there are 192 exclusive varieties Qingre Qushi granules applied for the most protection, with 5 manufacturers applying; Xinyi Biyan pills followed, with 4 manufacturers applying Among the manufacturers applying for the protection of traditional Chinese medicine, Tianshili Pharmaceutical Group obtained the most varieties, including 7 varieties, followed by Tianjin Zhongxin Pharmaceutical Co., Ltd and Henan Lingrui Pharmaceutical Co., Ltd., and Yunnan Baiyao Pharmaceutical Co., Ltd., Chongqing hilan Pharmaceutical Co., Ltd and Tibet nordikang Pharmaceutical Co., Ltd What are the market benefits of these products that are protected by traditional Chinese medicine? According to the statistics of traditional Chinese medicine protected varieties database and related announcements, and minenet database, there were 28 traditional Chinese medicine protected varieties with sales exceeding 500 million yuan in 2016, including 11 products with sales exceeding 1 billion yuan Among them, Xuesaitong (freeze-dried) for injection ranked first, with sales of more than 5.7 billion yuan in 2016 The manufacturers of Xuesaitong for injection (freeze-drying) include Zhenbaodao pharmaceutical and kunyao group The main sales market of the product is in the terminal of public medical institutions in China In terms of market share, Zhenbaodao pharmaceutical accounts for 59% and kunyao group 41% In 2016, there were 17 products with a sales growth rate of more than 10% and only 4 products with a negative growth rate of more than 500 million yuan The strength and potential of traditional Chinese medicine protection products in the market cannot be underestimated In some places, the weight of traditional Chinese medicine protection as an indicator of drug quality is not low Taking Shandong's 16-year standard as an example, the drug bidding group shows that the first level of traditional Chinese medicine protected varieties and patented drugs, national class 1 new drugs, national secret prescriptions, patented drugs that have expired the protection period, drugs that have won the second prize of national science and Technology Award and above, generic drugs that have passed the quality consistency evaluation, drugs that have won the major science and technology projects of national major new drug creation, and drugs that have won the United States, the European Union The first bidding group includes drugs certified by Australian and Japanese preparations, drugs purchased by Hong Kong Hospital Authority, and drugs first copied with patent; the second bidding group includes products of Protected Traditional Chinese medicine and products with "national key new products" certificate However, it is worth mentioning that in the 2017 version of the national health insurance catalog, the limited use scope of multiple traditional Chinese medicine injections has been increased In addition, Shanghai, Ningxia, Anhui, Xinjiang and other places have issued the notice on strengthening the monitoring of key drugs, which shows that some of the protected varieties of traditional Chinese medicine, especially some injection varieties, have been included in the monitoring list Some insiders said that this restriction is expected to affect future sales to a certain extent Relevant pharmaceutical companies have also increased research and re evaluation efforts For example, treasure island pharmaceutical said that the safety re evaluation of Xuesaitong for injection (freeze-dried) is in normal progress During the interview, Gu Wei, senior manager of strategic planning of treasure island pharmaceutical industry, told reporters, "the homogenization of traditional Chinese medicine is not serious, almost every product has a unique formula, which requires enterprises to do selling point mining and clinical evidence extraction In the field of traditional Chinese medicine, speaking with data has become a breakthrough point "