First knowledge: Zhengda Tianqing and his pillar variety "entecavir"

As a first-line anti hepatitis B drug, entecavir is familiar to us, but if it is really concerned by the industry, it is 90% price reduction from "4 + 7"! Such a collapse of the price reduction has made people doubt whether the manufacturers are making money at a loss, and more doubt whether they can hold on to it.. But not long ago, the interim report of China Bio pharmaceutical disclosed the sales revenue of entecavir, the pillar product that brings tens of billions of sales revenue to the company, seems to further release its energy Entecavir - brief introduction: the original research company is BMS, which was approved by FDA to be listed in 2005, with the trade name of "boluting" Entecavir, a guanine nucleoside analogue, can be phosphorylated into triphosphate, which can inhibit the reverse transcriptase (RT) of hepatitis B virus (HBV) The drug is suitable for the treatment of chronic hepatitis B virus infection in adults and children over 2 years old with active virus replication, continuous elevation of serum transaminase ALT (ALT or AST) or liver histology showing active lesions Entecavir domestic registration statistics Since entecavir was approved for import in 2005, more than 100 pharmaceutical companies in China have registered and applied for the product Among them, Jiangsu Zhengda Tianqing Pharmaceutical (first imitation), Hainan Zhonghe Pharmaceutical Co., Ltd., Fujian guangshengtang Pharmaceutical Co., Ltd., Jiangxi Qingfeng Pharmaceutical Co., Ltd., Suzhou Dongrui Pharmaceutical Co., Ltd., Shanghai Qingsong Pharmaceutical Co., Ltd., Sichuan hisico Pharmaceutical Co., Ltd., Shandong Lukang Pharmaceutical Co., Ltd., Zhejiang Huasheng biopharmaceutical Co., Ltd., Chang Zhishi Sanbao Biochemical Pharmaceutical Co., Ltd., Anhui Baker biopharmaceutical Co., Ltd., Hunan Xihe Pharmaceutical Co., Ltd., Beijing Xiehe Pharmaceutical Co., Ltd., Beijing Baiao Pharmaceutical Co., Ltd., and xinlitai Pharmaceutical Co., Ltd., etc.; further from the date of undertaking, the variety has entered the ranks of popular application varieties since 2007 Global / national sales of entecavir: since 2005, after the launch of Baraclude, the former research group of Bristol Myers Squibb, the global sales have been on the rise as a whole; from 2011 to 2017, the sales have exceeded US $1 billion for seven consecutive years, with the approval of generic drugs, the global sales of this product of the former research group have declined since 2013; see the figure below for details In the domestic market, according to the statistics of pharmacy intelligence data hospital sales database, there are mainly four dosage forms of entecavir tablets, entecavir dispersible tablets, entecavir capsules and entecavir maleate tablets There are six manufacturing enterprises, namely, the former Sino US Shanghai Shiguibao, Zhengda Tianqing Pharmaceutical Group, Suzhou Dongrui pharmaceutical, Jiangxi Qingfeng pharmaceutical, Fujian guangshengtang pharmaceutical and Beijing ZHONGXIN PHARMACEUTICAL Among them, the domestic pharmaceutical enterprises account for the most, which is Zhengda Tianqing, far more than the sum of other companies Profits brought by entecavir to Zhengda Tianqing in 2010, "Zhengda Tianqing" officially launched entecavir's first domestic imitated product, entecavir dispersive film (trade name: Runzhong), which quickly occupied part of the market and broke the monopoly of multinational enterprises After the product goes on the market, the sales volume grows rapidly, which is an important pillar of the company's profit In this process, we launched a fierce patent lawsuit with BMS, the original research company, and won the final victory In the past four years of 2015-2018, Runzhong (entecavir dispersible tablets) has brought huge profits to Zhengda Tianqing with an annual sales revenue of more than 3 billion yuan According to the annual reports over the years, in 2015, Runzhong (entecavir dispersible tablets) achieved sales revenue of 3.121 billion yuan; in 2016, sales revenue of 3.534 billion yuan; in 2017, sales revenue of 3.169 billion yuan; in 2018, sales revenue of 3.258 billion yuan Meanwhile, Runzhong passed the consistency evaluation in 2018 In November 2018, the pilot work of centralized drug purchase and use was officially launched under the environment of entecavir ~ "4 + 7" The public medical institutions in four municipalities directly under the central government and seven sub provincial cities were taken as the main body of centralized procurement to gather demand and strength, improve negotiation and bargaining ability, so as to achieve a significant "dive" in drug prices As soon as the policy was issued, the pharmaceutical industry was greatly impacted, and the final negotiation result was even more eye-catching! Among them, entecavir reduced the price by 90% for 0.5mg drugs, and the price of each tablet dropped from 10.55 yuan to only 0.62 yuan, which made the industry doubt whether Zhengda Tianqing had made a loss business.. In the first half of 2019, Zhengda Tianqing Runzhong's sales revenue On March 18, 2019, Zhongshan Hospital Affiliated to Xiamen University issued the first prescription of the national "4 + 7" urban centralized drug collection, namely entecavir, with a new price of 17.36 yuan / box (28 tablets / box) Recently, China biopharmaceutical released H1 financial data in 2019 Entecavir dispersible tablets achieved sales revenue of 1.599 billion yuan, an increase of - 7.83% year on year Table 1: summary of partial data of China biopharmaceutical 2019h1 In summary, after experiencing the pressure of "4 + 7", sales revenue of entecavir of Zhengda Tianqing decreased by 7.83% year-on-year, but in general, it stood the test As a pillar variety of the company, it once occupied the market with the first imitation qualification, and defeated the original research through invalid patent Now it can resist the pressure of "4 + 7" Entecavir has fully completed its mission, and Zhengda Tianqing has also been able to invest more funds in new drug development At present, China's drug market has become more and more standardized, and the positioning and pricing of drugs have become more and more transparent There are fewer and fewer opportunities to eat a variety of drugs If you want to grow into a domestic echelon of drug companies, it is absolutely necessary for you to have a hard variety, otherwise, you will never be able to withstand the tests of domestic policies! Gongmian ~ cheer up ~ statement: this point of view only represents the author, not the position of yaozhi.com, 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.