Hepatitis B drugs on the market and under research in China

Market outlook: according to the World Health Organization's global hepatitis report 2017 released in April this year, the number of people infected with hepatitis B or C globally has exceeded 325 million, and about 1.34 million people are killed each year In China, the number of chronic hepatitis B virus carriers has reached about 120 million There are 30 million chronic hepatitis B patients, only 2 million people have been treated, less than 1 / 10 of the total With the advent of hepatitis B vaccine, although the number of hepatitis B patients in China is decreasing, hepatitis B is still the first of the four major infectious diseases in China Relevant data shows that the market scale and drug demand of hepatitis B in China are huge in 2017, and will continue to maintain a high growth trend in the future According to the data of global data, China will still be the largest market of hepatitis B in the next decade It is estimated that by 2020, the market scale of hepatitis B drugs in China will reach 20 billion yuan and 30 billion yuan in the long term According to the 2015 version of the guidelines for the prevention and treatment of chronic hepatitis B, hepatitis B treatment drugs are mainly divided into two categories: interferon and nucleoside Because of the side effects of interferon, the current clinical use is more oral nucleoside drugs In China, nucleoside hepatitis B drugs account for about 80% of the market of hepatitis B drugs, and gradually become the mainstream drugs for the treatment of hepatitis B The commonly used nucleoside drugs are lamivudine, adefovir dipivoxil, entecavir, tenofovir dipivoxil, telbivudine, etc At present, tenofovir Dipivoxil and entecavir, the first-line drugs recommended as the guideline of hepatitis B prevention and treatment, will have great market potential At the same time, adefovir Dipivoxil and lamivudine will continue to maintain a certain market share Products on sale: Runzhong ® entecavir dispersible tablets, Mingzheng ® adefovir dipivoxil capsules, Tianding ® entecavir maleate tablets and Qingzhong ® tenofovir fumarate dipivoxil tablets   With its excellent bioequivalence test and phase III clinical trial of head-to-head control with the original research drug, the domestic generic drug Qingzhong ® has been put on the market, which ensures that its efficacy and safety are consistent with the original research drug, and at the same time, it is likely to reduce the price of the drug, thus greatly improving the accessibility of the drug, enabling more Chinese patients with chronic hepatitis B to benefit from it, and providing for clinicians More treatment options are available Product under development: TLR7 agonist is commissioned by Wuxi apptec Its main function is antiviral, such as hepatitis B and HIV Its molecular structure is similar to gs-9620 of Gilead, which may be me better Zhengda Tianqing and Johnson & Johnson pharmaceutical recently signed an exclusive license agreement to license the international development right of a potential anti HBV preclinical drug outside mainland China to Johnson & Johnson Johnson & Johnson will carry out the global development, production, registration and commercial promotion of the product outside China Under the agreement, Johnson & Johnson will pay Zhengda Tianqing a down payment of US $253 million (about RMB 1.6 billion) and mileage fee, as well as a post IPO sales commission Products on sale in Fujian guangshengtang: agandine (adefovir dipivoxil tablets), agandine (lamivudine tablets), ngandine (entecavir capsules) and fugandine (tenofovir dipivoxil fumarate capsules) The sales revenue in 2016 shows that agadine, he Ganding and en Ganding are the main revenue sources of guangshengtang The sales revenue is 31251500 yuan, accounting for 99.9% of the company's operating revenue At the same time, the company has upgraded the production process of adefovir Dipivoxil and entecavir, improved the quality and production capacity Up to now, the company's fuganding products have been put on record in 14 provinces / cities Among the hospitals with annual sales of over 4 million via oral antiviral (OVA), 76% of the company's promoters have paid the deposit and committed to the development and direct sales that have initially reached the development intention It is expected that fuganding's large-scale contribution to the performance will be reflected in 2018 and become the company's new main sales product Products under research: guangshengtang and yaomingkant have signed four innovative drug development contracts in the field of hepatitis B, fatty liver and liver cancer in 2016 The above cooperation project established and developed the gst-hg131 project (the total cost of which is 32 million yuan, and guangshengtang bears 24 million yuan) and the gst-hg141 project, and the research and development of the new drug gst-hg161 for liver cancer (the research and development cost of which is 34 million yuan, and guangshengtang bears 25.5 million yuan) based on the exclusive road map of curing hepatitis B proposed by guangshengtang Products on sale in Jiangxi Qingfeng Pharmaceutical Co., Ltd.: entecavir capsules, entecavir dispersible tablets, Anhui Baker drugs on sale: Yinding ® lamivudine tablets, beishuangding ® entecavir dispersible tablets, Zhengwen ® tenofovir fumarate dipivoxil tablets Bristol Myers Squibb on August 16, 2017, Bristol Myers Squibb announced that based on the clinical trial data of children's indications completed abroad and the long-term clinical observation data of adults' indications conducted in China, it would take orally the Antihepatitis B drug borudine (entecavir tablets) Recently, it was approved by CFDA for the treatment of chronic hepatitis B virus infection compensatory liver disease patients aged 2 to 18 years old This is the first nucleoside drug approved for use in children (< 12 years old) with hepatitis B in China In 2005, borudine ® (entecavir tablets) was approved in China for the treatment of adult chronic hepatitis B patients with active viral replication, continuous elevation of ALT or active liver histology GlaxoSmithKline's drugs on sale in China: GlaxoSmithKline (adefovir dipivoxil tablets), hepatine (lamivudine tablets), GlaxoSmithKline (GSK) and Gilead (Gilead) have reached an agreement to exclusively sell the sales agent of Viread ® (tenofovir dipivoxil fumarate tablets) for the treatment of adult hepatitis B in China, Hong Kong, Taiwan, South Korea and Singapore Drugs under study: antisense oligonucleotide drugs 3228836 and 3389404 of HBsAg in phase I clinical stage Novartis is on sale in China: tibiflodine tablet (Sullivan) Gilead is on sale in China: tenofovir fumarate dipivoxil tablet domestic clinical drug: fospropotenofovir tablet Gilead has developed the upgraded version of tenofovir in recent years The dosage of the upgraded version is only one tenth of that of tenofovir (TDF), so it has the same therapeutic effect The corresponding nephrotoxicity is one tenth of that of tenofovir, and the molecular structure is only a small modification of the precursor part of TDF Foreign clinical drugs: gs-9688 tlr-8 agonist is in phase I clinical research Note to the global pattern: click the picture to view the sales situation in a clear and large picture The data shows that in 2016, only the shares of entecavir and tenofovir dipivoxil in antiviral drugs for hepatitis B increased, while the shares of other varieties decreased in varying degrees The market share of entecavir is 58.3%, which is 6.5% higher than that of 2015 According to the data of domestic sample hospitals, in 2016, the total sales volume of entecavir, telbivudine, adefovir dipivoxil, lamivudine and tenofovir sample hospitals was 2.53 billion yuan Among them, entecavir's sales volume was 1.71 billion yuan, accounting for 63.4%; telbivudine's sales volume was 280 million yuan, accounting for 11.1%; adefovir's sales volume was 250 million yuan, accounting for 9.7%; Lamivudine's sales volume was 180 million yuan, accounting for 7.2%; tenofovir's sales volume was 110 million yuan, accounting for 1.5% In 2016, there were nearly 40 enterprises involved in the sales of nucleoside antiviral drugs in the sample hospital market, among which the top five enterprises accounted for 88.0% of the overall market with a total sales volume of 2.23 billion yuan The top five enterprises are: the sales of Squibb products in Shanghai, China and the United States is 830 million yuan, accounting for 32.9%; the sales of products in Zhengda Tianqing is 710 million yuan, accounting for 28.0%; the sales of products in GlaxoSmithKline is 310 million yuan, accounting for 12.5%; the sales of products in Beijing Novartis is 280 million yuan, accounting for 11.1%; the sales of products in Fujian guangshengtang is 87.63 million yuan, accounting for 3.5% Note: click the picture to see the clear big picture In 2016, the top five enterprises in entecavir's market sales were: Shanghai Squibb, Zhengda Tianqing pharmaceutical, Suzhou Dongrui pharmaceutical, Fujian guangshengtang pharmaceutical and Jiangxi Qingfeng pharmaceutical, with sales of 830 million yuan, 640 million yuan, 50.86 million yuan, 70.28 million yuan and 57.27 million yuan, respectively CFDA approval note: click the picture to see a clear big picture of medical insurance note: click the picture to see a clear big picture In short, the development of new products in the field of hepatitis B drugs is relatively slow In the next five years, it will still be two series of drugs of entecavir and tenofovir for market PK It is hoped that therapeutic hepatitis B drugs will be launched as soon as possible for the benefit of patients.