Analysis on the market of hepatobiliary drugs in China in 2014

According to the pattern data of various categories of medicine, the national sales of anti-tumor and immunomodulators, systemic anti infective drugs, digestive system and Metabolic Drugs rank in the top three As the three giants of domestic drug sales over the years, due to the influence of national anti drug restriction and other policies, the ranking of the giants has changed quietly The market share of anti infective drugs, once the leading leader, has been changed The rapid decline finally replaced by anti-tumor drugs in 2013, and the second position was gradually approached by digestive drugs, which has a great potential to surpass Thus, the domestic drug market trend gradually keeps consistent with the international market, and gradually gets rid of the wayward track Figure 1 the proportion of the top three drug categories in China's chemical drug market as a fast-growing digestive system drug market, which sub categories are the driving force for its growth? The data shows that the drugs for hepatobiliary diseases and diabetes mellitus Drugs and antacids have always been the major users of digestive system drugs The sum of the three sub categories has contributed more than 60% of the shares The agitation of the three categories of drug market can directly affect the ranking of chemical drug sales, so it needs to be focused on In view of the continuous popularity of hepatitis C drugs in the international market, it is necessary to review the current situation and possible growth trend of the market of hepatobiliary drugs in China Epidemiology shows that in the past decade, the chronic prevalence of digestive system diseases in China has remained at about 25 percent, among which acute gastritis, cirrhosis and gallbladder diseases are the diseases with high prevalence According to the 2013 China Health Statistics Yearbook, the mortality rate of major urban diseases and the mortality rate of digestive system ranked seventh in 2013, among which the highest mortality rate was liver disease, with a mortality rate of 676 / 100000 In terms of disease types, liver diseases include liver cirrhosis, liver tumor, drug-induced liver disease, alcoholic and non-alcoholic fatty liver disease, autoimmune liver disease, etc; In each stage of liver damage, the injury, distortion and extrusion of intrahepatic bile duct and capillaries can cause bile excretion disorder, and then the pathological characteristics of cholestasis can appear, such as non autoimmune hepatitis, chronic viral hepatitis and drug hepatitis At present, hepatitis, cirrhosis, cholestasis and liver cancer are the most common diseases in liver diseases From the perspective of drug therapy, nucleoside analogues and interferon are the mainstream products in the market, and these products also bring comfort to the huge patient population in China As a high incidence of hepatobiliary disease in the domestic market, which drugs have become the sales model of the market is worth looking forward to The bile acid derivative - No1 - ursodeoxycholic acid ursodeoxycholic acid is an endogenous bile acid of human body It was first registered and sold in Japan in 1957 by Japanese taganabe pharmaceutical, and then popularized in Europe, America and other countries It is used for the treatment of cholestatic liver disease caused by drug-induced liver injury, prevention of rejection of liver transplantation dosage form and treatment of cholesterol gallstone and other diseases Its main therapeutic mechanism is to promote bile secretion, protect hepatobiliary cells, antagonize the toxicity of bile acids and dissolve gallstones As a rare first-line therapeutic drug for primary biliary cirrhosis, ursodeoxycholic acid has little side effect and can be taken by patients for a long time This product has been the top selling product in the choleretic drug market for more than ten years since it entered China Its sales performance in 2013 has soared by 64% compared with that in 2012, which has attracted the attention of the industry With the hot liver disease drug market, the future growth momentum of ursodeoxycholic acid is bullish Guanine nucleosides - No1 - entekavir is a cyclopentyl guanine nucleoside analogue This product is easily phosphorylated into the active metabolite entekavir triphosphate by cytokinase in cells, the latter is a competitive inhibitor of HBV DNA polymerase / reverse transcriptase normal substrate dGTP and a DNA chain terminator It is mainly used in the treatment of chronic adult hepatitis B with active viral replication, continuous elevation of serum transaminase ALT or active pathological changes in liver histology Entecavir is a new molecular entity approved by the FDA by Squibb in 2005 The approved dosage forms include tablets and solutions In August 2014, Tyva took the lead in obtaining the approval of generic drugs Entecavir was brought into the domestic market by Shanghai Squibb in 2005 Although it has been produced by dozens of enterprises, the market share of Squibb and Zhengda Tianqing accounts for nearly 90% Adenine nucleosides - No1 - adefovir - adefovir is the prodrug of adefovir, adenine phosphate compound, which is converted into adefovir in vivo after oral administration to play an antiviral role Adefovir is a nucleotide analogue of adenosine monophosphate, which is phosphorylated into active adefovir diphosphate through the action of cell kinase in vivo The mechanism of adefovir diphosphate inhibiting HBV DNA polymerase or reverse transcriptase includes: (1) competition for deoxyadenosine triphosphate substrate; (2) termination of DNA strand extension Adefovir dipivoxil is a new molecular entity approved by Gilead in September 2002 It is clinically used in the treatment of adult chronic hepatitis B patients with liver function compensation due to active replication of hepatitis B virus and continuous elevation of serum amino acid transferase As a big country of hepatitis B, China has a huge demand for hepatitis B treatment drugs At present, there are many enterprises in China, such as Zhengda Tianqing, etc., among which the products of Tianjin Zhongmei Shike, Zhengda Tianqing and Tianjin Pharmaceutical Research Institute occupy the top three in sales Cytosine nucleosides - No1 - lamivudine lamivudine are both nucleoside reverse transcriptase inhibitors and analogues of azido-d-thymidine They were approved by FDA in 1998 for the treatment of chronic hepatitis B Its active form is lamivudine triphosphate As a competitive inhibitor of DCTP, it can inhibit the activity of viral reverse transcriptase, terminate the extension of viral DNA chain and inhibit the synthesis of viral DNA CFDA approved the drug to be imported mainly for hepatitis B treatment, with the Chinese trade name of "hepudine", which was officially sold in China in 1999 At present, there are more than ten domestic enterprises producing the product, but the market is basically controlled by Glaxo company Glycyrrhizic acid No 1 magnesium isoglycyrrhizate magnesium isoglycyrrhizate is a single stereoisomer of glycyrrhizic acid magnesium salt, Glycyrrhizic acid preparation has been used to assist the treatment of liver diseases for more than 20 years Compared with glycyrrhizin, the glycyrrhizic acid preparation of the first generation for the treatment of chronic hepatitis, magnesium isoglycyrrhizate of the fourth generation has strong anti-inflammatory, protective liver cell membrane, detoxification, anti biological oxidation and improvement of liver function It is used in the treatment of chronic viral hepatitis and acute drug-induced liver injury At present, isoglycyrrhizic acid magnesium injection is the exclusive product of Zhengda Tianqing in the domestic market After its sales exceeded that of the second generation glycyrrhizic acid preparation compound glycyrrhizin tablets in 2012, it has been ranked the first in the sales of such drugs Biological preparations - No1 - thymopentin Thymic hormones and cytokines have been used in the treatment of chronic hepatitis B and other diseases for decades Interferon, pegylated interferon and thymosin α 1 are familiar to the market As human immune regulators, they can regulate the immune balance of human body and have certain antiviral and anti-tumor effects Thymopentin is a synthetic pentapeptide, which is composed of five amino acids: arginine, lysine, aspartic acid, valine and tyrosine It can promote the differentiation and development of thymus and peripheral T cells, has a two-way regulatory effect on the immune function of the body, and can make the high or low immune response tend to normal At present, it is commonly used in chronic hepatitis B and some autoimmune diseases As a big country with high incidence of hepatitis B, all kinds of therapeutic drugs have the opportunity to show their talents and really achieve a hundred flowers blooming and a hundred schools of thought contend Foreign giants of new drugs for liver disease have also entered China very quickly, and domestic enterprises are in time to catch up with the market After years of market competition, the outcome has been divided In terms of varieties, ursodeoxycholic acid is No1 in the market of bile treatment drugs, while foreign enterprises dominate in the market share; Entecavir is No1 in the market of liver disease treatment drugs As the overall sales volume of entecavir is more than twice that of other liver disease drugs, and Squibb's share of such drugs in the market is more than 60%, so the enterprise of liver disease drug sales No1 should be a foreign enterprise Squibb; The overall performance of state-owned enterprises in liver disease drugs shows that there are many but most of them are relatively weak The strong one is Jiangsu Zhengda Tianqing Because it accounts for nearly 30% of the best-selling varieties and isoglycyrrhizic acid magnesium is the exclusive variety, the gold brand of state-owned enterprises selling No1 for liver disease drugs should be issued to Zhengda Tianqing.