Sales down 21% + six new hepatitis C drugs approved, interferon market is facing strong impact!

In October 2016, CDE announced the inclusion of new anti hepatitis C drugs in the priority review process, so that the registration application of such drugs can enter the fast lane In 2017, CFDA successively approved asunaprevir, daclatasvir, simeprevir, dasabuvir, ombitasvir, pariaprevir and Six new anti hepatitis C drugs, ritonavir and sofosbuvir, are on the market, which will change the market pattern of this field in China (click the picture to enlarge) according to who statistics, the global hepatitis C virus (HCV) infection rate is about 2.8%, the number is about 185 million, and about 350000 deaths are caused by HCV infection every year Hepatitis C is the fourth most common infectious disease in China Due to the strong concealment of hepatitis C and the lack of understanding of the disease in most patients, early detection, diagnosis and treatment of hepatitis C are difficult to achieve Most of the patients with hepatitis C in China were in the late stage of the disease and missed the best period of disease treatment Therefore, it is very important to control hepatitis C, improve the understanding of hepatitis C, early diagnosis and treatment On December 10, 2013, the European Society of Hepatology released the guidelines for the diagnosis and treatment of hepatitis C virus (HCV) infection On April 9, 2014, who issued guidelines for the treatment of hepatitis C This is a leap from quantitative change to qualitative change in the global chemical treatment of hepatitis C under the situation of new drugs emerging in large numbers, we will promote the treatment of hepatitis C into a new era From 2011 to August 2017, the US FDA approved 11 new oral anti HCV drugs, completely subverting the traditional hepatitis C treatment market In particular, after the advent of sophopewer, such cocktail therapies as sophopewer / redipavir, obipali + palirave + litonavir + dacatavir, dalatavir + ashurevir, ibaasvir + gezopravir, sophopewer / vpatavir, and glecaprevir + pirrentasvir came one after another, which promoted the shuffling of hepatitis C market (click the picture to enlarge) sofosbuvir, a nucleoside NS5B polymerase inhibitor of Gilead, is used in the treatment of adult patients with chronic hepatitis C of genotype 1, 2, 3 and 4 It has created a new type of pure oral anti hepatitis C drug that does not need to be combined with interferon for specific genotype 2 and 3, and promoted the development of hepatitis C market According to the annual financial report of multinational pharmaceutical companies, the global hepatitis C treatment drug market reached a peak of US $24.757 billion in 2015, an increase of 41.26% over the previous year However, with the competitive listing of new anti HCV drugs, the fierce outbreak of hepatitis C market caused by the sudden emergence of Gilead sovaldi entered a diving period: in 2016, the global market for anti hepatitis C drugs was 18.721 billion US dollars, down 24.29% year on year Six new hepatitis C drugs were approved in China on April 24, 2017 CFDA first approved dhalatavir (trade name: BLZ, daklinza) of BMS In 2014 and 2015, daklinza was approved in Japan, Europe and the United States for the treatment of hepatitis C virus infection Dhaltamivir is a pan genotype NS5A inhibitor of hepatitis C virus, which is used in combination with other drugs to treat adult chronic hepatitis C virus infection In 2016, daklinza's global sales reached US $1.55 billion, an increase of 17.87% over the previous year CFDA also approved NS3 / 4A protease inhibitor of BMS, asvir (trade name: sunvepra), which is used in combination with daratavir in the treatment of adult patients with genotype 1b chronic hepatitis C, who should be non cirrhosis or compensatory cirrhosis On August 24, 2017, CFDA approved Janssen cilag's cimerevir capsule (trade name: olsio) Cimerevir is a non structural protein NS3 / 4A protease inhibitor of HCV approved by the US FDA in November 2013, and a chronic hepatitis C genotype l patient who has no previous treatment history or failed to receive previous interferon based therapy in adults with cirrhosis treated with ribavirin In 2014, the global market of olysio reached 2.329 billion yuan With the increase of competition, the global market of olysio in 2016 has declined significantly On September 20, 2017, CFDA approved albove's obipali composite tablets (trade name: viekirax) and dasebovir tablets (trade name: ekiri, exviera) This new program is a combination of protease inhibitor, NS5A inhibitor, non nucleoside polymerase inhibitor obipali and dasebvir, which is suitable for chronic hepatitis C virus infection, including advanced cirrhosis In 2016, the global market of viekira Pak was USD 1522 million On the same day, CFDA also approved Gilead's suophobwei (trade name: suvaldi) In December 2013, FDA approved the drug for the treatment of adult patients with chronic hepatitis C of genotype 1, 2, 3 and 4, becoming a milestone in the field of hepatitis C Gilead is the leader of the global hepatitis C market, and its product portfolio of hepatitis C drugs has created multiple sales miracles Sovaldi has been approved to be listed in 79 countries In 2014, sovaldi's global market reached US $10.283 billion After the company's portfolio was listed, sovaldi was no longer the top selling brand in 2016, and the market fell to US $4.001 billion According to the data on CFDA website, 20 acceptance numbers of sophosfovir APIs and oral tablets have been released, as well as 2 acceptance numbers of redipavisfovir tablets The R & D work of 10 enterprises, including Zhengda Tianqing Pharmaceutical Co., Ltd., Sichuan Kelun, Fujian Haixi new drug development Co., Ltd., Nanjing Xiansheng Dongyuan, Zhejiang Haizheng, Zhongqi, Jiangxi Shimei, Beijing Wansheng, Zhejiang Huahai, is in full swing In March 2017, suophobuvir of Shanghai Hequan Pharmaceutical Co., Ltd was approved for clinical application (cyhl1600001 Zhejiang), and suophobuvir and patavir tablets (cxhl1600141 Zhejiang) of geelia (Hangzhou) were also in progress In addition, elbasvir + grazoprevir of mosadon and danoraway of golly are also under review The decline of anti hepatitis C interferon market has brought great impact on interferon drugs Interferon and ribavirin have been the first-line drugs in the treatment of hepatitis C, especially pegylated interferon α - 2A and pegylated interferon α - 2b have led the market of hepatitis C since they came into the market With the advent of anti HCV oral drugs, anti HCV interferon has been hit hard, which also led to the overall market decline of interferon In 2016, the global interferon market dropped from a high of $9.5 billion in 2012 to $5.4 billion, down 26.68% year on year in 2016 For many years, the combination of interferon and ribavirin is the main scheme for the treatment of hepatitis C; the main drugs for chronic hepatitis C are pegylated interferon α - 2A, recombinant human interferon α - 2b, pegylated interferon α - 2b, recombinant human interferon α - 1B and antiviral ribavirin Although pegylated interferon / ribavirin therapy has become the gold standard of hepatitis C treatment in China, its cure rate is only 44% - 70% In terms of treatment, at present, only less than 2% of patients diagnosed as hepatitis C use interferon based antiviral therapy In addition, the later the treatment of hepatitis C, the more complications, and thus the higher the cost of treatment Hepatitis C has brought a heavy economic burden to the families and countries of the patients and has become a serious social problem According to the data of menet HDM system, the sales volume of interferon in public hospitals in key cities in 2016 was 483 million yuan, down 21.46% year on year Interferon will continue to decline as new anti HCV drugs are launched in China