Who will dominate the market of hepatitis C drugs in China

On September 21, 2017, the combination therapy of direct antiviral drug for hepatitis C (DAAS) sovaldi (jxhs1700011) and similar drug for Albuquer (jxhs1700014) dasabuvir (jxhs1700015) was approved for marketing by CFDA So far, there are four hepatitis C direct antiviral drugs on the market in mainland China, including the combination therapy of asunaprevir soft capsule, daclatasvirdihydrochloride tables and simeprevir The author has also analyzed the global hepatitis C drugs, especially the direct antiviral drugs from multiple perspectives, including drug mechanism, the evolution of hepatitis C drugs, market pattern, clinical research progress, etc., which can be sure that the direct antiviral drugs developed by Gilead company have opened a whole new hepatitis C drug In the era of complete cure, Gilead also has a huge market return Although China's direct antiviral drug market is nearly 4 years later than that of foreign countries, but the big guy has successfully landed in the Chinese market, and the prelude to the war has been sounded Who will dominate the Chinese hepatitis C drug market? This is not known, after each pricing promotion strategy will be very important This paper focuses on the future trend of hepatitis C market and reviews the approval status of domestic hepatitis C drug market 1、 Huge downward pressure on earnings, landing in China market one after another In December 2013, since the direct antiviral drugs of Gilead sofibovir came into the market, due to the very high sustained virological response rate (SVR), the treatment of hepatitis C has entered a new era of complete cure Gilead's hepatitis C products such as sofibovir have been sought after all over the world, and the direct antiviral drugs have also sent Gilead's market value to a rare high, ranking among the top 10 in the world Below is the market share of major companies in the field of hepatitis C, with Geely Holding an absolute dominant position However, it is worth noting that: 1 Due to the particularity of hepatitis C disease, direct antiviral drugs have excellent SVR, and the number of effective patients has decreased dramatically; 2 The pricing rules have been controversial, and Gilead has maintained a very high market share, once reaching 75%, and Gilead has been controversial due to the pricing of local tyrants and nearly $1000 / tablet of drugs; 3 Indian and other generic pharmaceutical enterprises have obtained Gilead's imitation Under the system of authorization, it has been approved to sell to nearly 100 developing countries, and there is great pressure on price reduction This puts Geely and other companies under great downward pressure The market for hepatitis C is shrinking rapidly Geely will drop nearly $5 billion in 2017 alone However, the burden of hepatitis C in China is very heavy Genotype 1b and 2a are the most common genotypes of hepatitis C genotype 1, 2, 3 and 6 account for about 96%, and 1% of patients get effective treatment Undoubtedly, the market is a virgin land with a very broad market prospect, and it will be a place for the world to compete for hegemony At present, there are four companies that have approved the direct antiviral products of hepatitis C, which are respectively: product name acceptance No declaration unit status Approved by asunaprevir soft capsule jxhs160063 / 7 BMS, June 21, 2017 daclatasvir dihydrochloride tables jxhs160062 / 8 Approved by BMS, approved by simeprevir jxhs160064 J & J on June 21, 2017, approved by J & J on August 28, 2017 Sovaldi tables jxhs1700011 approved by Geely, dasabuvir tables, September 21, 2017 Approved by jxhs1700015, vierkira Pak jxhs1700014, September 21, 2017 Approved, on September 21, 2017, priority review of elbawegrarevac tablets by danorevir cxhs1600012 Geli pharmaceutical Jxhs1700035 review by mosadong II Geli medicine digs gold for hepatitis C, and domestic enterprises are reviewing hepatitis C products China Geli Pharmaceutical Co., Ltd is the leader in the development of hepatitis C direct antiviral drugs On December 27, 2016, China Geli Pharmaceutical Co., Ltd announced that Zhejiang food and drug administration has completed the on-site inspection of the company The listing application of danoprevir (asc08), the first innovative hepatitis C drug, has been officially accepted by CFDA Domestic hepatitis C drug R & D enterprises are mainly divided into two categories: 1 Hepatitis C drug R & D enterprises represented by Geli pharmaceutical, Dongguang pharmaceutical, ginkgo tree pharmaceutical, etc.; 2 Hepatitis C generic drug R & D enterprises represented by Zhengda Tianqing, hausen, Huahai, etc CDE rapidly promoted DAA drugs The progress of hepatitis C product registration application is summarized as follows: Overview of drug target R & D asc16 NS5A of Geli pharmaceutical Quoted from Roche, with independent intellectual property rights in the Chinese market Priority review, phase II clinical Geli pharmaceutical industry asc08, danorevir NS3 / 4A is quoted from Roche, with independent intellectual property rights in the Chinese market It has been reported to be the first one in China, and is expected to be listed in 2017 in phase II / III clinical trial of imitavir Guangdong dongyangguang phosphate Phase 1b clinical trial of sirarevir in Ginkgo Tree pharmaceutical industry, the research and development of this product started in 2010, and the application for ind was submitted at the end of 2013, and the clinical approval was obtained in the first half of 2015 Kaine technology / Beijing Furui Tiancheng kw-136 NS5A priority review, phase I clinical trial of Taijing pharmaceutical NS3 / 4A is approved preferentially, and the clinical trial was approved on August 12, 2016 China's hepatitis C patients have not been effectively treated and controlled, and China's hepatitis C treatment is still based on the combination of interferon and ribavirin, with a cure rate of only 44% - 70%, which is very backward The marketing of direct antiviral drugs certainly brings unprecedented cure rate to patients However, it is worth noting that the promotion and pricing strategy of hepatitis C drugs will be very important It is reported that B After Ms "ashuribe" + "dalatawei" combination was approved for listing, it cooperated with Shanghai Pharmaceutical and insurance institutions to carry out the market promotion work such as "pay for curative effect" innovative insurance project Several enterprises at home and abroad will face fierce market competition after the product of oral hepatitis C is put on the market Their respective effects will certainly not be bad The key is the pricing promotion strategy Attached table 1: the latest results of the 26th Asia Pacific Society for liver research clinical trials of hepatitis C products Gilead type 1 sofibvir + ribavirin + interferon, 12 weeks 94% sofibvir type 1 + ribavirin, 24 weeks 95% type 2 sofibwe + ribavirin, 92% type 3 sofibwe + ribavirin at 12 weeks, 24 95% type 6 sofibvir + ribavirin + interferon at week 12, 97% type 6 at week 12 Sufebuvir + ribavirin, 24 weeks, 100% BMS 1b, dalatavir hydrochloride + ashurevir, 24 weeks, 92-96% Albuquer 1b, non cirrhotic, onyx-i, obipali + dacebuvir ± ribavirin, 12 weeks, 99.5% 1b, cirrhotic decompensation, onyx-ii Obipali + dasebwe ± ribavirin, 12 weeks 100% song