A new drug to cure hepatitis C will be on the market! The first local DAA drug breakthrough

On December 27, Geli pharmaceutical announced that the company's first application for listing the original innovative hepatitis C drug danorevir (asc08) has passed the comprehensive on-site inspection of Zhejiang food and Drug Administration and has been accepted by the State Food and Drug Administration (CFDA) According to Wu JINZI, founder and CEO of Geli, the drug was launched in China in the first half of 2017 For the domestic hepatitis C drug market, this is undoubtedly a big news On the one hand, the company is close at hand, and as one of the representatives of local R & D enterprises, it has a chance to take the lead in the field of DAA On the other hand, if danorevir is successfully launched in the first half of 2017, it means that Geli will only take less than 5 years to launch an original research drug in China in the form of patent license, which will also refresh the record of new drug research and development in China Since the epoch-making Gilead hepatitis C drug suofebuvir was born, the global competition for the research and development of DAA hepatitis C drugs has entered a white hot trend In the Chinese market, relevant enterprises are also fighting against each other every second in order to win the market opportunity in the field of hepatitis C treatment Danorevir's application for listing was accepted by CFDA, marking another big step for Geli to be the first to launch the original small molecule antiviral drugs in China "Danoreway's successful declaration marks a perfect end to Geli's 2016 new year," said Wu In 2016, Geli made a series of significant progress and achieved satisfactory results in clinical research The construction of GMP industrialization base was completed, the professional marketing system was gradually formed, and the first application for listing of the original research drug was accepted by the general administration It has laid a solid foundation for the long-term development of the enterprise " 1 the first local DAA new drug! In recent years, a number of R & D and innovation enterprises have emerged in China Geli is one of them Wu JINZI, the founder of Geli, has the R & D experience of GSK, Amgen, Novartis, Aventis and other multinational pharmaceutical enterprises From the perspective of product line, Geli biology is mainly engaged in the research and development of new infectious diseases and cancer drugs, among which hepatitis C is one of its main directions In terms of R & D mode, under the situation of new drug trade and cooperation at home and abroad, Geli introduced four drugs for treatment of hepatitis C, liver cancer and AIDS from YANGSEN, presidio, Alnylam and other companies through cooperation Among them, danorevir is the core project of Geli in the research product line, and also the HCV NS3 / 4A inhibitor introduced by Geli from Roche pharmaceutical, a multinational pharmaceutical company It is reported that Roche has carried out some preliminary clinical trials for danorevir Wu JINZI and his team found that the product may be more effective for Chinese patients in the existing clinical data, "we found that asc08 is more effective for patients with genotype 1b, while nearly 60% of hepatitis C patients in China are genotype 1b." Wu JINZI told e drug manager earlier According to the clinical trial data published by Geli, the cure rate of asc08 to hepatitis C patients with genotype 1b is 100% It is reported that danorevir triple therapy for Chinese patients with hepatitis C gene I for 12 weeks, the cure rate is more than 95% The clinical research results will be released at the 26th annual meeting of the Asia Pacific Society of hepatology in 2017 In addition to danorevir, the HCV NS5A inhibitor, asc16, introduced by Geli from Presidio company in the United States through patent licensing, is another innovative hepatitis C drug developed by Geli In combination with danorevir, it is the first indigenous original all oral interferon free treatment scheme in China In April 2016, rividaway was included in the priority review process by CFDA Although there are many kinds of drugs transferred or traded at home and abroad, danorivir of Geli is likely to become the first innovative drug on the market in China Chen Kaixian, academician of the Chinese Academy of Sciences, deputy chief engineer of science and technology special program of national major new drug creation and chairman of Shanghai Association of science and technology commented that "the achievements of Geli in the field of small molecule direct antiviral drugs are not only the results of years of efforts of Geli, but also the first fruits of major science and technology special program of major new drug creation during the 13th Five Year Plan period The rise of a number of representative innovative pharmaceutical enterprises, such as Geli, has sent a positive signal of the transformation of China's pharmaceutical industry from imitation to innovation, indicating that China's biomedical industry is ushering in a golden era of development " 2 In the era of the Warring States period of DAA in the field of global DAA hepatitis C drugs, the listing of sofibovir, which can completely cure hepatitis C, is undoubtedly a pioneering work in the history of hepatitis C treatment Thanks to the drug, Gilead has also earned enviable profits from its peers From the end of 2013 to 2014, its sales reached US $10.283 billion, making it the second best-selling top 10 in the world Nowadays, the competition in the field of DAA hepatitis C drugs is unprecedented fierce Many multinational pharmaceutical companies such as MSD, Aberdeen, Gilead and BMS are seizing the market of DAA hepatitis C drugs with the attitude of tiger and wolf Their filings in China are also accelerating The first clinical DAA compound was approved in China Clinical trials began in September 2015 All three single drugs and combination compounds of BMS have been declared in China Daclatasvir and asunaprevir have carried out two clinical studies of combination drugs, and the scheme of triple combination has also been approved In the United States, Gilead, its suofebuvir and its compound also face off with Albright and BMS products in China According to the information released by CFDA drug review center earlier, hepatitis C drugs from Gilead, Aberdeen and Bristol Myers Squibb were included in the priority review process Although the research and development of DAA started late in China, there is no DAA drug on the market at present But in terms of the current form, it is not far from the "Warring States" era It is reported that the guideline for the treatment of hepatitis C in China is still in 2008 edition According to the guideline, the standard treatment plan for hepatitis C in China is still based on the combination of interferon and ribavirin, although the cure rate is only 44% - 70% At present, there are two main types of domestic research and development enterprises of hepatitis C DAA A class of enterprises focus on independent research and development of anti hepatitis C drugs with intellectual property rights, represented by Geli and Kaiyin The other is the research and development of sofibway generic drugs, such as Kelun pharmaceutical, Jiangsu Haosen, etc There are many domestic enterprises that independently research and develop hepatitis C DAA, including dongyangguang, gingko tree and Geli In the CFDA's clinical drug application system, in addition to danorevir and revadavir of Geli, there are silarevi of gingko tree and imitavir, an NS5A inhibitor of dongyangguang in Guangdong Province, which are also concerned These new stars are all fighting for the dividend outbreak period of hepatitis C drug market in China, which is hard to meet for many years Who has the first chance is not only to find a way to cure the patients suffering from hepatitis C, but also to endorse their own commercial value No wonder that the valuation of relevant drug companies in the pharmaceutical investment and financing market has risen rapidly in recent years Among them, imitavir, the NS5A inhibitor under dongyangguang, obtained the clinical approval in November 2014, and the phase I trials have been completed Earlier, the company established a cross-strait cooperation between imitavir and vorarevir with Taijing Pharmaceutical Co., Ltd in Taiwan to develop a local combination of hepatitis C and DAA The portfolio is considered by the industry to be able to compete with foreign DAA drugs In addition, the bl-8030 introduced from biolinerx, the combination of NS5A inhibitor fubetavir by Changzhou Yinsheng and Sichuan University, and the NS5A inhibitor developed by Beijing Kaiyin technology were also reported Now, with the acceptance of danorevir in CFDA, the domestic hepatitis C drug market will be booming again If the danorevir of Geli goes on the market smoothly, it will certainly stir the hepatitis C drug market in China In order to win, Geli's academic promotion for asc08 has already begun In the past year, Geli has shared the clinical trial results of asc08 with participating doctors through satellite conference and other forms "In 2017, Geli will accelerate the research and development of the second hepatitis C drug, revadavir, on the basis of the successful listing of danorevir, and launch a full oral hepatitis C treatment plan as soon as possible, so as to provide more treatment options for Chinese patients." Wu said.