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The race for an approved non-interferon regimen to treat Hepatitis C Virus (HCV) infections in China is on and market stakes are high. Starting in 2013, HCV clinical trial activity in China shifted from interferon (IFN) containing regimen to direct acting antiviral (DAAs), but a drug still has not been approved. HCV is a major blood-borne disease in China, with no vaccine and an increasing population suffering from chronic liver disease. Datamonitor estimates that there were roughly 45.9 million cases of HCV in China in 2011, and this is expected to increase to approximately 48.4 million cases by 2021 [1]. The standard of care in China continues to be the more toxic IFN based regimens and traditional Chinese medicine (TCM). Chinese patients do not have access to the new, direct acting antiviral (DAA) regimens that have become available in other countries (Hong Kong, Japan, South Korea, USA or the EU) [2].

 

According to Trialtrove, there are currently 16 ongoing and planned industry sponsored HCV trials evaluating IFN free treatments in China. (Figure 1) Ascletis was the first Chinese company to file a clinical trial application for IFN-free treatment in China [3]; the company currently has three early phase planned or ongoing trials. Another frontrunner is Bristol-Myers Squibb (BMS), who currently has one phase III ongoing trial and previously reported a 91% cure rate in a phase III trial of Daklinza (daclatasvir) and Sunpreva (asunaprevir) in Chinese genotype 1b patients after a treatment duration of 24 weeks [4]. Gilead’s Solvaldi was the first DAA to treat HCV patients without IFN [5], and the company is working with eleven generic drug manufacturers in India to make Sovaldi as well as Harvoni (ledipasvir and sofosbuvir combination) available in 101 developing countries [6]. Gilead currently has the highest number of phase III trials running in China. Interestingly, The First Bethune Hospital of Jilin University (Chinatrove hospital code Jilin-02) is participating in the majority (nine) of these currently planned/ongoing HCV studies [7] [8].

 

 

 

Figure 1 Ongoing and planned IFN-free HCV trials in China

 

Source: Trialtrove, March 24, 2016



To run new studies in China, clinical sites are required to gain approval by the China Food and Drug Administration (CFDA). The CFDA grants certifications in a specialty area to the authorized hospital for a period of three years. To date, the CFDA has authorized 105 hospitals to run new HCV studies, however, only 60 hospitals currently have an active hepatitis, hepatology or infectious disease certification as shown in Chinatrove (Figure 2) [10]. The majority of sites are 3A hospitals treating on average 5,000 patients per day. To date, Sitetrove has identified one hundred investigators with HCV trial experience who are currently located at one of these sixty CFDA approved hospitals. The highest number of investigators are in Beijing and notably, the smaller province of Shaanxi is among the leading locations with eight investigators.

 

Globally, China is among the countries with the highest prevalence (3.5% or greater) of Hep C [9]. Prevalence varies widely between provinces and is higher in urban than rural areas. Beijing has one of the larger number of HCV patients as well as the highest incidence rate in patients 40 years and older [1] Coupled with the fact that actively certified CFDA approved hospitals in Beijing see an average of 47,000 outpatients per day, this province potentially has the greatest patient population available for HCV trials. Henan and Liaoyang are also reported to have a higher number of newly diagnosed HCV cases, but have little to no CFDA approved hospitals to run new studies for improved HCV drug treatments (the province of Henan only has one hospital actively certified and the city Liaoyang has none). (Figure 2)

 

Figure 2. Chinatrove Hospitals with active HCV certifications by province

 

Figure 2 Chinatrove Hospitals with active HCV certifications by province

 

 

Source: Chinatrove, Sitetrove, March 24, 2016



With nine companies competing to market the first non-interferon regimen of HCV in China and recent CFDA announcements to included viral hepatitis in its list of seven priority diseases to review drug application for approval [11], we can optimistically say that the finish line is in sight. Visit Chinatrove for detailed information on Jilin-02 and other hospitals involved in these current studies, as well as to help identify the best hospitals for your next HCV study.

 

[1] Datamonitor Healthcare, January 2013

 

[2] http://www.hepbcppa.org/wp-content/uploads/2016/02/HepBC-Feb16.pdf



[3] http://ascletis.com.cn/20150624IFN-free.pdf



[4] http://investor.bms.com/investors/news-and-events/press-releases/press-release-details/2016/Data-Presented-at-APASL-from-First-Completed-Phase-3-Trial-of-All-oral-Chronic-Hepatitis-C-Regimen-in-Chinese-Patient-Population-Shows-Daclatasvir-and-Asunaprevir-DUAL-Therapy-Demonstrated-High-Cure-Rates-Among-HCV-Genotype-1b-Patients/default.aspx



[5] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm


[6] http://www.gilead.com/responsibility/developing-world-access/viral%20hepatitis



[7] Sitetrove, March 2016

 

[8] Jilin-02 is not included in Figure 2 because its certification expired on January 4, 2016.

 

[9] http://wwwnc.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/hepatitis-c



[10] Hospital certification list last updated by the CFDA on October 21, 2015.

 

[11] http://www.sfda.gov.cn/WS01/CL0844/145260.html

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