China’s clinical trial activity in NAFLD increasing

Non-alcoholic fatty liver disease

China is expected to record the highest diagnosed prevalence of non-alcoholic fatty liver disease (NAFLD) in 2029, representing 44% of cases within the 16 major pharmaceutical markets (16MM).  

As a result, the number of clinical trials conducted in the country for this indication is gradually increasing, driven mostly by international pharmaceutical companies. 

According to GlobalData’s Pharma Intelligence Center, China has the highest number of clinical trials that were initiated in NAFLD in the APAC region over the past decade. However, most of these clinical trials were sponsored either by non-commercial Chinese sponsors, like institutions or investigators, or by international commercial sponsors.  

Moreover, almost all clinical trials for drugs in mid-to-late-stage development in NAFLD were sponsored by medium and large sized international companies.  

GeneScience Pharmaceuticals, Gannex Pharma (a wholly owned company of Ascletis Pharma) and PegBio are the only Chinese companies currently known to have been active in early-to-mid stage clinical trials for drugs in NAFLD. 

However, there are currently 10 pre-clinical assets in NAFLD from major domestic companies in China, including publicly listed companies such as Innovent Biologics, Sihuan Pharmaceutical Holdings and Shenzhen Chipscreen Biosciences, as well as private companies like Shaanxi Micot Technology and CVI Pharmaceuticals. 

Significant market opportunity 

Sasmitha Sahu, Pharma Analyst at GlobalData, commented: “Domestic pharma companies in China are warming up to cater to the unmet needs in NAFLD and so we are now seeing companies like Ascletis, Shenzen, Pegbio and CVI Pharma with multiple assets in NAFLD in Phase I and pre-clinical stages.  

“As many of the preclinical molecules are against regular targets like thyroid hormone receptor beta (THR-β), adenosine monophosphate activated protein kinase (AMPK) and farnesoid X activated receptor (FXR) that are currently being investigated in mid-to-late-stage clinical trials by international companies, they are most likely to enter clinical phases.” 

Lipaglyn (saroglitazar) is currently the sole marketed therapy for NAFLD, but it is only approved in India, with no approved products for NAFLD in the US or the European Union.  

Sahu continued: “Owing to the rising prevalence of NAFLD in China and worldwide, there is a significant market opportunity for Chinese pharmaceutical companies to capitalise on this patient group with significant unmet demand.” 

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