What is the real reason why obeticholic acid has been discontinued in the country?

Obeticholic acid (Obeticholic acid) is a new semi-synthetic bile acid derivative, mainly used as a farnesoid X receptor (FXR) agonist for the treatment of primary biliary cholangitis (PBC). The drug was initially approved in the United States in 2016 and was viewed as a complementary treatment option for patients who were ineffective or resistant to ursodeoxycholic acid. However, after entering the Chinese market, its fate was not smooth, and it eventually faced a "suspension" status, which aroused widespread concern among patients and the medical community.

It needs to be clear that obeticholic acid is not banned in China due to "safety issues", but is the result of multiple factors such as the drug supply chain, approval strategy and risk-benefit assessment. First of all, according to public information, the drug was launched relatively late in China and the market penetration rate is low. Since the treatment population is relatively niche, belongs to the field of rare diseases, and the patient base is limited, pharmaceutical companies may believe that the market does not have sufficient commercial sustainability in the short term after evaluating the input-to-output ratio. In addition, obeticholic acid faces increasing safety discussions in the global market, especially in the United States, especially in studies for non-alcoholic steatohepatitis (NASH). Its long-term use may be associated with worsening of liver function or cholestasis. This potential drug risk has also triggered a cautious attitude from regulatory agencies.

Another important reason is that the drug was repeatedly rejected by the FDA during the application process for NASH indications in the United States. Part of the reason was concerns about its long-term safety and tolerability in patients with liver cirrhosis. This negative information caused a chain reaction around the world, and pharmaceutical companies carried out strategic contraction in their global market layout. For the Chinese market, companies may consider suspending promotion to avoid policy and reputation risks caused by uncertainty.

Reference materials:https://en.wikipedia.org/wiki/Obeticholic_acid