The latest news on the launch of obeticholic acid (Obeticholic) in the Chinese market in 2025

As of2025 year7 months, obeticholic acid (Obeticholic Acid) has not yet been officially approved by the National Food and Drug Administration (NMPA) in mainland China, so patients are temporarily unable to purchase the drug through formal domestic channels. Currently, obeticholic acid is mainly used to treat primary biliary cholangitis (PBC), especially for patients who have poor response or intolerance to ursodeoxycholic acid (UDCA). Although the drug has been approved in the United States, Europe and other countries and regions for many years, its domestic marketing process is still in the pre-approval or clinical trial stage.

Although it has not yet been launched in China, obeticholic acid already has the original drug and multiple generic versions in overseas markets. The original drugOcaliva is relatively expensive and is a high-end prescription drug, which brings a greater burden to patients with limited financial conditions. Generic drugs represented by India's Mylan have become the first choice for many Chinese patients to purchase drugs overseas due to their consistent ingredients and affordable prices. It is understood that the price of Indian generic drugs is less than 1,000 yuan, which is significantly lower than the price level of original drugs.

At present, some domestic pharmaceutical companies (such as Chia Tai Tianqing, Hengrui, etc.) are promoting the research and development and registration application for generic obeticholic acid. Some products have entered the BE trial stage and are expected to be gradually launched and included in medical insurance in the future. If the approval progresses smoothly, it will provide patients with more accessible and affordable treatment options, while reducing the economic and time costs of relying on overseas drug purchases.

In general, obeticholic acid, as a liver disease treatment drug with clear efficacy, is still in the early stages of introduction into the Chinese market. In the short term, patients will still have to rely on overseas versions, especially Indian generic drugs that are more affordable. In the medium to long term, with the advancement of the approval process and the gradual improvement of medical insurance policies, obeticholic acid is expected to become one of the important treatment options for domestic PBC patients.

Reference materials:https://www.drugs.com/