Gilead Sciences showcased a range of innovative treatments and initiatives in liver disease at the 9th China International Import Expo in Shanghai, highlighting its efforts to address unmet medical needs ranging from viral hepatitis to rare liver conditions as it seeks to expand access to therapies in China.
The US drugmaker presented treatments for hepatitis B and C alongside seladelpar, a first-in-class oral treatment for primary biliary cholangitis (PBC), a rare chronic liver disease. It also highlighted progress in clinical access, standardized diagnosis and treatment, and partnerships with healthcare institutions and other organizations.
A key focus was seladelpar, whose application for marketing approval in China is under review by the National Medical Products Administration. The treatment, marketed as Livdelzi in the United States, received accelerated approval from the US Food and Drug Administration in August 2024 for adults with PBC who have an inadequate response to ursodeoxycholic acid, or cannot tolerate it.
First showcased at the CIIE in 2024, seladelpar was subsequently made available to eligible patients through special access programs in Beijing and Hainan province in 2025, Gilead said. The treatment has also been included in overseas specialty drug lists under supplementary commercial health insurance plans in Beijing, Hainan, Jinan in Shandong province, and the cities of Suzhou and Nanjing in Jiangsu province.
PBC is a chronic autoimmune liver disease that mainly affects women and can cause persistent itching and fatigue. Without effective treatment, it can progress to cirrhosis or liver failure. The disease was included in China's second national list of rare diseases in 2023.
On Nov 5, Gilead reported positive results from its Phase 3 IDEAL trial of seladelpar. Among 96 adults with PBC enrolled in the study, 75.4 percent of those receiving seladelpar met the primary endpoint after 52 weeks, compared with 16.1 percent in the placebo group.
The endpoint was a composite measure requiring alkaline phosphatase, or ALP, a marker of disease activity, to reach the normal range and decline by at least 15 percent from baseline.
The trial focused on patients whose ALP levels remained above normal but below 1.67 times the upper limit of normal despite treatment with ursodeoxycholic acid for 12 months, or who could not tolerate the medicine. Gilead said the results would be discussed with regulatory authorities globally and that no new safety concerns had emerged.
"Over five consecutive years of participating in the CIIE, several of our innovative therapies have moved from exhibition displays into clinical use," said Jin Fangqian, vice-president and China general manager of Gilead Sciences.
From viral hepatitis to rare liver diseases, Gilead said it would continue working with government bodies, healthcare institutions and patient organizations to improve disease awareness, promote standardized care and expand access to innovative treatments in China.
