(Yicai) Nov. 6 -- Gilead Sciences is expecting to receive Chinese regulatory approval for two innovative drugs already available to some patients through special-access programs, according to Jin Fangqian, the US biopharmaceutical company’s vice president and China general manager.

Applications for lenacapavir, a twice-yearly injectable human immunodeficiency virus prevention drug, and seladelpar, a treatment for primary biliary cholangitis, are under review, Jin  said at the Ninth China International Import Expo in Shanghai.

Lenacapavir offers a more convenient and discreet option for HIV prevention, helping more people at risk , while seladelpar is designed to address unmet needs among PBC patients who don’t have an adequate response to existing treatments or have experienced severe pruritus, helping improve their quality of life, he explained.

Before nationwide approval in China, both products are already available to eligible patients through the Boao Lecheng International Medical Tourism Pilot Zone in Hainan province, while seladelpar is also available in Beijing’s Tianzhu Comprehensive Bonded Zone, according to the company. Jin noted that these two special-access programs can  accumulate real-world data, accelerate approval, and unlock broader clinical use, allowing Chinese patients to benefit earlier from global innovation. 

Their progress represents the broader spillover effect of the CIIE, Jin said. The two drugs, first introduced at a previous CIIE, were among Gilead's highlights at the CIIE last year. 

At this year’s edition, the fifth the firm has attended, it is showcasing further progress, as the company continues to expand its presence in China."The CIIE is a platform that encourages openness, innovation, and cooperation," Jin pointed out. Throughout the years, Gilead has turned many of its innovative products from exhibits into goods, he added.

Over the past five editions, a number of Gilead medicines first showcased at the expo have moved from exhibits toward broader patient access in China. Gilead’s antifungal drug AmBisome was included in the China National Essential Medicines List 2026. Coverage of its metastatic breast cancer treatment Trodelvy was expanded to more than 110 city-level supplementary medical insurance catalogs nationwide. Both drugs debuted at the Fifth CIIE in 2022.

 "The CIIE provides an important platform for global innovation to connect with China's healthcare needs," Jin said. "Seeing more innovative medicines move from the expo toward real-world patient access has strengthened our confidence in China and in continuing to bring innovation to Chinese patients."

Building on this progress, Gilead is also increasing the research and development in China. It has nearly 20 clinical projects underway in China, mainly in oncology and inflammatory diseases，covering early- and late-stage trials, Jin said. The company is also expanding partnerships with Chinese biotech firms, from early-stage research through late-stage development, creating more opportunities to integrate China-originated innovation into its global research and development pipeline. 

Gilead began commercial operations in China in 2017. So far, 13 of its medicines have been approved in China, eight of which are included in the National Reimbursement Drug List (NRDL)

At this year's CIIE, Gilead is also holding nearly 20 signing ceremonies and disease education activities covering HIV prevention and treatment, viral hepatitis, PBC, Oncology and Invasive fungal disease, reflecting its continued efforts to connect global innovation, local research and broader collaboration in China. Its 500-square-meter booth also features a patient story zone highlighting how innovation affects patients' lives.

Editor: Futura Costaglione