By Fineline Cube 
US-based Gilead Sciences, Inc. (NASDAQ: GILD) announced that its oral primary biliary cholangitis (PBC) treatment, Seladelpar, has received official approval to enter the Tianzhu Rare Disease Drug Security Pilot Zone in Beijing. The clearance was granted under the city’s temporary import policy, which expedites access for clinically urgent drugs.
Availability
- Location – Seladelpar will be made available at Beijing Friendship Hospital.
- Indications –
- Combination with ursodeoxycholic acid (UDCA) for adults with inadequate response to UDCA.
- Monotherapy for patients intolerant to UDCA.
Drug Profile
- Mechanism – First‑in‑class, selective peroxisome proliferator‑activated receptor delta (PPARδ) agonist.
- Development History – Originally developed by CymaBay Therapeutics; acquired by Gilead in February 2024 for $4.3 billion.
- Regulatory Milestones –
- U.S. FDA accelerated approval (brand Livdelzi) – August 2024.
- UK MHRA approval – January 2025.
- European Commission conditional marketing authorization – February 2025.
Rapid China Entry
Thanks to Beijing’s temporary import policy, Seladelpar’s approval process in China took just two months, dramatically shortening the time from global launch to local availability and delivering a much‑needed option for rare‑disease patients.-Fineline Info & Tech