Gilead Sciences (NASDAQ: GILD) announced that Seladelpar (marketed as Livdelzi), a potent and selective PPARδ agonist for Primary Biliary Cholangitis (PBC), has been approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone. The drug, acquired from CymaBay Therapeutics for $4.3 billion in February 2024, is indicated for PBC patients with inadequate response to ursodeoxycholic acid (UDCA) or as monotherapy in UDCA‑intolerant patients.
Regulatory Milestone
Item
Details
Approval Date
22 Dec 2025
Location
Hainan Boao Lecheng International Medical Tourism Pilot Zone, China
Product
Seladelpar (Livdelzi)
Indication
PBC in adults (combination with UDCA or monotherapy)
Mechanism
PPARδ agonist (first approved for PBC globally)
Innovation
First PPARδ therapy for rare liver disease
Global Approval Timeline
Date
Region/Agency
Milestone
Aug 2024
U.S. FDA
Accelerated approval (brand name Livdelzi)
Jan 2025
UK MHRA
Marketing authorization
Feb 2025
European Commission
Conditional marketing authorization
Sep 2025
Beijing Tianzhu Rare Disease Drug Security Pilot Zone
Approved for entry
Dec 2025
Hainan Boao Lecheng Pilot Zone
Medical tourism approval
Market Opportunity
Metric
Value
Context
China PBC Prevalence
~70,000‑100,000 patients (2025)
Rare autoimmune liver disease; high unmet need
China PBC Market
¥1‑1.5 billion (≈ US$140‑210 M)
Dominated by UDCA; limited second‑line options
Seladelpar Peak Sales
¥300‑500 million (≈ US$42‑70 M) by 2030
20‑30% share of refractory PBC segment in China
Pricing Strategy
Premium orphan drug pricing
Eligible for national reimbursement pilot programs
Acquisition Cost
$4.3 billion (Gilead acquisition of CymaBay)
Validates asset value
Strategic Implications
For Gilead:Hainan approval provides early market access while awaiting full NMPA approval; rare disease pilot zones accelerate patient access and real‑world evidence generation; global regulatory momentum (US/EU/UK) supports China filing.
For Patients:First PPARδ therapy offers new mechanism for refractory PBC; oral dosing improves convenience vs. bile acids; potential for functional cure vs. symptom management.
For Market: Demonstrates global pharma strategy leveraging China’s pilot zone policies; PBC rare disease category enables expedited review; Gilead’s metabolic/rare disease franchise expands beyond virology.
Forward‑Looking Statements This brief contains forward‑looking statements regarding Seladelpar’s China NDA timeline, market penetration, and reimbursement negotiations. Actual results may differ due to regulatory feedback, competitive responses, or pricing pressures.-Fineline Info & Tech
By Fineline Cube 