CStone Pharma 2025 Revenue RMB 269.6M Down 34% – NRDL Price Adjustment Hits Pralsetinib, Licensing Fees Decline

CStone Pharma 2025 Revenue RMB 269.6M Down 34% – NRDL Price Adjustment Hits Pralsetinib, Licensing Fees Decline

CStone Pharmaceuticals (HKG: 2616) reported 2025 financial results, with annual sales declining 33.8% YoY to RMB 269.6 million (USD 39 million). The drop reflected RMB 78.3 million in product sales (avapritinib, pralsetinib, sugemalimab), RMB 167.7 million in licensing fees, and RMB 23.6 million in sugemalimab royalties. Pralsetinib (Gavreto) sales fell significantly due to NRDL price adjustment preparation and one-time channel compensation, while licensing revenue decreased following large 2024 upfront/milestone payments. Net loss widened to RMB 437 million from RMB 91.2 million in 2024, with RMB 918.7 million cash providing 2+ years runway.

Financial Performance

Metric2025 ResultYoY ChangeCommentary
Total RevenueRMB 269.6M (USD 39M)-33.8%Product + licensing decline
Product SalesRMB 78.3M (USD 11.3M)Pralsetinib NRDL price impact
Licensing FeesRMB 167.7M (USD 24.25M)Lower vs. 2024 one-time payments
Royalty IncomeRMB 23.6M (USD 3.41M)Sugemalimab ex-China royalties
Net LossRMB 437M (USD 63.2M)Widened from RMB 91.2MLower gross profit + higher R&D
Cash PositionRMB 918.7M (USD 132.9M)2+ years runway

Revenue Mix & Strategic Drivers

Segment2025 RevenueKey Dynamics2026 Outlook
Product SalesRMB 78.3MPralsetinib price reduction for NRDL inclusion (effective Jan 1, 2026); one-time channel compensationVolume-driven recovery expected – NRDL access unlocks patient volume
LicensingRMB 167.7M2024 comparison base included large upfront/milestone (e.g., Zenas deal)Dependent on new BD execution – pipeline maturation required
RoyaltiesRMB 23.6MSugemalimab ex-China sales (EU, emerging markets)Growth trajectory with ESMO [I,A] recommendation

Pralsetinib (Gavreto) NRDL Transition

Factor2025 Impact2026+ Strategy
Price AdjustmentRevenue decline – preparation for NRDL listingVolume offset – NRDL inclusion (Jan 1, 2026) enables national reimbursement
Channel CompensationOne-time charge – distributor inventory adjustmentsNormalized margins – direct hospital sales post-NRDL
RET Fusion NSCLCCompetition from selpercatinib (Lilly)First-mover NRDL advantage – ~5,000 annual RET+ NSCLC patients addressable

Pipeline & Cash Runway

AssetStatusCatalyst
SugemalimabESMO [I,A] recommendation; EU commercializationRoyalty growth 2026
AvapritinibGIST, SM – stable niche salesPDGFRA D842V dominance maintained
CS5001 (ROR1 ADC)Phase I ongoingPotential out-license 2026–2027
Cash BurnRMB 437M annual loss2+ years runway – requires BD or financing 2027

Forward‑Looking Statements
This brief contains forward‑looking statements regarding 2026 pralsetinib volume recovery, sugemalimab royalty growth, and potential out-licensing transactions. Actual results may differ due to NRDL pricing dynamics, competitive entry in RET inhibitors, and BD market conditions for clinical-stage assets.-Fineline Info & Tech