Henlius Biotech Reports 2025 Revenue Growth 16.5% – Ex‑China Business Doubles as Global Expansion Accelerates

Henlius Biotech Reports 2025 Revenue Growth 16.5% – Ex‑China Business Doubles as Global Expansion Accelerates

Shanghai Henlius Biotech, Inc. (HKG: 2696) announced strong 2025 annual results, with revenue rising 16.5% year‑on‑year to RMB 6.67 billion and net profit of RMB 827 million, driven by 17.0% global product revenue growth and doubling of ex‑China business – validating the company’s international commercialization strategy across 60 countries and regions.

Financial Performance – FY2025

MetricFY2025YoY ChangeStrategic Significance
Total RevenueRMB 6.6666 billion+16.5%Sustained double‑digit growth amid biosimilar competition
Net ProfitRMB 0.8270 billionProfitableMargin expansion from licensing and ex‑China mix
R&D InvestmentRMB 2.4919 billion+35.4%Aggressive pipeline advancement; 27 INDs secured
Global Product RevenueRMB 5.7746 billion+17.0%International commercialization traction
Ex‑China Product Revenue>RMB 200 millionDoubled YoYCritical inflection point for global business
Ex‑China Product ProfitRMB 93.9 millionProfitableValidation of ex‑China unit economics

Global Regulatory & Commercial Footprint

MetricAchievementMarket Impact
Total Approvals10 products in 60 countries/regionsEstablished global biosimilar presence
China Approvals7 productsDominant domestic market position
US FDA Approvals4 productsPremium market access; HERCESSI (trastuzumab) launch
European Commission4 productsZercepac, Hetronifly established in EU
Patients Benefited>1 million globallyCommercial scale validation
2025 New Approvals28 marketing approvals + 27 INDsAccelerated global pipeline execution

Core Products Driving Growth

ProductGlobal Brand NamesTherapeutic AreaEx‑China Contribution
SerplulimabHetronifly (Europe)PD‑1 inhibitor (SCLC, etc.)Abbott, Eisai, Lotus partnerships
TrastuzumabHERCESSI (US), Zercepac (Europe)HER2+ breast/gastric cancerUS launch momentum; EU market leadership

Strategic Partnerships – 2025 Expansion

PartnerProduct/AssetPartnership TypeStrategic Value
AbbottSerplulimabCommercialization rightsEmerging market access; diagnostic synergy
EisaiSerplulimabCo‑development/marketingOncology expertise; Japan market potential
LotusSerplulimabRegional rightsSoutheast Asia expansion
Dr. Reddy’sHLX15 (daratumumab biosimilar)LicensingIndia + emerging markets manufacturing/commercial
SandozHLX13 (ipilimumab biosimilar)LicensingGlobal immunology franchise access

Market Impact & Outlook

  • China Biosimilar Market Leadership: Henlius’s 16.5% revenue growth outpaces industry average (~10%) driven by innovator‑quality manufacturing and aggressive pricing; trastuzumab (HERCESSI/Zercepac) and serplulimab (PD‑1) franchises defend against domestic competition (Bio‑Thera, Cinda Biologics) through global regulatory credibility (FDA/EMA approvals).
  • Ex‑China Inflection: Doubling of ex‑China revenue to >RMB 200 million with RMB 93.9 million profit demonstrates sustainable international unit economics – critical for valuation re‑rating from “China‑only biosimilar” to “global biotech platform”; US HERCESSI launch (2024‑2025) and EU Zercepac market share gains drive 2026‑2027 trajectory.
  • R&D Productivity: RMB 2.5 billion R&D investment (+35.4%) yields 27 INDs – industry‑leading pace for China biotech; pipeline includes HLX15 (daratumumab), HLX13 (ipilimumab), novel ADCs, and bispecific antibodies; Dr. Reddy’s and Sandoz partnerships validate early‑stage asset attractiveness for global licensing.
  • Partnership‑Driven Growth: 2025 collaborations with Abbott, Eisai, Lotus, Dr. Reddy’s, Sandoz transform Henlius from product‑centric to platform‑centric business model; licensing revenue streams (milestones, royalties) reduce dependency on product sales volatility; estimated RMB500‑800 million annual licensing revenue potential by 2027‑2028.
  • 2026 Strategic Priorities: US HERCESSI market share expansion (target 15‑20% of trastuzumab biosimilar volume); EU Hetronifly (serplulimab) launch completion; HLX15/HLX13 Phase III execution; novel biologics (ADCs, bispecifics) IND acceleration; potential secondary listing (US or EU) to access global capital markets.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding revenue growth expectations, partnership performance, and global expansion timelines for Henlius Biotech. Actual results may differ due to competitive pricing pressures, regulatory approval delays in key markets, and manufacturing scale‑up challenges for novel biologics.-Fineline Info & Tech