Shanghai Henlius Biotech (2696) H2 2025 earnings summary

Executive summary

• Achieved total revenue of RMB 6.67B in 2025, up 16.5% year-over-year, with global product sales of RMB 5.82B, up 17.8% year-over-year, driven by product sales, R&D services, and licensing income.

• Net profit reached RMB 827M, maintaining profitability, supported by higher sales of core products and overseas commercialization, with operating cash inflow of RMB 1.31B.

• Significant international expansion: 28 global BLA filings and 28 approvals across 60 countries/regions in 2025, with ten products (40 indications) approved in over 60 countries, benefiting over 1 million patients globally.

• Major international launches and regulatory approvals, including HANSIZHUANG, HLX14, and HLX11 in the US, EU, and other regions.

• Core products Serplulimab (HANSIZHUANG) and HANQUYOU drove growth, with Serplulimab sales of RMB 1.44B in China and HANQUYOU sales of RMB 2.81B.

Financial highlights

• Gross profit of RMB 5.00B in 2025, up 19.1% year-over-year.

• R&D expenditure increased 35.4% to RMB 2.49B, with expensed R&D up 46.4% to RMB 1.52B.

• Ex-China product revenue exceeded RMB 200M, more than doubling year-over-year.

• Selling and distribution expenses were RMB 2.20B (33% of revenue), and administrative expenses RMB 443M (6.6% of revenue).

• Earnings per share (basic and diluted) were RMB 1.52 and RMB 1.51, respectively.

Outlook and guidance

• Targeting global peak sales of RMB 10B for Serplulimab, with expansion into new indications and geographies.

• Multiple BLA filings and approvals expected in 2026 for key products in the U.S., EU, Japan, and emerging markets.

• Over 20 products expected to be approved globally by 2030, with 15+ in Europe and the US.

• Continued investment in innovative assets, with several IND submissions and clinical milestones planned for 2026, and integration of AI in R&D.

• HANSIZHUANG anticipated to gain new indications and approvals in China, EU, and US in 2026.