Shanghai Henlius Biotech, Inc. (HKG: 2696) released its first-half 2026 results, reporting total revenue of RMB 3.5882 billion, up 27.3% year-on-year, and net profit of RMB 430.4 million, up 10.3% YoY, driven by its trastuzumab-anchored breast cancer franchise and rapidly expanding overseas commercialization.
Financial Highlights
Metric
H1 2026
YoY Change
Total Revenue
RMB 3.5882 bn
+27.3%
Net Profit
RMB 430.4 m
+10.3%
Global Product Sales
RMB 2.9386 bn
+14.9%
Overseas Product Sales
RMB 105.3 m
+159.4%
Overseas Product Profit
RMB 59.5 m
>4x YoY
Breast Cancer Franchise – Trastuzumab Leads
Breast cancer therapeutic area revenue reached RMB 1.6983 billion, approximately 58% of global product sales, powered by four approved products:
Product
Molecule (Brand ex-China)
H1 2026 Sales
HANQUYOU
Trastuzumab (HERCESSI, US; Zercepac, EU)
RMB 1.4844 bn
HANNAIJIA
Neratinib
RMB 195.5 m
FUTUONING
Fovecitinib
RMB 10.7 m
HANBEIYOU
Pertuzumab (POHERDY, US/EU)
RMB 7.7 m
Solid Tumor Portfolio – Multi-Product Momentum
Product
Molecule
H1 2026 Performance
HANSIZHUANG
Serplulimab (Hetronifly, EU)
Global sales of RMB 597.5 m
HANBEITAI
Bevacizumab
RMB 218.2 m, +87.6% YoY; U.S. BLA approval expected in H2 2026
Mature Products & Denosumab – Stable Cash Flow
HANLIKANG (rituximab): RMB 335.7 m in sales and licensing revenue under partner agreements
HANDAYUAN (adalimumab): RMB 30.4 m in sales and licensing revenue
HLX14 (denosumab): RMB 73.1 m contribution; two specifications — BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL) — approved in the U.S., EU and U.K. in H2 2025
Clinical & Regulatory Progress
Item
Detail
In-house Teams
U.S., Europe, Japan, Australia
Concurrent Trial Geography
~30 countries and regions
Partner Trial Centers
1,000+
New IND Approvals (H1)
32
New MAA Approvals (H1)
25
Regulatory Coverage
~50 countries and regions
Manufacturing & Supply
1,400+ commercial production batches completed under GMP standards
100+ on-site inspections by global regulators and partners — 100% pass rate
9 first-to-market product launches executed in H1
18 overseas bulk shipments completed
Market Impact & Outlook
Overseas Inflection Point: Overseas profit more than quadrupling YoY on a 159.4% sales surge signals Henlius’s global commercialization is transitioning from licensing deals toward scalable product economics.
U.S. Catalyst Ahead: A positive H2 2026 decision on the bevacizumab BLA would add a second major U.S. commercial asset alongside HLX14 denosumab, which secured U.S., EU and U.K. approvals in late 2025 and is already contributing revenue.
Trastuzumab Dependency: HANQUYOU accounts for ~50% of global product sales, keeping concentration risk in focus even as pertuzumab, neratinib and fovecitinib build the broader breast cancer portfolio.
Pipeline Velocity: 32 IND and 25 MAA approvals in a single half-year across ~50 countries support continued multi-market launch cadence into 2027.
Forward‑Looking Statements This brief contains forward‑looking statements regarding regulatory decisions, product launches, and commercial expectations for Henlius and its portfolio. Actual results may differ due to risks including regulatory timelines, market adoption, pricing dynamics, and competitive pressures.-Fineline Info & Tech
By Fineline Cube 