Henlius Reports 27.3% Revenue Growth and Higher Profit on Robust Product Sales and Global Expansion

Bulletin Express08-21

Shanghai Henlius Biotech, Inc. released unaudited 1H 2026 results showing revenue of RMB 3.59 billion, up 27.30% year on year (1H 2025: RMB 2.82 billion). Drug sales, R&D services and licence income drove the topline, with global product sales contributing RMB 2.94 billion, an increase of 14.90%.

Total profit reached RMB 430.40 million, rising 10.30% from RMB 390.10 million a year earlier, supported by higher volumes of core commercial products and a four-fold jump in overseas profit (RMB 59.50 million). Non-IFRS profit advanced 46.70% to RMB 572.30 million; Non-IFRS EBITDA climbed 35.20% to RMB 904.10 million.

R&D expenditure expanded 45.70% to RMB 1.45 billion, reflecting accelerated investment in over 50 innovative assets across ten platforms, including monoclonal antibodies, ADCs, bispecifics and small molecules. Expensed R&D totalled RMB 826.00 million, up 41.10%.

Cash and bank balances stood at RMB 818.38 million as at 30 June 2026 (31 Dec 2025: RMB 772.21 million). Net current liabilities narrowed to RMB 1.05 billion, and the gearing ratio improved to 40.80% (31 Dec 2025: 43.20%).

Commercial portfolio expansion continued: • Ten marketed products across 60+ jurisdictions now benefit more than 1.1 million patients. • PD-1 antibody HANSIZHUANG obtained three new EU indications and approvals in Hong Kong, South Korea, Brazil and others, bringing total marketing authorisations to 50 regions. • Pertuzumab biosimilar HLX11 (POHERDY®) secured approvals in the EU and UK. • Denosumab biosimilars HLX14 (BILDYOS®/TUZEMTY®) were cleared in Canada.

Strategic partnerships strengthened: • February 2026: licensing agreement with Eisai for Japanese rights to HANSIZHUANG. • Amendment with Abbott expanded HANSIZHUANG coverage to 42 additional territories across Asia, Middle East, Africa and Eastern Europe. • August 2026: framework with Sandoz for up to ten mAb/ADC biosimilars; first three products already designated.

Pipeline progress: • 32 IND approvals and 25 NDA filings across nearly 50 countries during 1H 2026. • Key clinical milestones include multi-regional Phase 1–3 studies for HLX43 (PD-L1 ADC), HLX22 (anti-HER2 mAb) and HLX04-O (anti-VEGF for wet AMD, met Phase 3 primary endpoint). • Domestic NDA approval received for gastric-cancer perioperative indication of HANSIZHUANG; U.S. BLA submission for ES-SCLC first-line therapy planned in 2H 2026.

Manufacturing capacity: • Xuhui Facility completed FDA pre-marketing GMP inspection for HANBEITAI. • Songjiang First Plant passed GMP inspection for HLX11; Songjiang Second Plant Phase I completed acceptance, adding 36,000 L capacity.

No interim dividend declared. Principal place of business in Hong Kong changed to Room 1917, 19/F, Lee Garden One, 33 Hysan Avenue, Causeway Bay, effective 21 August 2026.

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