Antibody engineering, immunotherapy and AI-driven drug discovery continue to reshape global biopharma. More Asian biotech companies are clearing strict international quality audits and building overseas sales capabilities. Henlius (2696.HK), headquartered in Shanghai, China,is a global biopharmaceutical company developing both biosimilars and innovative biologics, while building integrated capabilities across R&D, clinical development,regulatory affairs, manufacturing and commercialisation to support its continued global expansion. Its strategy rests on two pillars: cash flow from commercial biosimilars and a broad pipeline for future competition. The review below draws on Henlius’s public disclosures and looks at three areas: industrial layout, product competitiveness and business performance under Globalisation 2.0. Figures are as reported by the company.
Henlius describes Globalisation 2.0 as a shift from “product going overseas” to “system going overseas”, with international expansion as the core goal. It aims to build full-chain capabilities across R&D, clinical development, regulatory affairs, manufacturing and commercialisation. CEO Dr.Jason Zhu said at JPM 2026 that biosimilar cash flow funds innovative R&D and pushes differentiated molecules into global markets. The stated goal is to become a China-headquartered multinational biopharmaceutical company (C-MNC).
I. Industrial Layout
Founded in 2010, Henlius says it has built a full drug value chain covering global research, multi-country clinical trials, cross-border regulatory submissions, GMP manufacturing and international commercialisation to support this international expansion. Over 4,000 employees work across key pharmaceutical hubs in China, the United States,Europe, and Japan. The company uses a self-funded R&D model: revenue from marketed biosimilars funds early-stage innovative-drug research.
As of early 2026, Henlius reported ten medicines approved in more than 60 countries and regions, including four FDA authorisations and five European Commission clearances. Henlius has passed more than 100 on-site inspections and audits conducted by global regulatory authorities and international partners, with a reported 100% pass rate. Manufacturing capacity reaches 84,000 litres with tri-regional GMP certifications, supplying products across six continents. In H1 2026, the company gained 32 new clinical approvals and 25 marketing authorisations. Cumulatively, it has completed more than 1,400 GMP commercial batches and shipped drug batches overseas.
For Western-market access, Henlius partners with Accord, Dr. Reddy’s, Organon and Sandoz, among others. In 2026 it announced three major international strategic collaborations: granting Eisai exclusive rights for serplulimab commercialisation in Japan; Abbott expanded the drug across multiple emerging regions; and Henlius signed a broad biosimilar collaboration with Sandoz.
II. Product Competitiveness
Henlius focuses R&D on oncology, autoimmune conditions and ophthalmology, with laboratories in Shanghai and the United States running joint global clinical programmes. Its in-house platforms cover immune checkpoint modulators, multi-specific T-cell engagers, ADCs and AI-driven molecule screening. More than 50 innovative candidates are in the pipeline, nearly 70% of which the company describes as showing potential best-in-class signals; more than 50 clinical trials are ongoing. H1 2026 R&D spending reached RMB 1.4507 billion, up 45.7% year-on-year, about 40.4% of total revenue.
Serplulimab (trade name: Hetronifly® in Europe, HANSIZHUANG in China, investigational code: HLX10), the company’s PD-1 monoclonal antibody, is authorised in more than 50 countries and regions and reimbursed in over 10 key European markets, with H1 2026 global sales of RMB 597.5 million. Among biosimilars, HLX04 is under FDA review. Its breast-cancer product portfolio generated global H1 sales of RMB 1.6983 billion. HANBEIYOU became the first and only Chinese-developed pertuzumab biosimilar approved in China, the US and EU. Two innovative candidates, HLX43 and Dulpatatug (HLX22), have entered pivotal global clinical trials.
III. Business Performance
For the H1 results ending 30 June 2026, Henlius reported total revenue of RMB 3.5882 billion (+27.3% year-on-year) and net profit of RMB 430.4 million (+10.3% year-on-year). Non-IFRS profit was RMB 572.3 million (+46.7% year-on-year). Ten commercial products serve more than 1.1 million patients worldwide. Overseas revenue rose 159.4% year-on-year to RMB 105.3 million, while overseas product profit was more than four times the H1 2025 figure.
Taken together, the disclosures above cover multi-country approvals, manufacturing capacity, partnerships and overseas revenue—the elements Henlius associates with Globalisation 2.0. Henlius states that it aims to become a full-value-chain Chinese multinational biopharma.
