Driven by rapid advancements in antibody engineering, immunotherapy development, and AI-empowered drug research, the global biopharmaceutical landscape has undergone substantial structural upgrades in recent years. A growing number of Asia-based biotech enterprises have completed global quality system verification and built cross-border commercial capabilities, emerging as important participants in international clinical treatment markets. Among them, Shanghai Henlius Biotech (2696.HK) stands out as a representative player with dual layout of biosimilar business and innovative drug pipeline.
Headquartered in Shanghai, China and listed on the Hong Kong Stock Exchange, Henlius has evolved from a biosimilar-focused company into an integrated biopharmaceutical company with expanding global capabilities. Differentiated from pure innovative drug biotechs and single-model biosimilar manufacturers, the company adopts a dual-drive operational structure: mature and profitable biosimilar products provide continuous cash flow, while diversified innovative pipelines support long-term product iteration and market competitiveness.
Founded in 2010, Henlius has established a full industrial chain system covering global R&D, multi-center clinical development, international regulatory declaration, GMP-standard production and cross-border commercialization. The company’s workforce of over 4,000 is distributed across China, the United States, Japan and other core pharmaceutical regions, supporting synchronous project advancement and market layout in multiple global regions.
One of Henlius’ core operational characteristics is its self-sustaining R&D mechanism. The stable revenue generated from commercialized biosimilar portfolios is continuously reinvested into innovative drug research and development, effectively reducing reliance on external financing. This business model ensures stable pipeline iteration and sustained technological iteration, laying a solid foundation for the steady advancement of its Globalization 2.0 strategic layout. In the highly competitive global biopharmaceutical industry, this profit-reinvestment cycle enables the company to balance operational stability and long-term technological innovation.
The global compatibility of R&D and manufacturing standards is the core threshold for biopharmaceutical enterprises to enter mainstream Western markets. Henlius has completed systematic verification in the world’s most stringent regulatory environments. Up to date, the company has obtained marketing authorizations for 10 products in more than 60 countries and regions worldwide, including 8 approved products in the Chinese market.
In high-barrier Western markets, four Henlius products have obtained marketing authorization from the U.S. Food and Drug Administration (FDA), and five products have been approved by the European Commission (EC). The company has passed multiple on-site inspections and audits by global regulatory authorities and international partners, supporting the alignment of its manufacturing and quality systems with major international regulatory requirements. The series of global regulatory approvals confirms that Henlius’ product quality meets the unified evaluation standards of international mainstream pharmaceutical markets.
Henlius focuses its clinical research and technological layout on three core therapeutic fields: oncology, autoimmune diseases, and ophthalmology. R&D centers in Shanghai and the United States operate collaboratively to launch synchronous global clinical trials and regulatory submissions, accelerating the overseas landing of innovative products.
The company has built a diversified technological platform covering immune checkpoint inhibitors, multi-specific T-cell engagers, antibody-drug conjugates (ADCs) and AI-assisted early drug discovery. At present, Henlius has more than 50 early-stage innovative assets in its pipeline, nearly 70% of which have best-in-class therapeutic potential. Over 30 global multi-center clinical trials are currently in progress. The pipeline covers multiple innovative action mechanisms, forming a differentiated product layout for refractory and difficult-to-treat diseases.
Serplulimab (trade name: Hetronifly® in Europe, Hansizhuang in China, investigational code: HLX10) is Henlius’ flagship PD-1 monoclonal antibody. The product has differentiated clinical positioning in global cancer treatment, as the world’s first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and perioperative treatment of gastric cancer.
Serplulimab has continuously expanded its indication layout in Europe. Following the European Commission’s approval for ES-SCLC in early 2025, the product obtained three additional EU indications in 2026, covering non-squamous non-small cell lung cancer (nsqNSCLC), esophageal squamous cell carcinoma (ESCC/OSCC), and squamous non-small cell lung cancer (sqNSCLC).
To date, serplulimab has been approved for marketing in more than 50 countries and regions worldwide. The product has been commercially launched in 16 European countries and has successfully secured medical insurance reimbursement qualifications in 12 European countries including the United Kingdom, Germany, Italy, Spain and Sweden. At the same time, the company continues to advance serplulimab’s regulatory and commercial development in additional international market, including the U.S. and Japans.
Henlius maintains a balanced product matrix of commercial biosimilars and innovative pipeline assets, ensuring stable market revenue while reserving long-term growth potential.
HLX04, a bevacizumab biosimilar marketed as Hanbeitai in China, covers multiple solid tumor indications such as metastatic colorectal cancer, non-small cell lung cancer, recurrent glioblastoma, hepatocellular carcinoma and gynecological malignancies. The product is currently with a U.S. FDA’s decision on its Biologics License Application expected in the second half of 2026..
In the innovative drug sector, two pipeline candidates have entered key clinical development stages. HLX43, a PD-L1 targeted ADC product, released positive early-phase clinical data for non-small cell lung cancer at the 2026 ASCO Annual Meeting. Dulpatatug (HLX22), a novel epitope-targeted anti-HER2 monoclonal antibody, is making steady progress in an international multi-center phase 3 clinical study that features a head-to-head comparison against the current first-line standard of care for HER2-positive gastric cancer. First patient enrollment has been completed across a broad geographic footprint, including China, the U.S., Europe, Japan, Australia, South Korea, and Latin America. The two candidates further enrich Henlius’ oncology product matrix and form a complementary layout with existing immune checkpoint therapies.
Henlius has built an integrated biopharmaceutical production network with a total capacity of 84,000 liters, holding GMP certifications from China, the European Union and the United States. The standardized production system supports stable product supply across six continents, meeting the growing market demand in both mature European and American markets and emerging markets.
To accelerate local market access and commercial operation progress in international markets, Henlius works with a broad network of international partners, including Accord, Organon, Eisai, Abbott and Sandoz, under different licensing, commercialization and development models. Relying on local partners’ channel resources, the company realizes efficient global commercialization and regional market adaptation of its products.
After years of layout, Henlius has evolved from a biosimilar-focused company into an integrated biopharmaceutical company with expanding global capabilities. Supported by internationally recognized quality systems, self-sustaining R&D cycle, multi-mechanism innovative pipeline and mature cross-border commercial capabilities, the company has established stable market positions in global mainstream pharmaceutical regions. With the continuous advancement of global clinical projects and overseas market expansion, Henlius is gradually becoming an important participant in the global innovative biopharmaceutical market.
MBTPG/ARC)