Amid the rapid evolution of the global biopharmaceutical industry, a growing number of biopharmaceutical players are bringing new treatment options to patients worldwide. For many Western clinicians, payers, and industry analysts, one name has risen in prominence over the past decade: Henlius. But what kind of company is Henlius? Headquartered in Shanghai and listed on the Hong Kong Stock Exchange (2696.HK), Shanghai Henlius Biotech, Inc. is a Chinese biopharmaceutical company with a global, innovation-driven mandate, dedicated to expanding access to biologic therapies for patients around the world. With core therapeutic focuses in oncology, autoimmune diseases, and ophthalmology, the firm has built a reputation for advancing both established biosimilar products and a rapidly expanding pipeline of innovative biologics and next-generation therapies.
Founded in 2010, Henlius has built an integrated, end-to-end biopharmaceutical platform spanning global R&D, clinical operations, regulatory affairs, manufacturing, and commercialization. Today, it employs nearly 4,000 people across key regions including China, the United States, and Japan. A defining feature of its business model is its strategy to reinvest stable cash flow from its established biosimilar portfolio into innovative research, a framework that has steadily moved the company into its “Globalisation 2.0” phase and supported the buildout of a scalable, sustainable global growth model. This self-sustaining approach has allowed Henlius to steadily expand its portfolio of both biosimilars and innovative biologics without overreliance on external capital.
As of early 2026, Henlius has secured regulatory approvals for 10 products across over 60 countries and regions worldwide, including 8 approvals in China. It has also notched key milestones in the world’s most stringent biopharmaceutical markets: 4 products have earned approval from the U.S. Food and Drug Administration (FDA), and 5 have been authorized by the European Commission (EC). These regulatory approvals reflect the company’s globally aligned R&D capabilities,quality systems, and manufacturing standards—and signal that its portfolio of innovative biologics and biosimilars meets the same rigorous benchmarks as longstanding Western industry leaders. The company has passed mutltiple FDA GMP inspections with zero Form 483 observations, underscoring its commitment to manufacturing excellence for U.S. patients.
As an innovation-driven biopharmaceutical company with deep expertise in antibody engineering, Henlius anchors its long-term growth strategy in a diversified innovation pipeline. Early-stage research activities are conducted across coordinated R&D hubs in Shanghai and the U.S., while product development is executed on a global basis. The company’s diversified, platform-based technology ecosystem spans immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early drug discovery platforms. Currently, it has more than 50 early-stage innovative assets in its pipeline, roughly 70% of which are positioned as potential best-in-class candidates, with over 30 clinical trials ongoing globally. This broad, mechanism-diverse portfolio solidifies Henlius’ standing as a developer of differentiated biologic medicines, with programs designed to address gaps in care across a wide range of diseases.
The centerpiece of Henlius’ oncology portfolio is serplulimab (marketed under the trade name Hetronifly® in Europe, trade name in China is Hansizhuang, company code: HLX10), a PD-1 monoclonal antibody that earned global recognition as the world’s first anti–PD-1 mAb approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and for perioperative gastric cancer. As a differentiated PD-1 inhibitor, serplulimab has demonstrated robust clinical efficacy and safety profiles across multiple solid tumor types, distinguishing it within a crowded therapeutic class.
Following its EC approval for ES-SCLC in early 2025, serplulimab expanded its European label significantly in 2026, securing subsequent regulatory approvals for non-squamous non-small cell lung cancer (NSCLC), oesophageal squamous cell carcinoma (OSCC, also written as esophageal squamous cell carcinoma, abbreviated as ESCC), and squamous non-small cell lung cancer (sqNSCLC) .To date, the PD-1 agent has been approved in over 50 markets worldwide, with commercial launch completed in 16 EU countries, and reimbursement secured in over 10 European countries including UK, Austria, Denmark, Germany, Ireland, Italy, Spain and Sweden. Its globalization trajectory continues to accelerate, with additional regulatory submissions advancing across North America and other global markets.
Alongside its flagship PD-1 program, Henlius is advancing a robust global pipeline encompassing both commercial-stage biosimilars and late-stage innovative assets. Its HLX04, a bevacizumab biosimilar marketed as Hanbeitai in China with established indications across metastatic colorectal cancer, non-small cell lung cancer, recurrent glioblastoma, hepatocellular carcinoma, epithelial ovarian cancer and cervical cancer, is currently undergoing marketing authorization review in the United States as a first entry point of the company’s North American commercial expansion. Beyond biosimilars, Henlius is progressing multiple high-potential innovative molecules through global pivotal clinical development. These include HLX43, a PD-L1-targeting antibody-drug conjugate whose early NSCLC data was presented at the 2026 ASCO Annual Meeting, and HLX22, an anti-HER2 monoclonal antibody targeting a novel epitope that has received FDA clearance to initiate Phase III trials in the U.S. Collectively, these candidates expand the company’s innovative oncology portfolio and complement its existing lineup of tumor immunotherapy therapies. The full breadth of its pipeline—from validated biosimilar agents to next-generation checkpoint inhibitors, antibody-drug conjugates and multispecific engagers—underscores Henlius’ ambition to address unmet clinical needs across oncology and other diseases.
As a fully integrated global biopharmaceutical company, Henlius backs its global commercial and clinical ambitions with a robust biologics manufacturing network with a total capacity of 84,000 liters, holding GMP certifications from regulatory authorities in China, Europe, and the United States. This infrastructure has allowed Henlius to establish a stable global supply system that serves six continents, ensuring that its biologic medicines can reach patients reliably even as demand grows across established and emerging markets. The company collaborates with established regional commercial players including Accord, Dr. Reddy’s, Organon, and Sandoz to accelerate market access and enable local commercialization across North America and Europe.
Guided by a patient-centered mission and its commitment to local markets including the US, Henlius has evolved from a biosimilar pioneer into a fully integrated global biopharmaceutical company with growing innovation capabilities. As its pipeline advances and global footprint expands, it is positioned to play an increasingly visible role in delivering innovative, high-quality biologic medicines to patients worldwide.
