Henlius: A China-Based Biopharmaceutical Company Driving Global Innovation

Company Overview

Henlius (2696.HK) is a Chinese biopharmaceutical company headquartered in Shanghai, focused on the research, development, production and commercialization of biologic drugs. 

Founded in 2010, Henlius has built an integrated, end-to-end biopharmaceutical platform spanning global R&D, clinical operations, regulatory affairs, manufacturing, and commercialization. It has over 4000 employees across key regions including China, the United States, and Japan.  

Henlius reinvests cash flow generated from its commercial biosimilar products into innovative research and development. This operating model has supported the company’s Globalisation 2.0 transition and underpinned its scalable global growth framework. Leveraging internal operating proceeds, Henlius has expanded its biosimilar and innovative biologic pipeline with limited reliance on external financing. 

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).  

Oncology Focus and the Hetronifly (Serplulimab) Franchise

Oncology is a cornerstone of Henlius’ global strategy. Through its standardized global manufacturing and regulatory compliance systems,the company develops novel and clinically optimized biologic drugs targeting areas with significant unmet needs. Its oncology pipeline includes a range of clinically validated immuno-oncology therapies. 

Henlius builds its oncology pipeline around serplulimab (marketed as Hetronifly® in Europe and Hansizhuang in China, internal code: HLX10), a PD-1 monoclonal antibody. The drug has secured world-first approvals as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) and for perioperative treatment of gastric cancer. As a uniquely positioned PD-1 inhibitor, serplulimab has shown consistent efficacy and a favorable safety profile in clinical trials across multiple solid tumor indications. 

Following its European approval for ES-SCLC in early 2025, serplulimab further expanded its approved indications in the European market in 2026, gaining new authorizations for the treatment of non-squamous non-small cell lung cancer (nsqNSCLC), esophageal squamous cell carcinoma (ESCC), and squamous non-small cell lung cancer (sqNSCLC). 

Beyond standard PD-1/PD-L1/PD-L2 blockade, serplulimab features a differentiated triple-mode immune-activating profile：

1. Enhanced PD-1 receptor internalization on T-cells
2. Unique reversed-domain binding structure to PD-1
3. Preservation of CD28 co-stimulatory signalling, sustaining durable anti-tumour T-cell activity.

These mechanistic advantages have translated into consistent clinical outcomes, facilitating the rapid expansion of both approved indications and geographic reach. To date, Serplulimab has obtained marketing authorizations in more than 50 countries and regions, including 16 EU member states, UK, Singapore, South Korea and India. Reimbursement has been secured in 12 European territories, including UK, Austria, Denmark, Germany, Ireland, Italy, Spain and Sweden. As of July 2026, It has been recommended by the National Institute for Health and Care Excellence (NICE) for routine use within the National Health Service (NHS) in England and Wales.  

Pivotal ASTRUM-series studies of Serplulimab have been published in The Lancet and JAMA Oncology, presented at ASCO / ESMO, and incorporated into CSCO clinical guidelines. Its globalization trajectory continues to accelerate, with additional regulatory submissions advancing across North America and other global markets. 

Commercial Biosimilars and Global Market Expansion

Alongside its flagship PD-1 program, Henlius is advancing a robust global portfolio of commercial-stage biosimilars. HLX04, a bevacizumab biosimilar marketed as Hanbeitai in China, has established indications across metastatic colorectal cancer, non-small cell lung cancer, recurrent glioblastoma, hepatocellular carcinoma, epithelial ovarian cancer, and cervical cancer. It is currently undergoing marketing authorization review in the United States as a first entry point for the company’s North American commercial expansion. In January 2026, the U.S. FDA accepted the review of the Biologics License Application (BLA) submitted by Henlius for HLX04. 

Late-Stage Innovative Clinical Pipeline

Beyond its commercial biosimilar portfolio, Henlius is advancing a pipeline of innovative drug candidates through global pivotal clinical trials. Key clinical-stage assets include:

• HLX43, a PD-L1 antibody-drug conjugate with preliminary clinical data in non-small cell lung cancer presented at the 2026 ASCO Annual Meeting.
• HLX22 (dulpatatug), an anti-HER2 monoclonal antibody targeting a distinct epitope, which is in the progress of an international multi-center phase III clinical study that features a head-to-head comparison against the current first-line standard of care for HER2-positive gastric cancer.

These candidates broaden Henlius’ innovative oncology pipeline and complement its existing immuno-oncology treatments. The company’s overall pipeline spans validated biosimilars, next-generation immune checkpoint inhibitors, antibody-drug conjugates and multispecific molecules. 

Global Biomanufacturing Network

Henlius operates a self-owned biomanufacturing network to support its global clinical and commercial operations. The facilities maintain GMP compliance for China, the EU and the U.S., adhering to consistent international quality standards. This established manufacturing base enables reliable global supply across mature and emerging markets, supporting sustained product delivery amid rising clinical and commercial demand. To date, the company has completed more than 1,400 GMP commercial production batches and successfully passed over 100 on-site inspections and audits conducted by regulatory authorities worldwide and international collaborators, with a 100% pass rate.