EN
Improve patients' lives by timely providing them with

quality and affordable protein therapeutics

Company Profile

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDA) of 3 products accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康® (rituximab), the first China-developed biosimilar, 汉曲优® (trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远® (adalimumab), the Company's first product indicated for autoimmune diseases, the NDAs of HLX04 (bevacizumab) and the two innovative mAbs HLX01 (rituximab) indicated for rheumatoid arthritis and serplulimab indicated for MSI-H solid tumors are under review. What's more, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.

Up to Now

In addition to 3 products launched commercially and 3 products under NDA review, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. 汉利康® (rituximab injection), the first product of Henlius, has been approved by the National Medical Products Administration (NMPA) as China's first biosimilar. The second product 汉曲优® (trastuzumab, Zercepac® in the EU) is the first Chinese mAb biosimilar approved both in the EU and China, bringing more treatment options to patients with HER2 positive breast and gastric cancer worldwide. HLX01 (rituximab injection) indicated for rheumatoid arthritis, HLX04 (bevacizumab injection) and HLX10 (serplulimab injection) were accepted for NDA review by the NMPA.

Company Milestone
  • 2021
  • 2020
  • 2019
  • 2018
  • 2017
  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
  • "B" marker ceases to be affixed to the Company's stock code
  • 汉达远® (adalimumab injection) sNDA approval for the treatment of noninfectious uveitis in China
  • Serplulimab (anti-PD-1 mAb) NDA accepted for review by the NMPA and be granted priority review status
  • First subject dosed in Phase 1 clinical trial of COVID-19 drug candidate HLX71 in the United States
  • HLX23 (anti-CD73 mAb) IND approval for advanced solid tumors by the FDA in the United States
  • HLX26 (anti-LAG-3 mAb) IND approval for solid tumors and lymphomas in China
  • HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection) clinical trial approvals obtained in China, Australia, the United States, Singapore and multiple EU countries. The first patient was dosed in Phase 1 clinical study in China in July.
  • Entering into a license agreement with NeuPharma for licensing in a small-molecule inhibitor of BRAF V600E HLX208
  • Entering into a license agreement with Chiome for licensing in antibodies targeting human TROP2
  • 汉达远® (adalimumab injection) approved in China
  • 汉曲优® (trastuzumab, Zercepac® in the EU) successively approved in the EU and China 
  • The drug substance (DS) line and drug product (DP) line for 汉曲优® (trastuzumab, Zercepac® in the EU) of Xuhui Manufacturing Facility passing the EU GMP on-site inspection, certificated by the EU GMP
  • HLX01 (rituximab injection) -RA NDA accepted for review by the NMPA
  • HLX04 (bevacizumab injection) NDA accepted for review by the NMPA
  • HLX70 (SARS-CoV-2 neutralizing antibody) and HLX71 (ACE2-Fc fusion protein) IND approvals by the FDA for the treatment of COVID-19 etc.
  • First patients dosed in China in a Phase 1 clinical trial of HLX11 (pertuzumab biosimilar), in a Phase 1 clinical trial of HLX14 (denosumab biosimilar) and in a Phase 2 clinical trial of Serplulimab (anti-PD-1 mAb) in combination with HLX07 (anti-EGFR mAb) for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck
  • HLX13 (ipilimumab biosimilar) IND approval in China; HLX15 (daratumumab biosimilar) IND application accepted for review in China
  • Entering into a license agreement with Accord US to develop and commercialise 汉曲优® (trastuzumab, Zercepac® in the EU) in the United States and Canada
  • Entering into a license agreement with Mabxience to develop and commercialise 汉曲优®(trastuzumab, Zercepac® in the EU) in Argentina, Uruguay and Paraguay
  • Entering into a global co-development and exclusive license agreement with Essex to jointly develop HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection) for the treatment of ophthalmic diseases 
  • National Science and Technology Major Project in the 13th Five-year Plan of China —— Major New Drug Research & Development Project
  • Listed on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code: 2696.HK
  • 汉利康® (rituximab injection) approved as the first biosimilar in China
  • 汉曲优® (trastuzumab, Zercepac® in the EU) NDA accepted for review and granted priority review status in China and MAA accepted for review in Europe 
  • 汉达远® (adalimumab injection) NDA accepted for review and granted priority review status in China; Phase 3 clinical trial completed
  • Entering into a license agreement with KG Bio to develop and commercialise Serplulimab (anti-PD-1 mAb) in 10 Southeast Asia countries
  • HLX22 (anti-HER2 mAb) IND approval, HLX55 (anti-c-MET mAb) IND approval and HLX04 (bevacizumab injection) IND approvals for two ocular diseases in China
  • Serplulimab (anti-PD-1 mAb) + HLX07 (anti-EGFR mAb) ( the second domestic dual mAbs combination therapy) IND approvals for recurrent or metastatic head and neck squamous cell carcinoma
  • HLX11 (pertuzumab biosimilar) IND application accepted for review by the NMPA
  • Serplulimab (anti-PD-1 mAb) IND approval in China
  • The first China-developed mAb combination therapy Serplulimab (anti-PD-1 mAb) + HLX04 (bevacizumab injection) IND approval in China
  • A Phase 3 clinical trial for HLX01 (rituximab injection)-RA initiated in China
  • HLX20 (anti-PD-L1 mAb) clinical approvals in Australia and China with Phase 1 clinical trial initiated in Australia
  • A Phase 1b/2 clinical trial for HLX07 (anti-EGFR mAb) initiated in China
  • HLX12 (ramucirumab biosimilar) IND approval in China
  • Two projects initiated and sponsored by "National Science and Technology Major Project in the 13th Five-year Plan of China —— Major New Drug Research & Development Project"
  • Entering into license agreements with multiple international partners such as Accord and Cipla
  • Series B capital increase of about ¥1.259 billion and Series C capital increase of about $156.5 million completed successively
  • 汉利康® (rituximab injection) NDA accepted for review in China and granted Drug Manufacturing Certificate
  • A global, multi-centre Phase 3 clinical trial in Ukraine, Poland, and the Philippines initiated for 汉曲优® (trastuzumab, Zercepac® in the EU)
  • A Phase 3 clinical trial initiated for 汉达远® (adalimumab injection) for psoriasis
  • Serplulimab (anti-PD-1 mAb) IND approval in the United States
  • Shanghai Henlius Biologics Co., Ltd. founded in Shanghai
  • Official agreement concluded with People's Government of Songjiang to locate the second manufacturing facility in Songjiang, Shanghai
  • The construction of Xuhui Manufacturing Facility in Shanghai Caohejing Hi-Technology Park completed
  • 汉曲优® (trastuzumab, Zercepac® in the EU) IND approval for gastric cancer in China
  • HLX04 (bevacizumab injection) IND approval for non-small cell lung cancer in China
  • HLX05 (cetuximab biosimilar) IND approval for metastatic colorectal cancer and squamous cell carcinoma of the head and neck in China
  • HLX07 (anti-EGFR mAb) IND approvals for solid tumors in China and the United States
  • 汉曲优® (trastuzumab, Zercepac® in the EU) IND approval for breast cancer in China
  • 汉达远® (adalimumab injection) IND approval for rheumatoid arthritis in China
  • HLX04 (bevacizumab injection) IND application filed for metastatic non-small cell lung cancer in China
  • HLX04 (bevacizumab injection) IND approval for metastatic colorectal cancer in China
  • HLX07 (anti-EGFR mAb) IND application filed for solid tumors in China
  • HLX04 (bevacizumab injection) IND application filed for metastatic colorectal cancer in China
  • 汉利康® (rituximab injection) IND approval for non-Hodgkin lymphoma in China
  • The Company's first "National Science and Technology Major Project in the 12th Five-year Plan of China —— Major New Drug Research & Development Project" passing the inspection
  • 汉达远® (adalimumab injection) IND application filed for rheumatoid arthritis in China
  • The Company's second "National Science and Technology Major Project in the 12th Five-year Plan of China —— Major New Drug Research & Development Project"
  • 汉曲优® (trastuzumab, Zercepac® in the EU) IND application filed for breast cancer in China
  • The Company's first "National Science and Technology Major Project in the 12th Five-year Plan of China —— Major New Drug Research & Development Project"
  • 汉利康® (rituximab injection) IND application filed for non-Hodgkin lymphoma in China
  • Shanghai Henlius Biotech, Inc. founded