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, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Application (NDA) 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 commercialization. It has established global innovation centers. It manufactured and operated in line with global Good Manufacturing Practice (GMP) and built an integrated manufacturing platform with Shanghai-based Xuhui Facility certificated by China and the EU GMP, and Songjiang First Plant certificated by China 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, 汉达远® (adalimumab) and 汉贝泰® (bevacizumab), the NDA of innovative product 汉斯状® (serplulimab) indicated for MSI-H solid tumors has been approved by the NMPA, and the NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review.


Up to Now

In addition to 5 products and 13 indications launched commercially and 2 NDAs accepted for review, Henlius has conducted over 20 clinical studies for 12 products and 10 immuno-oncology 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. In March 2022, the company’s first self-developed innovative monoclonal antibody, 汉斯状® (serplulimab injection), was approved by the NMPA for the treatment of Microsatellite Instability-High (MSI-H) solid tumors. Meanwhile, and the NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review.

Company Milestone
  • 2022
  • 2021
  • 2020
  • 2019
  • 2018
  • 2017
  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
    • HLX35 (anti-4-1BB*EGFR bispecific antibody) IND approval in China for the treatment of advanced malignant solid tumors
    • HLX208 (BRAF Inhibitor) IND approval in China for the treatment of BRAF V600E or BRAF V600 mutation-positive advanced solid tumors
    • First subject dosed with HLX301 (anti-PD-L1*TIGIT bispecific antibody) in Phase 1 clinical trial in Australia 
    • BRAF Inhibitor HLX208 IND for Phase 1b/2 Studies Approved by NMPA
    • First subject dosed in the phase 2 clinical trial of serplulimab plus HLX07 to treat EGFR high expression sqNSCLC patients
    • Entered into a collaboration with Getz Pharma to commercialise adalimumab biosimilar 汉达远, covering 11 emerging markets in Asia, Africa and Europe
    • 汉利康®  (rituximab injection) approved for the treatment of rheumatoid arthritis (RA) in China
    • 汉斯状® (serplulimab injection) was approved by the NMPA for the treatment of Microsatellite Instability-High (MSI-H) solid tumors
    • 汉斯状® (serplulimab injection) IND for MRCT Phase 3 Studies on First-Line LS-SCLC Patients Approved by NMPA
    • 汉斯状® (serplulimab injection) Granted Orphan-Drug Designation in the United States for Small Cell Lung Cancer
    • First Patient dosed in a Global Multicentre Phase 3 Clinical Study of HLX04-O for treatment of Ophthalmic Diseases in the EU
    • The NDA of 汉斯状® (serplulimab injection) for the First-Line Treatment of Small Cell Lung Cancer Accepted by NMPA
  • 汉贝泰® (bevacizumab injection) approved in China
  • Serplulimab (anti-PD-1 mAb) + HLX07 (anti-EGFR mAb) IND approvals for solid tumors
  • Serplulimab (anti-PD-1 mAb) Phase 3 clinical study for the treatment of first-line extensive-stage small cell lung cancer meeting primary study endpoint
  • HLX301 (anti-PD-L1*TIGIT bispecific antibody) Clinical Trial Notification acknowledged by the Therapeutic Goods Administration in Australia
  • Entering into strategic coopertation for ADC with NOVACYTE Therapeutics
  • HLX11 (pertuzumab biosimilar) Phase 1 clinical trial completed
  • First subject dosed in Phase 2 clinical trial to compare HLX22 (anti-HER2 mAb) in combination with 汉曲优® (trastuzumab) and chemotherapy as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients in Chinese mainland
  • Serplulimab (anti-PD-1 mAb) NDA for the treatment of MSI-H solid tumors and squamous non-small cell lung cancer accepted for review by the NMPA 
  • "B" marker ceases to be affixed to the Company's stock code
  • 汉曲优® (trastuzumab) sNDA approval for the new dosage form of 60 mg/vial
  • 汉达远® (adalimumab injection) sNDA approval for the treatment of noninfectious uveitis in China
  • First subject dosed with COVID-19 drug candidate HLX71 in Phase 1 clinical trial in the United States
  • HLX23 (anti-CD73 mAb) IND approval for advanced solid tumors by the FDA in the United States
  • First subject dosed with HLX26 (anti-LAG-3 mAb) in Phase 1 clinical trial in patients with advanced/metastatic solid tumours or 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 subject 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