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. 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 R&D facilities in Shanghai and California as well as a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).

Inspired by the vision and attracted by the corporate culture, a team of highly-skilled talents are thus assembled with extensive experience across research & development, clinical development, manufacturing, commercialisation, regulatory affairs, CMC, quality and compliance, etc. at leading multinational pharmaceutical companies. 

Henlius established the first manufacturing facility featuring the core technology of single-use bioreactors in Shanghai Caohejing Hi-Technology Park in 2016. The facility has passed the multiple on-site inspections conducted by the National Medical Products Administration (NMPA), European Medicines Agency (EMA), EU QP (Qualified Person) and was certificated by China and the EU GMP. To further scale up the production capacity, Henlius has also located manufacturing facilities in Songjiang District. Songjiang Manufacturing Facility (First Plant) has a planned production capacity of 24,000L. GMP production for clinical samples has been conducted. Songjiang Manufacturing Facility (Second Plant) covers about 130,000 square meters (200mu). When fully operated, it is expected to manufacture over 20 products simultaneously, becoming the largest biologic medicine manufacturing facility in China. It strictly follows international GMP standards and adopts new technologies such as continuous manufacturing technology, single-use technology etc. The structure of the main production building of Phase 1 project has been completed.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to date, Henlius has launched three products, 汉利康® (HLX01, rituximab injection) , the first biosimilar approved in China, 汉曲优® (HLX02, trastuzumab injection, Zercepac® in the EU), the first Chinese mAb biosimilar launched in both China and Europe and 汉达远® (HLX03, adalimumab injection), the Company's first product for the treatment of autoimmune diseases, among which 汉曲优® will bring more treatment options to patients with HER2 positive breast and gastric cancer worldwide. In addition, HLX01 (rituximab injection) indicated for rheumatoid arthritis and HLX04 (bevacizumab injection) were accepted for New Drug Application (NDA) review by the NMPA. Henlius has also 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 2 products under NDA review, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. 汉利康® (HLX01, rituximab injection), the first product of Henlius, has been approved by the NMPA as China’s first biosimilar, which also makes it the first commercially launched monoclonal antibody biosimilar in accordance with Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative). The second product 汉曲优® (HLX02, trastuzumab injection, 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 and HLX04 (bevacizumab injection) were accepted for NDA review by the NMPA.

Company Milestone
  • 2021
  • 2020
  • 2019
  • 2018
  • 2017
  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
  • "Shanghai Anti-tumor Biologic Medicine Engineering and Technology Research Centre" Plaque Mounted
  • Entering into a cooperation and license agreement with NeuPharma for small-molecule inhibitor RX208 targeting V600E mutation in human BRAF protein to enrich the innovation pipeline
  • Phase 2 study of HLX10 (anti-PD-1 mAb) in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors that fail to respond to the standard therapy has met the primary endpoint with NDA filing in China expected soon based on the study results
  • First patient dosed in Phase 2/3 clinical trial of HLX10 (anti-PD-1 mAb) in combination with HLX04 (bevacizumab injection) for the first-line treatment of metastatic colorectal cancer
  • HLX04-O (recombinant anti-VEGF humanised monoclonal antibody ophthalmic injection) clinical trial approval by the Therapeutic Goods Administration, Australia and FDA, the United States for the treatment of wet age-related macular degeneration
  • 汉达远® (HLX03, adalimumab injection) for the treatment of noninfectious uveitis sNDA accepted for review by the NMPA
  • Entering into an exclusive license agreement with Chiome for antibodies targeting human TROP2, further expanding target landscape
  • The third product 汉达远® (adalimumab injection) approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis
  • HLX01 (rituximab injection) indicated for rheumatoid arthritis NDA accepted for review by the NMPA
  • HLX04 (bevacizumab injection) NDA accepted for review by the NMPA
  • National Science and Technology Major Project in the 13th Five-year Plan of China —— Major New Drug Research & Development Project
  • Projects of antibody and fusion protein against COVID-19 (HLX70 and HLX71) receiving support from the Ministry of Science and Technology
  • HLX70 (SARS-CoV-2 neutralizing antibody) and HLX71 (ACE2-Fc fusion protein) IND approvals by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 etc.
  • Entering into an exclusive license agreement with Accord Healthcare Inc. (Accord US) to develop and commercialise 汉曲优® (HLX02, trastuzumab injection, Zercepac® in the EU) in the US and Canada
  • Entering into a global co-development and exclusive license agreement with Essex, to jointly develop HLX04 (bevacizumab injection) for the treatment of ophthalmic diseases 
  • The second launched product 汉曲优®(HLX02, trastuzumab injection, Zercepac® in the EU) successively approved in the EU and China. It is indicated for 1) HER2 positive early breast cancer 2) HER2 positive metastatic breast cancer and 3) HER2-positive metastatic gastric cancer, namely all the approved indications of the trastuzumab originator.
  • 汉曲优®(HLX02, trastuzumab injection, Zercepac® in the EU) new dosage form of 60mg/vial sNDA accepted for review
  • HLX02 (trastuzumab injection) granted the EU GMP Certificate
  • 汉利康®, HLX01 (rituximab injection) sNDA approval for new indications and new dosage form of 500mg/50ml/vial, as well as the addition of 2,000L production scale
  • Entering into a cooperation agreement with Sanyou Biopharmaceuticals Co., Ltd. (“Sanyou Bio”) and Shanghai ZJ Bio-Tech Co., Ltd. (“ZJ Bio-Tech”) in relation to the cooperation to develop fully human antibody drug for COVID-19
  • First patient dosed in Chinese mainland in a Phase 1 clinical trial of HLX11 (pertuzumab biosimilar) for the treatment of breast cancer, in a Phase 1 clinical trial of HLX14 (denosumab biosimilar) for the treatment of postmenopausal women with osteoporosis at high risk for fracture and in a Phase 2 clinical trial of HLX10 (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
  • First patient dosed in the 8th PD-1 immuo-oncology combination therapy 
  • HLX13 (ipilimumab biosimilar) IND approval in Chinese mainland; HLX56 (anti-DR4 mAb) clinical approval in Taiwan China; HLX15 (daratumumab biosimilar) IND application accepted by the NMPA
  • Entering into an exclusive license agreement with Mabxience, a global biotechnology company, to develop 汉曲优®(HLX02, trastuzumab injection, Zercepac® in the EU) in Argentina, Uruguay and Paraguay
  • The compiling of the first popular science book on biosimilar in China initiated by the Company
  • 汉利康®, HLX01 (rituximab injection) approved as the first biosimilar in China and granted the Certificate of Good Manufacturing Practices for Pharmaceutical Products, People’s Republic of China
  • Listed on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code: 2696.HK
  • The construction of Songjiang Manufacturing Facility began
  • KG Bio, a holding subsidiary to Kalbe Farma, one of the largest publicly-listed pharmaceutical companies in Southeast Asia, granted the exclusive rights to develop and commercialise HLX10 (anti-PD-1 mAb) in 10 Southeast Asia countries
  • HLX02 (trastuzumab injection)  NDA accepted and assigned to priority review list in China and MAA accepted for review in Europe
  • "Global + Combo" strategy in immuno-oncology combination therapy built to utilize proprietary anti-PD-1 mAb (HLX10) as backbone plus other products with global multi-centre clinical trials conducted worldwide
  • HLX03 (adalimumab injection)  NDA accepted and assigned to priority review list; Phase 3 clinical trial completed
  • HLX22 (anti-HER-2 mAb) IND approval for gastric cancer and breast cancer; first patient dosed in Phase 1 clinical trial
  • HLX55 (anti-cMET mAb) granted clinical trial approval in Taiwan China and Chinese mainland
  • HLX11 (pertuzumab biosimilar) IND under review by the NMPA
  • HLX04 (bevacizumab injection) IND approvals for two ocular diseases
  • HLX10 (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
  • Scientific Advisory Board established with four world-renowned scientists and experts joining in the Company
  • Two projects got initiated and sponsored by "National Science and Technology Major Project in the 13th Five-year Plan of China —— Major New Drug Research & Development Project"
  • Licence and commercialisation agreements concluded with multiple international partners, including Accord Healthcare, one of the fastest growing generic pharmaceutical companies from the UK, Cipla, a top international pharmaceutical company and Biosidus, a biopharmaceutical pioneer from Argentina
  • Exclusive licence agreement concluded with AbClon from Korea to globally develop and commercialise its proprietary antibody AC101
  • Series B capital increase of about ¥1.259 billion and Series C capital increase of about $156.5 million completed successively
  •  A Phase 3 clinical trial for rheumatoid arthritis initiated for HLX01 (rituximab injection)
  • The first China-developed mAb combination therapy HLX10 (anti-PD-1 mAb) + HLX04 (bevacizumab injection) IND approval for solid tumors in China
  • HLX20 (anti-PD-L1 mAb) IND approval for solid tumors in Australia and Chinese mainland
  • A Phase 1b/2 clinical trial for HLX07 (anti-EGFR mAb) initiated in Chinese mainland
  • HLX06 (anti-VEGFR-2 mAb) and HLX10 (anti-PD-1 mAb) IND approvals for solid tumors in Chinese mainland
  • HLX12 (ramucirumab biosimilar)  IND approval for late-stage gastric cancer, metastatic non-small cell lung cancer and metastatic colorectal cancer in China
  • HLX01 (rituximab injection) granted Drug Manufacturing Certificate and its NDA accepted for review
  • A global, multi-centre Phase 3 clinical trial in Ukraine, Poland, and the Philippines initiated for HLX02 (trastuzumab injection)
  • A Phase 3 clinical trial initiated for HLX03 (adalimumab injection) for psoriasis
  • HLX06 (anti-VEGFR-2 mAb) and HLX10 (anti-PD-1 mAb) IND approvals for solid tumors in the US and Taiwan China
  • 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
  • HLX02 (trastuzumab injection) IND approval for gastric cancer
  • HLX04 (bevacizumab injection) IND approval for non-small cell lung cancer
  • HLX05 (cetuximab biosimilar) IND approval for metastatic colorectal cancer and squamous cell carcinoma of the head and neck
  • HLX07 (anti-EGFR mAb) IND approval for solid tumors in Taiwan China, Chinese mainland and the US
  • HLX04 (bevacizumab injection) IND application filed for metastatic non-small cell lung cancer in China
  • HLX02 (trastuzumab injection) IND approval for breast cancer in China
  • HLX03 (adalimumab injection)  IND approval for rheumatoid arthritis in China
  • HLX04 (bevacizumab injection) IND approval for metastatic colorectal cancer in China
  • HLX07 (anti-EGFR mAb) IND application filed for solid tumours in China
  • HLX04 (bevacizumab injection) IND application filed for metastatic colorectal cancer in China
  • HLX01 (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" passed the inspection
  • HLX03 (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
  • HLX02 (trastuzumab injection) 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
  • HLX01 (rituximab injection) IND application filed for non-Hodgkin lymphoma in China
  • Shanghai Henlius Biotech, Inc. founded