Improve patients' lives by timely providing them with

quality and affordable protein therapeutics

Company Profile

We are a global biopharmaceutical company focusing on oncology and auto-immune diseases with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide. Founded in 2010 and headquartered in Shanghai, we have built three global R&D facilities in Shanghai, Taipei and California collaborating with each other to ensure the highly productive and cost-efficient R&D processes. Discovering new ways to improve and extend patients’ lives by driving access to high-quality biologic medicines worldwide, we are committed to biosimilars, innovative monoclonal antibody (mAb) products and immuno-oncology combination therapies with proprietary anti-PD-1/PD-L1 mAbs as backbones on an integrated platform covering the entire product lifecycle from R&D, commercial-scale production to commercialisation. On September 25, 2019, we were successfully listed on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code 2696.HK.

Our co-founders, Dr. Scott Liu and Dr. Wei Dong Jiang, each possesses over 20 years of hands-on experience in developing therapeutic drugs and holds leadership positions in R&D, manufacturing and quality management at world-renowned international biopharmaceutical companies. Inspired by our vision and attracted by our corporate culture, a team of highly-skilled talents are thus assembled with extensive experience across drug development, CMC, plant design, pharmaceutical production management, quality and compliance, clinical development, regulatory affairs, commercialisation and finance at leading multinational pharmaceutical companies. 

We established our 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 EU QP and has received the Certificate of Good Manufacturing Practices for Pharmaceutical Products, People’s Republic of China. In December 2017, we concluded official agreement with People's Government of Songjiang, Shanghai, to locate the second manufacturing facility in Songjiang. Covering 130,000 square meters and located in the Western Technology Park of National-level Shanghai Songjiang Economic & Technological Development Zone, Songjiang Manufacturing Facility is expected to manufacture 20-30 products and to become a large-scale biologic medicine manufacturing facility in China when fully operated. It strictly follows international GMP standards, adopts new technologies to ensure quality and reduce cost, meets the international level of biomedical automation, informatization, and intelligence (Pharmaceutical Industry 4.0) and features low carbon, energy conservation and eco-protection.

Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) priority review and one product under Marketing Authorization Application (MAA) review, we have conducted over 20 clinical studies for 15 products and 8 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), our first product, has been granted NDA approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their NDAs under priority review by the NMPA. HLX02 is the first China-manufactured biosimilar to enter a global multi-centre Phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, HLX02's MAA was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbones in combination with chemotherapies and other mAbs including HLX04 (bevacizumab biosimilar) and HLX07 (anti-EGFR mAb). The global multi-centre clinical trials are ongoing in various countries and regions worldwide.

Up to Now

In addition to one product launched commercially, two products under NDA review and one product under EMA review, Henlius has conducted over 20 clinical studies for 15 products and 8 combination therapies worldwide. HLX01 (汉利康®,rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China, which also makes it the first commercially launched monoclonal antibody biosimilar in accordance with Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative).


Company Milestone
  • 2020
  • 2019
  • 2018
  • 2017
  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
  • HLX11 (pertuzumab biosimilar) IND approval for breast cancer
  • HLX13 (anti-CTLA-4 mAb) IND under review by the NMPA
  • Ministry of Health "National Major New Drug Research & Development Project in the 13th Five-year Plan"
  • HLX14 (anti-RANKL mAb) IND under review by the NMPA
  • 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 for injection)  NDA accepted and assigned to priority review list in China and MAA accepted for review in Europe
  • "Global + Combo" strategy in immno-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-c-MET mAb) granted clinical trial approval in Taiwan China and Mainland China 
  • HLX11 (pertuzumab biosimilar) IND under review by the NMPA
  • HLX04 (bevacizumab biosimilar) 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 Major New Drug Research & Development Project in the 13th Five-year Plan"
  • Licence and commercialisation agreements concluded with multiple international partners, including Accord Healthcare, one of the fastest growing generic pharmaceutical companies from 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 biosimilar) IND approval for solid tumors in China
  • HLX20 (anti-PD-L1 mAb) IND approval for solid tumors in Australia and Mainland China 
  • A Phase 1b/2 clinical trial for HLX07 (anti-EGFR mAb) initiated in Mainland China
  • HLX06 (anti-VEGFR-2 mAb) and HLX10 (anti-PD-1 mAb) IND approvals for solid tumors in Mainland China
  • HLX12 (ramucirumab biosimilar)  IND approval for late-stage gastric cancer or adenocarcinoma of esophagogastric junction, 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 for 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 for injection) IND approval for gastric cancer
  • HLX04 (bevacizumab biosimilar) 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, Mainland China and the US
  • HLX04 (bevacizumab biosimilar) IND application filed for metastatic non-small cell lung cancer in China
  • HLX02 (trastuzumab for injection) IND approval for breast cancer in China
  • HLX03 (adalimumab injection)  IND approval for rheumatoid arthritis in China
  • HLX04 (bevacizumab biosimilar) IND approval for metastatic colorectal cancer in China
  • HLX07 (anti-EGFR mAb) IND application filed for solid tumours in China
  • HLX04 (bevacizumab biosimilar) 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 Major New Drug Research & Development Project in the 12th Five-year Plan" passed the inspection
  • HLX03 (adalimumab injection) IND application filed for rheumatoid arthritis in China
  • The Company's second Ministry of Health "National Major New Durg Research & Development Project in the 12th Five-year Plan of China"
  • HLX02 (trastuzumab for injection) IND application filed for breast cancer in China
  • The Company's first Ministry of Health "National Major New Drug Research & Development Project in the 12th Five-year Plan of China"
  • HLX01 (rituximab injection) IND application filed for non-Hodgkin lymphoma in China
  • Shanghai Henlius Biotech, Inc. founded