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Improve patients' lives by timely providing them with

quality and affordable protein therapeutics

Company Profile

We are a leading biopharmaceutical company in China focusing on oncology and autoimmune diseases with the vision to offer high-quality, affordable and innovative biologics for patients worldwide. Founded in 2010 and headquartered in Shanghai, we have built an integrated and efficient global R&D platform with key 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 biologics worldwide, we are committed to biosimilar, innovative monoclonal antibody (mAb) products and immuno-oncology combination therapies with proprietary anti-PD-1/PD-L1 mAbs as backbone on an integrated platform covering the entire product lifecycle from R&D, commercial-scale production to commercialization. On September 25, 2019, We were successfully listed and commenced trading 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 top 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, commercialization and finance at leading multinational pharmaceutical companies. 

We 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 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 the largest biologics 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) review and one product under Marketing Authorization Application (MAA) review, we have conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), our first product, has been granted 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-center phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, MAA for HLX02 was accepted to review by EMA.

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 14 products and 6 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
  • 2019
  • 2018
  • 2017
  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
  • HLX04 (Bevacizumab Biosimilar) IND approvals for two ocular diseases
  • HLX03 (Adalimumab Injection) granted NDA acceptance for priority review
  • HLX22 (Anti-HER-2 mAb Injection) IND approval for gastric cancer and breast cancer
  • 汉利康®, HLX01 (Rituximab Injection) approved as the first biosimilar in China
  • The second combination immunotherapy (HLX10+HLX07) IND approval
  • 汉利康®, HLX01 (Rituximab Injection) granted the Certificate of Good Manufacturing Practices for Pharmaceutical Products, People’s Republic of China
  • HLX02 (Trastuzumab for Injection) granted NDA acceptance for priority review in China and MAA acceptance for review in Europe
  • The construction of Songjiang Manufacturing Facility began
  •  HLX03 (Adalimumab Injection) phase 3 clinical trial completed
  •  HLX10 (Anti-PD-1 mAb) granted clinical trial approval in Taiwan China for the treatment of hepatitis B virus
  •  First patient dosed in phase 1 clinical trial of HLX22 (Anti-HER2 mAb)
  •  HLX55 (Anti-c-MET mAb) granted clinical trial approval in Taiwan China and Mainland China
  •  First patient dosed in phase 2 clinical trial of HLX10 (Anti-PD-1 mAb)as mono-therapy for the treatment of MSI-H/dMMR solid tumors
  •  First patients dosed in phase 3 clinical trials of HLX10 (Anti-PD-1 mAb) in combination with chemotherapy for the treatment of locally advanced/metastatic esophageal squamous-cell carcinomas, squamous non-small cell lung cancer and extensive-stage small cell lung cancer
  •  First patient dosed in phase 2 clinical trial of HLX10 (Anti-PD-1 mAb) in combination with HLX04 (Bevacizumab Biosimilar) for the treatment of advanced hepatocellular carcinoma
  •  Listed on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code: 2696.HK
  •  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 commercialize HLX10 (Anti-PD-1 mAb) in 10 Southeast Asia countries
  •  The latest clinical data of multiple core products including HLX02 phase 3 clinical study released at the CSCO Annual Meeting and the ESMO Congress 2019
  •  A strategic collaboration concluded with Wuxi Diagnostics on a PD-L1 companion diagnostic 
  •  New progress made on HLX02 (Trastuzumab for Injection) multi-center phase 3 clinical study
  •  HLX11 (Pertuzumab Injection) received IND application acceptance notification from NMPA
  •  A strategic collaboration concluded with Ascentage Pharma on a combination therapy
  •  "New Medical Reform and the Development of China Biosimilar Seminar" and Listing Celebration for Henlius held successfully in Shanghai
  •  汉利康®, HLX01 (Rituximab Injection) won "Biosimilar Initiative of the Year" at Global Generics & Biosimilars Awards 2019
  • HLX01 (Rituximab Injection) under priority review by the NMPA 
  • Scientific Advisory Board was established with four world-renowned scientists and experts joining in the Company
  • HLX01 (Rituximab Injection) entered phase 3 clinical trial for rheumatoid arthritis
  • 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
  • Series B capital increase of about ¥1.259 billion and Series C capital increase of about $156.5 million completed successively
  • HLX20 (Anti-PD-L1 mAb Injection) IND approval for solid tumors in Australia and Mainland China 
  • HLX07 (Anti-EGFR mAb Injection) initiated a phase 1b/2 clinical trial in Mainland China
  • HLX06 (Anti-VEGFR-2 mAb Injection) and HLX10 (Anti-PD-1 mAb Injection) IND approvals for solid tumors in Mainland China
  • HLX01 (Rituximab Injection) phase 3 clinical trial for non-Hodgkin lymphoma was completed and the clinical trial data of phase 1b and 3 were presented at the 21th CSCO Annual Meeting
  • HLX12 (Anti-VEGFR-2 mAb Injection)  IND approval for late-stage gastric cancer or adenocarcinoma of esophagogastric junction, metastatic non-small cell lung cancer and metastatic colorectal cancer in China
  • Exclusive licence agreement concluded with AbClon from Korea to globally develop and commercialise its proprietary antibody AC101
  • Public offering application filed to the Stock Exchange of Hong Kong Ltd. via Joint Sponsor
  • Two projects got initiated and sponsored by National Major New Drug Research & Development in the 13th Five-year Plan
  • The first China-developed mAb combination therapy HLX10 (Anti-PD-1 mAb Injection) + HLX04 (Bevacizumab Biosimilar) IND approval for solid tumors in China
  • HLX01 (Rituximab Injection) granted Drug Manufacturing Certificate and NDA acceptance for review
  • HLX02 (Trastuzumab for Injection) initiated a global, multi-center phase 3 clinical trial in Ukraine, Poland, and the Philippines
  • HLX03 (Adalimumab Injection) entered phase 3 clinical trial for psoriasis
  • HLX06 (Anti-VEGFR-2 mAb Injection) and HLX10 (Anti-PD-1 mAb Injection) IND approvals for solid tumors in the US and Taiwan China
  • Shanghai Henlius Biologics Co., Ltd. was 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 Injection) 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 Injection) 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 first "National Major New Drug Research & Development in the 12th Five-year Plan" project passed the inspection
  • HLX03 (Adalimumab Injection) IND application filed for rheumatoid arthritis in China
  • The second Ministry of Health "National Major New Durg Research & Development in the 12th Five-year Plan of China"
  • HLX02 (Trastuzumab for Injection) IND application filed for breast cancer in China
  • The first Ministry of Health "National Major New Drug Research & Development in the 12th Five-year Plan of China"
  • HLX01 (Rituximab Injection) IND application filed for non-Hodgkin lymphoma in China
  • Shanghai Henlius Biotech, Inc. (hereby "Henlius") was founded
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