About Henlius-Company Profile

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 approved for marketing in overseas markets, 18 indications approved worldwide, 1 New Drug Application (NDA) accepted for review in China, and 1 Biologics License Application (BLA) accepted for review in the U.S. 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 and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant 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 HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 20 clinical studies for 16 products and 12 immuno-oncology combination therapies, expanding its presence in major markets as well as emerging markets.

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
Songjiang First Plant certificated by China GMP
The sNDA of HANBEITAI for the treatment of recurrent glioblastoma was accepted by the 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