The monoclonal antibody-based therapeutics has emerged as a major therapeutic modality for targeted therapy. Therapeutic antibodies have demonstrated clinical efficacy with desirable safety profiles and commercial success for a variety of diseases including cancers and autoimmune diseases. 50% of the top 10 global pharmaceutical products by sales in 2015 according to IMS were antibody-based therapeutics. Technological breakthroughs in antibody-related technology has accelerated the increasing numbers of approved antibodies and expanded market growth of innovative antibody drugs, which is estimated to reach 125 billion US dollars by 2020.

Since its foundation in 2010, Henlix Biotech Ltd. has been amassed a core team of world-class biopharmaceutical industry experts. Our members specialize in the discovery, development and commercial manufacturing of antibody drugs as well as clinical, regulatory, commercial & strategic planning by leveraging R&D experiences in top multinational biopharmaceutical companies, such as Amgen, Genentech, Lilly, Bristol-Myers Squibb and Bayer. The core team has successfully developed a synergistic portfolio of products focusing on oncology and immuno-oncology.

研發管線

Product
(MOA)
Target
IND
Target
Cancers
Research Selection Preclinical Phase I
HLX07
(a-EGFR)
Dec‘15 H&N, CRC, lung
100%
HLX06
(a-VEGFR2)
Q2‘17 Solid tumors
75%
HLX10
(a-PD-1)
Q3’17 Solid tumors
75%
HLX20
(a-PD-L1)
Q4’17 Solid tumors
75%
HLX08
(a-PDGFRα)
2018 Solid tumors
25%
HLX31
(bispecific)
2018 Solid tumors
25%

Novel Monoclonal Antibody

Novel Monoclonal Antibody

HLX07

HLX07 is an innovative and proprietary biobetter antibody developed by Henlix Biotech Ltd. HLX07 is a humanized monoclonal antibody drug targeting at epidermal growth factor receptor (EGFR) that are expressed in malignant tumor cells. HLX07 is expected to deliver significant superior efficacy as well as improved safety profile for potential treatment of multiple tumors such as colorectal cancer and head & neck cancer. At present, HLX07 has entered Phase I clinical trial in Taiwan and approval by US FDA to initiate Phase I trials.

HLX06

HLX06 is an innovative and proprietary monoclonal antibody. As a fully human monoclonal antibody drug that targets the vascular endothelial growth factor receptor 2 (VEGFR2) on the malignant tumor cell surface, HLX06 has the potential to treat multiple cancers including gastrointestinal stromal tumor, renal cell carcinoma, color cancer, thyroid carcinoma, gastric carcinoma and prostate cancer in the future. At present, IND-enabling studies of HLX06 is near completion, and we target to submit the IND application for clinical trial to US FDA and Taiwan FDA in 2017.

HLX08

HLX08 is an innovative and proprietary humanized monoclonal antibody targeting platelet-derived growth factor α (PDGFRα) on malignant tumor cell surface, which is expected to treat tumors such as glioblastoma multiforme, gastrointestinal stromal tumor and non-small cell lung cancer in the future. At present, HLX08 has completed the pre-clinical pharmacological research.

HLX09、HLX10

HLX09、HLX10 are innovative and proprietary monoclonal antibodies targeting PD-1 and PD-L1 respectively. By harnessing the power of patients’ own immune system to attack cancer cells, HLX10 and HLX20 has the broad potential in treating many cancers including melanoma, lung cancer, renal carcinoma, bladder cancer and head and neck cancer. The IND applications are expected to be submitted to US FDA and Taiwan FDA in 2017.

Bispecific Antibody

Bispecific Antibody

HLX31

HLX31 is a bispecific antibody targeting HER2 and CD3 developed by Henlix Biotech Ltd. Bispecific antibodies can directly inhibit the tumor cell growth and engage the patients’ immune system to attack the tumor cells, thus attaining better clinical effects. Target indications for HLX31 includes breast cancer and gastric cancer.

Antibody-Drug Conjugates (ADCs)

Antibody-Drug Conjugates (ADCs)

HLX42、HLX43、HLX44

HLX42、HLX43、HLX44 are the antibody-drug conjugates (ADCs) developed by Henlix Biotech Ltd., which link the antibodies with the small molecule chemotherapy drugs. The goal of ADCs is to utilize the antibodies to deliver the chemotherapy agents directly to target cancer cells and reduce the effects of chemotherapy in normal cells. Target indications of our product candidates include breast cancer, prostate cancer, gastric cancer and head and neck cancer, etc.