JHL Biosimilar Pipeline

JHL1101, our lead therapeutic, is a proposed biosimilar of rituximab. JHL1101 is currently undergoing clinical trials in the European Union, and an application to conduct clinical trials in China has been filed with the CFDA and is under review. JHL is also developing JHL1922, a proposed biosimilar of dornase alfa, JHL1149, a proposed bevacizumab biosimilar, and JHL1188, a proposed biosimilar of trastuzumab.

Molecule
Potential Indication / Disease Area
Description
Status (Time to Market)
JHL1101 (Biosimilar Rituximab) Non-Hodgkin’s lymphoma, Chronic lymphocytic leukemia, Follicular lymphoma, diffuse large B cell lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiites, and microscopic polyangiites Anti-CD20 monoclonal antibody
EU Phase I in progress
China Phase I + III approval stage
JHL1922 (Biosimilar Dornase Alfa) Orphan Drug – Cystic Fibrosis Enzyme biologic
Global Phase I in progress
JHL1149 (Biosimilar Bevacizumab) Metastatic colorectal cancer, Advanced nonsquamous non-small cell lung cancer, Platinum-resistant ovarian cancer, Advanced cervical cancer, Metastatic renal cell carcinoma and Recurrent glioblastoma. Anti-vascular endothelial growth factor A (anti-VEGF) monoclonal antibody
EU Phase I accepted
China Phase I + III approval stage
JHL1188 (Biosimilar Trastuzumab) HER 2+ breast cancer
HER 2+ gastric cancer
Anti-HER2 monoclonal antibody
EU/China Phase I filing in progress
China Pre-Clinical Studies in progress

JHL1101 (rituximab)

JHL 1101 is a proposed biosimilar to rituximab, which is marketed by Roche under the trade name Rituxan® in the United States and MabThera® in all other locations. JHL1101 is currently undergoing Phase I clinical trials in the European Union, and a Clinical Trial Application to conduct clinical trials of JHL1101 in China is under review by the Chinese Food and Drug Administration.

Rituximab is a monoclonal antibody therapy used for treatment of a range of autoimmune diseases, primarily rheumatoid arthritis (“RA”) and non-Hodgkin lymphoma (“NHL”).

JHL1922 (dornas alfa)

JHL1922 is a proposed biosimilar to dornase alfa, which is marketed by Roche under the trade name Pulmozyme®. JHL’s Clinical Trial Application to conduct Phase I trials of JHL1922 is under review by the European Medicines Agency.

Dornase alfa is recombinant enzyme that is a standard-of-care treatment for cystic fibrosis. Cystic fibrosis is a genetic disease which affects the body’s ability to clear mucous from the airways. Cystic fibrosis patients suffer from mucous buildup in the lungs which can lead to inflammation, infection, and impaired lung ability. Dornase alfa facilitates clearance of this harmful buildup.

JHL1149 (bevacizumab)

JHL1149 is a proposed biosimilar to bevacizumab, which is marketed by Roche under the trade name Avastin®. JHL plans to file JHL1149 clinical trial applications with European and Chinese authorities in late 2017 and early 2018, respectively.

Bevacizumab is a monoclonal antibody therapy used for treatment of a range of cancers, including: colon, lung, breast, renal and brain cancers.

JHL1188 (trastuzumab)

JHL1188 is a proposed biosimilar to trastuzumab, which is marketed by Roche under the trade name Herceptin®. JHL plans to file JHL1188 clinical trial applications with European and Chinese authorities in the third quarter of 2018.

Trastuzumab is a monoclonal antibody used primarily for treatment of breast cancer. Trastuzumab works by attaching itself to HER2 receptors on the surface of breast cancer cells, allowing the antibody to stop or slow cell growth.

Interested in working with us?

JHL is open for partnerships and license agreements for its biosimilar assets worldwide. We can offer you access to our expertise in process development, manufacturing and regulatory management.