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
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
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 submission accepted
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
JHL1211  (Biosimilar Omalizumab) Allergic Asthma, Chronic Idiopathic Urticaria A recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE)
Pre-Clinical Stage
JHL1199 (Biosimilar Pertuzumab) Inflammatory carcinoma of the breast, Locally Advanced Breast Cancer (LABC), Metastatic Breast Cancer (MBC), Stage I Breast Carcinoma A recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of HER2.
Pre-Clinical Stage
JHL1266 (Biosimilar Denosumab) Osteoporosis, Bone CancerBone Loss, Bone pain, Fracture Bone, Spinal Cord Compression, Bone destruction, Giant cell tumor of the bone, High risk of fracture, Refractory Hypercalcemia of malignancy A novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL)
Pre-Clinical Stage

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”).

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.

JHL1211 (Omalizumab)

JHL1211 is a proposed biosimilar to omalizumab, which is marketed by Genentech under the trade name Xolair®.

Omalizumab is a monoclonal antibody therapy used for Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older, moderate to severe persistent allergic asthma in patients 6 years of age or older not controlled by inhaled corticosteriods.

JHL1266 (Denosumab)

JHL1266 is a proposed biosimilar to denosumab, which is marketed by Amgen under the trade name Prolia® and Xgeva®.

Denosumab is a monoclonal antibody therapy used for treatment of a range of osteoporosis, Colorectal cancer (CRC).

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.

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.

JHL1199 (Pertuzumab)

JHL1199 is a proposed biosimilar to pertuzumab, which is marketed by Genentech under the trade name Perjeta®.

Pertuzumab is a monoclonal antibody used prior to surgery (neoadjuvant treatment) in people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than 2 cm in diameter or node-positive) and used after surgery (adjuvant treatment) in people with HER2-positive early breast cancer that has a high likelihood of coming back.

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.