JHL1149 (bevacizumab biosimilar) / Eden Biologics - LARVOL DELTA

A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers (clinicaltrials.gov) - P1; N=156; Recruiting; Sponsor: JHL Biotech, Inc.

New P1 trial • Biosimilar

Europe approves JHL Biotech's clinical trial application for bevacizumab biosimilar to affordably treat colorectal, lung, and ovarian cancers (PRNewswire) - "JHL Biotech Inc. announced that the European authority, Bulgarian Drug Agency, has approved a Phase I Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149...JHL will conduct a three-arm pharmacokinetic study in healthy volunteers in Bulgaria beginning March 2018...Rituximab biosimilar, JHL1101, to treat rheumatoid arthritis and Non-Hodgkin's Lymphoma. Currently in Phase I trial in Europe. Expected Phase III trial in Europe and Phase I and III trials in China in 2018....Trastuzumab biosimilar, JHL1188, to treat breast cancer. Expected Phase I trial in Europe in 2018."

Clinical • New P1 trial • New P3 trial • Biosimilar • Hematological Malignancies • Immunology • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Solid Tumor

A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers (clinicaltrials.gov) - P1; N=154; Completed; Sponsor: JHL Biotech, Inc.; Recruiting ➔ Completed; Trial completion date: Jan 2019 ➔ Dec 2019

Clinical • Trial completion • Trial completion date

In agreement with Genentech, JHL must destroy its biosimilar cell lines and banks (Center for Biosimilars) - "Genentech has reached a memorandum of understanding with JHL Biotech in its civil lawsuit related to the theft of Genentech’s trade secrets. According to Genentech, the formal settlement, which remains to be executed, requires JHL to stop developing its biosimilars referencing Genentech’s products: rituximab (Rituxan), dornase alfa (Pulmozyme), trastuzumab (Herceptin), and bevacizumab (Avastin). JHL will also be required to destroy all cell lines and cell banks that are associated with these products, and the biosimilar developer must cease using or sharing any of Genentech’s confidential information."

Corporate lawsuit • Discontinuation