Date: 2017-12-20
Type of
information: Submission of a clinical trial application
phase: 1
Announcement: submission of a clinical trial application
Company: JHL Biotech (Taiwan)
Product: JHL1149 (biosimilar version of bevacizumab - Avastin®)
Action
mechanism:
- biosimilar/monoclonal antibody. JHL1149 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Avastin® (bevacizumab). Avastin® is approved in the U.S., EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous lung cancer in addition to metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications.
Disease:
Therapeutic
area: Cancer - Oncology
Country: Bulgaria
Trial
details:
Latest
news:
- • On December 20, 2017, JHL Biotech announced that it submitted a Phase I Clinical Trial Application on December 15, 2017 to Bulgarian Drug Agency for its proposed bevacizumab biosimilar, JHL1149. JHL is planning to conduct a single-site, three-arm pharmacokinetic study in healthy volunteers in Sofia, Bulgaria beginning March 2018. The data from this trial will support the rapid development and commercialization of JHL1149.
Is
general: Yes
