China Food and Drug Administration accept clinical trial application for JHL1101 in phase I and III trials in Non-Hodgkin Lymphoma

This month, on 4^th April 2017, the China Food and Drug Administration (CFDA) accepted a Clinical Trial Application (CTA) by JHL Biotech for JH1101 in phase I and III clinical trials in NHL patients.¹

JHL1101 is the first product in the company’s pipeline, and is a proposed biosimilar of rituximab.

JHL Biotech filed their application under the new guidelines for biosimilars issued in 2015 and data to support the CTA was produced at the company’s facility in Wuhan, China; the world's largest biopharmaceutical manufacturing facility based on single-use technologies.

In China, it is estimated that 80,000 cases of NHL are diagnosed each year.²