This month, on 4 thApril 2017, the China Food and Drug Administration ( CFDA) accepted a Clinical Trial Application (CTA) by JHL Biotechfor JH1101 in phase I and III clinical trials in NHL patients. 1
JHL1101is 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