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

Apr 12, 2017

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

  1. Pharmaceutical Daily News. Sanofi’s partner JHL Biotech accepted for clinical trial in China. 2017 Apr 05. http://www.pharmaceuticaldaily.com/sanofis-partner-jhl-biotech-accepted-for-clinical-trial-in-china/. [Accessed 2017 Apr 11].
  2. Chen W. et al.Cancer statistics in China, 2015. CA: A Cancer Journal for Clinicians. 2016 Mar-Apr;66(2):115-32. DOI: 10.3322/caac.21338.Epub 2016 Jan 25.