New Clinical Trial
Jansen, a multinational pharmaceutical company which has the right to Hanmi Pharmaceutical’s candidate material for biopharmaceutical drug JANJ-64565111 against diabetes and obesity, will start a new clinical trial in the second half after the problem of a delay in its clinical trial was resolved.
Hanmi Pharmaceutical announced on June 9 that Jansen finished the first phase of a clinical test of JNJ-64565111 (HM12525A) and begin the first phase of another new clinical test based on the same substance and indications for the use of the material in the second half of the year.
Prior to this, Clinical Trials, an international clinical trial registration site, said in the evening of June 8 (Korean standard time) that the first phase of a clinical test of Jansen JNJ-64565111 was completed.
"Jansen recently applied to the US FDA for the approval of a clinical test in order to start the first phase of a new clinical trial in the second half of this year," a Hanmi Pharmaceutical official said. “The issue of Jansen's manufacturing-related delay was resolved and the current clinical test proved the material safe. So, Jansen began the new clinical test."
Jansen had conducted the first phase of a clinical trial since signing a licensing agreement with Hanmi Pharmaceutical to take over the right to JNJ-64565111 in November 2015. But in November of last year, Jansen suspended the invitation of patents for clinical trials due to the production delay issue for the time being.