Harbin Gloria Pharmaceuticals (Gloria) will design and conduct the trial under the terms of its exclusive license, development, commercialization and supply agreement with Sucampo for Amitiza in China.
In connection with the IND acceptance, Sucampo will receive $500,000 from Gloria, which is the second tranche of the $1.5m upfront payment agreed to under the licensing deal.
Sucampo CEO Peter Greenleaf said: "The CFDA’s acceptance of this IND is an important first step for Gloria as they work to obtain approval for Amitiza in China.
"This pivotal study will form the basis for marketing authorization of Amitiza, and we believe that Amitiza could be an important new treatment for those patients in China for whom current options are not effective or sufficient."
The deal will see Gloria responsible for all development activities and costs, as well as commercialization and regulatory activities, for the product in China.
Sucampo will be the exclusive supplier of Amitiza to Gloria at an agreed upon supply price and will be eligible for an additional milestone payment upon the occurrence of a regulatory or alternatively a commercial milestone event.
Amitiza is a chloride channel activator that acts locally in the small intestine, by increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic idiopathic constipation.