Luye Pharma is expected to contribute its licensed rights to Crofelemer in China including Macao and Hong Kong for the indications of chronic diarrhea in people living with HIV/AIDS, adult acute infectious diarrhea, and pediatric diarrhea, and Napo will seek a sub-licensee with resources and experience in the gastro-intestinal and/or pediatric markets to achieve development, regulatory approval, and distribution of crofelemer in China.
Additionally, Napo Pharmaceuticals will have access to Chinese translations of regulatory and clinical data from previous research on Crofelemer, encompassing studies of more than 2,000 patients, as well as all data generated in the future.
Lisa Conte, CEO of Napo Pharmaceuticals, said: “We see a great opportunity for crofelemer in the rapidly expanding Chinese market, and in particular applaud the vision of Luye to seek expertise to most rapidly address the important pediatric need.
“We are looking forward to the end of the Phase 3 trial for CRO-HIV in the US, and believe the data from this trial and that of previously conducted CRO-ID trials provides a very attractive regulatory and clinical data package.”