JW Pharmaceutical said Wednesday its gout treatment, URC102, has won the approval to conduct clinical trials in China from the National Medical Products Administration.
Under the clinical plan, Simcere, JW’s partner company, tests safety, resistance and other factors on 40 healthy Chinese participants at Shanghai Public Health Clinical Center.
Gout is a disease that occurs when uric acid is over-generated in the body and not discharged properly. The existing treatment has had limitations to prescription due to side effects.
JW will receive $5 million in upfront payment from Simcere for licensing and up to $65 million in milestones, such as clinical development and commercialization. Total contract amounts to 84 billion won ($70 million) aside from royalty from sales.
JW Pharmaceutical has affirmed high safety and reduced blood uric acid levels in Phase 2a of URC102, conducted on 140 Korean gout patients.
In Phase 2b trial, researchers completed administration on subjects last month, and are awaiting clinical data. The results are to be released early next year, the Korean company said.
“With the approval of the clinical trial plan in China, URC102 has made the first advance overseas. We will continue to strengthen partnership with Simcere to develop the treatment quickly and supply treatments to Chinese people who have gout,” JW Pharmaceutical CEO Lee Sung-yeol said.
Based on the results of the phase 2 trial in Korea, the company will speed up tech transfer to multinational pharma companies, too, Lee added.
Source: Korean Biomedical Review