MARKETING AUTHORIZATION APPLICATION FOR DRY EYE DISEASE DRUG SHR8028 (CYCLOSPORINE OPHTHALMIC SOLUTION) DEVELOPED BY JIANGSU HENGRUI PHARMACEUTICAL HAS BEEN ACCEPTED IN THE PEOPLE’S REPUBLIC OF CHINA
Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), recently received the “Notice of Acceptance” from the Chinese National Medical Products Administration (NMPA). The marketing authorization application for SHR8028 (cyclosporine ophthalmic solution) eye drops for the treatment of the signs and symptoms of dry eye disease was accepted by NMPA.
The marketing authorization application is based on a multi-center, randomized, vehicle-controlled, double-blind, phase 3 clinical study (study number SHR8028-301). The results showed that SHR8028 eye drops, compared to its vehicle, significantly improved the signs and symptoms of dry eye disease. At the same time, SHR8028 eye drops were safe, reliable, and well tolerated. The incidence of adverse events and local instillation site reactions after taking the drops were comparable between SHR8028 and the vehicle.