BRIEF—Hengrui files for Chinese approval of SHR8058

Chinese drugmaker Hengrui is about to file a new drug application (NDA) in China for approval of the ophthalmic treatment SHR8058 (perfluorohexyloctane), an eye drop for lowering intraocular pressure (IOP) developed by the German biotech Novaliq, which in 2019 sold its China rights to Hengrui.

The multicenter, randomized, double-blind and placebo-controlled Phase III studies met primary efficacy endpoints with few serious adverse effects, according to Hengrui.

China has about 360 million people with dry eye disease, according to a 2020 report by the Chinese chain eye hospital Ai’er.

Outside China, Novaliq plans to submit an NDA for approval of the treatment (NOV03) in the USA in 2022.