Hengrui Medicine will submit an application for pre-market communication of SHR8058 eye drops

In the evening of November 30th,Hengrui MedicinereleaseannouncementAccording to the report, the company’s ophthalmic preparation SHR8058 eye drops for the treatment of meibomian gland dysfunction-related dry eye is a multi-center, randomized, double-blind, salt solution parallel controlled Phase III clinical trial (SHR8058-301). Set superiority standards. The company will submit a pre-market communication application to the Drug Evaluation Center of the State Drug Administration in the near future.

The results of the study showed that compared with placebo, SHR8058 eye drops can treat dry eye related to meibomian gland dysfunction and significantly improve the symptoms and signs of dry eye in patients. At the same time, SHR8058 eye drops are safe and reliable, with good local tolerance, and the incidence of local paresthesia after instillation is equivalent to that of placebo.

The announcement shows that SHR8058 eye drops areHengrui MedicineNOV03 (perfluorohexyl octane) introduced from Novaliq GmbH. SHR8058 eye drops are colorless and transparent, composed of 100% perfluorohexyl octane, which can quickly spread to the entire ocular surface and interact with the lipophilic part of the tear film to stabilize the tear film and prevent excessive evaporation of tears. In addition, SHR8058 eye drops can penetrate the meibomian glands, interact with the glands and dissolve the viscous secretions in the glands, so as to treat meibomian gland dysfunction-related hyperevaporative dry eye.

Up to now, SHR8058 related projects have invested about 68.9 million yuan in research and development expenses.

(Source: ShanghaiSecuritiesNewspaper ChinaSecuritiesnet)

Article source: Shanghai Securities News·China Securities Net

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Original title: Hengrui Medicine will submit an application for pre-market communication of SHR8058 eye drops