Drugs / SHR8058
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | dry eye disease associated with Meibomian gland dysfunction | 2023-02-17 | “The marketing authorization application for SHR8058 (perfluorohexyloctance) eye drops was accepted for the treatment of dry eye disease associated with Meibomian gland...” novaliq.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05515471 | Feb → Sep 2021 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-07-08 | Novaliq GmbH | Regulatory Breakthrough in Ophthalmology! Hengrui’s Heng Qin ® (Perfluorohexyloctane Eye Drops) Approved as First Treatment for Dry Eye Disease Associated with MGD novaliq.com ↗
Heng Qin ® is the first and only drug approved to treat DED associated with MGD and will be available to patients in China in the coming months. |
| 2023-02-17 | Novaliq GmbH | Regulatory Jiangsu Hengrui Pharmaceuticals’ Marketing Authorization Application for Innovative Drug SHR8058 (Perfluorohexyloctane) for the Treatment of Dry Eye Disease has been accepted in the People’s Republic of China novaliq.com ↗
The marketing authorization application for SHR8058 (perfluorohexyloctance) eye drops was accepted for the treatment of dry eye disease associated with Meibomian gland dysfunction by NMPA. |
| 2021-12-16 | Novaliq GmbH | Results Phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) conducted by Jiangsu Hengrui Pharmaceuticals in the People’s Republic of China shows statistically significant topline results novaliq.com ↗
The trial met its prespecified primary sign endpoint improvement of total corneal fluorescein staining (tCFS) and its prespecified primary symptom endpoint improvement of eye dryness score of the Visual Analogue Scale (VAS) at eight weeks with high statistical significance. |
All press releases naming this drug 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SHR8058 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05515471 ↗ |
| Known as | perfluorohexyloctane | “OBJECTIVE: To evaluate the efficacy and safety of SHR8058 (perfluorohexyloctane) eye drops in Chinese patients with DED associated with MGD through 57 days.” PMID 36929413 ↗ Apr 2023 |
| Route | Other | “SHR8058 eye drops” NCT05515471 ↗ |