PR93731

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

HEIDELBERG, Germany, and CAMBRIDGE, Mass., Dec. 16, 2021 /PRNewswire=KYODO JBN/--

Novaliq, a biopharmaceutical company focusing on first- and best-in-class

ocular therapeutics based on the unique EyeSol(R) water-free technology, today

provided a development update on the phase 3 trial of SHR8058 eye drops

(perfluorohexyloctane) for the treatment of dry eye disease (DED) associated

with Meibomian gland dysfunction (MGD) conducted by Jiangsu Hengrui

Pharmaceuticals Co., Ltd. ("Hengrui Pharma") (SSE: 600276) in the People's

Republic of China showing statistically significant topline results compared to

0.6% sodium chloride solution.[1]

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Hengrui Pharma has completed the Phase 3 clinical trial (SHR8058-301) which

enrolled 312 patients at 17 clinical sites in the People's Republic of China.

SHR8058-301 was a multi-center, randomized, double-masked, saline-controlled

clinical trial and was designed to evaluate the efficacy and safety of SHR8058

eye drops (100% perfluorohexyloctane) for the treatment of signs and symptoms

of DED associated with Meibomian gland dysfunction. SHR8058-301 evaluated its

primary efficacy at eight weeks.[2]

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. The trial showed an excellent

safety and tolerability profile for SHR8058 eye drops (perfluorohexyloctane)

comparable to placebo.

Hengrui Pharma expects to submit a pre-NDA communication application to the

National Medical Products Administration (NMPA)'s Center for Drug Evaluation

(CDE) in the People's Republic of China in the near term future.

About SHR8058 eye drops (perfluorohexyloctane)

SHR8058 eye drops is an investigational, proprietary, water-free and

preservative-free solution, based on Novaliq's EyeSol(R) technology. In 2019,

Hengrui Pharma and Novaliq announced a strategic collaboration under which

Hengrui Pharma secured exclusive rights to develop, manufacture, and

commercialize NOV03 (local drug name SHR8058 eye drops) and CyclASol(R) (local

drug name SHR8028 Eye Drops) in China.

About Novaliq

Novaliq is a biopharmaceutical company focusing on the development and

commercialization of first- and best-in-class ocular therapeutics based on

EyeSol(R), the worldwide first water-free technology. Novaliq offers an

industry-leading portfolio addressing today's unmet medical needs of millions

of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg,

Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term

shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor

in Life and Health Sciences companies. More on www.novaliq.com.  

References

1. Jiangsu Hengrui Pharmaceuticals Co., Ltd. reported the progress of the drug

clinical trial through the Shanghai Stock Exchange with announcement no. Lin

2021-175 on November 30th, 2021.

2. Clinical trial information available at www.chinadrugtrials.org.cn with

identifier CTR20210154.

Any product/brand names and/or logos are trademarks of the respective owners.

(c) 2021 Novaliq GmbH, Heidelberg, Germany.

Media Contact:

Novaliq

Simone Angstmann-Mehr

info@novaliq.com

SOURCE: Novaliq GmbH