U.S. Food and Drug Administration (FDA) Approval of Phase 2 Clinical Trial

[의학신문·일간보사=김영주 기자]Yuyu Pharmaceutical (CEO Won-sang Yoo) announced on the 12th that it has received US FDA approval to enter phase 2 clinical trial for a dry eye treatment (project name: YP-P10), which is being developed in anticipation of a next-generation global blockbuster.

View of Yuyu Pharmaceutical’s Jecheon Factory

YP-P10 is a new biopharmaceutical using synthetic peptides, and aims to relieve signs and symptoms of dry eye syndrome caused by inflammation by administering twice a day to treat dry eye syndrome. Through several animal experiments, it was confirmed that it has an excellent anti-inflammatory mechanism and an excellent corneal epithelial cell healing effect compared to existing drugs.

Yuyu Pharmaceutical CEO Yoo Won-sang said, “The US FDA has confirmed the final approval for YP-P10 phase 2 clinical trial, and we are planning to administer the first drug to patients within the first half of the year.”

The global dry eye syndrome market was valued at USD 3.9 billion in 2018 and is expected to reach USD 5.6 billion by 2026, growing at a CAGR of 6.14%.

With an aggressive R&D investment this year, Yuyu Pharm is focusing on three new drug pipelines, including a new drug, YP-P10, a treatment for dry eye syndrome, a new complex drug for benign prostatic hyperplasia, and a multiple sclerosis treatment under joint research with UCLA University in the United States. New drug candidates for hair loss and stroke recovery are also under development.

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