WMU’s Class I New Biological Drug Becomes Wenzhou’s First Innovative Drug Approved for Clinical Trial

The recombinant human keratinocye growth factor-2（KGF-2）eye drop, a new biological drug for  corneal surgery and diabetic ulcer treatment developed by Wang Xiaojie, Hui Qi, and Tian Haishan on the research team led by Professor Li Xiaokun from the School of Pharmaceutical Sciences at WMU, has been recently approved by China’s State Food and Drug Administration for clinical trial, making it Wenzhou’s first ever Class I innovative drug approved for clinical trial.

Corneal injury is common and frequently-occurring in clinical ophthalmology. With the increasing use of electronic office devices and household appliances in modern life, corneal injury has become more prevalent while the age of patients suffering from it has become increasingly younger. Corneal injury may be triggered by pure chemical, mechanical and traumatic injury or be developed from further deterioration of injuries caused by xerophthalmia, diabetes, laser surgery of myopia, and corneal transplantation. Without timely and effective treatment, it may result in corneal ulcer and even blindness. Up to now, there is no drug in clinical treatment that can cure corneal injury.

Apart from accelerating the healing process of corneal injury, KGF-2 eye drop boasts of clinical advantages including enhancing corneal transparency, inhibiting formation of corneal neovessels and making corneal injury scars less obvious. With no preservative, the product in single-dosed package can be used for repairing after corneal transplantation and corneal pterygium surgery. In addition, it can be used for long-term treatment of diabetic ulcer and xerophthalmia.

The approval of KGF-2 eye drop for clinical trial has filled up the gap in new drug research for WMU, indicating WMU has now been leading in biopharmaceutical development and standardization research. Multi-center clinical trials will be carried out in WMU’s Affiliated Eye Hospital and Beijing Tongren Hospital, Capital Medical University. It is expected that the production license for KGF-2 eye drop will be given within three years.