Nepidermin (INN proposed), also known as recombinant human epidermal growth factor (rhEGF), is a recombinant form of human epidermal growth factor (EGF) and a cicatrizant (a drug that promotes wound healing through formation of scar tissue). As a recombinant form of EGF, nepidermin is an agonist of the epidermal growth factor receptor (EGFR), and is the first EGFR agonist to be marketed. It was developed by Cuban Center for Genetic Engineering and Biotechnology (CIBG), and has been marketed by Heber Biotech as an intralesional injection for diabetic foot ulcer under the trade name Heberprot-P since 2006. As of 2016, Heberprot-P had been marketed in 23 countries, but remains unavailable in the United States. In 2015, preparations were made to conduct the Phase III trials required for FDA approval, The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) however as of 2023 developments in U.S.-Cuba relations have stymied importation of the drug from Cuba.
Various forms of rhEGF are marketed for the treatment of diabetic foot ulcers, wounds, and alopecia (hair loss) in Vietnam, the Philippines, Thailand, and China.
Production According to Heber Biotech, nepidermin is made by insering the 53-amino acid human EGF sequence into yeast. A 1991 paper from Cuba seems to describe its production in more detail. An improved process was described in 2009.
Other rhEGFs Several other products containing recombinant human EGF have been marketed. The potencies of these products can differ by the expression system used, despite all intending to match the structure of human EGF.
Instead of measuring by mass, the international unit system from the World Health Organization provides a way to describe the potency-adjusted amount of rhEGF. – Provides information on "unit" conversion of a number of hormones. According to the table, this supplier's rhEGF is 1.4 times as potent as the reference 91/530 at the same mass. However, the WHO does not prescribe a specific way of measuring the potency. rhEGF bioassay remains a field in active development.
Other preparations +List of rhEGF preparations Brand name Manufacturer Form Indication Description Heberprot-P Heber (Cuba) Lyophilized powder Ulcer See above. Drugs.com reports marketing in Vietnam and Georgia. Easyef Daewoong (Korea) Spray Ulcer, wounds See above. Drugs.com reports marketing in Thailand and Vietnam. Genesoft () Uni-Bio (Hong Kong); Licensed to GeneTech (China) Eye drop Corneal damage (?) Approved in China (Rx, 国药准字 S20040006). Yeast expression system. GeneTime () Spray Approved in China (Rx, 国药准字 S20010037–8). E. coli expression system. Kang He Su () Haohai (China) Lyophilized powder second-degree burns, wounds, ulcers Approved in China (Rx, 国药准字 S20010094–6, S20010099). To be used as a part of wound dressing, soaked in gauze. E. coli expression system. Yi Fu () Gel second-degree burns, wounds, ulcers Approved in China (Rx). Yeast expression system. Regen-D – Manufacturer page with PDFs Bharat Biotech (India) Gel Diabetic foot ulcer Approved in India and Thailand. E. coli expression system. Bharat also markets a gel with silver sulfadiazine and chlorhexidine for burns.
See also Becaplermin Murodermin
References