Holy Stone Healthcare Co., Ltd. (4194.TW) has received marketing authorization for NexoBrid® from the Taiwanese Food and Drug Administration (TFDA) to allow marketing of the drug in Taiwan’s market.
NexoBrid is developed by the Israeli company MediWound Ltd. (Nasdaq: MDWD), with whom Holy Stone Healthcare signed a distribution agreement in 2017 for exclusive distribution rights of NexoBrid in Taiwan. This innovative drug is indicated for the removal of eschar (debridement) in adults with deep partial- and full-thickness thermal burns.
The purpose of debridement, a key step in the treatment of severe burns, is to remove necrotic tissue from the burn wound to prevent it from inhibiting wound healing, hence reducing the risk of systemic infection and bacteremia. The current Standard of Care (SOC) for burns is surgical debridement, an invasive modality that uses specific surgical instruments to remove necrotic tissue from the burn wound, which inevitably damages viable tissue causing both more blood loss and unbearable pain to the patient.
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. NexoBrid is an innovative drug developed based on the company's proteolytic enzyme technology platform that replaces surgical debridement with a breakthrough enzymatic debridement. With enzymatic debridement, it requires only four hours of application for the burn wound to complete the debridement process. This minimizes the need for surgical debridement and achieves better patient’s outcomes, including less traumatic/surgeries, spare viable tissue, rapid debridement, less procedural pain/blood loss, and reduced skin area for grafting. NexoBrid also reduces the burden on healthcare resource spending, including less loading/use of surgeons, facilities, and anesthesia, therefore improves the overall complexity and effectiveness of burn care.
NexoBrid has been marketed in the EU since 2014, and has marketing approval in several international countries, including Argentina, South Korea, Russia and Israel. It is currently under application for marketing authorization in the U.S. In addition to funding NexoBrid’s R&D, the U.S. Biomedical Advanced Research and Development Authority (BARDA) has within the Assistant Secretary for Preparedness and Response (ASPR), a part of the U.S. Department of Health and Human Services (HHS), has begun procuring NexoBrid for emergency stockpile as part of the HHS mission to build national preparedness for public health medical emergencies. BARDA's cumulative funding and procurement is up to $202 million.
The launch of NexoBrid in the EU has caused a paradigm shift in burn care. Based on the clinical experience gained over the years, EU burn experts published initial and updated versions of enzymatic debridement guidelines in 2017 and 2020 respectively, to assist physicians and burn specialists over the world in using this breakthrough treatment for burn care.
Following NexoBrid’s launch in Taiwan, Holy Stone Healthcare will work with MediWound to promote this innovative product in major medical centers and apply for the product to be listed in the Taiwan national health insurance coverage, in order to make this breakthrough enzymatic debridement available for burn patients.