[Beijing, China,January 2, 2025] Mr. Jack Wang, founder, chairman and CEO of Hong Kong Winhealth Pharma Group ("Winhealth Pharma") announced today that the National Medical Products Administration (NMPA) accepted the marketing authorization application of Class 5.1 new drug Difelikefalin Injection. Winhealth Pharma holds exclusive rights for the development and commercialization of Difelikefalin Injection in China. As an innovative biopharmaceutical company, Winhealth Pharma has always adhered to its original intention of "Patient Comes First" and is committed to providing innovative therapies for patients.
As of August 22, 2024, Difelikefalin Injection has been approved in 41 countries, including the United States, the European Union (incl. Iceland, Norway, and Liechtenstein), Japan, the United Kingdom, Canada, Switzerland, Singapore, and Australia, for the treatment of moderate-to-severe pruritus associated with
chronic kidney disease in adult patients on haemodialysis.
Difelikefalin isκ-opioid receptor (KOR) agonist that inhibits the sensation of itching by binding to receptors. The hydrophilic peptide structure of Difelikefalin limits its penetration into the central nervous system (CNS), distinguishing it from centrally active KOR agonists. Compared to most opioids, Difelikefalin is not a controlled substance and does not cause adverse effects such as respiratory depression. This injection intravenous administration via the dialysis circuit after routine hemodialysis effectively addresses long-term compliance issue caused by the high burden for oral drug product in hemodialysis patients.
Winhealth Pharma and Vifor Fresenius Medical Care Renal Pharma signed a long-term exclusive license agreement for the development and commercialization of Difelikefalin injection on January 16, 2023, for the treatment of moderate to severe pruritus in adult hemodialysis patients in China.
Regarding Winhealth Pharma
Hong Kong Winhealth Pharma Group is a leading biopharmaceutical company based in Hong Kong, with commercial operations across the Greater China Area and an expanding regional footprint in Asia and Europe. Specialized in the commercialization of innovative medicines, the company is dedicated to delivering breakthrough therapies for patients with cardio-renal, gastrointestinal, and rare diseases, as well as other unmet and severely underserved medical needs.
Winhealth Pharma has established successful long-term partnerships with numerous world-leading pharmaceutical and biotechnology companies, creating a uniquely impactful and diversified portfolio that includes over 15 specialty products in both commercial and late clinical stages. Committed to patients and partners, Winhealth Pharma continuously expands its portfolio and seeks to bring more transformative therapies from its global network of partners.