[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.
About WinHealth Pharma
WinHealth Pharma is a China-based integrated pharmaceutical company with a core focus on kidney diseases and strategic expansion into hematology and other major therapeutic areas. It possesses comprehensive capabilities across the entire pharmaceutical value chain from research and development to manufacturing and commercialization. Guided by its “Patients-First” philosophy and the mission of “Advancing Health, Empowering Lives,” the company is dedicated to improving patients' quality of life through innovative therapies. By leveraging a multi-strategy-driven business model, WinHealth Pharma connects with global innovations to continuously build a diverse, differentiated, and highly competitive product portfolio. Anchoring a strong presence in China, the company is actively expanding into other Asian markets and key international regions, including Switzerland and Japan. WinHealth Pharma is committed to fostering an open and collaborative healthcare ecosystem, driving industry innovation to meet the evolving needs of patients worldwide. For more information, please visit www.winhealth.hk.