China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct Phase III clinical trials for its psoriasis treatment, MC2-01 cream. This marks a significant step forward in the development of this innovative dermatological agent.
MC2-01 Cream Overview
MC2-01 is a novel topical dermatological agent developed through a cooperation agreement between Huadong Medicine and MC2 Therapeutics Ltd., signed in August 2023. Huadong Medicine holds exclusive rights to the product in the Greater China region, including Mainland China, Hong Kong SAR, Macau SAR, and Taiwan.
Drug Mechanism and Formulation
MC2-01 is a fixed-dose combination of calcipotriol and betamethasone, designed for the topical treatment of adult plaque psoriasis, including scalp psoriasis. The product utilizes MC2’s proprietary drug delivery system, PAD, and is formulated as a user-friendly aqueous cream.
International Recognition and Approvals
MC2-01 received approval from the U.S. Food and Drug Administration (FDA) in 2020 and gained approval in Europe in 2021. It was launched in Australia in November 2024, underscoring its global potential and effectiveness in treating psoriasis.-Fineline Info & Tech
