HUADONG MEDICINE(SZ:000963) Zheng Quan Ri Bao·2025-10-31 13:41Core Viewpoint - Huadong Medicine's innovative topical formulation Roflumilast cream (ZORYVE®) has received acceptance for its market authorization application from NMPA, targeting localized treatment for plaque psoriasis in patients aged 6 and above [2][4]. Product Overview - Roflumilast, a highly selective non-steroidal PDE4 inhibitor, has shown significant advantages in clinical applications compared to previously approved topical psoriasis treatments, including rapid efficacy and improved safety profile [3][4]. - The cream utilizes HydroARQ technology, enhancing user comfort with a lightweight, easily absorbable moisturizing formula, and is suitable for long-term use without restrictions [3]. Market Potential - The psoriasis market in China has seen rapid growth, with the market size increasing from $604 million in 2018 to $1.436 billion in 2022, reflecting a compound annual growth rate (CAGR) of 24.2% [5]. - The Chinese psoriasis drug market is projected to reach ¥139 billion in 2023 and is expected to grow to ¥894 billion by 2032, with a CAGR of 59.1% [6]. Company Strategy - Huadong Medicine is focusing on the autoimmune disease sector, which is experiencing rapid global growth, with the market expected to rise from $132.3 billion in 2022 to $176.7 billion by 2030 [7]. - The company has developed a diverse product pipeline in the autoimmune field, covering various indications, and has over 20 innovative products in development [7]. Recent Developments - The acceptance of Roflumilast cream's NDA marks the seventh market application received by Huadong Medicine this year, indicating a strong pipeline of innovative products [8]. - The company is also advancing other clinical trials for autoimmune diseases, including a new JAK1 inhibitor for vitiligo and ongoing studies for atopic dermatitis and ankylosing spondylitis [8]. Future Outlook - Huadong Medicine's innovative pipeline is expected to enter a harvest phase between 2025 and 2026, with multiple new drug approvals anticipated, further enhancing its competitive position in the pharmaceutical market [10]. - The company aims to continue integrating global innovative resources and enhancing its independent innovation capabilities to provide comprehensive and efficient treatment options for patients [10].