罗氟司特乳膏0.3%NDA受理，华东医药自免创新布局里程碑不断

Core Viewpoint - Huadong Medicine has received acceptance for the marketing authorization application of its innovative topical formulation Roflumilast Cream (ZORYVE) 0.3%, aimed at treating plaque psoriasis in patients aged 6 and above, which is expected to enhance the company's competitiveness in the autoimmune disease sector and provide breakthrough treatment options for psoriasis patients in China [1][4]. Market Opportunity - The active ingredient Roflumilast is a highly selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor, approved by the FDA for treating various skin conditions, including plaque psoriasis, and is the first topical PDE4 inhibitor approved for this indication globally [2][3]. - The psoriasis market in China has shown significant 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% [4]. - 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% [4]. Product Advantages - Roflumilast Cream demonstrates significant clinical advantages, including rapid onset of action, effective reduction of plaques, and significant relief from itching, while its unique HydroARQ technology enhances user comfort [2][3]. - The cream is non-hormonal, allowing for long-term use without restrictions, making it suitable for sensitive areas such as the face and underarms [2]. Company Strategy and Pipeline - 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 [5]. - The company has developed a diverse product pipeline in the autoimmune field, covering various conditions, and has over 20 innovative products in development [6]. - Huadong Medicine has established a "golden product combination" for psoriasis treatment, including monoclonal antibodies and both oral and topical formulations, aiming to provide comprehensive treatment options for patients [6]. Future Outlook - The acceptance of the Roflumilast Cream application marks the seventh marketing application milestone for Huadong Medicine in 2023, indicating a strong pipeline of innovative products [6]. - The company is expected to see multiple innovative drugs approved between 2025 and 2026, further solidifying its competitive position in the pharmaceutical market [9]. - Huadong Medicine aims to enhance its core competitiveness and market position by focusing on clinical needs and integrating global innovative resources [9].