三生国健 20250627 摘要 2024 年公司研发投入达 5.4 亿元，因产品临床推进加速，现金储备 33 亿元，资金稳健。聚焦自免领域，管线数量增至 22 个，重点布局高发 病率及临床解决方案不足的自免疾病，目标未来五年内每年至少一到两 个产品提交 NDA 申报。 2025 年是数据读出大年，8 个产品将进入下一阶段，包括 2 个产品推 进到二期临床，5 个产品的相关适应症推进到三期临床，以及 1 个产品 推进到 NDA 状态，保障每年有一到两个产品提交 NDA 申报。 白介素 17A 产品（608）银屑病适应症已提交 NDA，强直性脊柱炎和 放射性阴性脊柱炎适应症将于 2025 年推进到三期临床。有效性方面， 核心指标改善超 90%，且持续缓解率高；安全性方面，Ada 发生率低于 2%。 伊赛普面临招标和指标压力，预计今年三款已上市产品仍将实现个位数 增长。白介素-17 产品预计 2025 年获批，计划 2024 年 Q4 组建销售团 队，竞争优势在于疗效、低不良反应率和 Q8W 给药方案。 Q&A 2024 年公司整体业绩表现如何，主要增长来源和利润构成是怎样的？ 2024 年公司营业收入达到 11 ...

Core Viewpoint - Huadong Medicine's subsidiary, Zhejiang Zhongmei Huadong Pharmaceutical, received approval for a Phase III clinical trial of 0.3% roflumilast foam (ZORYVE) for seborrheic dermatitis patients, indicating a significant advancement in treatment options for this condition [1][2]. Group 1: Product Development and Clinical Trials - The approved clinical trial targets local treatment for patients aged 9 and above with seborrheic dermatitis, utilizing roflumilast, a PDE4 inhibitor that reduces inflammation [2]. - Roflumilast foam has shown significant efficacy, with nearly 80% of patients achieving complete or near-complete clearance of symptoms by week 8, while maintaining good safety and tolerability [2]. - The product is designed for ease of use, with a once-daily application and no long-term usage restrictions compared to traditional topical corticosteroids [2]. Group 2: Market Potential and Demand - There is a substantial unmet clinical need for effective treatments for seborrheic dermatitis, as existing therapies often have limited efficacy and significant side effects [2]. - The Chinese psoriasis drug market is projected to reach $3.255 billion by 2025, while the global atopic dermatitis treatment market is expected to reach $24.5 billion by 2032, highlighting the market potential for roflumilast [4]. Group 3: Company Strategy and Innovation - Huadong Medicine is focusing on autoimmune diseases, with a comprehensive pipeline that includes over 20 innovative products targeting various conditions, including psoriasis and atopic dermatitis [5]. - The company has established an R&D platform for topical formulations and has built three production lines for external preparations, indicating a strong commitment to innovation in this area [8]. - Huadong Medicine aims to enhance the accessibility of innovative drugs and provide differentiated treatment options, positioning itself for long-term competitive advantage in the autoimmune sector [9].