亚盛医药 20250916 摘要 2025 年对于亚盛医药来说是一个丰收年。首先，公司在年初设定的几个催化 剂大部分已经完成，剩下的将在年底前完成。具体进展包括： APG-2,575 每日剂量递增的给药方式提高了患者依从性，起效速度更快， 且安全性更高，有望超越维奈克拉，预计销售峰值有望超过 40 亿美元， 带来巨大增长空间。 亚盛医药的 FAK 抑制剂 2,449 已进入临床三期，成药性确定，有望通过 联合疗法展现商业价值。公司还在细胞凋亡通路抑制剂、降解剂平台以 及贫血领域进行布局。 1. 阿里巴替尼（Olverembatinib）：该产品自 2021 年首次批准，2023 年全面批准，并于今年纳入医保覆盖，销售额在上半年翻了一倍，下半 年预计保持同样增长速度。阿里巴替尼针对慢性髓性白血病（CML）， 随着更多患者使用，该产品未来几年将继续显著增长。 2. 飞扬麒麟（Fayankirin）：公司正在推进 POS D1 试验，这是中国的一 线治疗试验，同时在美国进行三期注册临床试验。这两个临床试验的终 点分别是 3-6 个月的 MMR 率和 3 个月的 CMR 率，预计很快会有数据读 出。 3. APG-2 ...

2）多款细胞凋亡通路抑制剂、降解剂成差异化梯度布局。公司在临床阶段正推进MDM2-p53 抑制剂 APG-115、Bcl-2/Bcl-xL 抑制剂APG-1252 针对多个肿瘤适应症的早期研究，同时在临床前储备了获得提 名的P53-MDM2 降解剂、Bcl-xL 降解剂，降解剂相比传统小分子抑制剂具备诸多优势，例如在高靶标 蛋白水平下发挥作用、E3连接酶的表达差异带来组织选择性从而提升安全性等，公司有望凭借在细胞 凋亡领域药物发现、临床开发及注册上市的成功经验，继APG-2575 后在该领域持续推出具有竞争力的 创新药物。 3）APG-5918（EED 抑制剂），治疗贫血相关适应症I 期临床试验进行中。EED 相关在研药物少，竞争 尚不充分，其中FTX-6058 的I 期临床初始数据证明了其可实现胎儿血红蛋白绝对水平增加，但因临床 前数据FDA 启动了临床暂停，从适应症来看近年来诺和诺德、武田等MNC 们持续围绕贫血相关疾病达 成新药授权合作，APG-5918 有望在未来凭借具备初步验证的新兴机制，在具备市场前景的贫血领域取 得率先突破。 展望中短期，公司即将达成多个潜在里程碑事件：1）HQP1351：202 ...

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative performance increase of over 15% compared to the benchmark index within the next 6 to 12 months [23]. Core Insights - The company is transitioning from a biotech to a biopharma entity, with a focus on its first commercialized product, Aorebatinib, and the promising APG-2575, which is expected to partially replace and surpass Venetoclax in the large MDS and MM markets [4][21]. - APG-2575 is positioned as a potential "Best-in-Class" BCL-2 inhibitor, with unique clinical data supporting its convenient dosing regimen and improved safety profile compared to existing treatments [14][18]. - The company has a robust pipeline with multiple promising candidates, including APG-2449 and various apoptosis pathway inhibitors, which are expected to enhance its market position and growth potential [15][18]. Summary by Sections Financial Forecasts and Valuation - The company is projected to achieve revenues of 589 million, 1.509 billion, and 1.449 billion yuan for the years 2025 to 2027, with growth rates of -40%, 156%, and -4% respectively [4][21]. - The net profit attributable to the parent company is expected to be -681 million, 196 million, and 156 million yuan for the same period, indicating a significant turnaround [4][21]. - Earnings per share (EPS) are forecasted to improve from -1.83 yuan in 2025 to 0.42 yuan in 2027 [4][21]. Product and Market Insights - Aorebatinib's sales are expected to continue growing, with a 93% year-on-year increase to 217 million yuan in the first half of 2025, driven by effective hospital access and chronic disease management strategies [7][11]. - APG-2575 is anticipated to receive regulatory approval in mid-2025, further solidifying the company's leadership in the domestic hematological oncology market [11][12]. - The report highlights the potential of APG-2575 to achieve rapid relief and improved safety in treating high-risk myelodysplastic syndromes (HR MDS) compared to existing therapies [14][18]. Pipeline and Future Developments - The company has several promising candidates in its pipeline, including APG-2449, which is undergoing Phase III trials for ALK-positive NSCLC, and various apoptosis inhibitors that are expected to provide competitive advantages in the oncology market [15][18]. - Upcoming milestones include the completion of several Phase III clinical trials for key products, which are expected to enhance the company's market presence and revenue potential [20].