Investment Rating - The investment rating for the company is "Buy" with a target price of 95.42 HKD, compared to the last closing price of 74.25 HKD [1][10]. Core Views - The report highlights that the clinical data for IBI363, a dual-specific antibody fusion protein, has exceeded expectations in treating advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma [3][4][5][6]. - The company is expected to see significant revenue growth, with projected revenues of 94.22 billion HKD in 2024, increasing to 207.91 billion HKD by 2027, reflecting a growth rate of 51.82% in 2024 and 31.60% in 2027 [11][15]. Summary by Sections Company Overview - The total share capital is 1.65 billion shares, with a total market capitalization of 1,225 billion HKD [2]. - The company has a strong pipeline with multiple important developments expected in 2025, including approvals for various treatments [9]. Clinical Data - IBI363 showed a median progression-free survival (mPFS) of 9.3 months and a 12-month overall survival (OS) rate of 70.9% in patients with immune-resistant lung squamous cell carcinoma [4]. - In CRC patients, IBI363 demonstrated a median overall survival (mOS) of 16.1 months, indicating a significant improvement over existing treatment options [5]. - For melanoma, IBI363 achieved an mPFS of 5.7 months, with ongoing trials comparing it to pembrolizumab in treatment-naive patients [6]. Financial Projections - The company is projected to achieve a net profit of 6.23 billion HKD in 2025, with a significant increase to 30.77 billion HKD by 2027, reflecting a net profit growth rate of 132.26% in 2027 [11][15]. - The earnings per share (EPS) is expected to rise from -0.06 HKD in 2024 to 1.87 HKD in 2027 [11][15]. Valuation - The valuation methods used include DCF and NPV, resulting in a target market value of 1,574 billion HKD, which corresponds to the target stock price of 95.42 HKD [10].

此前，IBI363已被CDE纳入突破性治疗药物（BTD）品种名单，拟定适应症为既往未经过系统性治疗的 不可切除局部晚期或转移性肢端型及黏膜型黑色素瘤。 信达生物正在中国、美国、澳大利亚开展临床研究探索IBI363在针对各种恶性肿瘤的有效性和安全性。 IBI363已开出首个关键注册临床研究，用于治疗未经免疫治疗的粘膜型和肢端型黑色素瘤。IBI363已获 美国FDA两项快速通道资格认定，分别用于治疗晚期鳞状非小细胞肺癌和黑色素瘤。 由于新激活的肿瘤特异性T细胞同时表达PD-1和IL-2α，这一差异性策略可以更精确和有效地实现对该T 细胞亚群的靶向和激活。IBI363不仅在多种荷瘤药理学模型中展现出了良好抗肿瘤活性，在PD-1耐药和 转移模型中也表现出了突出的抑瘤效力。 智通财经APP获悉，5月23日，国家药品监督管理局（NMPA）药品审评中心（CDE）官网显示，信达 生物（01801）的PD-1/IL-2双特异性抗体融合蛋白IBI363拟纳入突破性疗法，用于治疗经含铂化疗及抗 PD-1/PD-L1免疫治疗失败的局部晚期或转移性鳞状非小细胞肺癌。 据悉，IBI363是由信达生物自主研发的全球首创PD-1/IL-2α ...