华福证券 其他生物制品 2025 年 08 月 09 日 公 司 研 究 康方生物（09926.HK） 引领全球 IO2.0，依沃西有望占据最大市场份额 投资要点： AK112 进度全球领先，有望占据全球二代 IO 市场的最大份额 公 司 动 态 跟 踪 看好 PD-1 和 VEGF 靶点的广谱泛癌作用，VEGF 单抗贝伐珠 2019 年 全球峰值销售额约 71 亿美元，PD-1/PDL1 单抗 2024 年合计全球销售达 516 亿美金，全球合计近 600 亿美金的存量市场，依靠双靶协同机制做出增量 市场，空间巨大。目前 PD1/VEGF 或 PDL1/VEGF 双抗对外授权交易首付 款已达 39 亿美元，总金额已达 288 亿美元，代表性产品包括公司/Summit 的 AK112（13 项注册 3 期）、BMS/BioNTech 的 PM8002（3 项注册 3 期） 和 Pfizer/三生制药的 SSGJ-707（1 项注册 3 期），我们认为产业趋势趋于 清晰，看好 PD1/VEGF 双抗成为二代 IO 基石药物。 从进度来看，目前公司 AK112 国内已有 2 项适应症获批上市，1 项纳 入国家医保 ...

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [1]. Core Insights - The company is positioned as a leader in the dual antibody sector, spearheading a new era in immuno-oncology with its innovative products, particularly AK104 and AK112, which are nearing commercialization [8][13]. - The revenue forecast indicates significant growth, with projected revenues of 3.672 billion, 5.342 billion, and 7.240 billion CNY for 2025, 2026, and 2027 respectively, reflecting a strong upward trajectory [1][24]. - The company has a robust cash reserve of 7.344 billion CNY, which supports ongoing research and development efforts [29]. Summary by Sections Company Overview - The company focuses on developing innovative antibody drugs and has established a comprehensive drug development platform, ACE, with over 20 product pipelines [13][14]. - It has successfully launched the world's first dual immune checkpoint inhibitor, AK104, for cervical cancer in June 2022, and is expanding its product offerings [13][14]. Financial Performance - The company reported total revenue of 2.124 billion CNY in 2024, with a significant increase in product sales revenue to approximately 2.002 billion CNY, marking a year-on-year growth of 24.88% [24][25]. - The gross profit margin remains high at 86.39%, indicating strong profitability relative to industry standards [25][28]. Product Pipeline - AK104 is the only approved PD-1/CTLA-4 dual antibody globally, with multiple indications approved and ongoing clinical trials for additional cancers [33][34]. - AK112 is also positioned to challenge existing therapies, with promising clinical trial results and a strong market potential [8][19]. Market Position and Future Outlook - The company is expected to achieve a market valuation of 160 billion HKD based on the anticipated revenues from its core products [8]. - The report projects a target price of 163.33 CNY per share, indicating a potential upside from the current market price [8].

年内火热的创新药板块遭遇意外！ 6月2日，A股因端午节假期休市，香港市场的创新药板块全线下跌。截至当日收盘，康方生物大跌超10%，康 诺亚-B跌超5%，金斯瑞生物科技跌近3%。市场普遍认为，康方生物海外最新临床数据存在争议，导致公司大 跌，从而冲击市场对国内创新药整体信心。 不过，也有机构人士分析，本次全球3期临床研究成功意义重大，AK112中国与欧美数据具有高度的一致性， 说明目前国内数据质量很高，AK112是让全球患者获益且安全的PD-1双抗，全球IO2.0的地位进一步确定。 这项全球性试验旨在评估ivonescimab联合化疗与安慰剂联合化疗在局部晚期或转移性非鳞状非小细胞肺癌患 者中的疗效，这些患者的肿瘤携带表皮生长因子受体(EGFR)突变。这类患者对第三代EGFR酪氨酸激酶抑制剂 治疗无效。 Summit援引3期HARMONi试验的顶线数据称，这款PD-1/VEGF双特异性抗体与化疗联用，在无进展生存期 (PFS)这一主要终点上达到了统计学显著且具有临床意义的改善。此外，该公司表示，尽管另一项主要终点 ——总生存期(OS)未达到统计学显著差异，但数据显示出积极趋势。 展望创新药板块，市场分析认为，未 ...