康宁杰瑞 20251222 摘要 康宁杰瑞的 KN026 预计 2026 年获批用于二线及以上 HER2 阳性胃癌， 疗效超越现有临床指南药物，销售峰值预期超 30 亿元。一线乳腺癌及 新辅助临床数据也将在 2026 年读出并申报上市。 GSK003 是一种 HER2 双表位 ADC，采用糖基化定点偶联技术，疗效 和安全性优于 TDM1 等单靶 ADC。预计 2026 年二线 HER2 阳性乳腺 癌数据读出并申报上市，销售峰值预期超 25 亿元。 康宁杰瑞拥有糖基化定点偶联和皮下注射给药两大技术平台。糖基化平 台效率高于 Synaffix，皮下注射平台提升患者依从性。KN035 销售收 入和对外授权许可费是主要营收来源，公司 2024 年已扭亏为盈。 ADC 市场快速发展，康宁杰瑞专注于新一代 ADC 治疗范式，其糖基化 定点偶联平台产出的 ADC 疗效与安全性优于现有单靶 ADC，差异化靶 点布局带来 BD 机遇。公司管线包含多款创新型双抗和复方制剂。 KN026 在 HER2 阳性胃癌的临床试验中，mPFS 和 MOS 均优于现有疗 法，HR 值低于 0.3，可显著降低疾病进展和死亡风险。一线治疗 MOS ...

智通财经APP获悉，国金证券发布研报称，预测2025/2026/2027年康宁杰瑞制药-B(09966)营业收入 4.43/4.86/5.50亿元，同比-30.87%/+9.78%/+13.22%，归母净利润-1.05/-0.98/-0.24亿元，同 比-162.91%/+6.62%/+75.61%。采用DCF估值法，给予目标价14.30港元/股，首次覆盖，给予"买入"评 级。 JSKN003为公司自研HER2双抗ADC，该产品针对多适应症的III期临床试验在中国有序推进：在铂类耐 药卵巢癌全人群适应症中，其疗效与安全性已展现出优于Enhertu的特征，预计2027年完成数据读出并 报产;预计2026年向CDE提交2L HER2阳性乳腺癌的NDA;2025年10月启动中国HER2阳性转移性结直肠 癌适应症III期临床，该行预期JSKN003预期27/28/29年销售分成为0.05/0.57/1.08亿元。 差异化靶点布局与自研偶联平台双轮驱动，存在BD机遇 公司依托自有糖基化定点偶联核心技术平台，结合差异化靶点布局策略，构筑了多元化双抗ADC产品 矩阵：其中JSKN016为全球首个TROP2/HER3双抗AD ...

风险提示：临床试验进展不及预期;新药研发结果不及预期;市场推广及销售不及预期 JSKN003凭借技术创新构筑差异化竞争优势 JSKN003为公司自研HER2双抗ADC，该产品针对多适应症的III期临床试验在中国有序推进：在铂类耐 药卵巢癌全人群适应症中，其疗效与安全性已展现出优于Enhertu的特征，预计2027年完成数据读出并 报产;预计2026年向CDE提交2L HER2阳性乳腺癌的NDA;2025年10月启动中国HER2阳性转移性结直肠 癌适应症III期临床，该行预期JSKN003预期27/28/29年销售分成为0.05/0.57/1.08亿元。 差异化靶点布局与自研偶联平台双轮驱动，存在BD机遇 公司依托自有糖基化定点偶联核心技术平台，结合差异化靶点布局策略，构筑了多元化双抗ADC产品 矩阵：其中JSKN016为全球首个TROP2/HER3双抗ADC，已在肺癌、乳腺癌等适应症入组超400例患 者，市场潜在空间广阔;JSKN022作为全球FIC靶向PD-L1/ITGB6双抗ADC于十月启动首例患者给药， JSKN027为具备细胞毒性杀伤、抗血管生成及免疫调节三重作用机制的全球FIC双抗ADC，有望近期申 ...

Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [1]. Core Views - The company is moving towards a harvest period with multiple licensing collaborations validating its platform value [1]. - The company achieved its first profit in 2024, driven by significant licensing income and a strong focus on R&D [6][22]. - The company has a robust pipeline of HER2-targeted products, with key candidates in late-stage clinical trials [6][25]. Summary by Sections 1. Technical Innovation as a Driver - The company focuses on antibody-drug conjugates (ADC) and bispecific antibodies, leveraging core technologies for differentiated cancer immunotherapy [11]. - The management team has extensive experience in research and development, ensuring innovation and operational efficiency [11][19]. - The company has secured multiple high-value licensing agreements, enhancing its platform and pipeline value [19][20]. 2. HER2-targeted Product Strategy - The company has three HER2-targeted products, including KN026 (HER2 bispecific antibody) and JSKN003 (HER2 bispecific ADC), positioned for various cancer indications [25][30]. - KN026 is expected to submit a domestic application for 2L+ HER2-positive gastric cancer by 2025, with promising clinical data [30][34]. - JSKN003 has a commercial collaboration with a partner, with a total transaction value of 30.8 billion RMB [39]. 3. JSKN016 (TROP2/HER3 ADC) Development - JSKN016 is being explored for both monotherapy and combination treatments, targeting high-expression TROP2 and HER3 in various tumors [7][25]. - The drug is in clinical phase 2, focusing on unmet needs in triple-negative breast cancer and EGFR-TKI resistant non-small cell lung cancer [7][25]. 4. Financial Performance and Projections - The company achieved a revenue of 6.4 billion RMB in 2024, a year-on-year increase of 192.6%, with a profit of 1.66 billion RMB [22][23]. - The R&D expenditure for 2024 was maintained at 4.04 billion RMB, ensuring continued investment in clinical development [22][24]. - Revenue projections for 2025-2027 are estimated at 4.58 billion RMB, 4.90 billion RMB, and 3.98 billion RMB respectively [6][25].