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 ...

Summary of Corning Jereh Conference Call Company Overview - **Company**: Corning Jereh - **Focus**: Development of innovative drugs targeting HER2-positive cancers, including breast and gastric cancers Key Points Industry and Product Pipeline - Corning Jereh plans to submit KN026 for HER2-positive gastric cancer in 2025, with expected approval by mid to late Q2 2026, showing strong clinical trial results with an ORR over 40% and PFS over 8.6 months [2][5][6] - The company is developing multiple new molecules (022, 027, 021) aimed at enhancing treatment efficacy and expanding indications, with IND submissions planned for 2025 or Q1 2026 [2][8] - KN026 has completed enrollment for a Phase III trial in breast cancer with nearly 900 participants, with full data interpretation expected in 2026 [2][32] Clinical Trials and Data - KN026's Phase II trial demonstrated competitive results, with PFS significantly better than competitors [6] - GSK003, another HER2-targeted ADC, is in a Phase III trial for HER2-positive breast cancer, with completion of enrollment expected in 2025 [2][3] - The company is also exploring new indications for existing drugs, including cervical cancer and other HER2-effective treatments [3][19] Market Potential - The market potential for second-line gastric cancer treatment is estimated to exceed 1 billion RMB, with ongoing exploration for first-line indications [10] - The domestic anti-HER2 product market is valued at approximately 25-30 billion RMB, with 80-85% attributed to breast cancer [15] Competitive Landscape - KN026 is positioned as a safer first-line treatment compared to competitors like 8,201, which has shown significant toxicity issues [12][13][14] - The sales peak for KN026 is projected to exceed 6 billion RMB, making it a leading product in the market [15][29] Development and Regulatory Strategy - The company is actively pursuing regulatory submissions and has positive feedback from CDE regarding KN026 [5][27] - Plans for data presentations at academic conferences to support future collaborations and submissions [9][39] Collaboration and Partnerships - Corning Jereh emphasizes external collaborations, having made significant partnerships in the past year, particularly for late-stage products [26][39] - The company is also exploring global development opportunities for new molecules [26] Financial and Operational Outlook - Recent stock performance has been under pressure, but the company maintains a positive outlook on operational and product development progress [27][38] - Key milestones include upcoming IND submissions and data readouts in 2026 for various products [27][28] Unique Technology and Risks - The ADC platform utilizes glycosylation-based conjugation technology, offering better stability and reduced toxicity compared to traditional ADCs [33] - There are some patent risks associated with certain projects, but the company is actively managing these concerns [34][39] Employee Incentives - The company has established incentive mechanisms for key personnel to ensure stability and drive R&D progress [35] This summary encapsulates the critical insights from the conference call, highlighting the company's strategic direction, product pipeline, market potential, and operational strategies.