EGFRADCSYS6010海外已启动EGFR mu III期临床，wtNSCLC注册路径积极沟通中 EGFRADCSYS6010早期数据得到中美药品监管认可，已拿到多项认证，期待后续注册临床进度。 SYS6010已获得美国FDA授予的三项快速通道资格(FTD)，分别为覆盖EGFR突变阳性、EGFR高表达鳞 状型以及不伴EGFR突变的非鳞状NSCLC患者。SYS6010已获得NMPA的BTD，适应症为单药用于经 EGFR-TKI和含铂化疗治疗失败的EGFR突变阳性晚期NSCLC患者。 首个国产HER2双抗KN026申报上市 公司与康宁杰瑞合作开发的HER2双抗KN026(安尼妥单抗注射液)的新药上市申请于2025年9月获中国国 家药监局受理，适应症为联合化疗用于至少接受过一种系统性治疗(必须包含曲妥珠单抗联合化疗)失败 的HER2阳性局部晚期、复发或转移性的胃/胃食管结合部腺癌。本次上市申请主要是基于一项关键II/III 期临床试验(KC-WISE)。III期临床研究的首次期中分析结果显示，与目前的标准治疗相比，KN026联合 化疗可显著提高临床疗效，延长无进展生存期和总生存期，且在安全性方面无新发安全性风险 ...

Core Viewpoint - The company is leveraging technological innovation as a driving force for its drug development, with key products in advanced clinical stages and expected market submissions in the near future [1][2]. Group 1: Product Development and Clinical Trials - The company has two main products, KN026 (HER2 bispecific antibody) and JSKN003 (HER2 bispecific antibody ADC), both in Phase 3 clinical trials, with KN026 expected to submit for market approval for 2L+ HER2-positive gastric cancer in 2025 [1]. - KN026 is involved in three Phase 3 clinical trials, including a combination study with chemotherapy for 2L+ HER2-positive gastric cancer, which has met the primary endpoint for progression-free survival (PFS) [1]. - JSKN003 is also in three Phase 3 clinical trials targeting HER2-positive breast cancer and platinum-resistant recurrent epithelial ovarian cancer [1]. Group 2: Financial Performance and Collaborations - In 2024, the company achieved significant licensing revenue from multiple collaborations, including a $700.8 million deal for KN035 and a $308 million deal for JSKN003, leading to a total revenue of 640 million yuan, a year-on-year increase of 192.6% [2]. - The company turned a profit of 166 million yuan in 2024, marking its first profitable year, while maintaining a stable R&D expenditure of 404 million yuan [2]. - Cash reserves at the end of 2024 stood at 1.571 billion yuan, providing a solid financial foundation for ongoing clinical development [2]. Group 3: Future Outlook and Strategic Focus - The company is focusing on the development of JSKN016 (TROP2/HER3 ADC), which is currently in Phase 2 clinical trials, aiming to enhance efficacy through dual-targeting mechanisms [2]. - The clinical strategy for JSKN016 includes targeting unmet needs in triple-negative breast cancer (TNBC) and EGFR-TKI resistant non-small cell lung cancer (NSCLC) [2]. - Revenue projections for 2025-2027 are estimated at 458 million, 490 million, and 398 million yuan respectively, with a recommendation for investment based on the promising pipeline [3].