2025 年 6 月 19 日 证券研究报告/公司研究 化学制剂/化学制药/医药生物 首药控股-U 688197.SH 基础数据： | | | huchenxi@gwgsc.com 执业证书编号：S0200518090001 联系电话：010-68085205 weiyuqi@gwgsc.com 执业证书编号：S0200123060002 联系电话：010-68099389 公司地址： 楼中国长城资产大厦 16 层 ALK-TKI 双代布局，SY-707 上市在即 主要观点： ◆聚焦 NSCLC 小分子创新药领域，同时拥有第二代、三代 ALK-TKI。 公司是一家专注于小分子创新药自主研发的企业，研发管线涵盖多种 肿瘤适应症及其他临床需求迫切的疾病，聚焦于 NSCLC 适应症，公司 布局了第二代 ALK-TKI SY-707、第三代 ALK-TKI SY-3505、高选择性 RET-TKISY-5007、KRASG12C 抑制剂 SY-5933 等产品，是国内首个同 时拥有第二代、三代 ALK-TKI 的创新药企。此外，公司多个早期研发 项目获得了阶段性的成绩，确定了多个 PCC，包括 LMP7 抑制剂、第 ...

Core Insights - Lung cancer is the most prevalent and deadly malignancy in China, with approximately 1.0606 million new cases and 733,300 deaths reported in 2022, accounting for 22.0% and 28.5% of all cancer cases respectively [1][3] - Advances in genetic testing and targeted therapies have improved survival rates for patients with rare targets like ALK and ROS1, transforming lung cancer into a manageable chronic disease for some patients [1][2] - There is a pressing need to enhance awareness and understanding of rare targets among clinicians and to ensure equitable access to medical resources for comprehensive lung cancer diagnosis and treatment [1][5] Group 1: Disease Burden and Treatment Advances - Lung cancer accounts for 80%-85% of all cases of non-small cell lung cancer (NSCLC) in China, with ROS1 fusion positivity occurring in about 2% of patients, most of whom are diagnosed at advanced stages [3][4] - The introduction of targeted therapies has shifted the treatment paradigm from chemotherapy to personalized molecular treatments, with FDA-approved therapies targeting mutations such as EGFR, ALK, and ROS1 [4][7] - Research indicates that with appropriate targeted treatment, patients with rare targets can significantly extend their survival, with some achieving over ten years [1][2] Group 2: Challenges in Diagnosis and Treatment - The actual rate of genetic testing for ROS1 fusion is significantly lower than recommended, influenced by regional differences in physician awareness and patient access to testing [5][6] - Economic burdens and the high costs of testing contribute to the underutilization of targeted therapies, with many patients opting for chemotherapy due to delays in obtaining test results [6][8] - There is a need for improved detection methods and faster turnaround times for test results to enhance patient outcomes [6][10] Group 3: Standardization and Education - Standardization and quality control in cancer diagnosis and treatment are critical, with ongoing efforts to improve the skills of clinicians in rural areas through education and training programs [9][10] - The establishment of efficient testing platforms is essential to manage the increasing number of lung cancer patients, requiring collaboration among manufacturers, enterprises, and government [10]