Core Viewpoint - The company announced that its subsidiary, Sichuan Kelun-Botai Biopharmaceutical Co., Ltd., received approval for a third indication of its antibody-drug conjugate, sac-TMT (also known as SKB264/MK-2870), for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1] Company Summary - The approved drug, sac-TMT, targets TROP2 and is positioned to address a significant patient population in the NSCLC segment [1] - This approval marks a significant milestone for the company, expanding its product offerings in the oncology space [1] Industry Summary - The approval of sac-TMT aligns with the growing trend of developing targeted therapies for cancer treatment, particularly in the NSCLC market [1] - The NSCLC market is increasingly competitive, with a focus on innovative therapies that can provide options for patients who have limited treatment responses [1]

Core Viewpoint - Kelong Pharmaceutical's subsidiary Sichuan Kelong Botai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) sac-TMT (also known as SKB264/MK-2870) for a new indication in treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1] Group 1 - The approved indication for sac-TMT is specifically for EGFR gene mutation-positive patients who have progressed after TKI treatment [1] - Sac-TMT is the first and only ADC globally to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy [1] - In predefined OS analysis, sac-TMT demonstrated statistically and clinically significant improvements in progression-free survival and overall survival compared to the current standard of care [1]

科伦药业（002422）(002422.SZ)发布公告，公司近日获悉，公司控股子公司四川科伦博泰生物医药股 份有限公司(简称"科伦博泰")靶向人滋养细胞表面抗原2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗 (sac-TMT，亦称SKB264/MK-2870)(佳泰莱)获国家药品监督管理局(NMPA)批准第三项适应症，用于治 疗经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR基因突变阳性的局部晚期或 转移性非鳞状非小细胞肺癌(NSCLC)成人患者。 芦康沙妥珠单抗(sac-TMT)是迄今为止全球首个且唯一对比含铂双药化疗显示出显著的总生存期(OS)获 益，并且已获批用于仅接受过TKI治疗后进展(2L)的晚期NSCLC的ADC。在预设的OS期中分析中，与 目前含铂双药化疗标准治疗相比，芦康沙妥珠单抗(sac-TMT)单一疗法在无进展生存期和总生存期均具 有显著统计学意义和临床意义的改善，显著延长此类患者的无进展生存期和总生存期。 ...

科伦药业(002422.SZ)发布公告，公司近日获悉，公司控股子公司四川科伦博泰生物医药股份有限公司 (简称"科伦博泰")靶向人滋养细胞表面抗原 2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT， 亦称SKB264/MK-2870)(佳泰莱®)获国家药品监督管理局(NMPA)批准第三项适应症，用于治疗经表皮生 长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞 状非小细胞肺癌(NSCLC)成人患者。 芦康沙妥珠单抗(sac-TMT)是迄今为止全球首个且唯一对比含铂双药化疗显示出显著的总生存期(OS)获 益，并且已获批用于仅接受过 TKI 治疗后进展(2L)的晚期NSCLC 的 ADC。在预设的 OS 期中分析中， 与目前含铂双药化疗标准治疗相比，芦康沙妥珠单抗(sac-TMT)单一疗法在无进展生存期和总生存期均 具有显著统计学意义和临床意义的改善，显著延长此类患者的无进展生存期和总生存期。 ...

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the third indication of the antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1][2] Group 1 - The approval is based on a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study aims to evaluate the efficacy and safety of sac-TMT administered as a monotherapy compared to pemetrexed combined with platinum-based therapy in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who failed EGFR-TKI treatment [2] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy in this patient population [1][2] Group 2 - In March 2025, sac-TMT was approved by NMPA for patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who progressed after EGFR-TKI and platinum-based chemotherapy [2] - The monotherapy with sac-TMT significantly extended the overall survival of these patients compared to standard treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC has completed patient enrollment in China [2]

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the third indication of the antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1][2] Group 1 - The approval is based on a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which will present its findings at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study evaluates the efficacy and safety of sac-TMT administered as a monotherapy compared to pemetrexed combined with platinum-based therapy in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who failed EGFR-TKI treatment [2] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to standard platinum-based doublet chemotherapy in this patient population [1][2] Group 2 - In March 2025, sac-TMT was approved by NMPA for patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who progressed after EGFR-TKI and platinum-based chemotherapy [2] - The monotherapy with sac-TMT significantly extended the overall survival of these patients compared to standard treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC has completed patient enrollment in China [2]

四川科伦药业股份有限公司 关于子公司核心产品 TROP2 ADC 芦康沙妥珠单抗(sac-TMT) 获国家药品监督管理局批准第三项适应症（用于治疗 EGFR-TKI 治 疗后进展的 EGFR 突变非小细胞肺癌）上市的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 证券代码：002422 证券简称：科伦药业 公告编号：2025-073 本 次 批 准 是 基 于 一 项 随 机 、 开 放 标 签 、 多 中 心 III 期 临 床 研 究 (OptiTROP-Lung04)，该研究已入选 2025 年欧洲肿瘤内科学会(ESMO)大会最新 突破性摘要(LBA)，并将以主席论坛(Presidential Symposium)口头报告（报告编号： LBA5）的形式发布。OptiTROP-Lung04 研究旨在评估芦康沙妥珠单抗(sac-TMT) 单 一 疗 法 每两 周 (Q2W) 5mg/kg 静 脉 注 射 对比 培 美 曲 塞 联 合 铂类 治 疗 经 EGFR-TKI 治疗失败的 EGFR 突变的局部晚期或转移性非鳞状 NSCLC 患者的有 效性和安全 ...

Core Viewpoint - Kelong Pharmaceutical's subsidiary, Sichuan Kelong Botai Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate, sac-TMT (also known as SKB264/MK-2870), for a third indication in treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1] Group 1 - Kelong Pharmaceutical's subsidiary, Sichuan Kelong Botai, has developed an ADC targeting TROP2 [1] - The newly approved indication is specifically for EGFR gene mutation-positive NSCLC patients [1] - This approval marks the third indication for sac-TMT, enhancing its therapeutic applications [1]

Core Viewpoint - The approval of sac-TMT, a targeted antibody-drug conjugate (ADC) by Kelun Pharmaceutical's subsidiary, marks a significant advancement in the treatment of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR mutations after progression on EGFR tyrosine kinase inhibitors (TKIs) [1] Group 1 - Kelun Pharmaceutical's subsidiary, Kelun Biotech, received approval from the National Medical Products Administration (NMPA) for sac-TMT for a third indication [1] - Sac-TMT is the first and only ADC globally that has shown significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy [1]

Core Viewpoint - The domestic innovative drug industry is transitioning from a follower to FIC/BIC innovation, supported by engineer dividends, abundant clinical resources, and favorable policies, indicating a qualitative improvement as it enters the 2.0 era [1][2] Group 1: Industry Development - The innovative drug sector is expected to benefit from policy reforms in payment systems, enhancing the profitability of innovative drug companies as they commercialize domestic products [2] - The upcoming ESMO conference in mid-October is anticipated to provide new investment opportunities through the release of relevant clinical data and business development (BD) activities [2] Group 2: Investment Climate - The investment landscape has improved since early this year, with a notable reversal in the financing trend for the innovative drug industry, particularly in the A/H market [3] - The recovery of IPO projects and financing activities in the secondary market is expected to positively impact investment data in Q3, benefiting domestic CROs and upstream research sectors [3] Group 3: Policy Support - Continuous advancement of commercial medical insurance policies since 2025 is likely to accelerate payment system reforms, easing supply-demand conflicts and supporting domestic innovation [4] - Fiscal policy enhancements are expected to increase market interest in domestic medical equipment stocks [4] Group 4: Target Companies - A-share targets include: BeiGene (688235.SH), Hengrui Medicine (600276.SH), Kelun Pharmaceutical (002422.SZ), WuXi AppTec (603259.SH), Tigermed (300347.SZ), New Industry (300832.SZ), BGI Genomics (688114.SH), Huatai Medical (688617.SH), and Dian Diagnostics (300244.SZ) [5] - H-share targets include: Kelun Biotech (06990), CSPC Pharmaceutical (01093), China Biologic Products (01177), CanSino Biologics (09926), WuXi Biologics (02269), Junshi Biosciences (01877), and Zai Lab (09688) [5]