撰文丨王聪 编辑丨王多鱼 排版丨水成文 芦康沙妥珠单抗 （ Sacituzumab tirumotecan，sac-TMT） 是由 科伦博泰 开发的一款 TROP2 靶向的抗 体药物偶联物 （ TROP2- ADC） ，该 ADC 药物已在国内获批上市，用于治疗晚期三阴性乳腺癌。此 外，该药物还在进行多项临床试验，治疗非小细胞包肺癌等多种癌症。 2025 年 8 月 19 日，中山大学肿瘤防治中心 方文峰 教授、 张力 教授团队 在 Nature Medicine 期刊发表 了题为： First-line sacituzumab tirumotecan with tagitanlimab in advanced non-small-cell lung cancer: a phase 2 trial 的临床研究论文。 该论文首次发布了 芦康沙妥珠单抗 （ 科伦博泰开发的 TROP2 靶向的 ADC 药物 ） 联合 塔戈利单抗 （ tagitanlimab， 科伦博泰开发的抗 PD-L1 单抗 ） 一线治疗 驱动基因阴性晚期 或转移性 非小细胞肺癌 （ NSCLC） 的 OptiTROP-Lung01 研究的 2 ...

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received breakthrough therapy designation from the National Medical Products Administration (NMPA) for its TROP2 ADC product, sac-TMT, in combination with PD-L1 monoclonal antibody, Tagolizumab, for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver gene mutations [2][3]. Group 1: Product and Clinical Development - Sac-TMT is a novel TROP2 ADC developed by Kelun Botai, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), and gynecological tumors [3][5]. - The drug utilizes a new linker and has a drug-antibody ratio (DAR) of 7.4, employing a topoisomerase I inhibitor as an effective payload to induce DNA damage in tumor cells [3][5]. - Sac-TMT has previously received four other breakthrough therapy designations for various indications, including triple-negative breast cancer (TNBC) and EGFR mutation-positive NSCLC [3][4]. Group 2: Regulatory and Market Position - Sac-TMT is the first domestically developed ADC with global intellectual property rights and the first TROP2 ADC approved for lung cancer indications globally [5]. - The drug has already been approved for two indications in China, including treatment for advanced TNBC and EGFR mutation-positive NSCLC after prior treatment [4][5]. - Kelun Botai has initiated eight registration clinical studies in China, while Merck has started 14 ongoing global Phase III clinical studies for sac-TMT in various cancer types [5]. Group 3: Collaborations and Partnerships - In May 2022, Kelun Botai granted Merck exclusive rights to develop, use, manufacture, and commercialize sac-TMT outside Greater China [4]. - Tagolizumab, the PD-L1 monoclonal antibody used in combination with sac-TMT, is the first approved PD-L1 antibody for first-line treatment of nasopharyngeal carcinoma in China [6].

Group 1 - Core product Lukanasatuzumab (SAC-TMT) received breakthrough therapy designation from China's National Medical Products Administration (NMPA) for treating locally advanced or metastatic non-squamous non-small cell lung cancer without driver gene mutations [1] - This is the fifth breakthrough therapy designation for Lukanasatuzumab, which is an innovative antibody-drug conjugate (ADC) targeting advanced solid tumors such as non-small cell lung cancer, breast cancer, gastric cancer, and gynecological tumors [1][2] - Lukanasatuzumab has two approved indications in China, including treatment for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and EGFR mutation-positive non-small cell lung cancer after platinum-based chemotherapy [2] Group 2 - The company plans to place 5.918 million H-shares at a price of HKD 331.8 per share, raising approximately HKD 1.943 billion, marking the largest new share placement in the Hong Kong biopharmaceutical sector this year [3] - Proceeds from the placement will be used for product research and development, clinical trials, regulatory filings, manufacturing, and commercialization, aiming to enhance R&D capabilities and expand the product pipeline [3] - The company has seen a cumulative stock price increase of 110.04% this year, reflecting strong market interest in innovative drug concepts [3]

Core Viewpoint - The company Kolon Biotech has received breakthrough therapy designation from the NMPA for its antibody-drug conjugate sac-TMT in combination with the PD-L1 monoclonal antibody for the treatment of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver gene mutations, indicating significant clinical advantages over existing treatments [1][2]. Group 1 - The breakthrough therapy designation aims to expedite the research, development, and promotion of innovative treatments to address urgent medical needs [1]. - This marks the fifth breakthrough therapy designation for sac-TMT, with previous recognitions for treating various cancers including triple-negative breast cancer (TNBC) and hormone receptor-positive breast cancer [2]. - The results of the phase 2 OptiTROP-Lung01 clinical study for sac-TMT combined with Tagoli monoclonal antibody in treating advanced or metastatic non-squamous NSCLC patients will be presented at the 2025 ASCO annual meeting [2].

Core Viewpoint - The company, Kelun Pharmaceutical, is set to present six clinical research results at the 2025 American Society of Clinical Oncology annual meeting, showcasing advancements in cancer treatment [1] Group 1: Clinical Research Results - Kelun Biotech, a subsidiary of Kelun Pharmaceutical, will present data on antibody-drug conjugate Lukanasatuzumab targeting TROP2, monoclonal antibody Tagolisumab targeting PD-L1, and RET inhibitor KL590586 [1] - Lukanasatuzumab demonstrated a confirmed objective response rate of 45.1% in a randomized clinical study for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC), with a median progression-free survival of 6.9 months [1] - Tagolisumab combined with gemcitabine and cisplatin showed a 53% reduction in the risk of disease progression or death in a randomized, double-blind Phase 3 clinical study for recurrent or metastatic nasopharyngeal carcinoma [1] - KL590586 achieved a confirmed objective response rate of 63.0% in a Phase I clinical study for patients with advanced RET gene mutation medullary thyroid carcinoma (MTC) [1]

Group 1: Banking Industry Analysis - The six major state-owned banks achieved a net profit growth of 1.8% year-on-year in 2024, with Agricultural Bank leading at 4.7% [8][9] - Asset allocation is stable, with an increase in the proportion of loans and bond investments, while the overall asset scale growth rate rose to 7.9% [9] - The asset quality remains stable, with a slight increase in retail non-performing loan ratios, while the overall capital adequacy ratio is improving [9] Group 2: Pharmaceutical Company Analysis - Kelun-Biotech - The company has over 30 products in development and three commercialized products, with its core product, Lukanasa, approved for two indications in China [11][15] - Revenue is projected to reach 1.824 billion, 2.875 billion, and 4.521 billion yuan from 2025 to 2027, with a "recommend" rating given for the stock [15] - The company is transitioning towards an integrated model of innovative research and commercial sales, with significant global partnerships enhancing its clinical research capabilities [12][15] Group 3: Pharmaceutical Company Analysis - Kailaiying - The company reported a revenue of 1.541 billion yuan in Q1 2025, reflecting a growth of 10.10%, with a net profit of 327 million yuan, up 15.83% [16][18] - The emerging business segments, including peptides and ADCs, have shown over 80% growth, contributing significantly to revenue [17] - The company maintains a strong recommendation rating, with profit forecasts of 1.126 billion, 1.378 billion, and 1.740 billion yuan for 2025 to 2027 [19] Group 4: Biotechnology Company Analysis - Aopumai - The company achieved a revenue of 297 million yuan in 2024, a growth of 22.26%, but faced a net profit decline of 61.04% [25] - The core business of culture media is growing rapidly, with participation in 247 research pipelines, indicating strong future demand [26] - The company maintains a "recommend" rating, with adjusted profit forecasts of 65 million, 92 million, and 126 million yuan for 2025 to 2027 [26]