研究报告 Research Report 26 Aug 2025 科伦博泰生物-B Sichuan Kelun-Biotech Biopharmaceutical (6990 HK) [Table_yemei1] 观点聚焦 Investment Focus [Table_Info] 维持优于大市 Maintain OUTPERFORM 评级 优于大市 OUTPERFORM 现价 HK$469.80 目标价 HK$519.20 HTI ESG 3.0-3.0-3.0 E-S-G: 0-5, (Please refer to the Appendix for ESG comments) 市值 HK$76.47bn / US$9.79bn 日交易额 (3 个月均值) US$40.25mn 发行股票数目 162.77mn 自由流通股 (%) 25% 1 年股价最高最低值 HK$469.80-HK$154.00 注：现价 HK$469.80 为 2025 年 08 月 25 日收盘价 资料来源： Factset 1mth 3mth 12mth 绝对值 24.3% 43.7% 180.6% 绝对值（美元） 24.9% 4 ...

Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the biopharmaceutical industry, indicating an expected price increase exceeding the benchmark index by over 10% [9]. Core Insights - The biopharmaceutical industry has shown significant clinical breakthroughs, particularly with innovative drugs like sac-TMT, which demonstrates promising efficacy in treating various cancers, including NSCLC and TNBC [3][5]. - The report highlights the strong performance of sac-TMT in clinical trials, with an overall objective response rate (ORR) of 70.7% in first-line TNBC and 59.3% in non-squamous NSCLC [4][5]. - The report emphasizes the potential of sac-TMT in combination therapies, showing improved progression-free survival (PFS) rates compared to traditional treatments [4][5]. Summary by Sections Industry Performance - The biopharmaceutical sector has outperformed the market over the past year, with innovative drugs leading the way in clinical advancements [1]. Key Drug Analysis - sac-TMT, a novel TROP2 ADC, has shown significant clinical benefits across multiple cancer types, with a favorable safety profile and manageable adverse events [3][5]. - In clinical trials, sac-TMT demonstrated an ORR of 45% in previously treated EGFR-mutant NSCLC, significantly outperforming traditional therapies [4]. Clinical Trial Results - In first-line TNBC, sac-TMT achieved an ORR of 70.7% and a median PFS of 13.4 months, indicating strong anti-tumor activity [5]. - The report notes that sac-TMT's efficacy extends to various PD-L1 expression levels, with mPFS rates varying from 12.4 to 17.8 months depending on PD-L1 TPS [4].

Core Viewpoint - Kolonbo Tai Biotech's stock price reached a new high of 363 HKD per share, driven by the significant clinical data release of TROP2 ADC, Lukanosatuzumab, for treating EGFR-mutant advanced non-small cell lung cancer (NSCLC) at the 2025 ASCO annual meeting [2] Group 1: Clinical Research Findings - The OptiTROP-Lung03 study demonstrated that Lukanosatuzumab significantly improved clinical outcomes in EGFR-TKI and platinum-based chemotherapy-resistant patients compared to the docetaxel group, with better objective response rate (ORR), median progression-free survival (PFS), and median overall survival (OS) [3][4] - The study reported a median follow-up of 12.2 months, showing statistically significant advantages for the Lukanosatuzumab group, although OS data is not yet fully mature [4] - The safety profile of Lukanosatuzumab was manageable, with the most common grade 3 or higher treatment-related adverse events (TRAE) being neutropenia (42.9%), leukopenia (25.3%), oral mucositis (16.5%), and anemia (12.1%) [4] Group 2: Regulatory Approval and Market Potential - Based on the positive results from the OptiTROP-Lung03 study, the National Medical Products Administration (NMPA) of China has approved Lukanosatuzumab for post-line treatment of EGFR-mutant NSCLC, making it the first TROP2 ADC approved for lung cancer indications globally [4] - The success of Lukanosatuzumab represents a significant breakthrough in clinical research and enhances the drug's accessibility in clinical practice, especially as previous similar Phase III trials abroad did not achieve approval [4] - The treatment strategy for TROP2 ADC Lukanosatuzumab is expanding from post-line to first-line therapy and from monotherapy to combination therapy [5] Group 3: Treatment for Rare EGFR Mutations - A Phase II open-label, multi-cohort study presented at ASCO evaluated the efficacy and safety of Lukanosatuzumab in previously treated patients with rare EGFR mutations, showing promising clinical activity with an ORR of 35.7% and a disease control rate (DCR) of 85.7% [6] - The study included 42 patients with rare EGFR mutations, with a median follow-up of 9.9 months, indicating a median PFS of 9.5 months and a 6-month duration of response (DoR) rate of 90.9% [6] - These results highlight the potential of Lukanosatuzumab as a new treatment option for patients with non-classical EGFR mutations [6]