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科伦博泰生物-B(06990.HK):业绩符合预期 核心产品商业化进展顺利 后续管线多维度展开
Ge Long Hui· 2025-08-21 19:35
SKB264 临床进展顺利,国内海外同步加速推进中:2L EGFRmt NSCLC 国内注册临床数据预计于25 年 ESMO 大会读出,目前国内注册临床包含肺癌3 个(联用K药治疗1L EGFRwt NSCLC PD-L1 TPS≥1%; 联用K 药针对1L EGFRwt nsq PDL1(-)NSCLC;联用奥希治疗 1L EGFRmt nsq NSCLC)和乳腺癌2 个 (1L TNBC;2L+ HR+/HER2- BC);默沙东已开启14 个海外临床,全面覆盖了肺癌5 个(联合K 药新 辅助Ⅱ-Ⅲb NSCLC、联合K 药治疗1L PD-L1 高表达、单药治疗EGFR TKI耐药的2L/3L 突变型、单药对 照标准化疗治疗2L+ EGFR m 非鳞癌、联合K 药维持治疗1L 鳞癌)、乳腺癌4 个(联合K 药治疗术后未 达pCR 的TNBC 及1L TNBC、单药治疗2L+ HR+/HER2- BC)、子宫内膜癌2 个、2L 宫颈癌、3L+胃食 管腺癌、铂敏感复发性卵巢癌等,我们预计26Q4 开始海外陆续有数据读出。 机构:东吴证券 研究员:朱国广/张翀翯 事件:公司25 年H1 收入9.82 亿元(人民 ...
中金:维持科伦博泰生物-B(06990)跑赢行业评级 升目标价至550港元
Zhi Tong Cai Jing· 2025-08-21 04:13
Core Viewpoint - CICC maintains an outperform rating for Kelun-Biotech (06990) due to strong revenue recognition from licensing and effective cost control, raising the target price by 57.1% to HKD 550, indicating a 20.6% upside from the current stock price [1] Group 1: Financial Performance - In 1H25, the company reported revenue of CNY 950 million, exceeding CICC's expectations [1] - The commercial revenue for 1H25 reached CNY 310 million, with 97.6% attributed to the product Jiatailai [2] Group 2: Product Development and Market Expansion - The marketing team has grown to over 350 members, covering 30 provinces and achieving sales in over 1,000 hospitals [2] - The company is expected to receive domestic approval for 2L NSCLC in the second half of 2025 and is actively working on insurance inclusion for 2026 [2] Group 3: R&D Catalysts - The company has submitted a listing application for sac-TMT for 2L NSCLC, with expected approval in 2H25 and data presentation at the upcoming ESMO conference [3] - The company plans to submit a listing application for A400 (RET inhibitor) within 2025 [3] Group 4: Early Pipeline Developments - The company will present phase 1 clinical data for SKB315 (CLDN18.2 ADC) at the ESMO conference [4] - Global phase 1/2 trials for SKB410 (Nectin-4 ADC) have been initiated by Merck [4] - The dual-antibody ADC SKB571 is set to begin phase 2 clinical trials in China [4]