Core Viewpoint - The report from CMB International indicates an optimistic outlook for the sales of Sac-TMT and Bodo-Tuzumab based on regulatory approval progress, leading to an upward revision of revenue forecasts for 2025-2027 by 0-5% and an increase in peak sales projections to RMB 6.4 billion and RMB 1.1 billion respectively. The DCF target price has risen to HKD 549, maintaining a "Buy" rating for Kelun-Botai Biopharmaceuticals (06990), driven by the significant global value of the ADC product matrix supported by clinical data [1]. Group 1 - Sac-TMT sets a new benchmark for EGFR mutation-resistant NSCLC treatment: The results of the Phase III OptiTROP-Lung04 study presented at the ESMO conference show that the Sac-TMT treatment group achieved statistically and clinically significant improvements in PFS and OS compared to the control group, with median PFS of 8.3 vs. 4.2 months (HR=0.49, 95% CI: 0.39-0.62, p<0.0001) and median OS of NR vs. 17.4 months (HR=0.60, 95% CI: 0.44-0.82, two-tailed p=0.001) [2]. - The application for marketing authorization for this indication was approved in October, and Sac-TMT shows lower incidence rates of oral mucositis, ocular toxicity, and interstitial lung disease compared to competitor Dato-DXd, although it has a higher incidence of hematological toxicity [2]. Group 2 - The ADC product matrix has also made significant progress in breast cancer: The marketing application for Sac-TMT for second-line and above HR+/HER2- breast cancer has recently been accepted by the CDE, and Bodo-Tuzumab was approved for the first time in October for 2L+ HER2-positive breast cancer. The results of their respective Phase III studies were also presented at the ESMO conference [3]. - In the OptiTROP-Breast02 study, Sac-TMT achieved statistically significant PFS improvement (median 8.3 vs. 4.1 months, HR 0.35, p<0.0001), with preliminary OS HR of 0.33 observed across all predefined subgroups [3]. - In the KL166-III-06 study, Bodo-Tuzumab outperformed T-DM1, significantly extending median PFS (11.1 vs. 4.4 months, HR 0.39, p<0.0001) [3].
交银国际：维持科伦博泰生物-B“买入”评级 目标价上升至549港元