Core Viewpoint - The recent approval of a new 100mg specification for SKB264 by NMPA is expected to enhance treatment accessibility and convenience for patients with advanced breast cancer and non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Research and Product Development - SKB264's two key clinical studies have been selected for presentation at the 2025 ESMO conference, with the OptiTROP-Lung04 study being featured in the Presidential Symposium, highlighting its potential in treating EGFR-mutant NSCLC [1] - The company anticipates significant revenue growth, projecting revenues of 2.084 billion, 2.876 billion, and 4.663 billion yuan for the years 2025, 2026, and 2027 respectively [1] - SKB264 has received approval for the treatment of EGFR-mutant NSCLC in China and is making progress in earlier lines of treatment, with a New Drug Application (NDA) for 2L NSCLC submitted and prioritized for review [1] Group 2: Efficacy in Rare Mutations and Other Indications - SKB264 has shown promising results in treating rare EGFR mutations, achieving an overall response rate (ORR) of 35.7% and a disease control rate (DCR) of 85.7% in a Phase II study [2] - Ongoing clinical trials for SKB264 in various NSCLC settings are demonstrating superior efficacy compared to other investigational drugs and existing therapies [2] Group 3: Breast Cancer Applications - SKB264 has been approved for use in triple-negative breast cancer (TNBC) and is under review for HR+/HER2- breast cancer, with the NDA based on the successful OptiTROP-Breast02 study [3] - The OptiTROP-Breast02 study has met its primary endpoint, showing significant improvements in progression-free survival (PFS) and a positive trend in overall survival (OS) for HR+/HER2- breast cancer patients [3]
天风证券:上调科伦博泰生物-B(06990)评级至“买入” 公司核心产品商业化进程顺利