Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [6]. Core Views - The company focuses on differentiated small molecule drug development, with its core asset, Pimicotinib, expected to be commercialized soon [6][12]. - The company achieved its first annual profit in 2024, with a net profit of 28.3 million yuan and total revenue of 504 million yuan, primarily from licensing agreements [6][23]. - The company has a robust pipeline with 19 oncology products, 12 of which are in clinical development [6][12]. Summary by Sections Section 1: Commitment to Differentiated Small Molecule Development - The company is dedicated to developing differentiated small molecule therapies for oncology, with 12 clinical candidates in its pipeline [12]. - The management team has extensive experience in drug development, enhancing the company's innovation capabilities [18]. - A stock repurchase plan of up to 200 million HKD is set to start in 2025, reflecting management's confidence in future growth [21]. - The company reported its first annual profit in 2024, with a strong cash reserve of 1.959 billion yuan [23]. - The core product, Pimicotinib, is expected to submit applications for market approval in China and the U.S. in 2025 [26]. Section 2: CSF-1R Pimicotinib for TGCT - Pimicotinib has reached the primary endpoint in its Phase 3 trial for treating TGCT, with plans to submit market applications in 2025 [30][32]. - The drug shows promising efficacy and safety in treating chronic graft-versus-host disease (cGvHD) in its Phase 2 trials [38][44]. Section 3: FGFR Small Molecule Inhibitors - The company has a multi-faceted approach to FGFR inhibitors, with ABSK011 entering pivotal Phase 2/3 trials for liver cancer [7]. - ABSK061, the first FGFR2/3 inhibitor in clinical trials, is expected to advance in 2025 for various indications [7]. Section 4: Oral PD-L1 Inhibitor ABSK043 - The global PD-(L)1 market is projected to exceed 50 billion USD in 2024, with the company exploring the potential of its oral PD-L1 inhibitor [4]. Section 5: Early Pipeline and Dual-Antibody ADC Platform - The company maintains a rich early-stage pipeline, which is crucial for its long-term growth [7].
和誉-B：专注小分子差异化研发，核心资产匹米替尼待商业化-20250410