和誉-B（02256）：首次覆盖：专注于小分子肿瘤精准治疗，扭亏为盈迎来拐点

Investment Rating - The report initiates coverage with an OUTPERFORM rating, targeting a price of HK$13.40 from a current price of HK$8.06 [2]. Core Insights - The company is focused on precision therapy with small molecules in oncology and is expected to achieve profitability in 2024, driven by significant revenue growth from licensing agreements [3][4]. - The core pipeline includes Pimicotinib, which is anticipated to submit a global NDA in 2025, with potential peak sales exceeding USD 2 billion [4][19]. - The company has a robust pipeline targeting FGFR mutations, with potential coverage for approximately 1.9 million patients globally [4][39]. Financial Projections - Revenue projections for FY24, FY25, FY26, and FY27 are RMB 504 million, RMB 595 million, RMB 420 million, and RMB 560 million respectively, with net profit expected to reach RMB 28 million in FY24 [3][8]. - The company is projected to achieve a net profit of RMB 173 million by FY27, with a significant increase in diluted EPS from RMB 0.04 in FY24 to RMB 0.25 in FY27 [3][8]. Pipeline Development - The company has advanced clinical trials for Pimicotinib, which has shown promising results in treating TGCT with an ORR of 87.5% [28]. - The pipeline includes multiple candidates targeting FGFR, with ABSK011 and ABSK061 expected to achieve peak sales of over USD 3 billion collectively [14][39]. - The oral PD-L1 inhibitor ABSK043 is positioned to capture a share of the USD 52 billion PD-(L)1 market, with a projected launch in 2030 [6][14]. Management and Team - The management team has extensive experience in drug development and commercialization, with backgrounds in leading pharmaceutical companies [11][13]. - The company emphasizes early-stage R&D, allocating over 30% of its budget to this area, which supports a pipeline of over 15 preclinical candidates [7][10]. Market Opportunity - The global market for PD-(L)1 therapies is substantial, with no approved small molecule PD-1/PD-L1 drugs currently available, indicating a significant opportunity for the company's oral PD-L1 inhibitor [6][14]. - The unmet medical needs in the treatment of cGvHD and TGCT present additional market opportunities for the company's pipeline [33][25].