和誉医药 20250703 摘要 晚期肝癌治疗已从传统 TKI 转向靶免或双免方案，有效率从 2008 年的 2%提升至 36%，疾病控制率从 43%提升至 81.3%，生存时间翻倍至 近两年，显著改善患者预后。 和悦医药自主研发的小分子 ABSK011 联合阿替利珠单抗的数据显示， 该组合对晚期肝细胞癌具有显著疗效，支持靶向和免疫联合疗法在改善 患者预后方面的潜力。 尽管靶向和免疫治疗取得进展，但肝癌治疗仍面临疗效瓶颈，最高有效 率约为 36%，中位生存期停滞在两年左右，需探索新的联合方案和作用 机制的药物。 二线治疗是肝癌临床研发的痛点，现有方案效果有限。瑞戈非尼联合帕 博利珠单抗的全球多中心研究显示，客观缓解率仅为 5.9%，无进展生 存期仅为 2.8 个月。 新型联合疗法如 PD-L1 联合 CTLA-4 抑制剂加贝伐珠单抗，以及针对 TG 抗体的药物（如罗氏 Inbre 152 研究），具有改善疗效瓶颈和推动 前、后线治疗的潜力。 Q&A 肝癌在中国的发病情况如何？为什么肝癌药物研发显得尤为重要？ 肝癌在中国的发病率非常高，每年新增病例约 36 万，占全球总数的一半。肝 癌在恶性肿瘤中发病人数排名第 ...

Core Viewpoint - The announcement of the inclusion of ABSK011 (Ipagotinib) as a breakthrough therapy for advanced hepatocellular carcinoma (HCC) patients who have failed previous treatments marks a significant milestone for the company, indicating its potential to become a "billion-dollar molecule" [1][2][3]. Group 1: Breakthrough Therapy Designation - ABSK011 has been officially designated as a breakthrough therapy for treating FGF19 overexpressing advanced HCC patients who have previously undergone immune checkpoint inhibitors (ICI) and multi-targeted tyrosine kinase inhibitors (mTKI) [1][2]. - This designation follows the earlier approval of Pimicotinib (ABSK021), making ABSK011 the second major product of the company to receive such recognition [1]. Group 2: Clinical Data and Efficacy - Recent clinical data presented at the ESMO conference showed that the 220mg BID dosage of ABSK011 achieved an overall response rate (ORR) of 44.8% in patients with FGF19 overexpressing HCC who had previously been treated with ICIs and mTKIs [3][4]. - The drug demonstrated a median duration of response (mDOR) of 7.4 months and a median progression-free survival (mPFS) of 5.5 months, significantly outperforming existing therapies [3][4]. Group 3: Market Potential and Competitive Advantage - The global liver cancer market is projected to reach approximately $5.3 billion by 2029, with immunotherapy accounting for about 72.2% of the market share [6]. - The company has developed ABSK011 as the first small molecule inhibitor targeting the aberrant activation of the FGF19/FGFR4 signaling pathway, which is expected to provide a differentiated treatment option for HCC patients [2][6]. Group 4: Financial Performance and Investment Value - The company has achieved its first full-year profitability in 2024, generating substantial cash flow and signaling a sustainable growth trajectory [8]. - The management has been actively repurchasing shares, reflecting confidence in the company's future and commitment to returning value to investors [8][9]. Group 5: Stock Market Performance - Following a period of volatility, the company's stock price rebounded significantly, reaching a peak of 8.95 HKD, with a maximum increase of 62.14% over a one-and-a-half-month period [11]. - This price recovery indicates strong market interest and confidence in the company's fundamentals and growth potential [11].

首次覆盖：专注于小分子肿瘤精准治疗，扭亏为盈迎来拐点 Focusing on Precision Therapy with Small Molecules in Oncology, Achieving Profitability and Reaching an Turning Point: Initiation [Table_yemei1] 观点聚焦 Investment Focus 研究报告 Research Report 14 May 2025 和誉-B Abbisko (2256 HK) [Table_Info] 首次覆盖优于大市 Initiate with OUTPERFORM 评级 优于大市 OUTPERFORM 现价 HK$8.06 目标价 HK$13.40 HTI ESG 4.8-4.8-4.5 - -G: 0- , (Please refer to the Appendix for ESG comments) 市值 HK$5.48bn / US$0.70bn 日交易额 (3 个月均值) US$5.95mn 发行股票数目 680.11mn 自由流通股 (%) 67% 年股价最高最低值 HK$8. ...