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 ...

2025年1月，司普奇拜单抗获批季节性过敏性鼻炎适应症，成为全球唯一治疗季节性过敏性鼻炎的IL- 4Rα抗体药物。"中重度季节性过敏性鼻炎症状的有效控制长期以来是临床面临的难题。"吉林大学中日 联谊医院朱冬冬教授指出，"司普奇拜单抗直接靶向季节性过敏性鼻炎的核心驱动因子IL-4发挥作用， 首次给药2天后鼻塞症状快速缓解，52%的患者4天实现鼻腔通气；2次用药后，累计94%的患者眼痒/灼 热、流泪、眼红等眼部症状达到轻度或消失程度。司普奇拜单抗以鼻部和眼部多种症状的快速有效缓 解，推动季节性过敏性鼻炎迈入生物制剂治疗时代。" 在5月16日的"鼻部疾病靶向生物治疗学术研讨会"上，围绕鼻科疾病治疗的学术探讨成为焦点。众多专 家的分享与交流，推动鼻科治疗理念从传统的"一刀切"模式向精准靶向治疗转变，为临床实践带来了全 新思路，引领鼻科治疗领域实现重大飞跃。同时，与会专家共同见证我国首个针对慢性鼻窦炎伴鼻息肉 生物制剂、全球唯一治疗季节性过敏性鼻炎IL-4Rα抗体药物——康悦达司普奇拜单抗的上市里程碑。 慢性鼻窦炎伴鼻息肉与季节性过敏性鼻炎为鼻科常见的2型炎症性疾病，其中，约50%的慢性鼻窦炎伴 鼻息肉患者对传统治疗应 ...

Core Viewpoint - The 2025 CSCO Guidelines Conference has introduced the 2025 edition of the CSCO Guidelines for the Diagnosis and Treatment of Primary Non-Small Cell Lung Cancer (NSCLC), highlighting the inclusion of Hansoh Pharmaceutical's Amelot (Ametinib Mesylate Tablets) as the first Chinese original third-generation EGFR-TKI to receive a Class I recommendation for consolidation therapy in EGFR mutation-positive stage III unresectable NSCLC patients after chemoradiotherapy [1][2][3] Group 1 - The new recommendation is based on positive results from the POLESTAR study, a nationwide, multicenter, randomized, double-blind, controlled phase III clinical trial assessing the efficacy and safety of Amelot in consolidation therapy for stage III unresectable NSCLC patients with EGFR mutations after chemoradiotherapy [2] - The mid-term analysis of the POLESTAR study, presented at the 2024 World Lung Cancer Conference, showed a median progression-free survival (mPFS) of 30.4 months for the Amelot group, compared to 3.8 months for the placebo group, indicating an 8-fold improvement and an 85% reduction in the risk of disease progression or death [2] - The POLESTAR study exclusively included Chinese patients, demonstrating the significant efficacy of original EGFR-TKIs for domestic patients and providing high clinical relevance for China [2] Group 2 - NSCLC accounts for approximately 85% of all lung cancer cases in China, with nearly one-third being locally advanced (stage III) NSCLC, highlighting the urgent need for more precise and effective treatment options [2] - The rapid development of third-generation EGFR-TKIs represents a significant advancement in targeted therapy, offering more treatment choices to improve the diagnosis and treatment levels of stage III unresectable NSCLC and enhance patient prognosis [2] - The inclusion of Amelot as a Class I recommendation for consolidation therapy in this context confirms its application potential and is expected to guide the development of precision diagnosis and treatment for NSCLC in China, ultimately benefiting patients [3]