该适应症的获批主要是基于一项关键临床试验，入组对象为未接受过系统性抗肿瘤治疗、经组织学或细 胞学确诊的不可切除的局部晚期或转移性胰腺癌患者。在2024年美国临床肿瘤学会(ASCO)年会已披露 的结果显示，该产品用于晚期胰腺癌一线治疗可显著延长无进展生存期(PFS)(风险比(HR)为0.55，疾病 进展或死亡风险降低45%)，在客观缓解率(ORR)、缓解持续时间(DOR)及总生存期(OS)方面均呈现获益 趋势，且安全性良好，相比普通制剂实现了减毒增效的作用。 该产品已于2023年9月15日在中国获批上市，首个获批的适应症为与5-氟尿嘧啶(5-FU)和亚叶酸(LV)联 合用于接受吉西他滨治疗后进展的转移性胰腺癌患者，为国内企业首个获批上市的盐酸伊立替康脂质体 注射液。本次获批的适应症为该产品在中国获批的第二个适应症，亦是伊立替康脂质体注射液在国内首 次获批用于胰腺癌一线治疗。目前，该产品用于胰腺癌术后辅助治疗的关键注册III期临床试验正在进行 中。 石药集团(01093)发布公告，集团开发的盐酸伊立替康脂质体注射液(商品名：多恩益)的新适应症已获得 中华人民共和国国家药品监督管理局上市批准。本次获批的新适应症为与 ...

Core Insights - The company reported a total revenue decline of 7.8% year-on-year, primarily due to a decrease in the sales of its prescription drug business, with a slight drop in gross margin by 0.5 percentage points to 70.0% [1] - Shareholder profit attributable to the company decreased by 26.3% to 4.328 billion yuan [1] Revenue Breakdown - Total revenue from various segments includes: - Raw materials: 23,718.33 million yuan - Functional foods: 1,994.26 million yuan - Other categories: 1,588.91 million yuan - Total revenue: 29,404.00 million yuan [2] Business Review - The company underwent structural adjustments in 2024, creating a flatter organizational structure that reduced operational costs and improved decision-making efficiency [4] - The company faced challenges with significant price reductions for two products,津优力 and 多美素, by approximately 58% and 23% respectively [4] - New products launched recently, such as 明复乐 and 多恩益, have shown rapid growth and contributed significantly to sales [4] Research and Development - The company has increased its R&D investment, achieving a steady improvement in R&D efficiency, with 16 production licenses and 66 clinical licenses obtained in 2024 [5] International Expansion - The company is advancing its international strategy by establishing sales companies in the U.S. and Southeast Asia, focusing on high-end complex injection formulations and other advanced products [6] - Collaborations with strategic clients in Indonesia and the Philippines for new drug development are underway, enhancing overseas business contributions [6]