淫羊藿素软胶囊(阿可拉定)

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盛诺基淫羊藿素软胶囊新增治疗胰腺癌适应症获临床批件
Zhong Guo Jing Ji Wang· 2025-09-22 04:52
盛诺基医药与南开大学生科院及北京大学肿瘤医院等单位合作,采用20多例胰腺癌病人的肿瘤样本培养 成类器官进行体外实验,也证实了淫羊藿素与胰腺癌一线治疗方案(吉西他滨+白蛋白紫杉醇)及(白蛋白 紫彬醇+PD1抗体)联合有显著的协同作用并观察到淫羊藿素促进T细胞趋向肿瘤类器官,进一步验证了 临床的协同增效结果,为即将开展的临床试验提供了重要依据。 9月19日,北京盛诺基医药科技股份有限公司(以下简称盛诺基医药)旗下子公司北京珅诺基医药科技有 限公司收到国家药品监督管理局药品审评中心核准签发的《药物临床试验批准通知书》,由北京珅诺基 医药科技有限公司申报的淫羊藿素软胶囊(商品名:阿可拉定)新增联合注射用紫杉醇(白蛋白结合型)和 注射用盐酸吉西他滨(简称AG方案)用于治疗局部晚期不可切除或转移性胰腺癌。 来自浙江大学邵逸夫医院开展的"淫羊藿素软胶囊与AG联合治疗晚期胰腺癌"研究数据显示,该研究共 纳入20例新诊断的晚期胰腺导管腺癌(PDAC)患者,所有患者接受6周期的淫羊藿素软胶囊联合AG治 疗,客观缓解率(ORR)达到了50%,疾病控制率(DCR)高达90%,6个月生存率为90%。尤为振奋人心的 是,35%的初始不可 ...
淫羊藿素软胶囊联合化疗为晚期胰腺癌治疗带来新希望
Zhong Guo Jing Ji Wang· 2025-05-30 09:06
Group 1 - The research team from Zhejiang University School of Medicine has presented a groundbreaking study on the treatment of advanced pancreatic cancer using "Epimedium extract soft capsules (Akeladin) + AG (Gemcitabine + Albumin-bound Paclitaxel)" at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, attracting significant attention in the oncology community [1][2] - Pancreatic cancer, known as the "king of cancers," has a 5-year survival rate of less than 10%, with most patients diagnosed at an advanced stage, making surgical intervention impossible. Traditional treatment regimens like FOLFIRINOX and AG are currently the main chemotherapy options, but patient survival rates remain poor [2] - The study is a single-arm, single-center prospective Investigator-Initiated Trial (IIT) involving 20 newly diagnosed patients with advanced pancreatic ductal adenocarcinoma (PDAC), all of whom received 6 cycles of treatment with Epimedium extract soft capsules combined with AG [2][3] Group 2 - As of December 15, 2024, the study has shown promising results, with an objective response rate (ORR) of 50%, a disease control rate (DCR) of 90%, and a 6-month survival rate of 90%. Notably, 35% of initially unresectable patients became resectable after treatment [3] - The safety profile indicated that the incidence of grade ≥3 treatment-related adverse events (TRAEs) was 40%, primarily associated with chemotherapy drugs, with no fatal TRAEs reported. This research provides a new treatment option for advanced PDAC patients and demonstrates significant potential for further studies and the development of other indications [3] - The Epimedium extract soft capsules, developed by Beijing Shengnuo Pharmaceutical Technology Co., Ltd., are a first-in-class immunomodulatory drug derived from traditional Chinese medicine, primarily used for treating advanced hepatocellular carcinoma. The drug has recently received approval for clinical trials in combination therapy for advanced colorectal cancer with specific genetic markers [4]