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药品集采新规解读与优化思考
Di Yi Cai Jing· 2025-09-24 13:24
Core Viewpoint - The new centralized procurement rules for pharmaceuticals aim to address historical issues and promote sustainable development in the pharmaceutical industry, balancing price control, quality assurance, and supply stability [1][10]. Group 1: Historical Issues and Data - The new procurement rules are designed to resolve past issues such as low-price competition, quality instability, and supply shortages, which have been prevalent since the initiation of the centralized procurement system [2][4]. - The latest round of procurement includes 55 drug varieties across various therapeutic areas, with an average of 15 companies competing for each variety, indicating strong market interest and competition [2][3]. Group 2: Reporting and Supply Assurance - The reporting phase for the latest procurement batch requires medical institutions to submit annual demand volumes that are generally not less than 80% of the average usage from 2023 to 2024, allowing for brand recognition in the reporting process [3][6]. - The new rules designate selected companies as the primary responsible parties for supply assurance, imposing penalties for non-compliance, which aims to reduce the occurrence of supply shortages [3][6]. Group 3: Impact on Pricing and Quality - The optimization of procurement rules is expected to alleviate the pressure on companies that previously relied on extremely low bids, promoting a healthier competitive environment [6][10]. - The new regulations encourage a balance between price and quality, ensuring that patients benefit from affordable medications without compromising on safety and efficacy [7][10]. Group 4: Industry Dynamics and Future Outlook - The changes are likely to accelerate the elimination of weaker players in the pharmaceutical sector, favoring larger, more capable companies that can maintain quality and supply stability [8][10]. - The shift from a price-first approach to one that equally values quality and supply stability is anticipated to enhance public confidence in generic drug quality and support the sustainable development of the healthcare system [10].
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 ...