度伐利尤单抗(英飞凡)
Search documents
阿斯利康前中国区总裁,被提起公诉
3 6 Ke· 2026-02-12 12:50
阿斯利康 图源:时代财经张羽岐摄 在被带走配合调查逾一年后,阿斯利康(AZN.US)中国区前"一号人物"王磊涉骗保和走私案又有新进展。 2月12日,据媒体消息,阿斯利康前全球执行副总裁、国际业务主席及中国区总裁王磊(Leon Wang)被中国官方正式提起公诉。目前,阿斯利康方面已 向媒体证实了针对王磊的起诉书内容。 市场消息显示,指控具体案由为非法进口药物、非法收集个人信息和医疗保险欺诈。 2月12日,时代财经就上述消息的真实性及公司是否有进一步信息披露等问题采访阿斯利康方面,截至发稿暂无任何回复。 在最新披露的年报中,阿斯利康也对外表示,2025年11月,深圳市检察院完成审查,阿斯利康中国、阿斯利康一名前执行副总裁和一名前高级员工因涉嫌 非法收集个人信息、非法贸易、医保欺诈,正面临正式刑事指控。 阿斯利康并未在年报中披露涉案人员的具体姓名,但经多家媒体证实,年报中"前执行副总裁"所指的正是王磊。 阿斯利康表示,这两名前员工将在深圳市中级人民法院受审,开庭日期暂未确定。 从传奇人物到阶下囚 从2024年10月底因涉案被调查开始,王磊,这位与阿斯利康中国区紧密捆绑的高管话题不断,属于他的时代也在风波中骤然落幕。 ...
度伐利尤单抗在华获批新适应症,治疗局限期小细胞肺癌
Bei Ke Cai Jing· 2025-06-04 12:16
Core Insights - AstraZeneca's durvalumab (brand name: Imfinzi) has been approved for a new indication in China, becoming the first and only immunotherapy for the treatment of limited-stage small cell lung cancer (LS-SCLC) in adult patients who have not experienced disease progression after platinum-based chemoradiotherapy [1][2] - The approval is based on positive results from the ADRIATIC Phase III clinical trial, which demonstrated significant overall survival benefits, with a three-year overall survival rate of 57% for patients treated with durvalumab [1] - The trial results were published in a top-tier medical journal and presented at a major oncology conference, confirming the efficacy of durvalumab in the Chinese patient population [1][2] Group 1 - The ADRIATIC trial showed that the median progression-free survival for the durvalumab treatment group was 16.6 months compared to 9.2 months for the placebo group [1] - 46% of patients receiving durvalumab did not experience disease progression at two years, compared to 34% in the placebo group [1] - The Chinese cohort's overall survival and progression-free survival benefits were consistent with global study results, indicating a 29% reduction in the risk of death and a 33% reduction in the risk of disease progression or death compared to placebo [1][2] Group 2 - Approximately 34,000 patients in China are treated for limited-stage small cell lung cancer each year, with a poor prognosis where only 15%-30% survive beyond five years [2] - The approval of durvalumab marks a significant advancement in treatment options for LS-SCLC, which has seen little progress in recent decades [2] - Durvalumab has also been approved in the US, EU, and Japan for the same indication, and it is approved for use in combination with chemotherapy for extensive-stage small cell lung cancer based on the CASPIAN Phase III trial [3]
阿斯利康再披露中国区涉嫌走私及侵犯公民信息案件进展
Xin Lang Cai Jing· 2025-04-30 03:43
Core Viewpoint - AstraZeneca is currently facing two significant investigations in China regarding illegal drug imports and the infringement of personal information, which could lead to substantial financial penalties and reputational damage [1][2][4]. Group 1: Illegal Drug Import Investigation - AstraZeneca has received a notice from the Shenzhen Customs Anti-Smuggling Bureau indicating that the company is suspected of evading import taxes amounting to over $1.6 million [1]. - The drug involved in this case is Enhertu (deruxtecan), which was approved for sale in China in February 2023 [1]. - If found liable, AstraZeneca could face fines ranging from one to five times the unpaid import taxes [1]. Group 2: Personal Information Infringement Investigation - The company has also received a notice from the Bao'an District Public Security Bureau regarding allegations of infringing on personal information, stating that AstraZeneca has no illegal gains from this behavior [2]. - AstraZeneca has committed to cooperating fully with the relevant Chinese authorities [2]. Group 3: Financial Performance and Market Impact - Enhertu generated global sales of $1.086 billion in Q1 2025, with approximately $68 million coming from China, reflecting a 57.1% year-on-year growth [5]. - The drug is indicated for several types of cancer, including HER2-positive breast cancer and HER2-mutant non-small cell lung cancer [5]. - The previous investigation regarding illegal drug imports involved Imfinzi and Imjudo, with tax evasion amounts reported at $900,000 [4]. Group 4: Executive Investigation and Company Actions - The ongoing investigations are linked to the detention of Wang Lei, AstraZeneca's Global Executive Vice President and China President, who is cooperating with the investigation [5][6]. - The investigations are said to focus on individuals rather than the company as a whole, and are not related to previous insurance fraud cases [6]. - AstraZeneca has made significant investments in China, including a $2.5 billion plan to establish a new global strategic R&D center in Beijing [7].
免疫疗法改写小细胞肺癌治疗困局,无进展生存期延长近两年
Xin Jing Bao· 2025-03-31 03:47
新京报讯(记者王卡拉)日前在法国巴黎举行的欧洲肺癌大会(ELCC)上,吉林省癌症中心主任程颖 教授公布了度伐利尤单抗(商品名:英飞凡)治疗同步放化疗后疾病无进展的局限期小细胞肺癌在 ADRIATIC三期临床试验中国队列研究数据,数据显示,与安慰剂相比,患者在两个主要研究终点总生 存期(OS)和无进展生存期(PFS)的获益趋势与全球患者一致。 小细胞肺癌是一种高侵袭性的肺癌类型。Ⅰ-Ⅲ期的局限期小细胞肺癌约占小细胞肺癌的30%。尽管局 限期小细胞肺癌患者对初始化疗和放疗有应答,但仍会复发并且进展迅速 。局限期小细胞肺癌患者预 后极差,只有15%-30%的患者在确诊后可活过5年。 基于ADRIATIC的试验结果,度伐利尤单抗已在美国、欧洲和一些其他国家获批。目前,中国、日本及 其他多个国家与地区的监管机构正在进行相关审评。 在全球530例随机受试者中,95例(17.9%)为中国人群。中国队列的数据显示:与安慰剂相比,度伐 利尤单抗可降低死亡风险29%,两组患者的中位OS均未达到;度伐利尤单抗单药治疗和安慰剂治疗的 三年生存率预估分别为63.7%和55.4%;度伐利尤单抗还将疾病进展或死亡风险降低了33%。度伐利尤 ...