此次获批是基于ADRIATIC Ⅲ期临床试验的积极结果。此前，ADRIATIC全球临床试验的数据成功发表 于全球四大顶级医学期刊之一《新英格兰医学杂志》（NEJM）；其中国队列研究数据的结果已于今年 在欧洲肺癌大会（ELCC）上公布。 ADRIATIC试验中，接受度伐利尤单抗治疗的患者显示出了显著的总生存获益，三年总生存率高达 57%。度伐利尤单抗单药治疗组的中位无进展生存期为16.6个月，而安慰剂组为9.2个月。估计接受度伐 利尤单抗治疗的患者中有46%在两年时未出现疾病进展，而安慰剂组为34%。此外，ADRIATIC中国队 列研究数据显示，中国患者群体的总生存期（OS）与无进展生存期（PFS）获益结果与全球研究的总体 结果一致，表明与安慰剂相比，度伐利尤单抗可将死亡风险降低29%，将疾病进展或死亡风险降低 33%。 小细胞肺癌是一种高侵袭性的肺癌类型。在中国，每年大约有34000名局限期小细胞肺癌（LS-SCLC， Ⅰ-Ⅲ期）患者正在接受治疗。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。 新京报讯（记者 ...

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].