欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Hetronifly
适用类别Human
治疗领域Small Cell Lung Carcinoma;Carcinoma, Non-Small-Cell Lung;Esophageal Squamous Cell Carcinoma
通用名/非专利名称serplulimab
活性成分serplulimab
产品号EMEA/H/C/006170
患者安全信息No
许可状态Authorised
ATC编码L01FF12
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2025/02/03
上市许可开发者/申请人/持有人Accord Healthcare S.L.U.
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2024/09/19
欧盟委员会决定日期2026/04/30
修订号5
治疗适应症Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC). Non-small cell lung carcinoma (NSCLC) Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC. Oesophageal squamous cell carcinoma (OSCC) Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.
适用物种
兽用药物ATC编码
首次发布日期2024/09/20
最后更新日期2026/05/13
产品说明书https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/hetronifly
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