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hanghai Henlius Biotech, Inc.  announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly in Europe), has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment of adult patients with  extensive stage- small cell lung cancer (ES-SCLC.

hanghai Henlius Biotech，Inc.宣布其抗PD-1单克隆抗体HANSIZHUANG（serplulimab，在欧洲以Hetronifly的形式销售）已被欧盟委员会（EC）正式批准与卡铂和依托泊苷联合使用，作为成人广泛期小细胞肺癌（ES-SCLC）患者的一线治疗。

This approval establishes serplulimab as the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC.

该批准将serplulimab确立为欧盟批准用于治疗ES-SCLC的第一种也是唯一一种抗PD-1单克隆抗体。

Serplulimab is the world’s first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab.

Serplulimab是世界上第一个被批准用于ES-SCLC一线治疗的抗PD-1单克隆抗体。。迄今为止，全世界已有4800多名受试者参加了serplulimab的临床试验。

This latest approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein. Commercialisation in Europe will be led by Intas’ subsidiary, Accord Healthcare Ltd (“Accord”).

这项最新批准涵盖了所有27个欧盟成员国以及包括挪威、冰岛和列支敦士登在内的欧洲经济区国家。欧洲的商业化将由Intas的子公司Accord Healthcare Ltd（“Accord”）领导。

The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre Phase III study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC.

EC对serplulimab的批准主要基于ASTRUM-005研究的数据，该研究是一项随机，双盲，安慰剂对照的国际多中心III期研究，评估了serplulimab联合化疗与安慰剂联合化疗作为ES-SCLC一线治疗的疗效和安全性事件概况。

The study has set up a total of 128 sites across countries including China, Poland, Turkey, and Georgia, enrolling 585 subjects, of whom around 31.5% were Caucasians. Results from ASTRUM-005 were first presented orally at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and later published in the Journal of the American Medical Association (JAMA), making it the first SCLC immunotherapy study to publish on JAMA.

该研究在包括中国、波兰、土耳其和格鲁吉亚在内的国家共建立了128个网站，招募了585名受试者，其中约31.5%是白种人。ASTRUM-005的结果首次在2022年美国临床肿瘤学会（ASCO）年会上口头介绍，后来发表在《美国医学会杂志》（JAMA）上，使其成为第一个在JAMA上发表的SCLC免疫治疗研究。

Based on ASTRUM-005, serplulimab has been approved in China, Southeast Asian countries, and the EU for the first-line treatment of ES-SCLC, establishing it as the world’s first anti-PD-1 mAb approved for the indication. Additionally, Henlius is conducting a head-to-head bridging trial in the U.S. comparing serplulimab with atezolizumab, the current standard of care, to further support its U.S.

基于ASTRUM-005，serplulimab已在中国，东南亚国家和欧盟被批准用于ES-SCLC的一线治疗，成为世界上第一个被批准用于该适应症的抗PD-1单克隆抗体。此外，Henlius正在美国进行一项头对头的桥接试验，比较serplulimab和atezolizumab（目前的护理标准），以进一步支持其美国。

regulatory submission..

监管提交。。

Citation;

引用；

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Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung CancerThe ASTRUM-005 Randomized Clinical Trial

一线Serplulimab与安慰剂联合化疗对广泛期小细胞肺癌患者生存的影响ASTRUM-005随机临床试验

;

;

Ying Cheng, MD

医学博士Ying Cheng

;

;

Liang Han, MD

医学博士Liang Han

;

;

Lin Wu, PhD

林武博士

;.

;.

Jun Chen, PhD

陈军博士

;

;

Hongmei Sun, BS

孙红梅，BS

;

;

Guilan Wen, MMed

;

;

Yinghua Ji, MD

博士：Yinghua Ji，MD

;

;

Mikhail Dvorkin, MD

医学博士Mikhail Dvorkin

;

;

Jianhua Shi, MMed

施建华，MMed

;

;

Zhijie Pan, PhD

Zhijie Pan，博士

;

;

Jinsheng Shi, BMed

施金生，BMed

;

;

Xicheng Wang, MMed

王希成，MMed

Yuansong Bai, MD, PhD

基线、医学博士、哲学博士

;

;

Tamar Melkadze, MD

Tamar Melkadze，医学博士

;

;

Yueyin Pan, MD, PhD

Yueyin Pan，医学博士，博士

;

;

Xuhong Min, BMed,

Xuhong Min，BMed，

Maksym Viguro, MD

Max Viguro，医学博士

i et al.,

我等人。，

for the ASTRUM-005 Study Group.

ASTRUM-005研究小组。

JAMA.

JAMA。

2022;328(12):1223-1232. doi:10.1001/jama.2022.16464.

2022年；328（12）：1223-1232。doi:10.1001/jama.2022.16464。

Condition:

条件：

Small Cell Lung Cancer

小细胞肺癌

Type:

类型：

drug

药物