由中国四川百利天恒药业股份有限公司开发的一款抗癌药物上周在马德里举行的欧洲肿瘤内科学会（ESMO）大会的压轴口服报告环节中备受瞩目。
ticancer drug developed by Sichuan Biokin Pharmaceutical took centre stage in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress in Madrid last week.
研究人员表示，这款名为iza-bren的药物在一项涵盖中国73家医院、有432名晚期肺癌患者参与的3期随机双盲临床试验中，展现出优于含铂化疗的显著优势。
Researchers said the drug, iza-bren, showed a significant advantage over platinum-based chemotherapy in a phase 3 randomised, double-blind clinical trial conducted at 73 hospitals in China and involving 432 patients with advanced lung cancer.
在研究中，接受化疗但未接受iza-bren治疗的参与者的中位无进展生存期（PFS，指患者在治疗期间或治疗后病情未恶化的生存时间）为5.7个月。
The median progression-free survival (PFS) – the length of time a patient lives with a disease without the condition getting worse during or after treatment – for participants who received chemotherapy but not iza-bren in the study was 5.7 months.
根据该研究在大会报告后于10月26日由《柳叶刀》在线发表的论文，静脉注射iza-bren的组别的中位无进展生存期为11.1个月，接近化疗组的两倍。
For the group receiving iza-bren intravenously, the median PFS was 11.1 months, nearly double that of chemotherapy, according to the study, which was published online by The Lancet on October 26, after the presentation at the congress.
研究人员表示，与化疗药物相比，iza-bren的不良反应发生率有所增加，主要体现在血细胞计数方面，但未发现新的安全性问题。
Compared with chemotherapy drugs, iza-bren showed an increased incidence of adverse reactions, mainly in terms of blood cell counts, but no new safety concerns were identified, the researchers said.
中山大学肿瘤防治中心肺癌首席专家、该论文的共同资深作者之一张力表示，研究结果表明iza-bren“可能会改变该疾病的发展轨迹，在病情恶化前为患者提供更多时间”。
Zhang Li, a leading lung cancer expert at Sun Yat-sen University Cancer Centre and one of the paper’s joint senior authors, said the findings suggested iza-bren “could change the trajectory of the disease, offering patients more time before their disease worsens”.
他在百利天恒在中国境外就该新疗法的合作方百时美施贵宝（BMS）发布的声明中表示：“这些结果可能标志着我们应对该疾病获得性耐药方式的重要转变，从而显著改善患者的治疗效果。”
“These results could mark an important shift in how we approach acquired resistance in this disease to significantly improve patient outcomes,” he said in a statement from Bristol Myers Squibb (BMS), Biokin’s collaborator outside China on the new treatment.
iza-bren的全名为isalontamab brengitecan，是一种同类首创的双特异性抗体偶联药物（ADC），可靶向两种肿瘤相关抗原EGFR和HER3，能够使肿瘤治疗更有效。
Iza-bren – full name izalontamab brengitecan – is a first-in-class bispecific antibody-drug conjugate (ADC) that targets two tumour-associated antigens, EGFR and HER3, and could make treatment of tumours more effective.
它是全球首个且唯一获批的双特异性抗体偶联药物，这类药物将结合特异性肿瘤相关抗原的靶向抗体与作用于肿瘤细胞的细胞毒性有效载荷结合起来。
It is the world’s first and only approved bispecific ADC, a type of drug that combines a targeting antibody that binds to specific tumour-associated antigens with a cytotoxic payload that acts on tumour cells.
研究显示，3期试验中98%的参与者患有4期癌症。所有人都曾接受过第三代EGFR酪氨酸激酶抑制剂（TKI）治疗。72%至73%的患者还曾接受过一线系统性治疗。
According to the study, 98 per cent of participants in the phase 3 trial had stage 4 cancer. All had received a third-generation EGFR tyrosine kinase inhibitor (TKI) treatment. Between 72 and 73 per cent had also received one previous line of systemic therapy.
一旦患者对靶向疗法产生耐药性，化疗几乎成了仅存的选择。这种新疗法正是为了克服这一挑战而设计的。
Once patients develop resistance to targeted therapies, chemotherapy is almost the only remaining option. The new treatment is precisely aimed at overcoming this challenge.
在确认的客观缓解率（肿瘤负荷缩小达到预设最低幅度的患者比例）方面，iza-bren组达到了60.2%，而接受化疗的患者为34.5%。
In terms of confirmed objective response rate – the proportion of patients whose tumour burden shrank by a pre-specified minimum amount – the iza-bren group achieved 60.2 per cent versus 34.5 per cent for the patients who received chemotherapy.
接受iza-bren治疗的患者中79%发生了严重副作用，化疗组这一比例为62%。仅有1.9%的接受新药治疗的患者因治疗相关不良事件严重而停药。
Severe side effects occurred in 79 per cent of patients who received iza-bren and 62 per cent in the chemotherapy group. Only 1.9 per cent of those on the new drug discontinued it because of the severity of treatment-related adverse events.
百时美施贵宝执行副总裁、首席医疗官兼开发负责人克里斯蒂安·马萨切西（Cristian Massacesi）表示，3期临床试验结果“标志着iza-bren的一个重要拐点”。
According to Cristian Massacesi, executive vice-president, chief medical officer and head of development at BMS, the phase 3 clinical trial results “mark an important inflection point for iza-bren”.
他在百时美施贵宝的声明中表示：“[这些结果]增强了我们的信心，如果获得批准，这种具有同类首创潜力的EGFR×HER3双特异性抗体偶联药物可能会改善整个癌症治疗领域的疗效。”
“[The results] reinforce our belief that this potentially first-in-class EGFR×HER3 bispecific ADC could, if approved, improve outcomes across the cancer treatment landscape,” he said in the BMS statement.
百利天恒于1996年成立于中国西南部的四川省，最初生产仿制药和中药。自2011年以来，其重心已转向新型ADC肿瘤治疗药物的研发。
Founded in southwest China’s Sichuan province in 1996, Biokin initially produced generic drugs and traditional Chinese medicines. Since 2011, it has shifted focus to the research and development of novel ADC-based tumour therapeutic drugs.
2023年12月，这家中国公司与全球制药巨头百时美施贵宝就其旗舰资产iza-bren达成了独家许可协议。
In December 2023, the Chinese company entered into an exclusive licensing agreement for its flagship asset iza-bren with the global pharmaceutical giant BMS.
这笔交易的总潜在价值高达84亿美元，其中包括8亿美元的首付款，这也是当年中国创新药金额最大的一笔海外“授权出海”交易。
The transaction – with a potential total value of up to US$8.4 billion, including an upfront payment of US$800 million – was also the largest overseas “out-licensing” deal for innovative drugs in China that year.
截至2026年6月，在中国和美国针对iza-bren开展了40多项涵盖不同肿瘤类型的临床试验，该药物在五项评估不同适应症的3期试验中均显示出临床获益。
As of June 2026, there were more than 40 clinical trials, targeting various tumour types, being conducted in China and the United States into iza-bren, which has shown clinical benefits across five phase 3 tests, each assessing a distinct indication.
这些试验包括EGFR突变非小细胞肺癌、鼻咽癌、食管鳞状细胞癌以及两种类型的乳腺癌。所有患者此前均接受过治疗。
These included EGFR-mutated non-small-cell lung cancer, nasopharyngeal carcinoma, esophageal squamous cell carcinoma and two types of breast cancer. All had been previously treated.
中国已批准iza-bren用于鼻咽癌和食管鳞状细胞癌两种适应症，另外三种适应症（肺癌和两种乳腺癌）的上市申请正在审评中。
China has already approved iza-bren for two indications – nasopharyngeal and esophageal squamous cell carcinomas – and three more, lung cancer and two types of breast cancer, have marketing applications under review.
以该疗法尚未在美国或欧洲上市，但越来越多的欧美患者选择来到价格更低、且能提早采用最新抗肿瘤药物的中国进行购买。这些新疗法帮助中国在成本和疗效方面占据了领先地位。
The treatment has not yet been launched in the US or Europe but an increasing number of European and American patients are choosing to come to China, with its lower prices and early adoption, to buy the latest anti-tumour drugs. These new treatments have helped China to take a leading position in both cost and efficacy.
根据英国医学期刊《英国医学杂志》的研究，在2024年1月至2025年6月期间，中国是临床试验注册的领先者，占全球总数的24%。
According to research by Britain-based medical journal the BMJ, China was the leader in clinical trial registrations and accounted for 24 per cent of the global total between January 2024 and June 2025.
美国医学会期刊《美国医学会杂志》2026年3月发表的一项研究显示，中国在全球早期药物研发项目中所占份额从2015年的8%上升到2024年的32%，缩小了与美国的差距。研究称，在此期间，美国的份额从48%下降到37%。
A study published in the March 2026 issue of JAMA, the American Medical Association’s journal, China’s share in global early-stage drug development projects increased from 8 per cent in 2015 to 32 per cent in 2024, narrowing the gap with the US. During the same period, the United States’ share decreased from 48 per cent to 37 per cent, it said.
《南华早报》已联系四川百利天恒药业股份有限公司和百时美施贵宝寻求置评。
The South China Morning Post has contacted Sichuan Biokin Pharmaceuticals and Bristol Myers Squibb for comment.