美国生物制药公司 ArriVent BioPharma 的股价在一场涉及其从中国引进的抗癌药物的后期临床试验失败后暴跌。分析师指出，这一挫折凸显了中国生物技术企业在海外扩张过程中所面临的挑战。
US firm ArriVent BioPharma’s shares plummeted after a late-stage trial failure involving a cancer drug licensed from China, a setback that analysts said highlighted the challenges facing Chinese biotech companies expanding overseas.
这家在纽约上市的公司在周二收盘时股价下跌了近 47%，原因是其开发的抗癌药物 firmonertinib 在三期临床试验中未能达到预期目标。
New York-listed ArriVent closed down nearly 47 per cent on Tuesday after reporting that its cancer treatment firmonertinib failed to meet its main goal in a phase 3 trial.
Firmonertinib 最初由上海艾力斯药业公司研发，用于治疗非小细胞肺癌（NSCLC），该药物针对的是一种名为“表皮生长因子受体外显子 20 插入”（epidermal growth factor receptor exon 20 insertion）的基因突变。
Firmonertinib was originally developed by Shanghai Allist Pharmaceuticals to treat non-small cell lung cancer (NSCLC), targeting a mutation known as an epidermal growth factor receptor exon 20 insertion.
ArriVent 于 2021 年获得了在中国以外地区开发和销售该药物的独家权利，成为最早从中国引进药品技术并进行商业化的美国生物技术企业之一。
ArriVent acquired the exclusive rights in 2021 to develop and commercialise the drug outside China, becoming one of the earliest US biotechnology firms licensing Chinese drug assets.
该公司表示，三期临床试验未能证明 firmonertinib 能够显著延缓疾病进展（即与标准化疗相比具有更好的治疗效果）。
The company said its phase 3 trial failed to demonstrate that firmonertinib could significantly delay disease progression compared with standard chemotherapy treatment.
ArriVent 的董事长兼首席执行官姚冰在一份声明中表示，这些“令人失望”的结果“超出了我们的预期”，公司正在全面分析试验数据，以确定该药物的最佳开发路径。
ArriVent chairman and CEO Bing Yao said in a statement that the “disappointing” results were “not what we hoped for”, and that the company was evaluating the full trial dataset to determine the “most appropriate development path” for the drug.
麦格理资本（Macquarie Capital）亚洲医疗保健研究负责人 Tony Ren 表示，许多从中国引进的药品正在面临严峻的考验，因为它们需要接受更严格的审查，并符合更高的全球标准。
Tony Ren, head of Asia healthcare research at Macquarie Capital, said many “out-licensed Chinese drugs are starting to face their moments of truth as they come under more rigorous scrutiny and higher global standards”.
Ren 指出，虽然 firmonertinib 已于今年 2 月在中国获得批准，被批准用于二线治疗，但 ArriVent 的临床试验实际上是将该药物作为一线治疗药物进行评估的。在癌症治疗领域，一线治疗通常是标准的首选治疗方法，而二线治疗通常是在一线治疗失败或无效时才使用的。
Ren noted that while firmonertinib won approval in China in February as a second-line treatment, ArriVent’s trial evaluated the drug as a first-line therapy for the same type of mutation. In cancer, first-line therapies are the standard initial treatment, while second-line options are typically used when the first therapy fails or stops working.
Ren 说：“药物在后期治疗阶段取得成功，但在早期治疗阶段失败的情况非常常见。”
“It is quite common for a drug to succeed in later line settings but fail in early settings,” Ren said.
随着越来越多的中国药物进入全球临床试验阶段，我们应当预料到：在取得成功的同时，也会出现更多的失败案例。——David Zhang，Trivium China Trivium China 的分析师 David Zhang 表示，这次在海外失败的临床试验凸显了一个关键事实：即在中国取得商业成功，并不意味着这些药物能在新的适应症或海外市场上同样取得临床成功。
As more Chinese drugs enter global trials, we should expect more visible failures alongside the successesDavid Zhang, Trivium China The failed overseas trial highlighted a key reality for Chinese drug makers – that commercial success in China did not guarantee clinical success in new indications or overseas markets, said David Zhang, analyst at Trivium China.
Allist 公司开发的 firmonertinib 已在中国获得批准，可用于治疗三种类型的非小细胞肺癌（NSCLC）；2026 年上半年，该药物的销售额达到了约 31.4 亿元人民币（4.68 亿美元）。
Allist’s firmonertinib is approved in China for three types of NSCLC treatment and generated about 3.14 billion yuan (US$468 million) in sales in the first half of 2026.
该公司在 8 月份表示，该药物帮助其上半年的收入比去年同期增长了近 40%。
The company said in August that the drug helped lift its first-half revenue by nearly 40 per cent from a year earlier.
由于中国大陆的金融市场在 10 月 1 日至 7 日期间因国庆假期而关闭，上市于上海的 Allist 公司在周三并未进行交易。
Shanghai-listed Allist did not trade on Wednesday because mainland China’s financial markets were closed for the National Day holiday from October 1 to 7.
近年来，随着全球制药巨头纷纷将目光投向中国以寻求创新疗法，中国的生物技术企业也在海外迅速扩张。
Chinese biotech firms have expanded rapidly overseas in recent years as global pharmaceutical giants increasingly turn to China for innovative therapies.
Zhang 指出，跨境合作的快速增长并未消除药物研发过程中固有的风险。
Zhang said the rapid growth in cross-border partnerships did not eliminate the risks inherent in drug development.
“这次失败案例再次凸显了即便是已经上市的产品，在临床应用中仍存在诸多不确定性，”Zhang 说，“随着更多中国药物进入全球临床试验阶段，我们应当预料到：在取得成功的同时，也会出现更多的失败案例。”——Xinmei Shen
“This setback highlights the clinical uncertainty that remains even for an established product,” Zhang said. “As more Chinese drugs enter global trials, we should expect more visible failures alongside the successes.”