Therapeutics Inc. 表示，美国监管机构拒绝批准其肺癌药物，这使得该公司利用一款最早由中国开发的药物挑战标准疗法的计划受挫。
Therapeutics Inc. said US regulators declined to approve its lung cancer medicine, setting back its quest to challenge the standard of care with a drug first pioneered in China.
这家生物技术公司曾寻求批准该疗法用于一小部分经 EGFR 靶向药物治疗后病情进展的晚期非小细胞肺癌患者，EGFR 是一种可驱动肿瘤细胞生长的蛋白质。美国食品药品监督管理局（FDA）的这一决定，对 Summit 的中国合作伙伴康诺亚生物医药科技有限公司（Akeso Inc.）也是一个打击，该药物 Ivonescimab（伊沃西单抗）由康诺亚首创，并由其在中国上市销售。
The biotech firm had sought approval for the treatment’s use in a small subtype of advanced non-small cell lung cancer after prior treatment with drugs targeting EGFR, a protein that can drive the growth of tumor cells. The Food and Drug Administration’s decision is also a blow for Summit’s Chinese partner Akeso Inc., which first developed the drug, ivonescimab, and markets it in China.
Summit 在周日发布的声明中称，FDA 发出了一份所谓的“完整回复信”，指出无法以目前的形式批准 Summit 的申请，因为该药物未能在统计学显著性上帮助患者延长生存期。虽然它能阻止癌症恶化，但仅凭这一点不足以支持获批。
The FDA issued a so-called Complete Response Letter saying that it can’t approve Summit’s application in its present form because the drug didn’t help patients live longer in a statistically significant way. While it kept cancer from getting worse, this alone isn’t sufficient to warrant approval, the company said in a statement on Sunday.
“我们为正在等待这一治疗领域更多治疗选择的患者及其家属感到失望，”Summit 首席执行官 Bob Duggan 在声明中说。他表示，公司将继续研究该药物对其他类型癌症的疗效。
“We are disappointed for patients and their families awaiting additional treatment options in this setting,” Summit’s Chief Executive Officer Bob Duggan said in the statement. The company will continue to study the drug’s effect on other types of cancer, he said.
“我们的使命依然是改善面临重大未满足临床需求的患者的预后，这是值得坚持的事业，”Duggan 说。
“Our mission remains to improve outcomes for patients facing significant unmet needs, which is work worth doing,” Duggan said.
伊沃西单抗是最先进的双重作用癌症免疫疗法药物。与传统免疫疗法一样，它能激活患者的免疫系统攻击癌细胞，但同时也靶向肿瘤血管生长的一个驱动因素。
Ivonescimab is the most advanced dual-action cancer immunotherapy drug. Like traditional immunotherapies, it unleashes patients’ immune systems to attack cancer, but it also targets a driver of tumor blood-vessel growth.
FDA 的决定聚焦于一个相对小众的人群：肺癌由 EGFR 基因突变驱动、且常用一线治疗无效或失效的患者。Summit 此前估计，每年将有超过 1.4 万名美国患者符合治疗条件，而彭博行业研究分析师 Javier Manso Polo 预测，到 2035 年潜在销售额仅为 2.3 亿美元。
The FDA decision focused on a relatively niche population: patients whose lung cancer is driven by mutations in the gene known as EGFR and for whom a common first-line treatment didn’t work or stopped working. Summit had previously estimated that more than 14,000 US patients would be eligible for treatment every year, while Bloomberg Intelligence analyst Javier Manso Polo has predicted just $230 million in potential sales by 2035.
此次拒批可能产生更广泛的影响。2024年，Summit与合作伙伴康诺亚宣布，其源自中国的药物在一项中国晚期临床研究中击败了默克公司的Keytruda（全球销售额最高的抗癌药），由此获得国际关注并具有了象征性意义。其前景激发了一系列涉及中国类似药物的许可交易。
The rejection could have wider reverberations. Summit’s China-originated drug took on symbolic significance after garnering international attention in 2024, when Summit and its partner Akeso said it beat Merck & Co’s Keytruda, the world’s top-selling cancer drug, in a late-stage clinical study in China. Its promise inspired a series of licensing deals involving similar drugs from China.
自此，依沃西单抗已成为中国生物技术行业整体的风向标。周日的挫折意味着，投资者将不得不等待更长时间，以获得在中国取得的成功能否在全球复制的证据。
Since then, ivonescimab has become a barometer for the broader Chinese biotech industry. Sunday’s setback means investors will have to wait longer for proof that success in China can be replicated globally.
尽管监管机构警告数据不够充分，Summit仍寻求FDA批准用于EGFR亚型——这一适应症一直是默克Keytruda未能攻克的。杰富瑞分析师在10月27日的报告中写道，获批预期“极低”。
Summit sought FDA clearance for the EGFR subtype — which has eluded Merck’s Keytruda — despite being warned by regulators that it didn’t have strong enough data. Expectations for approval were “minimal,” Jefferies analysts wrote in a Oct. 27 note.
该公司雄心不止于这一初始适应症，目前正在进行多项全球III期研究，以证明依沃西单抗在其他癌症类型中的疗效，其中包括直接对标Keytruda的研究。
The company has ambitions beyond this initial setting, currently running several more global Phase 3 studies to prove ivonescimab’s effects in other cancer types, including studies pitting it directly against Keytruda.
9月，阿斯利康宣布投资20亿美元与Summit合作开发依沃西单抗，并将其与阿斯利康的其他药物联用，凸显了其在多种癌症中的潜力。
In September, AstraZeneca Plc announced a $2 billion investment in Summit to collaborate on ivonescimab and combine it with AstraZeneca’s other medicines, underscoring its potential across a range of cancers.
据BI（注：应指商业智能或相关数据机构）统计，分析师估计，如果正在进行的研究取得成功，到2030年该药物总销售额可能达到38亿美元。康诺亚有望从美国产品销售中获得低双位数比例的特许权使用费。
If the ongoing studies succeed, analysts estimate that the drug could bring in $3.8 billion in total sales by 2030, according to BI. Akeso stands to earn low double-digit royalties from US product sales.