Akeso lung cancer drug shines in trials, boosting hopes in US$20b market

Akeso’s ivonescimab has delivered another blow to the established order in oncology. The Chinese biotech announced Monday that its phase three trial showed the drug reduced the risk of death by 34% in patients with squamous non-small cell lung cancer, a particularly aggressive form strongly linked to smoking. This is the same drug that last year sparked what some in the industry called biotech’s “DeepSeek moment” — a reference to the Chinese AI model that stunned global competitors with its efficiency and performance. The new data targets a patient population that has long been underserved. Squamous cell lung cancer accounts for roughly 25% to 30% of all non-small cell lung cancer cases, and the link to smoking is stark: 80% of cases in men and 90% in women are attributable to tobacco use, About 92% of patients in the trial had late-stage locally advanced or metastatic disease. For these patients, treatment options have been limited, and the standard of care — PD-1 inhibitors like Merck’s Keytruda — has dominated for years. Ivonescimab now threatens that dominance. The global non-small cell lung cancer market was estimated at US$20.2 billion in 2024, and analysts project it will grow from US$22.1 billion in 2025 to US$53.9 billion in 2034. With this expanded indication, ivonescimab could become a backbone therapy, capturing a significant slice of that expanding pie. Several analysts have already revised their target prices for Akeso upward. What the casual observer might miss is the strategic significance of the timing. Akeso secured its first approval in China in 2024 for patients with EGFR-mutant lung cancer — a smaller, genetically defined subset. The new squamous cell indication opens the door to a much larger, smoking-related population that is far more prevalent globally. This is not merely an incremental win; it is a pivot from a niche to a mainstream market. Yet the market reaction on Monday was oddly muted. Akeso’s Hong Kong-listed shares dropped 1.86% to HK$115.9, even as the Hang Seng Index rose 0.86%. The dip likely reflects profit-taking after a strong run, but it also hints at lingering skepticism about whether ivonescimab can replicate its Chinese success in Western markets. Regulatory approval in the US and Europe remains a high-stakes question. The drug’s mechanism may give it an edge. Ivonescimab is a bispecific antibody that targets both PD-1 and VEGF, potentially offering a dual attack on tumors while reducing resistance. If the phase three data holds up in real-world use, it could redefine first-line treatment for squamous NSCLC. Akeso now holds two approved uses in China, with more trials likely on the way. The question is no longer whether ivonescimab works — it does. The question is how fast the global medical establishment will rewrite its playbook.

Akeso, whose drug ivonescimab was hailed as biotech’s “DeepSeek moment” amid US competition last year, announced better-than-expected clinical results showing it can treat a type of lung cancer commonly found in smokers, potentially expanding its approved u...

Akeso’s expanded trial data positions ivonescimab to capture a significant share of the $20B NSCLC market, challenging established PD-1 inhibitors.

The development adds to a wider Greater China healthcare story in which companies are being judged on execution, capital access, regulatory fit and the credibility of their regional expansion plans.

For business readers, the important question is whether this becomes an isolated announcement or part of a more durable operating pattern across customers, financing channels, partners and public-market expectations.