Akeso lung cancer drug cuts death risk 34 in landmark trial
Akeso's ivonescimab reduced the risk of death by 34% in a phase three trial for squamous non-small cell lung cancer, with patients living nearly four months longer than those on the current standard therapy. The drug becomes the first Chinese-originated oncology treatment selected for ASCO's plenary session in 61 years.TL;DR
Akeso, the Chinese biotechnology company whose drug ivonescimab was dubbed “biotech's DeepSeek moment” last year, has reported phase three clinical trial results showing a 34% reduction in the risk of death for patients with advanced squamous non-small cell lung cancer. The data, filed with the Hong Kong stock exchange on Monday and selected for the American Society of Clinical Oncology's plenary session, mark the first time in the society's 61-year history that a China-originated investigational oncology drug has earned that distinction.
The trial, called HARMONi-6, enrolled 532 patients with locally advanced or metastatic squamous NSCLC, roughly 92% of whom were in the late stages of the disease. Squamous cell lung cancer is strongly linked to smoking, accounting for 80% of cases in men and 90% in women, according to the US National Library of Medicine.
Patients receiving ivonescimab plus chemotherapy had a median overall survival of 27.9 months, nearly four months longer than the 23.7 months recorded for patients on tislelizumab plus chemotherapy. Tislelizumab, marketed by global oncology developer BeOne, generated $737 million in global sales in 2025, up 18.6% year on year. Two-thirds of patients on ivonescimab, 64.7%, were still alive at two years, compared with 48.6% in the control group.
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Ivonescimab is a first-in-class bispecific antibody that combines PD-1 immune checkpoint blockade with anti-VEGF angiogenesis inhibition in a single molecule. Prior to these results, no therapy had successfully challenged the dominance of PD-1-based regimens in a head-to-head phase three trial in this cancer type. The DeepSeek comparison, first applied when ivonescimab's earlier data emerged, reflects a pattern in which Chinese-originated innovation is disrupting fields previously dominated by Western incumbents.
The global non-small cell lung cancer market was estimated at $20.2 billion in 2024 and is projected to grow to $53.9 billion by 2034, according to Global Market Insights. Ivonescimab already has two approved uses in China: for lung cancer patients with epidermal growth factor receptor mutations (approved 2024) and as a first-line treatment for PD-L1 positive NSCLC (approved 2025).
The US pathway runs through Summit Therapeutics, which licensed exclusive rights for the United States, Canada, Europe, and Japan from Akeso in a 2022 deal worth up to $5 billion in upfront and milestone payments. Summit has already filed a Biologics License Application with the US FDA, which has set a target action date of 14 November 2026 for ivonescimab in EGFR-mutated NSCLC. The squamous NSCLC data from HARMONi-6 would support a further label expansion.
Zhang Jialin, head of China healthcare research at Nomura, called the results “a big success not only for the company but also for the drug class, also a sentiment booster for the sector.” Akeso chairwoman Xia Yu said the ASCO selection “signifies the study's potential to establish a new standard of care and reshape clinical guidelines and practices.”
Ivonescimab's clinical success arrives as China's broader biotech industry transitions from generic drug manufacturing to innovative drug development. Chinese technology companies including ByteDance are entering drug discovery with AI-designed therapies, and AI-driven drug discovery platforms are proliferating globally. Established pharmaceutical firms like Innovent Biologics recently signed a $10.5 billion deal with Pfizer for 12 cancer drug trials.
The Chinese drug regulator has accelerated approvals for domestically developed innovative medicines, creating a pipeline that is beginning to compete directly with Western pharmaceuticals in global markets. China's innovation machine is producing globally competitive products across sectors from AI to biotechnology, a trend that is reshaping competitive dynamics for Western incumbents.
Despite the strong data, Akeso's Hong Kong-listed shares fell 1.86% to HK$115.9 on Monday, bucking a broader market rally. Analysts attributed the decline to profit-taking after a sustained run-up ahead of the results. Several brokerages revised their target prices upward following the data release, with consensus moving toward ivonescimab becoming a backbone therapy in the NSCLC treatment landscape.