Akeso's lung cancer medication reduces the risk of death by 34% in a significant trial.
TL;DR
Akeso's ivonescimab has shown a 34% reduction in mortality risk in a phase three trial for squamous non-small cell lung cancer, allowing patients to live nearly four months longer than those undergoing standard treatment. This makes it the first oncology drug of Chinese origin to be featured in ASCO's plenary session in 61 years.
Akeso, the Chinese biotech company behind ivonescimab, previously referred to as “biotech’s DeepSeek moment,” announced phase three trial results demonstrating a 34% decrease in death risk for patients suffering from advanced squamous non-small cell lung cancer. The findings, which were disclosed to the Hong Kong stock exchange on Monday and chosen for the American Society of Clinical Oncology’s plenary session, represent the first time in the organization's 61-year existence that a China-originated investigational oncology drug has received such recognition.
The HARMONi-6 trial involved 532 patients with locally advanced or metastatic squamous NSCLC, with approximately 92% in the later stages of the illness. Squamous cell lung cancer is heavily associated with smoking, accounting for 80% of cases in men and 90% in women, as reported by the US National Library of Medicine.
Patient Outcomes
Patients treated with ivonescimab in combination with chemotherapy experienced a median overall survival of 27.9 months, nearly four months longer than the 23.7 months seen in those given tislelizumab alongside chemotherapy. Tislelizumab, sold by global oncology developer BeOne, achieved $737 million in global sales in 2025, marking an 18.6% year-on-year increase. At the two-year mark, 64.7% of patients on ivonescimab remained alive, compared to 48.6% in the control group.
Ivonescimab is a pioneering bispecific antibody that merges PD-1 immune checkpoint inhibition with anti-VEGF angiogenesis suppression into a single molecule. Prior to these findings, no treatment had effectively challenged the supremacy of PD-1-based therapies in a direct phase three trial for this type of cancer. The “DeepSeek” analogy, first made when ivonescimab's earlier data was released, illustrates a trend where innovations from China are disrupting sectors traditionally led by Western entities.
A $20 Billion Opportunity
The global market for non-small cell lung cancer was valued at approximately $20.2 billion in 2024 and is anticipated to rise to $53.9 billion by 2034, according to Global Market Insights. Ivonescimab is already approved for two indications in China: for lung cancer patients with epidermal growth factor receptor mutations (approved in 2024) and as a first-line therapy for PD-L1 positive NSCLC (approved in 2025).
In the US, the path for ivonescimab is being managed by Summit Therapeutics, which secured exclusive rights for the United States, Canada, Europe, and Japan from Akeso in a 2022 agreement worth up to $5 billion in upfront and milestone payments. Summit has submitted a Biologics License Application to the US FDA, with a target action date of November 14, 2026, for ivonescimab in EGFR-mutated NSCLC. The results from the squamous NSCLC trial HARMONi-6 could support further label expansions.
Zhang Jialin, the head of China healthcare research at Nomura, described the results as “a significant success not only for the company but also for the drug category, serving as a morale booster for the sector.” Akeso chairwoman Xia Yu stated that the ASCO selection “highlights the study's potential to set a new standard of care and transform clinical guidelines and practices.”
Advancements in China’s Biotech Sector
The clinical success of ivonescimab coincides with a shift in China's broader biotech industry from generic drug production to innovative drug development. Tech companies in China, such as ByteDance, are venturing into drug discovery with AI-designed treatments, and AI-driven drug discovery platforms are becoming widespread globally. Established pharmaceutical entities like Innovent Biologics recently entered a $10.5 billion partnership with Pfizer for 12 cancer drug trials.
The Chinese drug regulatory authority has expedited the approval process for domestically created innovative medications, leading to a pipeline that is increasingly competing with Western pharmaceuticals in international markets. China’s innovation ecosystem is generating globally competitive products across various sectors, including AI and biotechnology, a trend that is altering the competitive landscape for Western incumbents.
Despite the promising data, shares of Akeso listed in Hong Kong dropped by 1.86% to HK$115.9 on Monday, diverging from a wider market rally. Analysts attributed this decline to profit-taking after a notable rise in share value preceding the results. Following the data release, multiple brokerages raised their target prices, with
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Akeso's lung cancer medication reduces the risk of death by 34% in a significant trial.
Akeso's ivonescimab lowers the risk of death by 34% in a phase three trial for lung cancer, marking the first Chinese medication chosen for ASCO's plenary in 61 years, aimed at a $20 billion market.
