Akeso's lung cancer medication reduces the risk of death by 34% in a groundbreaking trial.

      Akeso’s ivonescimab demonstrated a 34% reduction in death risk in a phase three trial for squamous non-small cell lung cancer, with patients living nearly four months longer compared to those receiving the current standard treatment. This drug is notable as it is the first oncology therapy of Chinese origin selected for ASCO's plenary session in 61 years.

      The Chinese biotechnology firm Akeso, whose ivonescimab was likened to “biotech’s DeepSeek moment” last year, released phase three clinical trial results indicating a 34% decrease in the death risk for patients with advanced squamous non-small cell lung cancer. This data, submitted to the Hong Kong stock exchange on Monday and chosen for presentation at the American Society of Clinical Oncology’s plenary session, marks a historical milestone as the first China-originated investigational oncology drug to achieve this recognition in the society’s 61-year existence.

      The trial, named HARMONi-6, involved 532 participants suffering from locally advanced or metastatic squamous NSCLC, with approximately 92% in the later stages of the disease. Squamous cell lung cancer is significantly associated with smoking, comprising 80% of cases in men and 90% in women, as noted by the US National Library of Medicine.

      In terms of survival outcomes, patients treated with ivonescimab in combination with chemotherapy reported a median overall survival of 27.9 months, nearly four months longer than the 23.7 months for those on tislelizumab plus chemotherapy, which is marketed by BeOne, a global oncology developer, and saw $737 million in global sales in 2025, reflecting an 18.6% increase year-on-year. Additionally, 64.7% of ivonescimab patients were still alive after two years, compared to 48.6% in the control group.

      Ivonescimab is a pioneering bispecific antibody that merges PD-1 immune checkpoint blockade with anti-VEGF angiogenesis inhibition within a single molecule. To date, no treatment has effectively contested the leading position of PD-1-based therapies in head-to-head phase three trials for this cancer type. The “DeepSeek” analogy, first introduced when last year's ivonescimab data was released, illustrates a trend where innovations from China are disrupting sectors traditionally led by Western companies.

      In terms of market potential, the global non-small cell lung cancer sector was valued at approximately $20.2 billion in 2024 and is anticipated to grow to $53.9 billion by 2034, according to Global Market Insights. Ivonescimab has two approved applications in China: for lung cancer patients with epidermal growth factor receptor mutations (approved in 2024) and as a first-line treatment for PD-L1 positive NSCLC (approved in 2025).

      In the United States, the pathway involves Summit Therapeutics, which secured exclusive rights for the US, Canada, Europe, and Japan from Akeso in a 2022 agreement valued at up to $5 billion in upfront and milestone payments. Summit has already submitted a Biologics License Application to the US FDA, which has set a target action date of November 14, 2026, for ivonescimab in EGFR-mutated NSCLC, with the HARMONi-6 data potentially aiding further label expansion.

      Zhang Jialin, head of healthcare research at Nomura in China, described the results as a significant achievement not just for the company but for the entire drug class, also boosting sentiment for the sector. Akeso chairwoman Xia Yu emphasized that the ASCO selection “signifies the study's potential to set a new standard of care and transform clinical guidelines and practices.”

      Ivonescimab’s clinical success comes as China's broader biotech industry evolves from focusing on generic drug production to pursuing innovative drug developments. Chinese tech companies like ByteDance are venturing into drug discovery with AI-designed therapies, while AI-driven drug discovery platforms are rapidly emerging worldwide. Moreover, established pharmaceutical companies, such as Innovent Biologics, have recently entered into a $10.5 billion partnership with Pfizer for 12 cancer drug trials.

      China's regulatory body has expedited approvals for innovative medicines developed domestically, resulting in a pipeline that increasingly competes with Western pharmaceuticals in global markets. The pace of innovation in China is yielding globally competitive products across various sectors, including AI and biotechnology, altering the competitive landscape for Western businesses.

      Despite the positive data, Akeso’s shares on the Hong Kong exchange fell by 1.86% to HK$115.9 on Monday, defying a broader market rally. Analysts speculated that the drop might be due to profit-taking following a significant rise before the results announcement. Following the data release, several brokerage firms adjusted their target prices upward, with a growing consensus that ivonescimab could become a mainstay therapy in the NSCLC