China’s oncology market is entering another phase of competition as regulators approve new treatment combinations for lung and breast cancer. The latest decisions cover Akeso’s ivonescimab in combination with chemotherapy for first-line squamous non-small cell lung cancer (NSCLC), as well as AstraZeneca and Daiichi Sankyo’s Enhertu with Roche’s Perjeta for previously untreated HER2-positive metastatic breast cancer.
The approvals highlight the growing role of combination approaches in cancer care, particularly as drugmakers seek to improve survival outcomes without relying solely on established treatment regimens. They also strengthen China’s position as an important market for next-generation oncology therapies, with domestic and multinational pharmaceutical companies competing across increasingly sophisticated treatment categories.
For patients, the developments could broaden access to cancer chemotherapy combinations supported by late-stage clinical evidence, while giving physicians additional options for managing advanced disease. The decisions also show how targeted therapies, immunotherapy and antibody-drug conjugates are increasingly being integrated with conventional chemotherapy to improve treatment outcomes.
Ivonescimab approval raises competition in lung cancer
Akeso has received approval in China for ivonescimab, a bispecific antibody designed to target both PD-1 and VEGF, in combination with chemotherapy for the first-line treatment of advanced squamous NSCLC. The decision was supported by results from the Phase 3 HARMONi-6 trial.
The study compared ivonescimab plus chemotherapy with tislelizumab, marketed by BeOne Medicines as Tevimbra, alongside chemotherapy. According to the reported results, patients receiving the ivonescimab combination experienced a 34% reduction in the risk of death compared with the control group.
Median overall survival reached 27.9 months for patients treated with ivonescimab and chemotherapy, compared with 23.7 months for those receiving Tevimbra and chemotherapy.
The results are particularly significant because HARMONi-6 represents a head-to-head Phase 3 success against an established PD-1-based treatment strategy in the first-line squamous NSCLC setting. Such evidence could increase interest in bispecific approaches that attempt to address more than one biological pathway through a single therapy.
Akeso CEO Xia Yu described the approval as an important milestone for the company and for the development of newer immuno-oncology treatments.
The regulatory decision also arrives as the broader PD-1 and VEGF combination field becomes increasingly competitive. Summit Therapeutics, which has partnered with Akeso on ivonescimab, is awaiting progression-free survival data from the squamous NSCLC cohort of its global HARMONi-3 Phase 3 study. That trial is comparing ivonescimab with Merck’s Keytruda, with both treatments being evaluated alongside chemotherapy.
The development of HARMONi-3 is being closely watched after an interim analysis failed to reach statistical significance on its primary endpoint, surprising some analysts and putting additional attention on the forthcoming data.
Meanwhile, other pharmaceutical companies are moving into the same treatment class. AbbVie has registered a global Phase 3 study of ABBV-1480, a PD-1xVEGF candidate licensed from China-based RemeGen. The agreement, announced earlier this year, included a $650 million upfront payment, highlighting the commercial interest surrounding the technology.
The competition suggests that the clinical and commercial value of PD-1xVEGF therapies will increasingly depend on comparative efficacy, safety and their ability to demonstrate advantages over existing immunotherapy combinations.
Enhertu and Perjeta gain first-line breast cancer use
China’s National Medical Products Administration has separately approved AstraZeneca and Daiichi Sankyo’s Enhertu in combination with Roche’s Perjeta as a first-line treatment for HER2-positive metastatic breast cancer.
The decision expands the use of Enhertu, an antibody-drug conjugate, into an earlier treatment setting and is based on findings from the Phase 3 DESTINY-Breast09 trial.
In the study, the Enhertu and Perjeta combination reduced the risk of disease progression or death by 44% compared with the traditional THP regimen, which consists of a taxane, Herceptin and Perjeta.
DESTINY-Breast09 enrolled patients with HER2-positive metastatic breast cancer who had not previously received chemotherapy or HER2-directed therapy for advanced disease. Patients who had received earlier treatment in the neoadjuvant or adjuvant setting were eligible if more than six months had passed before their advanced or metastatic diagnosis.
The approval gives physicians in China another first-line option for a patient population where HER2-targeted treatment has already transformed the standard of care. It also further strengthens the position of Enhertu, which has rapidly expanded across multiple indications and markets.
Daiichi Sankyo said the Chinese approval represents the fourth new indication for Enhertu in the country in less than a year. That pace reflects the company’s broader strategy of expanding the drug’s use across different cancer settings as additional clinical evidence becomes available.
Taken together, the two Chinese approvals illustrate a broader shift in oncology development. Drugmakers are increasingly looking beyond single-agent therapies and testing combinations that bring together immune pathway targeting, targeted medicines, antibody-drug conjugates and chemotherapy.
For pharmaceutical companies, China is becoming an increasingly important environment for this competition because of its large patient population, expanding clinical research capabilities and growing participation in global drug development. For healthcare providers, the arrival of additional evidence-backed combinations could provide greater flexibility when selecting treatment based on disease characteristics and patient needs.
The developments also reinforce the importance of comparative Phase 3 evidence. As more therapies enter crowded oncology markets, regulatory approval alone may not determine commercial success. Demonstrating meaningful improvements in survival, disease control or treatment convenience against established standards is likely to remain central to adoption.
For Akeso, the HARMONi-6 approval gives ivonescimab an important commercial foothold in lung cancer while the industry waits for further global evidence. For AstraZeneca and Daiichi Sankyo, the Enhertu and Perjeta decision adds another first-line opportunity for a drug that has become central to their oncology portfolio.
The next stage will therefore depend on how these treatments perform beyond the initial approvals and how quickly competing therapies establish their own clinical advantages.
Ref: https://www.fiercepharma.com/pharma/fierce-pharma-regulatory-tracker-2026-h2
