Summit Therapeutics’ partner Akeso Inc has announced receipt of Marketing Authorisation (MA) in China from the National Medical Products Administration (NMPA) for the use of ivonescimab, a novel, potential first-in-class investigational bispecific antibody, in combination with chemotherapy for the first-line treatment of patients with advanced squamous Non-Small Cell Lung Cancer (NSCLC).

This marks the third NMPA-approved indication for an ivonescimab-containing regimen in China since the molecule’s initial approval in May 2024. The latest NMPA approval is based on the positive results of the landmark HARMONi-6 trial, a single region, multi-center, phase 3 study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analysed by Akeso.

HARMONi-6 evaluates ivonescimab in combination with platinum-based chemotherapy compared to tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC irrespective of PD-L1 expression. Overall Survival (OS) data from the phase 3 HARMONi-6 trial were recently presented in the Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

HARMONi-6 demonstrated statistically significant and clinically meaningful superiority in both Progression-Free Survival (PFS) and OS. Ivonescimab continued to demonstrate an acceptable and manageable safety profile in the HARMONi-6 study, which was consistent with previous phase 3 studies of ivonescimab plus chemotherapy.

Bob Duggan, Chairman and Co-CEO, Summit, said, “Today’s approval in China marks another extraordinary milestone for ivonescimab and reinforces the strength of the clinical evidence generated to date. HARMONi-6 is the first known phase 3 study in NSCLC—or any tumor type—to demonstrate a statistically significant and clinically meaningful Overall Survival benefit over an anti-PD-(L)1 antibody plus chemotherapy regimen in a head-to-head setting.”

In major markets globally, first-line therapy for patients with advanced NSCLC without driver mutations is most commonly a PD-1 inhibitor plus platinum-based chemotherapy. Prior to HARMONi-6, there were no known phase 3 clinical trials to show a statistically significant and clinically meaningful improvement when compared to PD-(L)1 inhibitor therapy in combination with chemotherapy in a head-to-head setting, in patients with advanced NSCLC or any tumor type.

Dr. Michelle Xia, Chairwoman and Chief Executive Officer (CEO), Akeso, said, “The NMPA approval of ivonescimab in China in combination with chemotherapy for first-line advanced squamous NSCLC represents a landmark achievement for patients, physicians and the field of oncology. Based on the HARMONi-6 trial, ivonescimab has now demonstrated both Progression-Free Survival and Overall Survival superiority versus a PD-1 inhibitor plus chemotherapy regimen, establishing a new benchmark in one of the most widely treated settings in cancer care. This third approval for an ivonescimab-containing regimen in China reflects the strength of Akeso’s innovation platform, the dedication of our clinical investigators and patients, and the transformative potential of ivonescimab as a next-generation immuno-oncology therapy. Together with Summit, we are committed to bringing the full potential of ivonescimab to patients worldwide.”

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the US and Europe.