-Summit Therapeutics Inc.  noted that, on August 12, 2026, its partner Akeso Inc. (Akeso, HKEX Code: 9926.HK) announced receipt of marketing authorization 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 III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed 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 III 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 III studies of ivonescimab plus chemotherapy.

“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 III 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,” said Bob Duggan, Chairman and Co-CEO of Summit.

“For Summit, the HARMONi-6 results further strengthen our conviction in ivonescimab’s potential to advance beyond today’s immunotherapy standards and redefine what patients and physicians can expect from first-line cancer treatment,” said Dr. Maky Zanganeh, President and Co-CEO of Summit. “We congratulate our partner Akeso on this important approval and remain focused on accelerating the global development of ivonescimab for patients in our licensed territories.”

“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,” said Dr. Michelle Xia, Chairwoman and Chief Executive Officer of Akeso. “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.”

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 III 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.

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