Ivonescimab Plus Chemotherapy Approved for First-Line Squamous NSCLC; HARMONi-6 Establishes New Gold Standard in Lung Cancer Treatment

HONG KONG, Aug. 12, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that the China National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for ivonescimab injection in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC).

The approval of ivonescimab combination therapy as a first-line treatment for squamous NSCLC marks the third lung cancer indication for ivonescimab. In a randomized, double-blind Phase III trial, this regimen demonstrated statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared with a PD-1 inhibitor plus chemotherapy. These results establish a new first-line standard of care for squamous NSCLC and mark a major milestone in the treatment of lung cancer worldwide.

This latest approval is supported by the breakthrough results from the Phase III HARMONi-6/AK112-306 study. The positive OS data were presented in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the first time a China-originated novel therapy has been featured in an ASCO Plenary Session. The full results were simultaneously published in The Lancet. The positive PFS results were previously presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) Congress, with the full paper concurrently published in The Lancet as well.

The HARMONi-6 study enrolled a total of 532 patients. Approximately 63% had centrally located squamous tumors, 39.0% had PD-L1 TPS <1%, and 33.8% had multi-site metastases, liver metastases, or brain metastases. The study met all primary and secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in both PFS and OS, with a favorable safety profile.

Key findings from the HARMONi-6 study:

• Ivonescimab plus chemotherapy significantly prolonged OS. Ivonescimab plus chemotherapy reduced the risk of death by 34% versus tislelizumab plus chemotherapy (HR=0.66 [95% CI: 0.50-0.87], P=0.0017). Median OS was 27.9 months in the ivonescimab arm versus 23.7 months in the control arm. The 12-month OS rate was 78.9% with ivonescimab plus chemotherapy versus 72.2% in the control arm, and the 24-month OS rate was 64.7% versus 48.6%, respectively. The survival benefit continued to widen over time, reflecting a more durable and clinically meaningful long-term survival advantage compared with PD-1 inhibitor plus chemotherapy.

• At the prespecified interim analysis for PFS, ivonescimab plus chemotherapy had already demonstrated a clinically meaningful and statistically significant improvement in PFS compared with tislelizumab plus chemotherapy, with a median PFS of 11.1 months versus 6.9 months (HR=0.60 [95% CI: 0.46-0.78], P<0.0001).

• Consistent and substantial OS benefit was observed across all prespecified subgroups, regardless of PD-L1 expression levels or metastatic burden.

• The overall safety profile of the ivonescimab combination was favorable and comparable to that of the control arm.

Professor Shun Lu, Principal Investigator of HARMONi-6, Director of the Oncology Department, Shanghai Chest Hospital:

"We are highly encouraged by the dual-positive PFS and OS results from HARMONi-6 and proud to see the approval of ivonescimab plus chemotherapy for first-line sq-NSCLC. By outperforming PD-1 plus chemotherapy, this regimen has rewritten the gold standard of care and represents a landmark advance in the treatment of lung cancer.

HARMONi-6 provides clear evidence that compared to PD-1 plus chemotherapy, the ivonescimab treatment significantly prolongs both OS and PFS, reduces the risks of death and disease progression, delivers consistent benefit across subgroups, and helps patients maintain better quality of life for longer. These findings fully demonstrate the breakthrough clinical value of the PD-1/VEGF bispecific mechanism and the strengths of this next-generation immuno-oncology therapy. The regimen also overcomes the previous limitation that anti-angiogenic agents could not be used in sq-NSCLC, filling an important clinical gap.

Ivonescimab combination therapy offers patients a new, more effective and safer treatment option, bringing particular hope to those with squamous cell carcinoma who have had limited choices. This is what we as clinicians and patients have long been waiting for. We look forward to seeing ivonescimab continue to deliver strong results globally and help reshape cancer treatment worldwide."

Dr. Xia Yu, Founder, Chairwoman, President and CEO of Akeso:

"We are incredibly pleased by the approval of ivonescimab plus chemotherapy for first-line advanced squamous NSCLC. This approval marks a critical milestone in the development of next-generation immuno-oncology therapies worldwide. We sincerely thank all the investigators, patients, and regulatory authorities who made this possible. Since its inception, ivonescimab's every advance has drawn significant global attention and is recognized as a benchmark therapy poised to shape the pharmaceutical landscape from 2026 onward and redefine treatment paradigms. With robust dual-positive PFS and OS data, it has successfully challenged PD-1 plus chemotherapy, rewritten the first-line standard of care for squamous NSCLC, and established a new benchmark for clinical benefit.

Currently, ivonescimab stands as the cornerstone of Akeso's IO2.0 + ADC2.0 strategy. We are advancing a portfolio of highly differentiated therapies that continue to elevate and reshape the global treatment landscape in major cancers such as lung and breast cancer. This work includes extensive combination studies with our proprietary next-generation ADCs and bispecific ADCs, as well as partnerships with multiple high-potential ADC candidates from collaborators around the world. The breakthrough results from HARMONi-6 further strengthen our confidence in ivonescimab's transformative clinical value and its potential for even greater success worldwide. Together with Summit, we are committed to bringing the full value of ivonescimab to patients worldwide."

Previously, in patients with advanced non-squamous NSCLC who had progressed on EGFR-TKI therapy, the HARMONi-A study of ivonescimab became the first immunotherapy trial to demonstrate clinically meaningful and statistically significant improvements in both PFS and OS. In the Phase III HARMONi-2 study, first-line ivonescimab delivered a median PFS of 11.14 months in PD-L1-positive NSCLC, compared with 5.8 months for pembrolizumab, making it the first drug to demonstrate a positive Phase III result against the leading PD-1 therapy.

These results position ivonescimab as a cornerstone of the immuno-oncology 2.0 era. Across comparisons with PD-1 monotherapy, PD-1 plus chemotherapy (the current optimal standard of care in many tumors), and VEGF-targeted therapies, ivonescimab has shown clear clinical advances and a strong capacity to improve upon existing treatment options.

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About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms.

Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, 27 candidates have advanced into clinical trials—including 15 bispecific or multispecific antibodies and bispecific ADCs—and 8 innovative drugs have reached commercial stage.

Through efficient and groundbreaking R&D, Akeso integrates premier global resources to develop transformative medicines, deliver high-quality, affordable therapeutic antibodies to patients worldwide, and generate sustained commercial and societal value as it strives to become a global leader in biopharmaceutical innovation.

Forward-Looking Statements
This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the P.R. China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

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