Ivonescimab's Updated Label Shows Positive Dual Results in PFS and OS from HARMONi-A Study

HONG KONG, Jan. 6, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced that the National Medical Products Administration has approved a significant label update in China for its internally developed, first-in-class PD-1/VEGF bispecific antibody, ivonescimab. The updated label incorporates final analysis data from the AK112-301/HARMONi-A study, which demonstrated statistically significant and clinically meaningful dual benefits in both progression-free survival (PFS) and overall survival (OS) for ivonescimab combination therapy in patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) who had progressed after EGFR-TKI therapy.

This update highlights how the HARMONi-A trial stands as the world's first Phase III immunotherapy study in EGFR-TKI-resistant nsq-NSCLC to deliver clinically meaningful and statistically significant improvements in both co‑primary endpoints, PFS and OS. It is also the first randomized, double‑blind Phase III trial in this setting to report positive outcomes for both survival endpoints concurrently, supporting the exceptional benefits for patients from Akeso's combination of immunotherapy and anti-angiogenic approach.

The final OS analysis, with a median follow-up period of 32.5 months, showed that the ivonescimab plus chemotherapy regimen provided a clinically meaningful and statistically significant improvement in OS compared to chemotherapy alone:

• At 77% data maturity, ivonescimab combination lowered the risk of death by 26% (OS HR=0.74, P=0.019), with the survival benefit becoming more evident over time. It also reduced the risk of disease progression or death by 54% (PFS HR=0.46, P＜0.001), extending median PFS from 4.8 to 7.1 months.
• With a median follow-up of 32.5 months, the long-term safety profile of the ivonescimab combination therapy remained favorable, with no new safety signals identified. The incidence of common treatment-related adverse events (TRAEs) showed no significant difference between the two groups.

Based on the positive clinical data from the HARMONi-A study, ivonescimab received approval from the China National Medical Products Administration in May 2024 for this indication. In November 2024, ivonescimab was added to China's National Reimbursement Drug List (NRDL), effective January 1, 2025, ensuring widespread patient access to this life-saving treatment.

In April 2025, ivonescimab's new indication for the first-line treatment of PD-L1-positive NSCLC was also approved, and subsequently included in China's NRDL later in the same year, effective January 2026. The first-line treatment approval and the NRDL inclusion provides a new, highly effective, well-tolerated, and durable chemotherapy-free therapeutic option for the first-line treatment of NSCLC in China.

Forward-Looking Statement of Akeso, Inc.
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 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.

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, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

SOURCE Akeso, Inc.