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Hong Kong, Jan 06 - 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=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.