Akeso (09926.HK) Opens Nearly 4% Higher as Ivonescimab Achieves Positive OS Results in HARMONi-2 Trial, Iterating Beyond Keytruda

Shares of Akeso, Inc. (09926.HK) climbed nearly 4% at the open on Wednesday, trading at HKD 91.0 with turnover reaching HKD 29.13 million. The biotech company's stock surge followed a major clinical milestone announcement that could reshape the global lung cancer treatment landscape.

On September 3, Akeso disclosed that its flagship drug ivonescimab (brand name: Yidafang®) met the key secondary endpoint of overall survival (OS) in the Phase III HARMONi-2 trial. The registrational study compared ivonescimab head-to-head against pembrolizumab as first-line treatment for patients with PD-L1 positive (TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

An independent data monitoring committee's pre-specified interim analysis confirmed statistically significant and clinically meaningful positive results for overall survival, the company said.

A New Era in Cancer Immunotherapy

Pembrolizumab, marketed as Keytruda by Merck, stands as the most iconic drug that launched the 1.0 era of cancer immunotherapy. The PD-1 inhibitor transformed lung cancer treatment and became one of the world's most commercially successful innovative drugs.

Now ivonescimab, classified by Akeso as a "tumor immunotherapy 2.0 foundation drug," has demonstrated the ability to deliver even greater patient benefits on top of pembrolizumab's achievements. The positive OS data positions ivonescimab as a potential next-generation cornerstone therapy in cancer immunotherapy.

The HARMONi-2 study (also known as AK112-303) was designed as a randomized, double-blind, controlled, multi-center registrational Phase III trial. The trial's success in meeting its OS endpoint represents a breakthrough clinical value for ivonescimab and signals substantial commercial potential.

As the first-in-class tumor immunotherapy 2.0 drug, ivonescimab's ability to outperform the current standard of care could significantly expand Akeso's footprint in the global oncology market. Investors are watching closely to see how this clinical success translates into commercial performance.