#China #Hong Kong #Akeso #Ivonescimab #HARMONi-A

Significant Update on Ivonescimab's Label in China

On January 6, 2026, Akeso, Inc. (9926.HK) proudly announced that the National Medical Products Administration (NMPA) in China has granted approval for a crucial update to the label of ivonescimab, a groundbreaking PD-1/VEGF bispecific antibody developed by the company. This development marks a milestone in cancer therapy, particularly for patients suffering from non-squamous non-small cell lung cancer (nsq-NSCLC) who have not responded well to EGFR-TKI treatments.

HARMONi-A Study Results

The revised label incorporates data from the AK112-301/HARMONi-A study, a pioneering Phase III clinical trial that demonstrated statistically significant dual benefits in progression-free survival (PFS) and overall survival (OS). This trial was notable for being the world’s first to report dual improvements in both primary endpoints for patients with advanced lung cancer resistant to EGFR-TKIs, reinforcing the efficacy of Akeso’s innovative combination therapy.

The results were particularly striking. After a median follow-up of 32.5 months, the ivonescimab-combined chemotherapy regimen showed a significant reduction in mortality risk by 26%, as supported by an OS hazard ratio of 0.74 (P=0.019). Furthermore, the combination also led to a 54% decrease in the risk of disease progression or death (PFS HR=0.46, P<0.001), effectively extending median PFS from 4.8 months to 7.1 months.

Positive Long-Term Safety Profile

Long-term safety evaluations of the ivonescimab combination therapy revealed a favorable profile, with no new safety signals emerging during the follow-up. The incidence of treatment-related adverse events was consistent between treatment groups, indicating reliable safety standards in this innovative therapy.

Regulatory Approvals and Availability

Akeso's advances did not stop at the HARMONi-A study's conclusions. The combination therapy received green light from the Chinese regulatory authorities for commercialization in May 2024. Subsequently, ivonescimab was included in China's National Reimbursement Drug List (NRDL) effective January 1, 2025, which significantly enhances patient access to this innovative treatment.

In addition, in April 2025, the new indication for ivonescimab in treating PD-L1-positive NSCLC was also approved, with inclusion in the NRDL slated for January 2026. This expansion offers patients a highly effective and well-tolerated treatment option that does not rely on traditional chemotherapy, further establishing Akeso's commitment to enhancing cancer care in China.

Akeso's Commitment to Innovation

Founded in 2012, Akeso has rapidly positioned itself as a leader in biopharmaceutical innovation, focusing on first-in-class therapies with a robust pipeline comprising over 50 innovative assets targeting various critical healthcare needs, from cancer to autoimmune diseases. The combination of their unique RD platforms and their bi-specific antibody development technology allows Akeso to remain at the forefront of oncological therapies, ensuring high accessibility and socio-economic value for patients worldwide.

In conclusion, the positive dual outcomes reported in PFS and OS for ivonescimab position it as a cutting-edge treatment for patients battling advanced lung cancer. With the ongoing commitment to excellence and innovation, Akeso continues to transform the landscape of cancer therapy, making substantial strides in improving patient care.

For more information about Akeso and its innovative treatments, visit the Akeso profile page.