The regulatory submission follows positive data from the pivotal Phase III AFFIRM-205 clinical trial, where the drug met its primary endpoint of progression-free survival. The study demonstrated significant clinical benefits over the control arm, paired with a favorable safety profile. As the first domestically developed AKT inhibitor in China, afuresertib is positioned to address therapeutic resistance in the approximately 50% of breast cancer patients who harbor PIK3CA, AKT1, or PTEN genetic alterations.

Laekna is coordinating with its strategic partner, Qilu Pharmaceutical, to manage the regulatory pathway and eventual commercial rollout. Under a licensing agreement signed in November 2025, the company stands to receive up to RMB 2.045 billion in milestone payments, alongside tiered royalties. While this application marks a transition toward commercialization for the Shanghai-based firm, development efforts for the drug are simultaneously expanding into prostate cancer treatments and international markets.