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 Seeks China Approval for AKT Inhibitor Afuresertib
China's National Medical Products Administration has accepted a new drug application for afuresertib, a targeted therapy developed by Laekna for patients with locally advanced or metastatic HR+/HER2- breast cancer who have seen their disease progress following standard endocrine treatments.
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.
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