Chinese biotechnology company Laekna (HK:2105) announced on Tuesday that the New Drug Application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer (LA/mBC) with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy (with or without a CDK4/6 inhibitor).

The NDA is supported by positive results from a Phase III clinical trial (AFFIRM-205) which successfully met its primary endpoint of progression-free survival (PFS), demonstrating a highly statistically significant and clinically meaningful improvement over the control arm. LAE002 (afuresertib) also showed a favourable safety and tolerability profile.

Detailed study results will be presented at an upcoming international scientific conference.

Laekna is collaborating with its strategic partner, Qilu Pharmaceutical, to expedite the regulatory approval and commercialisation of LAE002 (afuresertib) in China. Under an exclusive licensing agreement for the China region signed in November 2025, Laekna is eligible to receive up to CNY2,045m in upfront and milestone payments, as well as tiered royalties on future net sales of LAE002 (afuresertib) in the licensed territory, at percentages ranging from the low teens to the low twenties.

Laekna said that it plans to pursue strategic partnerships in ex-China regions to accelerate development and commercialisation of LAE002 (afuresertib) in international markets.