LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally.

In April 2026, the phase III clinical trial (AFFIRM-205) ofLAE002 (afuresertib) plus fulvestrant combination in HR+/HER2- breast cancer patients successfully met its primary endpoint, achieving a highly statistically significant and clinically meaningful improvement of PFS versus control. Laekna has entered into an exclusive licensing agreement with Qilu Pharmaceutical Company Limited to accelerate the commercialization for LAE002 (afuresertib) in the China region. Laekna will work together with Qilu Pharma to submit the NDA for LAE002 (afuresertib) to the CDE of NMPA.

In February 2026, an article titled “Afuresertib plus fulvestrant for pretreated HR positive, HER2-negative, advanced breast cancer: a phase Ib trial” was published in Nature Communications, a leading international scientific journal. The article primarily reports the results of this Phase Ib clinical trial, which evaluated afuresertib in combination with fulvestrant for the treatment of pretreated HR-positive/HER2- negative advanced breast cancer. The findings indicate that this combination regimen demonstrates promising anti-tumor activity and a well-tolerated safety profile in this patient population.