Shanghai-based Laekna's (HKEX: 2105.HK) pan-AKT inhibitor afuresertib has moved into regulatory review in China following a Phase III breast cancer win, putting the Shanghai biotech on course for its first potential product approval. The NMPA's CDE accepted the NDA for locally advanced or metastatic HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations following progression on endocrine therapy, with or without a CDK4/6 inhibitor. If approved, afuresertib would become the first domestically developed AKT inhibitor to reach the Chinese market.
The submission is backed by the Phase III AFFIRM-205 trial, a multicenter, randomized, double-blind, placebo-controlled study that met its primary PFS endpoint. Laekna described the improvement as highly statistically significant and clinically meaningful, but has yet to disclose the numbers behind the result. Median PFS, the hazard ratio and p-value remain under wraps, with detailed results due at an upcoming international scientific conference.
Afuresertib inhibits all three AKT isoforms (AKT1, AKT2, and AKT3), blocking downstream PI3K/AKT/mTOR signaling irrespective of which upstream alteration — PIK3CA mutation, AKT1 mutation, or PTEN loss — activates the pathway. Collectively, these alterations affect approximately 50% of HR+/HER2- breast cancer patients, according to Laekna.
The NDA filing positions afuresertib directly against AstraZeneca's Truqap (capivasertib), the first approved AKT inhibitor globally. The FDA approved capivasertib in combination with fulvestrant for HR+/HER2- advanced breast cancer with PIK3CA/AKT1/PTEN alterations in November 2023, and in June 2026 extended that approval to cover PTEN-deficient metastatic hormone-sensitive prostate cancer in combination with abiraterone and prednisone. Capivasertib has also received NMPA approval in China. Laekna claims afuresertib demonstrated a best-in-class efficacy and safety profile in AFFIRM-205 relative to what is publicly known about the class, though cross-trial comparisons are constrained by the absence of published numerical data.