Laekna, Inc. (Laekna; HKEX: 02105) announced that China’s Center for Drug Evaluation of the National Medical Products Administration has accepted the New Drug Application for LAE002 (afuresertib) as a treatment for patients with locally advanced or metastatic HR+/HER2- breast cancer carrying PIK3CA, AKT1 or PTEN alterations and previously exposed to endocrine therapy, with or without a CDK4/6 inhibitor.
The filing is backed by data from the Phase III AFFIRM-205 trial, which met its primary endpoint by delivering a highly statistically significant and clinically meaningful improvement in progression-free survival versus control. Afuresertib also demonstrated a favorable safety and tolerability profile; full results will be disclosed at an upcoming international scientific conference.
Afuresertib is a potent, pan-AKT inhibitor targeting all three AKT isoforms and is regarded as one of the two most advanced assets in the class for breast and prostate cancers. Alterations in PIK3CA, AKT1 and PTEN are present in roughly 50% of breast-cancer patients, underscoring the therapeutic potential of AKT blockade.
Commercial framework: In November 2025 Laekna licensed exclusive China rights to Qilu Pharmaceutical, becoming eligible for up to RMB 2.05 billion in upfront and milestone payments, alongside tiered net-sales royalties ranging from the low-teen to low-twenty percent levels. Beyond China, the company intends to seek additional partners to accelerate global development and commercialization.
Sector backdrop: AstraZeneca’s capivasertib (Truqap) became the first AKT inhibitor approved by the U.S. FDA for HR+/HER2- breast cancer in November 2023 and secured a further approval in June 2026 for PTEN-deficient metastatic hormone-sensitive prostate cancer, emphasizing the expanding clinical relevance of AKT inhibition.
Risk disclosure: Laekna cautions that afuresertib may ultimately not achieve successful development or commercialization, and shareholders and potential investors should exercise due caution when dealing in the company’s securities.