LAEKNA-B (02105.HK): NDA for LAE002 (Afuresertib) Accepted by NMPA for HR+/HER2- Breast Cancer
NewTimeSpace News: On 12 August 2026, Laekna, Inc. (stock code: 02105) voluntarily announced 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 HR+/HER2- locally advanced or metastatic breast cancer (LA/mBC) harbouring any PIK3CA/AKT1/PTEN alterations who have relapsed or progressed following prior endocrine therapy (with or without CDK4/6 inhibitors).
The NDA is based on the positive results of a Phase III clinical trial (AFFIRM-205) conducted by the Group in the aforementioned patients. The pivotal study successfully met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with the control arm, and LAE002 also demonstrated a favourable safety and tolerability profile. Detailed results are planned to be presented at a subsequent international scientific conference.
The Group entered into an exclusive license agreement with Qilu Pharmaceutical in November 2025 in respect of the China region. Under the license agreement, the Group is eligible to receive upfront and milestone payments of up to RMB 2.045 billion in aggregate, and is also entitled to tiered royalties on future net sales within the licensed territory, with royalty rates ranging from the low-teens to the low-twenties percentages. The Group plans to seek strategic partnerships outside China to accelerate the international development and commercialization of LAE002.
LAE002 (afuresertib) is a potent AKT inhibitor that simultaneously inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) and is one of the two most advanced AKT inhibitors globally targeting breast and prostate cancer. The first AKT inhibitor approved worldwide was AstraZeneca's capivasertib (Truqap), approved by the U.S. FDA in November 2023 for HR+/HER2- breast cancer; in June 2026, the U.S. FDA further approved capivasertib in combination with abiraterone and prednisone for the treatment of PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), substantially broadening the therapeutic scope of AKT inhibitors. Overall, approximately 50% of breast cancer patients harbour PIK3CA, AKT1 or PTEN alterations.
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