LAEKNA-B (02105): The new drug application for LAE 002 (Afuresertib) has been accepted by the National Medical Products Administration.

LAEKNA-B (02105) announced that the new drug application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It is indicated for the treatment of patients with HR+/HER2- locally advanced or metastatic breast cancer (LA/mBC) who have experienced disease recurrence or progression after receiving endocrine therapy (with or without CDK4/6 inhibitors), accompanied by any changes in PIK3CA/AKT1/PTEN. The NDA is based on the positive results of a Phase III clinical trial (AFFIRM-205) conducted by the group in the aforementioned patient population. This pivotal study successfully achieved its primary endpointprogression-free survival (PFS)showing a highly statistically significant and clinically meaningful improvement compared to the control group. LAE002 (afuresertib) also demonstrated good safety and tolerability. The group entered into an exclusive licensing agreement with Qilu Pharmaceutical in November 2025 for the Chinese market. Under the licensing agreement, the group is eligible to receive up to RMB 2.045 billion in upfront and milestone payments and has the right to earn tiered royalties based on future net sales within the licensed territory, with rates ranging from over ten percent to over twenty percent. In addition, the group plans to seek strategic partnerships outside of China to accelerate the development and commercialization of LAE002 (afuresertib) in international markets. The first AKT inhibitor to be approved globally is AstraZeneca's capivasertib (Truqap), which received FDA approval in the United States in November 2023 for HR+/HER2- breast cancer. In June 2026, the FDA further approved capivasertib (Truqap) in combination with abiraterone and prednisone for the treatment of PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). This approval significantly expands the treatment range for AKT inhibitors and highlights their tremendous potential in addressing unmet treatment needs across various tumor types.