Laekna said China's Center for Drug Evaluation, the drug review arm of the National Medical Products Administration, has accepted the New Drug Application for LAE002, also known as afuresertib, to treat locally advanced or metastatic HR+/HER2- breast cancer in patients with PIK3CA, AKT1 or PTEN alterations after recurrence or progression on endocrine therapy, with or without a CDK4/6 inhibitor. The filing is supported by the Phase III AFFIRM-205 study, which met its primary endpoint of progression-free survival and showed a highly statistically significant and clinically meaningful benefit over the control arm, alongside what the company described as a best-in-class efficacy and safety profile. Detailed trial data are expected to be presented at future international scientific conferences. Laekna said approval would make LAE002 China's first domestically developed AKT inhibitor, while prostate cancer development is also advancing and the company is seeking strategic partnerships outside China to support broader commercialization. The company has an exclusive China licensing deal with Qilu Pharmaceutical signed in November 2025, under which it is eligible for up to NT$2.04 billion, about $63.4 million, in upfront and milestone payments plus tiered royalties in the low teens to low twenties on future net sales.