Laekna's Breast Cancer Drug LAE002 NDA Accepted in China

Laekna, Inc. (2105.HK), a Hong Kong-based biotechnology company, has announced that its New Drug Application (NDA) for LAE002, developed for the treatment of HR+/HER2- positive advanced breast cancer, has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). This development marks a pivotal milestone in Laekna's transition from the research and development (R&D) phase to commercialization, underscoring the company's progress in its innovative drug pipeline. LAE002, also known as afuresertib, is a potent AKT inhibitor.

The NDA submission for LAE002 was supported by positive data from the pivotal Phase III AFFIRM-205 clinical trial. This multicenter, randomized, double-blind, placebo-controlled study successfully met its primary endpoint of progression-free survival (PFS). The trial results demonstrated a highly statistically significant and clinically meaningful improvement compared to the control arm, while also exhibiting a best-in-class efficacy and safety profile. LAE002 targets HR+/HER2- breast cancer patients with PIK3CA/AKT1/PTEN genetic alterations whose disease has progressed following endocrine therapy (with or without CDK4/6 inhibitors). In November 2025, Laekna entered into an exclusive licensing agreement with Qilu Pharmaceutical for the China market. Under this agreement, Laekna is eligible to receive total upfront and milestone payments of up to RMB 2.045 billion (approximately $63.4 million), along with tiered royalties ranging from the low teens to the low twenties as a percentage of future net sales.

This development has significant implications for the biopharmaceutical sector, particularly within the Chinese market. If approved, LAE002 would become China's first domestically developed AKT inhibitor. This status would not only bolster Laekna's potential market share but also serve as a source of prestige for the local pharmaceutical industry. The therapeutic potential of AKT inhibitors has been globally validated with AstraZeneca's (AZN) capivasertib (Truqap) receiving U.S. Food and Drug Administration (FDA) approval in November 2023 for HR+/HER2- breast cancer. LAE002 is positioned as one of the two most clinically advanced AKT inhibitors globally for both breast and prostate cancers.

Breast cancer remains a leading cause of death among women worldwide, with approximately 2.43 million new cases annually and claiming around 694,000 lives. In China, breast cancer is the second most common cancer among women, with roughly 70% of patients belonging to the HR+/HER2- subtype. Genetic alterations in PIK3CA, AKT1, and PTEN collectively affect approximately half of all breast cancer patients. While these patients may initially benefit from endocrine therapy and/or CDK4/6 inhibitors, most eventually develop drug resistance, leading to treatment failure. In this context, the emergence of AKT inhibitors brings new hope to these patients with resistant disease.

Market analysts note that the acceptance of LAE002's NDA not only signifies Laekna's formal transition from clinical-stage R&D to commercial operations but also injects additional resources and confidence into the company's subsequent pipeline development across core therapeutic areas, including metabolic diseases and oncology. Detailed study results are expected to be presented at upcoming international scientific conferences. Laekna also aims to pursue strategic partnerships in ex-China regions to accelerate the international development and commercialization of LAE002. These potential collaborations could ensure broader global market access for the drug.