Laekna (2105.HK) has announced that China’s Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for LAE002 (afuresertib) for the treatment of patients with locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer carrying PIK3CA, AKT1 or PTEN alterations.

The application covers patients whose disease has recurred or progressed following endocrine therapy, with or without prior treatment with a CDK4/6 inhibitor. The regulatory submission is supported by positive results from the Phase 3 AFFIRM-205 clinical trial, which evaluated LAE002 in the specified patient population.

According to Laekna, the pivotal study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared with the control arm. LAE002 also demonstrated a favourable safety and tolerability profile. Detailed results from the study are expected to be presented at an upcoming international scientific conference.

Laekna is working with its strategic partner Qilu Pharmaceutical to accelerate the regulatory review and potential commercialisation of LAE002 in China.

Dr. Chris Lu, Chairman and CEO of Laekna, said the NDA submission represents a significant milestone for the company and reflects the contributions of investigators, trial participants and partners involved in the programme. He described LAE002 as a potential Class I innovative drug for breast cancer and said the company expects the therapy to provide a new treatment option for patients with advanced disease if approved.

Beyond breast cancer, Laekna is also advancing the clinical development of LAE002 in prostate cancer. The company is pursuing strategic partnerships outside China to support the drug's development and commercialisation in international markets.

The company views LAE002 as a key milestone in its transition toward the commercial stage. Laekna said it plans to continue developing innovative therapies across major therapeutic areas, including oncology and metabolic diseases.

Laekna and Qilu Pharmaceutical entered into an exclusive licensing agreement for China in November 2025. Under the agreement, Laekna is eligible to receive up to RMB 2.045 billion in upfront and milestone payments, along with tiered royalties on future net sales of LAE002 in the licensed territory. The royalty rates range from the low teens to the low twenties.

The company is continuing to explore partnerships in markets outside China with the aim of accelerating the global development and potential commercialisation of LAE002 and expanding access to the therapy for patients with advanced cancers.