China’s National Medical Products Administration Accepts New Drug Application for LAE002 (Afuresertib)
Laekna (2105.HK) announced today 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 locally advanced or metastatic HR+/HER2- breast cancer (LA/mBC) with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4/6 inhibitor).
The NDA is supported by positive results from the Phase III Clinical Trial (AFFIRM-205) conducted in the aforementioned patient population. This pivotal study successfully met its primary endpoint of progression-free survival (PFS), demonstrating a highly statistically significant and clinically meaningful improvement over the control arm. LAE002 (afuresertib) also showed a favorable safety and tolerability profile. The detailed study results will be presented at an upcoming international scientific conference. We are collaborating with our strategic partner, Qilu Pharmaceutical, to expedite the regulatory approval and commercialization of LAE002 (afuresertib) in China.
“The NDA submission for LAE002 would not have been possible without the trust and support of every investigator, study participant, and partner. It is the result of the unwavering dedication and perseverance of the Laekna team over the years,” said Dr. Chris Lu, Chairman and CEO of Laekna. “As a potential Class I novel drug for breast cancer and the first domestically developed AKT inhibitor in China, the clinical results of LAE002 (afuresertib) have demonstrated a best-in-class efficacy and safety profile. We look forward to its approval and commercial launch as soon as possible, bringing hope to patients and families affected by advanced breast cancer, and offering clinicians a novel therapeutic option.”
Dr. Chris Lu further noted that, beyond breast cancer, the clinical development of LAE002 (afuresertib) for prostate cancer is also advancing rapidly. Laekna is actively pursuing strategic partnerships in ex-China regions to accelerate development and commercialization of LAE002 (afuresertib) in international markets, aiming to bring benefits to more patients overseas as soon as possible. He emphasized, “LAE002 (afuresertib) marks the first breakthrough of our innovative pipeline, as well as a significant milestone in our transition to the commercial stage. Across major therapeutic areas, including metabolic diseases and oncology, we will continue to develop innovative drugs that offer significant clinical value and global competitiveness, bringing greater benefits to patients and shareholders”.
Laekna and Qilu Pharmaceutical entered into an exclusive licensing agreement for the China region in November 2025. Under the License Agreement, Laekna is eligible to receive up to RMB2,045 million in total in upfront and milestone payments and is also entitled to receive tiered royalties on future net sales of LAE002 (afuresertib) in the licensed territory, at percentages ranging from the low teens to the low twenties. Laekna plans to pursue strategic partnerships in ex-China regions to accelerate development and commercialization of LAE002 (afuresertib) in international markets.
https://www.laekna.com/
https://www.laekna.com/
