China's NMPA Accepts New Drug Application for Laekna's AKT Inhibitor Afuresertib in HR+/HER2- Breast Cancer
核心洞察
Laekna (搜索)'s NDA for LAE002 (afuresertib) has been accepted by China's NMPA for treating locally advanced or metastatic HR+/HER2- breast cancer (搜索) with PIK3CA/AKT1 (搜索)/PTEN (搜索) alterations after endocrine therapy progression.
The submission is supported by positive Phase III AFFIRM-205 trial results, which met its primary endpoint of progression-free survival with statistically significant and clinically meaningful improvement.
Afuresertib is positioned as the first domestically developed AKT (搜索) inhibitor in China, with a reported best-in-class efficacy and safety profile.
Laekna (搜索) (2105.HK) announced on August 11, 2026, that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for LAE002 (afuresertib), a potent AKT (搜索) inhibitor, for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer (搜索) (LA/mBC) harboring PIK3CA/AKT1 (搜索)/PTEN (搜索) alterations, following recurrence or progression on or after endocrine therapy with or without a CDK4/6 inhibitor.
The acceptance marks a pivotal milestone for the Shanghai-based biotechnology company, representing its transition from clinical development to commercialization. Afuresertib, if approved, would become the first domestically developed AKT (搜索) inhibitor in China and a potential Class I novel drug for breast cancer.
Phase III AFFIRM-205 Trial Supports NDA
The NDA submission is underpinned by positive results from the AFFIRM-205 pivotal study, a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial. The trial successfully met its primary endpoint of progression-free survival (PFS), demonstrating what the company described as a highly statistically significant and clinically meaningful improvement over the control arm. LAE002 (afuresertib) also showed a favorable safety and tolerability profile. Detailed study results are expected to be presented at an upcoming international scientific conference.
"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 (搜索) 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 (搜索) inhibitor in China, the clinical results of LAE002 (afuresertib) have demonstrated a best-in-class efficacy and safety profile."
Mechanism and Competitive Landscape
LAE002 (afuresertib) is an internally developed AKT (搜索) inhibitor that targets all three AKT isoforms (AKT1 (搜索), AKT2, and AKT3). It is one of the two most advanced AKT inhibitors globally in development for both breast and prostate cancer. The AKT inhibitor class gained its first regulatory approval when AstraZeneca's capivasertib (Truqap) received U.S. FDA approval for HR+/HER2- breast cancer (搜索) in November 2023, followed by a second approval in June 2026 for PTEN (搜索)-deficient metastatic hormone-sensitive prostate cancer (mHSPC) in combination with abiraterone and prednisone.
Dr. Lu further noted that clinical development of afuresertib for prostate cancer is advancing rapidly, and Laekna (搜索) is actively pursuing strategic partnerships in ex-China regions to accelerate development and commercialization in international markets.
Strategic Partnership with Qilu Pharmaceutical (搜索)
Laekna (搜索) and Qilu Pharmaceutical (搜索) entered into an exclusive licensing agreement for the China region in November 2025. Under the agreement, Laekna is eligible to receive up to RMB 2,045 million in total upfront and milestone payments, along with tiered royalties on future net sales ranging from the low teens to the low twenties in percentage terms. The companies are collaborating to expedite regulatory approval and commercialization of LAE002 (afuresertib) in China.
Unmet Need in Breast Cancer
Breast cancer has become the leading cause of cancer death for women globally, with approximately 2.43 million new cases diagnosed annually and around 694,000 lives lost to the disease. In China, breast cancer ranks as the second most common cancer among women, with approximately 70% of patients found to be HR+/HER2-. Genetic alterations in PIK3CA, AKT1 (搜索), and PTEN (搜索) collectively affect approximately 50% of breast cancer patients.
Although most patients with this subtype initially benefit from first- or second-line endocrine therapy combined with CDK4/6 inhibitors and/or chemotherapy, drug resistance frequently develops, leading to treatment failure. AKT (搜索) inhibitors represent a novel therapeutic option for this drug-resistant population.
"LAE002 (afuresertib) marks the first breakthrough of our innovative pipeline, as well as a significant milestone in our transition to the commercial stage," Dr. Lu emphasized. "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."