SHANGHAI, China, August 12, 2026
Laekna announced that China’s 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 HR+/HER2- breast cancer carrying PIK3CA, AKT1, or PTEN alterations following recurrence or progression after endocrine therapy, with or without a CDK4/6 inhibitor. The regulatory acceptance marks a significant milestone for Laekna as the company moves its lead oncology candidate from clinical development toward potential commercialization in China. The NDA is supported by positive results from the pivotal Phase III AFFIRM-205 clinical trial, which achieved its primary endpoint of progression-free survival (PFS) and demonstrated a statistically significant and clinically meaningful improvement compared with the control arm.
LAE002 Supported by Positive Phase III Results
The AFFIRM-205 Phase III trial was designed as a multicenter, randomized, double-blind, placebo-controlled study evaluating LAE002 in patients with advanced HR+/HER2- breast cancer with relevant pathway alterations. According to Laekna, the study successfully met its primary PFS endpoint, with LAE002 demonstrating a statistically significant and clinically meaningful benefit for patients. The company also reported a favorable safety and tolerability profile for the investigational treatment. Detailed results from the pivotal study are expected to be presented at an upcoming international scientific conference. The positive Phase III outcome provides the clinical foundation for the NDA accepted by China’s NMPA and represents an important step toward potential regulatory approval of afuresertib as a novel AKT-targeted therapy for patients whose disease has progressed following endocrine-based treatment.
AKT Inhibition Targets Treatment-Resistant Breast Cancer
LAE002 (afuresertib) is an internally developed AKT inhibitor designed to inhibit all three AKT isoforms—AKT1, AKT2, and AKT3. The drug is being developed for cancers in which abnormalities in the PI3K/AKT/PTEN signaling pathway may contribute to tumor growth and treatment resistance. Laekna said alterations involving PIK3CA, AKT1, and PTEN collectively affect a substantial proportion of breast cancer patients, creating an important therapeutic opportunity for targeted treatments. Patients with HR+/HER2- breast cancer may initially respond to endocrine therapy combined with CDK4/6 inhibitors and other treatments, but resistance can eventually develop, creating a need for additional therapeutic options. The potential availability of an AKT inhibitor for biomarker-selected patients could therefore provide another treatment strategy after disease progression.
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Laekna and Qilu Prepare for China Commercialization
Laekna is working with Qilu Pharmaceutical to advance the regulatory review and potential commercialization of LAE002 in China. The companies entered an exclusive China licensing agreement in November 2025 under which Laekna is eligible to receive up to RMB 2.045 billion in upfront and milestone payments, along with tiered royalties on future net sales in the licensed territory. The NDA acceptance also represents a key step in Laekna’s broader transition from a clinical-stage biotechnology company toward a potential commercial-stage organization. Beyond breast cancer, LAE002 is also being developed for prostate cancer, while Laekna is pursuing strategic partnerships outside China to accelerate the drug’s international development and commercialization.
The regulatory milestone comes as the AKT inhibitor class continues to expand across oncology. Capivasertib became the first approved AKT inhibitor from AstraZeneca, receiving U.S. FDA approval in 2023 for HR+/HER2- breast cancer and subsequently gaining an additional indication in prostate cancer in 2026. Laekna believes LAE002 could become an important addition to this emerging therapeutic class. With the China NDA now accepted, the company is positioned to advance regulatory discussions while continuing its broader global development strategy. The progress of LAE002 highlights the growing role of biomarker-driven targeted therapies in addressing treatment resistance and unmet needs among patients with advanced breast cancer.
Source: Laekna press release
