Laekna's LAE002 Drug Application Accepted Marking a Milestone in Breast Cancer Treatment

Laekna Receives NDA Acceptance for LAE002

Laekna Biopharma has recently announced a significant milestone in oncology, as its New Drug Application (NDA) for LAE002, also known as afuresertib, has been accepted by the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA). This promising drug is being positioned as a treatment for patients suffering from locally advanced or metastatic HR+/HER2- breast cancer whose conditions are marked by PIK3CA/AKT1/PTEN alterations, especially in cases where earlier endocrine therapies have failed.

The acceptance of the NDA is underpinned by compelling results from the Phase III clinical trial, known as the AFFIRM-205 study, which focused on this specific patient demographic. The trial demonstrated that LAE002 not only improved progression-free survival (PFS) significantly but also maintained a favorable safety profile, which are crucial metrics in the ongoing battle against breast cancer. The detailed findings from this study will highlight the drug’s efficacy and will be presented at an upcoming international scientific conference.

Dr. Chris Lu, the Chairman and CEO of Laekna, expressed gratitude towards the investigators, study participants, and partners involved in the NDA process. He emphasized that this achievement reflects the team’s dedication and hard work over the years. As the first domestically developed AKT inhibitor in China, LAE002 promises to revolutionize the therapeutic landscape for breast cancer, potentially acting as a best-in-class option with robust clinical outcomes.

In addition to treating breast cancer, Laekna is exploring the application of LAE002 in prostate cancer treatment, indicating an ambitious plan for the drug’s potential market expansion. The company is also actively seeking strategic partnerships in regions beyond China to accelerate both the development and commercialization processes, aiming to alleviate patient suffering on a global scale.

The NDA follows an exclusive licensing agreement with Qilu Pharmaceutical, initiated in November 2025. Under this agreement, Laekna stands to benefit from significant financial incentives, including milestone payments and tiered royalties from net sales of LAE002 in the licensed territories. This partnership is set to enhance the efficiency of regulatory approval processes and pave the way for swift market entry of the novel treatment.

Understanding Breast Cancer and the Need for Innovation

Breast cancer continues to be a leading health crisis worldwide, affecting millions of women each year. It was estimated that about 2.43 million new cases were diagnosed in 2024, with a staggering number of fatalities attributed to this disease. Specifically in China, breast cancer is the second most prevalent cancer in women, impacting approximately 70% of diagnosed patients who have HR+/HER2- breast cancer, a subtype often characterized by genetic alterations in PIK3CA, AKT1, and PTEN.

Patients with these mutations frequently encounter resistance to traditional therapies after an initial period of efficacy, creating a critical need for innovative treatment options. The launch of LAE002 signifies a beacon of hope, targeting those patients who have exhausted existing therapies and are desperately in need of alternative interventions.

Dr. Lu further highlighted Laekna's commitment to expanding its in-house pipeline of innovative therapeutic candidates across various disease areas, including other metabolic diseases and conditions involving liver fibrosis. The late-stage positioning of LAE002 exemplifies the company’s proactive approach towards meeting unaddressed medical needs and enhancing patient quality of life.

At Laekna, scientific inquiry and patient welfare drive the mission forward, reflected in substantial investments in research and development. With a global operational reach that includes collaborations and clinical studies conducted in China, the United States, and Australia, Laekna is set to redefine the therapeutic landscape in oncology and beyond.

In conclusion, as Laekna advances towards the commercial launch of LAE002, the anticipation builds around its potential to transform treatment protocols for breast cancer patients facing the harrowing impacts of drug resistance, while simultaneously addressing the global imperative for innovative oncological therapies.