New Drug Application for LAE002 (afuresertib) Accepted by China's National Medical Products Administration

SHANGHAI, Aug. 11, 2026 /PRNewswire/ -- 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.

About AKT Inhibitor

Capivasertib (Truqap‌) was the first approved AKT inhibitor from AstraZeneca, which was approved by the U.S. FDA for HR+/HER2- breast cancer in November 2023. In June 2026, the U.S. FDA further approved capivasertib (Truqap) in combination with abiraterone and prednisone for the treatment of PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). This approval significantly broadens the therapeutic scope of AKT inhibition and highlights its potential to address unmet needs across multiple tumor types.

LAE002 (afuresertib) is a potent AKT inhibitor internally developed by Laekna that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3). It is one of the two most advanced AKT inhibitors globally in development for breast and prostate cancer. The Phase III clinical trial (AFFIRM-205), a multi-center, randomized, double-blind, placebo-controlled pivotal study, has met its primary endpoint of progression-free survival. It showed statistically significant and clinically meaningful benefits to patients with HR+/HER2- breast cancer and demonstrated a best-in-class efficacy and safety profile.

About Breast Cancer

Breast cancer has become the leading cause of death for women globally, with approximately 2.43 million new cases diagnosed each year and around 694,000 lives lost to the disease. In China, breast cancer ranks the second most common cancer among women, with approximately 70% of the patients found to be HR+/HER2-*.

Collectively, genetic alterations in PIK3CA, AKT1 and PTEN affect approximately 50% of patients with breast cancer. Although most patients with this subtype of breast cancer can initially benefit from first/second-line treatment by endocrine therapy + CDK4/6 inhibitors and/or chemotherapy, they may gradually develop drug resistance and result in treatment failure. Novel therapeutic options are urgently needed for patients after drug resistance. As an innovative therapy for drug-resistant patients with this subtype of breast cancer, AKT inhibitors offer new hope for them and their families.

* Data: Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries

About Laekna

HKEX Stock Code: 2105.HK

Patient needs in major disease areas—such as metabolic diseases, oncology, and liver fibrosis—remain the driving force behind our mission. Laekna, a science-driven biotechnology company, is committed to bringing novel therapeutics to patients around the world.

Leveraging our tremendous experience and extensive know-how in disease biology, we have built a pipeline of over 20 internally discovered innovative drug candidates with proprietary intellectual property rights. We keep expanding our global reach through strategic partnerships, fostering collaborative success across regions.

In oncology, the Phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) for breast cancer (AFFIRM-205) was completed and successfully met its primary endpoint. We've submitted NDA to the CDE (Center for Drug Evaluation, China National Medical Products Administration) in August 2026, which marks Laekna's pivotal transition from clinical development to commercialization. Laekna has entered into an exclusive licensing agreement with Qilu Pharma to further accelerate the delivery of this novel therapeutic to patients across China.

In metabolic diseases, building on our deep expertise and extensive knowhow in the ActRII pathway, we have established a globally competitive, differentiated portfolio comprising LAE102, LAE103, and LAE123. We are rapidly advancing the clinical development of LAE102 in both China and the United States. In the U.S., Laekna has successfully completed the Phase I SAD study, in collaboration with Eli Lilly, to accelerate the global development of this high-quality weight management therapy.

From our laboratory in Zhangjiang Pharma Valley in Shanghai, to clinical trials conducted across China, the U.S., and Australia, our footprint spans the globe. Looking ahead, Laekna will continue to collaborate with international partners to accelerate delivery of novel therapeutics to patients worldwide.

For more information, please visit: https://www.laekna.com/  or https://www.linkedin.com/company/74110713/

SOURCE Laekna