April 15, 2026 — Laekna (2105.HK) announced today that LAE002 (afuresertib) plus fulvestrant has demonstrated strong positive topline results in the phase III clinical trial (AFFIRM-205) in locally advanced or metastatic HR+/HER2- breast cancer (“LA/mBC”) patients with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4/6 inhibitor). This pivotal study successfully met its primary endpoint, achieving a highly statistically significant and clinically meaningful improvement of progression-free survival (“PFS”) versus control.

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 only two AKT inhibitors globally in late-stage development for breast and prostate cancer.

AFFIRM-205 is a multi-center, randomized, double-blind, placebo-controlled pivotal study to assess the anti-tumor efficacy and safety of the combination therapy. 

Efficacy

• The study met its primary endpoint, LAE002 (afuresertib) plus fulvestrant combination demonstrated a highly statistically significant and clinically meaningful improvement of PFS versus control.

Safety Profile

• Treatment with oral, once-daily LAE002 was well tolerated, with very low rates of discontinuation due to adverse events. The overall safety profile was consistent with previous data evaluating this combination.

The detailed study results of AFFIRM-205 will be presented at an upcoming international scientific conference.

Based on the positive results from the phase III pivotal study, Laekna will work together with Qilu Pharmaceutical Company Limited (“Qilu Pharma”) to submit the new drug application (“NDA”) for LAE002 (afuresertib) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration in the near term.

Laekna and Qilu Pharma 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 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.

“We are proud to share that the Phase III clinical trial of LAE002 (afuresertib) for breast cancer has met its primary endpoint. The treatment has brought significant and clinically meaningful improvements to patients, with the top-line results clearly demonstrating best-in-class efficacy and safety profile.” said Dr. Chris Lu, Chairman and CEO of Laekna. “In response to the high unmet medical needs, we are pursuing collaborations with partners to accelerate patient access to this novel therapy in global markets.”

About Breast Cancer

Breast cancer has become the leading cause of death for women globally, with approximately 2.29 million new cases diagnosed each year and around 666,000 lives lost to the disease. In China, breast cancer ranks the second most common cancer among women, with approximately 72% of the patients found to be HR+/HER2- (hormone receptor-positive/HER2-negative)¹.

Collectively, 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 a new treatment for drug-resistant patients with this subtype of breast cancer, AKT inhibitors offer new hope for them and their families.

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¹Data: The International Agency for Research on Cancer (IARC), 2022

Contact Us

IR  ir@laekna.com

Corporate and Business Development  BD@laekna.com

About Laekna

HKEK 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 plan to submit NDA to the CDE in 2026, which will mark 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. Top-line results from Phase I studies of LAE002 (ActRIIA monoclonal antibody) for obesity, conducted in both China and the United States, consistently demonstrated dose-dependent trends in lean mass increase and fat mass reduction, as well as a well-tolerated safety profile. The Phase I study in the U.S. was completed in collaboration with the global R&D leader Eli Lilly, aiming to jointly accelerate the global development of this high-quality weight management therapy. The Phase I SAD study of LAE103 (ActRIIB monoclonal antibody) has been commenced in Australia.

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/

Forward-Looking Statements

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