- LAE002 (afuresertib) is one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally

- Laekna targets to readout the topline data of this phase III pivotal study in the first half of 2026, followed by submission of NDA to CDE later in the year

- Laekna and Qilu Pharma have entered into an exclusive licensing agreement to accelerate the commercialization of LAE002 (afuresertib) in China region

Dec 15, 2025 —Laekna, Inc. (2105.HK) today announced that the company has completed patient enrollment in the phase III clinical trial AFFIRM-205 for LAE002 (afuresertib, an oral AKT inhibitor) plus fulvestrant in patients with PIK3CA/AKT1/PTEN alterations and HR+/HER2- locally advanced or metastatic breast cancer.

LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. The phase III clinical trial 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.

Laekna targets to readout the topline data of this phase III pivotal study in the first half of 2026, followed by submission of the new drug application (NDA) to the center for drug evaluation of China’s National Medical Products Administration later in the year.

"I would like to extend my sincere gratitude to Academician Binhe Xu, the lead principal investigator of this Phase III clinical trial, as well as to all the oncology experts, patients, and partners involved in this study. At the same time, I am proud of Laekna’s cross-functional team for their exceptional efficiency and dedication, which enabled us to complete patient enrollment ahead of schedule." said Dr. Chris Lu, Chairman and CEO of Laekna. " This milestone positions LAE002 (afuresertib) to potentially become the first domestically developed AKT inhibitor in China, an achievement that would hold significant importance for patients with advanced breast cancer and their treating physicians. It will also mark a pivotal chapter in the company’s development— our transition from a clinical-stage to a commercial stage company, with LAE002 (afuresertib) as our first approved innovative therapy."

Dr. Chris Lu stated: “Moving forward, Laekna will collaborate closely with Qilu Pharma to facilitate the regulatory approval and commercialization of LAE002 (afuresertib). I firmly believe that leading innovative pharmaceutical companies in China are capable of not only developing world-class groundbreaking therapies but also, through excellent partnerships, maximizing both clinical values and commercial success.”

Laekna and Qilu Pharma have entered into an exclusive licensing agreement on November 12, 2025. Subject to terms and conditions of the License Agreement, Qilu Pharma is granted an exclusive license for research, development, and commercialization of LAE002 (afuresertib) in the China region.

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. Although most of 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.

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

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Contact Us

IR  ir@laekna.com

Corporate and Business Development  BD@laekna.com

About Laekna

Stock Code: 2105.HK

Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world.

As of June 30, 2025, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib) and other drug candidates to address unmet medical needs in obesity and cancers.

LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We are advancing the Phase I clinical trials for obesity indication in both China and the U.S. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity.

In addition to LAE102, LAE103 is our internally discovered ActRIIB-selective antibody, LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Laekna has established a comprehensive ActRII portfolio and is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications.

In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other clinical and pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track.

Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023.

For more information, please visit: http://www.np3h179.cn/  or https://www.linkedin.com/company/74110713/

About Qilu Pharma 

Qilu Pharmaceutical is now one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures and distributes both Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs). Qilu currently has 12 subsidiaries, 11 domestic manufacturing sites and over 36,000 employees worldwide. Qilu ranks among Top 3 in Chinese pharmaceutical industry in 2024. Dedicated to offering high-quality & trustworthy medicines to the world and improving people‘s well-being, Qilu is vigorously exporting its products to over 100 countries and regions around the world. To date, Qilu has launched over 300 products with over 55 products “First-to-Launch” in China. The company has also fostered a robust pipeline including over 200 generic products, over 20 biosimilars and over 80 innovative products. Qilu Pharmaceutical is subsidiary of Qilu Pharmaceutical Group Co., Ltd.

Forward-Looking Statements

This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.