Dec 31, 2025 —Laekna, Inc. (2105.HK) today announced that the company has commenced study recruitment in phase I single ascending dose study (the “SAD study”) of LAE103, an internally discovered monoclonal antibody against ActRIIB in Australia. As of the date of this announcement, first subject has been dosed.

The SAD study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE103, administered subcutaneously, in healthy overweight or obese participants. The company targets to read out the topline data of this SAD study in the third quarter of 2026.

LAE103 is an ActRIIB selective antibody. The company targets to bring this precision therapy to cardiovascular and metabolic diseases with high unmet medical needs, such as obesity, sarcopenia and heart failure, etc.

Laekna team has accumulated tremendous experiences and extensive knowhow in the specific area of targeting ActRII receptors and is developing more drug candidates to maximize the value of the target. The preliminary results of the Phase I MAD study of LAE102 (ActRIIA monoclonal antibody) was announced in September 2025 which demonstrated an encouraging trend towards lean body mass increase and fat mass reduction, a well-tolerated safety profile and robust PK/PD (Read more). LAE123 is a dual inhibitor against ActRIIA/IIB and has advanced to IND-enabling studies.

–  End –

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/

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.