- The second IND approval obtained in 2025, which demonstrates the company’s robust internal discovery capabilities and commitments to innovation

- The global prevalence of sarcopenic obesity among adults is rising rapidly

- The academic community, industry, clinical practitioners and patients all hold strong expectations for the efficacy and safety of the drug candidates targeting ActRII pathway in humans

July 31, 2025 — Laekna (2105.HK) announced today that the U.S. Food and Drug Administration (FDA) has approved the IND for LAE103, an internally discovered monoclonal antibody against ActRIIB for the treatment of sarcopenic obesity and muscle related disease.

Sarcopenic obesity is a chronic disease characterized by the simultaneous presence of decreased skeletal muscle mass and function, alongside an excessive accumulation of adipose tissue. The multifactorial etiology of sarcopenic obesity may involve aging, inappropriate lifestyle (sedentary, improper diet, lack of exercise), inflammation, and comorbidities of acute and chronic diseases. This dual condition poses significant health risks, particularly in older adults, as it is linked to increased frailty, cardiovascular diseases, fractures, and higher mortality rates. The global prevalence of sarcopenic obesity among adults is rising rapidly, driven by demographic shifts and lifestyle changes.¹ In the Asia-Oceania, which is one of the world’s fastest aging regions, a 14-year prospective study (NHANES III) revealed a sarcopenic obesity prevalence rate of 18.1% among elderly women and as high as 42.9% in men aged 60 and above, posing an escalating threat to public health. ²

“We are pleased to obtain the IND approval from FDA for LAE103, marking Laekna’s second IND achievement in 2025. This milestone underscores our robust internal discovery capabilities and commitments to innovation”, said Dr. Justin Gu, Chief Scientific Officer of Laekna. “As a pioneer in research and development of ActRII pathway, we presented the pre-clinical study results of our innovative portfolio targeting the pathway at the 85th scientific sessions of the American Diabetes Association, including LAE102 (an ActRIIA-selective antibody), LAE103 (an ActRIIB-selective antibody) and LAE123 (an ActRIIA/IIB dual antagonistic antibody). The first-in-human study results of LAE102 in healthy volunteers were also presented at the scientific sessions for the first time. Various stakeholders, including the academic community, industry, clinical practitioners, and patients— demonstrated significant interest in the mechanisms and synergistic effects of these drug candidates targeting ActRII pathway, hold strong expectations for the efficacy and safety of ActRII pathway in humans”.

LAE102 is currently in Phase I clinical trials for obesity in both China and the U.S. IND approval for LAE103 has been obtained from the U.S. FDA and IND-enabling studies of LAE123 has been initiated. 

¹ Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement （February 23, 2022）

² The Asia–Oceania consensus: Definitions and diagnostic criteria for sarcopenic obesity

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Contact Us

IR  ir@laekna.com

Corporate and Business Development  BD@laekna.com

About Laekna

Stock Code: 2105.HK

Founded in 2016, 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 December 31, 2024, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib), LAE001 and LAE005 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’ve obtained IND approvals from the FDA and the CDE for LAE102 in obesity indication and are advancing the Phase I clinical trial in China. 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.

Laekna team has accumulated tremendous experiences and deep know-how in the specific field of targeting ActRII receptors and is developing more drug candidates (LAE103 and LAE123), in addition to LAE102, to maximize the value of the target. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor against ActRIIA/IIB. Both are our internally discovered antibodies 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 seven 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: https://www.laekna.com/  or https://www.linkedin.com/company/74110713/

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