In the global metabolic drug field, as clinical research continues to release positive signals, the therapeutic potential of activin type II receptors (ActRII) is attracting growing attention from the industry.
The potential value of this target in high-quality weight loss, muscle-related diseases and critical illnesses such as heart failure is also drawing intense interest from major international pharmaceutical companies.
In this emerging ActRII field, Chinese innovative drug companies have continued the competitive advantages they have built across multiple innovative drug segments. Among them, Laekna-B (02105), listed in Hong Kong, has achieved world-class depth in this niche track, securing leadership in both R&D progress and pipeline layout.
LAE103 emerges as a standout
On November 9, 2026, Laekna-B (02105) announced that its ActRIIB-targeting monoclonal antibody LAE103 had completed a Phase I single-ascending-dose (SAD) study in overweight or obese subjects in Australia.
This marks another clinical advance for the company's ActRII product portfolio, following the positive Phase I results in both China and the United States for LAE102, which targets ActRIIA.
Judging from the clinical results released this time, LAE103 has delivered quite positive signals. The Phase I SAD study completed in Australia used a randomized, double-blind, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the subcutaneous formulation of LAE103 in overweight or obese subjects.
The results showed that after a single subcutaneous injection, LAE103 demonstrated clear target binding capacity and induced pharmacodynamic biomarker changes in line with expectations. As the administered dose increased, LAE103 exhibited dose-proportional pharmacokinetic characteristics, and a clear correlation was also observed between drug exposure levels in the body and pharmacodynamic changes.
This means that LAE103 not only demonstrated the expected pharmacological activity in humans, but the relationship between drug effect and dose was also preliminarily verified, proving its potential for once-monthly subcutaneous dosing and its excellent drug developability.
In terms of safety, LAE103 also delivered an encouraging report card. During the study, a single subcutaneous injection of LAE103 showed good safety and tolerability, with no serious adverse events reported and no cases of dosing discontinuation due to adverse events, adding an important advantage to its subsequent clinical development.
Comprehensive layout across the ActRII track
The positive progress of LAE103 further highlights the competitive advantage of Laekna-B (02105) in its comprehensive layout and coordinated advancement across the ActRII track.
At present, around the ActRII signaling pathway, Laekna-B (02105) has established a product portfolio consisting of three candidate drugs: LAE102, which selectively blocks the ActRIIA receptor; LAE103, which selectively blocks the ActRIIB receptor; and LAE123, which acts on both ActRIIA and ActRIIB receptors.
The three products start from different regulatory strategies to comprehensively explore the therapeutic potential of the ActRII pathway. Within this portfolio, LAE102 has the most advanced R&D progress, having already achieved positive results in Phase I clinical studies in both China and the United States, with encouraging muscle-building and fat-reducing signals observed across different studies.
A previously announced Chinese Phase I multiple-ascending-dose (MAD) study showed that at week 5, subjects treated with LAE102 at a dose of 6 mg/kg achieved an average lean body mass increase and fat mass reduction of 4.6% and 3.6%, respectively, after adjustment for the placebo group.
In March this year, the U.S. Phase I SAD study conducted in collaboration with Eli Lilly further produced positive results, with significant muscle-building and fat-reducing effects observed, consistent with the domestic clinical results.
In October this year, the 24-week monotherapy clinical study of LAE102 completed treatment of the low-dose group, with results consistent with the previous SAD and MAD studies while further showing encouraging weight-loss effects. Over the 24-week treatment period, the drug was well tolerated, with no serious adverse events reported and no cases of diarrhea, muscle cramps or acne, demonstrating BIC (best-in-class) safety data.
Currently, the high-dose study of the 24-week monotherapy is being actively advanced. In addition, Laekna-B (02105) has also laid out LAE123, a dual-target antibody targeting both ActRIIA and ActRIIB, which is currently in the IND-enabling study stage and is planned to submit a clinical trial application before the end of 2026.
Such a pipeline covering the entire ActRII pathway is extremely rare globally. Laekna-B (02105) has achieved world-class depth in a cutting-edge niche track and is expected to systematically capture the potential opportunities in the ActRII field.
Potential BD deal opportunities
In the global metabolic drug field, as GLP-1 drugs have achieved tremendous commercial success, novel therapeutic mechanisms that can further reduce fat while protecting or even increasing muscle are becoming an important direction for multinational pharmaceutical companies to improve their metabolic disease product portfolios and compete for advantages in the next stage of market competition. This has also spawned active pipeline BD transactions in this direction.
In 2023, Eli Lilly acquired Versanis Bio for a potential transaction consideration of up to US$1.925 billion, obtaining Bimagrumab, an ActRII dual-receptor antibody then in Phase IIa clinical trials. After the obesity/overweight indication, on November 6 this year, Bimagrumab registered the global Phase II clinical trial ACTIVATE-HFpEF for the treatment of heart failure, further advancing into the field of critical illness.
Roche, meanwhile, reached two important transactions in 2026: first, it brought in Hanmi Pharmaceutical's Phase I-stage UCN2 analog HM17321 for a US$190 million upfront payment and a potential total consideration of up to US$2.3 billion; second, it reached a global licensing agreement with China's Great Wisdom Biosciences for a US$100 million upfront payment and near-term milestone payments, with a potential total of up to US$1.16 billion, obtaining its preclinical ALK7-targeting RNAi candidate drug.
The above BD transactions show the transaction demand of multinational pharmaceutical companies for differentiated pipelines in the metabolic field. Their transaction considerations and clinical development stages also provide market reference points of significance for subsequent potential BD projects.
The differentiated ActRII pipeline portfolio of Laekna-B (02105) meets the conditions to align with the strategic needs of multinational pharmaceutical companies. Facing a broad range of potential partners, there is reason to expect BD transactions that match the value of its pipeline. We shall wait and see.
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