The next frontier on the metabolic circuit, Laikai Pharmaceutical (02105) is a full-line card

In the global field of metabolic drugs, as clinical research continues to release positive signals, the therapeutic potential of activin type II receptor (ActRII) is receiving more and more attention from the industry. The potential value of this target in high-quality weight loss, muscle-related diseases, and critical diseases such as heart failure is also drawing great attention from major international pharmaceutical companies.

In the emerging field of ActRii, China's innovative pharmaceutical companies have continued their competitive advantage in many innovative drug segments. Among them, Lai Kai Pharmaceutical (02105), which is listed on the Hong Kong stock market, has also achieved world-class depth in this segmentation circuit, leading the way in R&D progress and pipeline layout.

LAE103 is making a splash

On November 9, 2026, Laikai Pharmaceutical issued an announcement announcing that its monoclonal antibody LAE103, which targets ActRIIb, has completed a Phase I single-dose escalation study (SAD) for overweight or obese subjects in Australia.

This is another clinical advance in the company's ActRII product portfolio, following LAE102, which previously targeted Actriia, with positive Phase I results in China and the US.

Judging from the clinical results announced this time, LAE103 sent quite positive signals.

The Phase I single-dose escalation (SAD) study completed in Australia used a randomized, double-blind, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE103 in overweight or obese subjects.

Research results showed that LAE103 showed clear target binding ability after a single subcutaneous injection and caused changes in pharmacodynamic biomarkers in line with expectations.

As the dosage increased, LAE103 showed pharmacokinetic characteristics proportional to the dose, and there was also a clear correlation between the level of exposure of the drug in the body and changes in pharmacodynamics.

This means that LAE103 not only showed expected pharmacological activity in humans, but the relationship between its drug action and dose was also initially verified, proving that it has therapeutic potential and excellent drug developability when administered subcutaneously once a month.

In terms of safety, LAE103 also handed over an encouraging questionnaire.

During the study, LAE103 showed good safety and tolerability in a single subcutaneous injection. No serious adverse events were reported, and administration was not terminated due to adverse events, adding an important advantage to its subsequent clinical development.

Comprehensive layout of the ActRii track

The positive development of LAE103 has further highlighted Laikai Pharmaceutical's competitive advantage in comprehensive layout and collaborative promotion at the ActRII circuit.

Currently, Laikai Pharmaceutical has established a product portfolio composed of three drug candidates around the ActRII signaling pathway:

LAE102: Selectively blocks ActRIIa receptors;

LAE103: Selectively blocks ActRIIb receptors;

LAE123: acts on both ActRIIa and ActRIIb receptors.

Starting from different regulatory strategies, the three products comprehensively explore the therapeutic potential of the ActRII pathway.

In this product portfolio, LAE102 is the most advanced in development. It has now achieved positive results in phase I clinical studies in China and the US, and encouraging muscle gain and fat loss signals have been observed in various studies.

According to the Chinese Phase I Multiple Dose Increment (MAD) study published earlier, subjects treated with LAE102 at 6 mg/kg had an average lean body weight gain of 4.6% and 3.6% of fat loss, respectively, after being adjusted for the placebo group.

In March of this year, the US Phase I Single Dose Increment (SAD) study carried out in collaboration with Eli Lilly achieved further positive results. Remarkable muscle gain and fat loss effects were observed, which were consistent with domestic clinical results.

In October of this year, LAE102's 24-week monotherapy clinical study completed treatment in the low dose group. Results consistent with previous SAD and MAD studies were observed, while further showing encouraging weight loss effects.

During the 24-week treatment, the drug was well tolerated, no serious adverse events were reported, and no symptoms such as diarrhea, muscle cramps, or acne occurred, showing BIC (best in class) safety data. Currently, high-dose research on 24-week monotherapy is being actively promoted.

In addition, Laikai Pharmaceutical has also deployed LAE123, a dual-target antibody targeting both ActriIa and ActRIIB. It is currently in the IND supporting research phase and plans to submit a clinical trial application by the end of 2026.

This kind of pipeline, which fully covers the ActRII channel, is extremely scarce worldwide. Laikai Pharmaceutical has achieved world-class depth in a cutting-edge segment circuit, and is expected to systematically capture potential opportunities at the ActRII circuit.

Potential BD trading opportunities

In the field of global metabolic drugs, with the huge commercialization success of GLP-1 drugs, a novel treatment mechanism that can further reduce fat while protecting and even increasing muscle mass is becoming an important direction for multinational pharmaceutical companies to improve their metabolic disease product portfolios and compete for competitive advantage in the next stage of the market. This has also spawned active pipeline BD transactions in this direction.

In 2023, Eli Lilly acquired Versanis Bio at a potential transaction price of up to US$1.925 billion and obtained the ActRII double receptor antibody bimagrumab, which was in phase IIA clinical phase at the time. Following the obesity/overweight indications, on November 6 this year, Bimagrumab registered the global phase II clinical trial Activate-HFPEF to treat heart failure, further advancing into the field of critical illness.

Roche, on the other hand, reached two major deals in a row in 2026: first, to introduce HM17321, a UCN2 analogue of Hanmei Pharmaceuticals in the Phase I clinical phase I with a down payment of US$190 million and a global licensing agreement with China Darex Biotech with a potential total of up to US$1.16 billion to obtain its pre-clinically targeted RNAi drug candidate.

The BD transaction described above shows the transaction demand of multinational pharmaceutical companies for differentiated pipelines in the metabolic field. Its transaction consideration and clinical development stage also provide a reference market basis for future potential BD projects. Laikai Pharmaceuticals' differentiated ActRII pipeline portfolio has the conditions to meet the strategic needs of multinational pharmaceutical companies. For a wide range of potential partners, there is reason to look forward to reaching a BD transaction that matches the value of their pipeline. We will wait and see.

This article is reprinted from the WeChat account of “Pharmaceutical Investment Tribe”, Zhitong Finance Editor: Feng Qiuyi.