Will Lai Kai Pharmaceutical (02105) be the next big winner on the weight loss track?

After cancer and self-immunity, the strong rise of the weight loss race will be the variable that will have the greatest impact on the global pharmaceutical industry pattern in the next few years.

The arms race around the weight reduction circuit has become one of the highest priority R&D topics for many pharmaceutical giants, and related mergers and acquisitions and BD transactions are also very active.

Just this past September, Pfizer bought Metsera, a biotech company that has only been in existence for more than 3 years, for an astonishing $7.3 billion to obtain the other party's package of weight-loss drug pipelines.

As far as Chinese innovative pharmaceutical companies are concerned, in the past year or more, there have also been many foreign BDs on weight-loss drug pipelines with initial payments of more than 100 million US dollars. Buyers include many large multinational pharmaceutical companies such as Novo Nordisk, Merck, and Regenerative.

But this is probably just a prelude. In the strategic circuit of weight loss drugs, it is a glorious chapter for China's innovative pharmaceutical companies, and it is still being prepared.

Safer ActRII monoclonal antibody

On September 29, 2025, an ActrII monoclonal antibody LAE102 from the Chinese Biotech company Laikai Pharmaceutical (02105) released phase I clinical MAD study data.

This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of LAE102 administered subcutaneously in overweight/obese subjects.

Everyone who is concerned about this pipeline is quite encouraged by the research results announced this time.

On the one hand, in the MAD test, the trend of LAE102 muscle gain and fat loss was observed: at week 5, the average lean body weight of LAE102 participants in the 6 mg/kg dose group increased by 1.7% compared to the baseline, and the average fat mass also decreased by 2.2%; after adjustment in the placebo control group, the average lean body weight increased by 4.6%, and the average fat mass decreased by 3.6%.

On the other hand, it is LEA102's huge potential in terms of safety.

There were no serious adverse events during this phase I MAD study. Most of the adverse events that occurred during treatment were mild (grade 1) laboratory abnormalities, and no cases of diarrhea, muscle cramps, or acne were reported during the entire process.

This safety result is consistent with LAE102 safety assessment data previously disclosed, and no new safety signals were observed.

Previously, as a star target on the weight loss circuit, the efficacy of activin type II receptor (ActRII) for fat loss and muscle gain has been convincingly verified, but safety is still a matter of concern.

At the 2025 ADA conference, Eli Lilly first announced the 2b clinical study results of its antibody drug Bimagrumab and simeglutide targeting ActRII on the indications of overweight and obesity.

Judging from the weight loss effect, the data is amazing: in 72 weeks of treatment, the Bimagrumab monotherapy group lost 10.8% of the weight, but 100% came from fat and 2.5% muscle gain; the simeglutide treatment group lost 15.7% of the weight, but only 71.5% came from fat and 7.4% muscle loss; the combined treatment group lost 22.1% of the weight, 92.9% from fat, and only 2.9% muscle loss.

Tilpotide is currently the most popular weight loss drug in the world. Previously, in the SURMOUNT-5 global clinical study, the 72-week average weight loss data was 20.2%.

In other words, the target combination of “ACTIIR+GLP-1” is completely capable of competing with tirbotide in terms of weight loss effects.

At the same time, ActiIR targeted drugs have significant muscle building abilities, which most GLP-1 drugs do not have.

After 72 weeks of administration of Bimagrumab alone, the average lean body weight of the enrolled patients increased by 2.5% compared to baseline.

However, Bimagrumab appears to have flaws in terms of safety and tolerability.

The main adverse effects of Bimagrumab include diarrhea, muscle cramps, or acne cases. In the case of single medication, the proportion of diarrhea exceeded 40%, muscle spasms reached 46% in the low dose group, over 73% in the high dose group, and the proportion of acne was around 30% to 40%.

In contrast, no cases of diarrhea, muscle cramps, or acne have been found in Laikai Pharmaceutical's LAE102 clinical trials so far, which is significantly different from Bimagrumab.

This shows that LAE102 has huge potential advantages in terms of safety, and is likely to become the “best in class” among similar drugs targeting ActRII.

potential buyers

As the only ActRII targeted drug in the world to enter clinical trials for weight loss indications, the reading of LAE102's latest clinical research data greatly increased the probability of this drug being BD.

As Eli Lilly, which is betting heavily on the ActRII target, has reached a clinical trial cooperation with Laikai Pharmaceuticals on LAE102.

In November 2024, Eli Lilly and Eli Lilly signed a clinical cooperation agreement. Eli Lilly will be responsible for carrying out a phase I clinical trial of LAE102 in the US and bearing related expenses, while Lai Kai Pharmaceuticals retains the global rights of LAE102.

Obviously, as a commercial company, Lilly chose to pay out of his own pocket to conduct clinical trials for LAE102. There must be a lot of interest in this pipeline, so the possibility of more in-depth cooperation in the future is not ruled out.

Although Eli Lilly already has a Bimagrumab, that doesn't mean it will go black.

Just in September, according to several media reports, Lilly terminated a clinical trial of Bimagrumab and tiverpotide alone or in combination to treat obese or overweight type 2 diabetics.

As for the reason for the termination, Eli Lilly did not give a detailed explanation; it only stated that it was “based on strategic commercial reasons.”

Regardless of the specific reason, this incident shows that Bimagrumab's position in Eli Lilly's research pipeline sequence is not absolutely unshakable, and Lilly's investment in this pipeline has also made trade-offs.

In addition to safety factors, LAE102 also has a huge advantage over Bimagrumab.

Although it is a “new star” on weight loss tracks, the Bimagrumab molecule has been around for a long time.

As early as 2013, Bimagrumab was certified as a “breakthrough therapy” by the FDA for the treatment of sporadic inclusitis.

By 2030, Bimagrumab's patent will expire.

Therefore, for Eli Lilly, it will face a rather embarrassing prospect: it may face a patent cliff 2 to 3 years after Bimagrumab is officially approved for listing.

In contrast, Laikai Pharmaceutical's LAE102 is still very “young”. Its patent expires in 2042, which provides plenty of time for commercialization of the drug after it is marketed.

As a result, LAE102 has better safety potential, better ability to gain lean body weight, and a longer patent validity period.

There is always a chance of eventually reaching a BD deal with Lilly.

Of course, Eli Lilly isn't the only potential buyer.

Take Novo Nordisk as an example. The company's flagship drug simeglutide is currently gradually at a disadvantage in competition with terpotide, and the company's stock price has also been seriously affected.

However, Novo Nordisk doesn't have a better card in the short term.

In view of the combined effects of simeglutide and Bimagrumab, which has been proven by convincing clinical data, introducing an existing ActRII targeted drug that is probably safer, and a combination therapy with simeglutide is clearly an option worth serious consideration for Novo Nordisk.

In fact, at a time when “fat lossing+muscle gain” has become a new clinical paradigm in the field of weight management, almost all multinational pharmaceutical companies that have deployed weight loss drugs have a reason to build supporting muscle building drug pipelines as soon as possible; otherwise, they are likely to be at a disadvantage in future market competition.

BD expectations

In September 2025, Laikai Pharmaceutical successfully completed a Hong Kong stock placement, raising net capital of HK$578 million, of which nearly 90% will be invested in R&D.

Earlier, there was a rumor in the market that Lai Kai Pharmaceutical's financing was due to poor clinical data performance.

The release of MAD clinical study data also shows that the above rumor is pure nonsense.

In fact, for any unprofitable biotech, until it had significant hematopoietic capacity, financing was a core task as important as R&D.

Being able to continuously raise the massive amount of capital required for research and development is not only a reflection of the core competencies of a Biotech company, but also a sign that its differentiated value is highly recognized by the capital market.

After the completion of this allotment of shares, the cash on Laikai Pharmaceutical's account exceeded 1.2 billion dollars, and R&D capital was further replenished.

This is undoubtedly major good news. Not only does the company have sufficient capital to advance research and development, but it is also more emboldened in BD negotiations to maintain selectivity in evaluating potential cooperation structures to ensure the synergy of interests of all parties, thereby maximizing the global commercial value of related pipelines.

Regarding LAE102's external cooperation, Laikai Pharmaceutical has also always maintained an open and pragmatic attitude. The company said that it is actively discussing with many potential partners, plans to seek partners with serious commitments and financial strength, and is willing to prioritize this project to accelerate LAE102's clinical development and commercialization process.

In addition to LAE102, which targets ActriIa, Laikai Pharmaceuticals also has LAE103, an antibody targeting ActRIIb, and LAE123, a dual-target antibody that completely targets Bimagrumab and targets ActriIA/IIb at the same time.

At a time when the probability of developing drugs targeting ActRII targets overweight/obesity is already extremely high, it is not surprising if LAE103 and LAE123 are favored by multinational pharmaceutical companies.

Packing BD together with the above three pipelines is also a possibility.

Considering that Eli Lilly won Bimagrumab at a transaction price of 1.9 billion US dollars, there is every reason to expect that at some point in the future, Laikai Pharmaceuticals will contribute a major contribution to China's innovative pharmaceutical industry.

In addition to ActRII pipelines, Laikai Pharmaceutical also has an LAE002, which is also quite interesting.

LAE002 is a potent AKT inhibitor that can inhibit all three AKT subtypes (AKT1, AKT2, and AKT3). According to public data, compared with other AKT inhibitors, LAE002 has many advantages such as higher efficacy, better efficacy, more significant tumor suppressing exposure, and better safety.

LAE002 is expected to submit a marketing application in the first half of 2026. As one of the only two anti-tumor AKT inhibitors in the world that are in or have completed a critical clinical development stage, this pipeline also has expectations for external BD.

This article comes from: “Pharmaceutical Investment Tribe” WeChat account; Zhitong Finance Editor: Chen Xiaoyi.