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The GLP-1 weight loss drug market has entered a more intense and exciting second half: On one side, giants Eli Lilly and Novo Nordisk are engaged in a full-scale competition in clinical trials, capacity expansion, and commercialization; on the other side, Chinese pharmaceutical companies are accelerating their research and development pace, seeking breakthroughs through improved drug efficacy and differentiated designs.
Meanwhile, a new wave of weight loss drugs is quietly emerging, becoming a new "blue ocean." Among them, ActRII-targeted drugs stand out with their unique dual effects of weight loss and muscle gain.
Recent developments have brought exciting news: Eli Lilly has initiated a Phase II clinical trial for the combination of Bimagrumab and Tirzepatide, targeting both muscle gain and fat loss. Additionally, Laekna’s clinical trial for LAE102 has made significant progress, leading to a nearly 40% surge in the company’s stock price.
Laekna, a seemingly marginal biotech company, is now attracting strong market attention and expectations due to its impressive capabilities.
GLP-1-targeted weight loss drugs have been one of the hottest fields in recent years, with giants Eli Lilly and Novo Nordisk both seeing significant increases in both revenue and stock prices.
More importantly, the next global "king of drugs" is likely to emerge in the GLP-1 weight loss drug sector.
In the first half of 2024, Novo Nordisk’s Semaglutide sales reached $12.9 billion, up 43% year-on-year, closing in on the current global "king of drugs," Keytruda (with $14.2 billion in sales, up 21% year-on-year). During the same period, Eli Lilly’s Tirzepatide sales reached $6.656 billion, a year-on-year increase of 329%.
Looking at weight loss indications, the injectable version of Semaglutide (Wegovy) generated $3.08 billion in sales, up 74%, while Tirzepatide’s weight loss version Zepbound achieved $1.76 billion in sales.
However, GLP-1 weight loss drugs are not perfect. While they reduce fat, they also cause muscle loss, leading to the much-discussed "Semaglutide face" (facial hollowing and skin sagging).
Against this backdrop, targets that promote both fat loss and muscle gain have become a new arena for competition, including ActRII, Apelin, and HIF2. Among these, ActRII is an activin receptor expressed in both fat and muscle cells. Blocking the ActRII pathway promotes muscle regeneration and reduces fat.
This has given rise to ActRII monoclonal antibodies that can achieve both weight loss and muscle gain. Given the massive potential of the weight loss drug market, ActRII is regarded as the next "gold mine" after GLP-1, attracting the attention of the capital markets.
On October 16, Laekna announced major progress in the Phase I clinical trial of its independently developed, world-first ActRIIA monoclonal antibody LAE102 for overweight/obesity in China: The subcutaneous injection portion of the single ascending dose study has been initiated.
The news sent Laekna’s stock soaring nearly 40% in just three trading days, highlighting the market’s high expectations for this "next-generation weight loss drug star."
Another factor driving the stock surge is Eli Lilly’s announcement of the launch of a Phase II clinical trial for the combination of Bimagrumab and Tirzepatide for muscle gain and fat loss. Notably, there are only a few ActRII-targeted drugs (for overweight/obesity) currently in clinical stages worldwide, significantly enhancing Laekna’s intrinsic value.
In the race to develop ActRII-targeted drugs, Eli Lilly and Laekna are leading the way.
In July 2023, Eli Lilly made a major acquisition, purchasing Versanis for nearly $2 billion to acquire its key asset, Bimagrumab (an ActRIIA/B monoclonal antibody). Meanwhile, Laekna has strategically developed three ActRII-targeted drugs: LAE102 (ActRIIA monoclonal antibody), LAE103 (ActRIIB monoclonal antibody), and LAE123 (ActRIIA/B monoclonal antibody). This forward-looking strategy has given Laekna an early advantage in future market competition.
Eli Lilly's Bimagrumab is advancing quickly, currently in a Phase IIb BELIEVE study aimed at evaluating its effects in overweight or obese adults after 48 weeks of monotherapy or in combination with Semaglutide.
According to previously disclosed Phase II trial data, after 48 weeks of Bimagrumab treatment, patients experienced a 20.5% reduction in total body fat and a 3.6% increase in muscle mass, along with improvements in metabolic indicators.
When combined with GLP-1 drugs, it shows even greater efficacy, making ActRII-targeted therapies one of the best "companion drugs" for GLP-1 treatments. Eli Lilly is currently validating this combination therapy in clinical trials, and the market eagerly awaits the next set of data.
The ActRII market is still a blue ocean, and Laekna is building its competitive advantage through differentiation. Its lead pipeline, LAE102, has been approved for Phase I clinical trials targeting obesity in both China and the U.S. Preclinical studies have already shown that it increases muscle mass while reducing fat.
Given ActRII’s potential to treat muscle diseases, obesity, diabetes, and cancer, Laekai plans to explore LAE102 for additional indications. In May 2023, the FDA approved a clinical trial for LAE102 to treat non-small cell lung cancer (NSCLC), which has a large patient population.
For its weight loss indication, Laekna is conducting a randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study. This study evaluates the safety, tolerability, and pharmacokinetics of LAE102 administered via intravenous infusion and subcutaneous injection in healthy adults and overweight/obese participants.
As of September 30, 2024, over half of the intravenous dosing cohorts have completed treatment, with early signs of target engagement and expected PD biomarker changes observed in the low-dose group. Recently, Laekna announced the start of the subcutaneous injection portion of the single-dose escalation study, which is expected to be completed by the end of 2024.
Dr. Lu Xiangyang, Chairman and CEO of Laekna, stated, "Compared to intravenous administration, subcutaneous injections offer greater advantages for long-term use in chronic disease patients, making it easier to combine with GLP-1 receptor agonists." LAE102 combined with GLP-1 receptor agonists can further reduce fat and significantly minimize the muscle loss caused by GLP-1 receptor agonists.
As more biotech companies achieve "license out" agreements and expand globally, Laekna’s early submission of clinical trial applications for LAE102 to the FDA may also pave the way for future business development (BD) transactions.
Laekna's pipeline extends beyond ActRII-targeted drugs, with additional focus on fibrosis and metabolic diseases. However, its most notable asset is its rich pipeline targeting cancer.
Currently, Laekna has developed 10 pipelines in oncology, including 5 small-molecule drugs and 5 biologics, targeting various cutting-edge pathways such as AKT, CYP17A/CYP11B2, PI3Ka, and PARP1. The fastest-moving drugs are LAE002 and LAE001.
LAE002 (Afuresertib) is a potent AKT inhibitor targeting all three AKT isoforms (AKT1, AKT2, and AKT3). It is one of only two AKT inhibitors in late-stage clinical development globally, targeting breast and prostate cancer.
AKT inhibitors are a promising blue ocean field, with only AstraZeneca’s Capivasertib currently approved for market. According to Clarivate, Capivasertib is expected to generate over $1 billion in sales in G7 markets by 2031, with some analysts predicting peak sales could reach $3.8 billion.
Laekna is conducting multiple clinical trials for LAE002 in breast cancer, prostate cancer, ovarian cancer, and PD-1/PD-L1-resistant solid tumors, with three studies already in late-stage clinical trials. According to public data, compared to other AKT inhibitors, LAE002 shows higher efficacy, better pharmacodynamics, more significant tumor inhibition, and superior safety, positioning it as a potential "best-in-class" (BIC) drug.
According to Frost & Sullivan, the number of breast cancer cases globally and in China is expected to reach 2.666 million and 372,400, respectively, by 2030. Approximately 60% of Chinese breast cancer patients exhibit HR+/HER2- molecular characteristics, for which the first- and second-line therapies are endocrine/anti-estrogen therapies combined with CDK4/6 inhibitors.
However, 15% to 20% of patients develop primary resistance, and an additional 30% to 40% develop resistance over time. HR+/HER2- breast cancer after CDK4/6 inhibitor and endocrine treatment remains a significant unmet medical need, with market potential worth billions of dollars.
In May 2023, Laekna initiated a Phase III clinical trial in China for LAE002 combined with Fulvestrant for HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN alterations (AFFIRM-205 study).
LAE001, the world’s first CYP17A1/CYP11B2 dual-target inhibitor, has shown better efficacy and safety than the CYP17A1 inhibitor Abiraterone. In May 2023, the FDA approved a Phase III clinical trial for LAE002 combined with LAE001 in patients with metastatic castration-resistant prostate cancer (mCRPC). The combination therapy has already demonstrated impressive efficacy in Phase II trials.
As of November 21, 2023, 40 patients with disease progression after receiving 1-3 lines of standard therapy (including at least one line of Abiraterone or second-generation AR antagonists) have been enrolled in the recommended Phase II dose group. The median rPFS (radiographic progression-free survival) was 8.1 months, a significant improvement over the 2-4 months typically seen in mCRPC patients receiving standard treatment.
Both LAE002 and LAE001 have enormous BD potential. Laekna is actively seeking strategic partners to accelerate their development and commercialization.
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