On May 13, Laikai Pharmaceutical-B (02105) announced that after being approved by the US FDA for the New Drug Clinical Trial (IND), its self-developed LAE102 (ActRIa monoclonal antibody) has obtained IND approval from the Drug Evaluation Center of the China National Drug Administration for the treatment of obese patients. The company is speeding up preparations for the Phase I clinical trial and will soon start recruiting subjects for obesity.

As a monoclonal antibody independently developed by Laikai Pharmaceutical, LAE102 mainly targets ActriIA, a new target involved in regulating muscle regeneration and fat metabolism. In previous preclinical studies, LAE102 has shown the effect of increasing muscle and reducing fat. The data shows that LAE102 in combination with GLP-1 receptor agonists can further reduce fat and significantly reduce muscle loss caused by GLP-1 receptor agonists, making LAE102 a high-quality weight control candidate to maintain muscle mass while losing fat.

To accelerate the development and commercialization process of LAE102, Lai Kai will also seek strategic partners to address significant unmet needs in the field of obesity.

“This time, the LAE102 weight loss indications were approved by both the Chinese and US reports. This is the result of Lai Kai's research team's years of accumulation and lack of development in the Activin-ActRII pathway. It also reflects the speed, efficiency and execution of the cross-functional team.” Dr. Lu Xiangyang, Chairman of the Board of Directors and CEO of Laikai Pharmaceutical, said that the company has made thorough preparations to complete the enrollment of the first LAE102 patient group as soon as possible, and is looking forward to providing accurate treatment for obese patients around the world.

According to the Zhitong Finance App, in recent years, GLP-1 targeted diet pills, led by simeglutide, have taken the entire market by storm. According to J.P. Morgan's forecast, the revenue of the GLP-1 market will exceed 100 billion US dollars by 2030; according to IQVIA data, the number of clinical trials of obesity drugs in 2023 increased 68% compared to 2022, and 124 drugs are currently being actively developed. In 2024, the concept of diet pills is still very popular. Novo Nordisk and Eli Lilly's continued surge in performance is also due to a surge in market demand for diet pills.

However, these products also have pain points. A review study showed that nearly 40% of the body weight lost by simeglutide subjects was muscle, which increased the risk of cardiovascular disease, osteoporosis, and even muscle loss. In this context, the value of the supporting industry chain for weight loss drugs to solve pain points is gradually emerging. Among them, the dazzling “rising star” is ActRII antibody drugs. Meanwhile, Bimagrumab purchased by Eli Lilly for 1.95 billion US dollars and LAE102 (Actriia monoclonal antibody) independently developed by Laikai Pharmaceuticals are pioneers in this race.