“TG103 INJECTION” OBTAINS CLINICAL TRIAL APPROVAL FOR THE TREATMENT OF ALZHEIMER’S DISEASE

“TG103 Injection”, a class 1 biological innovative drug of the Group, has been granted approval by the National Medical Products Administration of the PRC to conduct clinical trials for the treatment of Alzheimer’s disease (AD) in China.

Alzheimer’s disease (AD) is a degenerative disorder of the central nervous system most common among older adults, with symptoms of progressive cognitive impairment and behavioral impairment. It is the most common cause of senile dementia, and its early manifestation is mild cognitive impairment. According to the epidemiological data published in The Lancet in 2020 about dementia in people aged over 60 years in China, the prevalence was 6.0% for dementia, 3.9% for Alzheimer’s disease, and 15.5% for mild cognitive impairment. The data indicated that there were about 38.77 million patients with mild cognitive impairment and 9.83 million patients with Alzheimer’s disease in China. AD can cause cognitive impairment in memory, learning, language, performance, and visuospatial abilities. Other symptoms such as mental, behavioral and personality abnormalities may develop as the disease progresses, which will severely affect the patients’ daily life and impose a heavy burden on families and society. Approved drugs for AD are mainly cholinesterase inhibitors and NMDA receptor antagonists, which are used to improve dementia symptoms and reduce complications, but unable to block further progression of the disease. In recent years, a number of clinical trials of disease-modifying AD therapies to delay disease progression have been conducted internationally, only two drugs have obtained marketing approval or conditional marketing approval, but with controversial effectiveness. With the aging population in China, the clinical value and social significance of the research and development of new drugs with AD diseasemodifying effects have become more important.

TG103 Injection, an innovative long-acting recombinant human glucagon-like peptide-1 (GLP-1) Fc fusion protein, is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) which has stable and effective pharmacological effects, good safety and long half-life. Results of preclinical studies on animals and clinical studies of drugs with the same target indicate that GLP-1 RA can improve the pathological changes of AD and show positive effects on brain metabolism and cognitive function in AD patients with disease-modifying effects. TG103 Injection may be able to slow down the progression of AD and provide potential clinical benefit to AD patients. Other indications for TG103 Injection under development include type-2 diabetes, overweight/obesity and non-alcoholic steatohepatitis.