On November 16, 2023, good news came from Henan EMICRO Biomedicine Co., Ltd.: the company's innovative Class I anti-tumor drug "BTK inhibitor TM471-1 capsule", which has won international cutting-edge technology, has been approved for clinical trials (Notice No.: 2023LP02297).

　　This marks a milestone for the company's Class I anti-tumor innovative drug, which has invested 120 million yuan and undergone arduous research and development, to obtain the "pass" to start clinical trials.

　　With the unremitting efforts of all employees in the company, the preclinical study of TM471-1 project has been completed. The research results show that it has multiple indicators in terms of safety and efficacy, such as kinase selectivity, cardiac safety, bioavailability, blood drug exposure, low toxicity, excellent medication window, and the ability to penetrate the blood-brain barrier, which are superior to similar international drugs and have good drug properties. After the project is developed, it will bring good news to patients with lymphoma and autoimmune diseases.

　　Developing an anti-tumor drug requires a significant investment of manpower and resources, and takes at least seven to eight years. The safety and efficacy of drugs are crucial, and clinical trial results are the gold standard for evaluating drugs. Dr. Ding Qingjie, the Chief Scientist of the company, is a Chinese American who holds a PhD in Chemistry from Brown University and later conducted postdoctoral research at Georgetown University School of Medicine in the United States. Formerly served as Chief Scientist at Roche Pharmaceuticals in the United States. Under his leadership, the research team of EMICRO Biomedicine Company has achieved excellent data in preclinical studies. Based on this, the company will actively promote the clinical trials of the TM471-1 project, conduct research on human drug tolerance and pharmacokinetics, preliminarily evaluate the therapeutic effect and safety of the drug on target indication patients, and further verify the therapeutic effect and safety of the drug on target indication patients.

　　This application has been approved in advance by CDE due to the rigorous and solid scientific materials and experimental data. Preclinical research experiments are conducted on animals such as rats, mice, and dogs, while phase one clinical trials are conducted on subjects. The experiments aim to test the safety, tolerability, pharmacokinetics, bioavailability, and digestive and circulatory system effects of drugs in the subjects (human body), which is a crucial step in the development of drugs. The first phase of clinical trials takes about a year. Dr. Yang Yinke, a clinical expert who had maintained close communication before, joined the company full-time; He is a Ph.D. from Boston University and a postdoctoral fellow from Harvard University, with many years of clinical medical experience both domestically and internationally. He serves as the CMO of the company and leads clinical trials.

　　The approval of this project will greatly promote the company's scientific research progress, improve the level of scientific research, further promote the research and development of other pipelines, achieve multi-dimensional development of the company, and lay a solid foundation for contributing to society and benefiting humanity.