Pharmaceutical Industry:
At present, prostate cancer has become the second most common cancer among male in the world and the fifth most common cancer among men in China. In 2016, there were 120,000 new cases of prostate cancer in our country. It has been estimated that by 2023, the number of new cases of prostate cancer in my country will reach 240,000, and more than 600,000 patients each year. According to the U.S. treatment cost standard, the relevant market in China reached US$3 billion in 2016 and is expected to reach US$6.8 billion in 2023. In Europe and the United States, the metastasis rate and death rate of prostate cancer are less than 10%; however, in China, the metastasis rate and death rate reach to 70%. The high ratio difference between China and foreign countries shows that we have an urgent need for prostate anti-cancer drugs.
Zhuhai Topower New Energy Company has established friendly business contacts with prestigious scientific research institutions and pharmaceutical enterprises in western Europe, such as University of Cambridge, London University College(UCL), Alienor Farma of France, British Biomedical Incubators(FDI), FERRER of Spain, BLAL of Portugal, DOMPE of Italy, etc.In addition, we have already established cooperation with many well-known medical experts and institutions at home and abroad.
In 2019, we have signed a cooperative research and development agreement with Alienor Farma, a Pharmaceutical Company of France, and successfully licence-in an advanced anticancer drug(Phase II completed) to continue the Phase III clinical trials and new drug application(NDA) in China. The project has already landed in Beijing. At present, the company has organized a team composed of six senior expert consultants, eight full-time personnel (including two PhDs, three masters and three bachelors), which provides the confidence and capability to analyze and evaluate the high-standard innovative achievements in the pharmaceutical field abroad. Our company is committed to promoting the licensing-in and transformation of international advanced biomedical achievements in China to meet the unmet clinical needs and for the benefit of the Chinese people.
At present, our subsidiary is committed to introducing targeted drugs with a new mechanism of action that can inhibit tumor cell growth and induce differentiation. That new mechanism of action can treat prostate cancer and obtain significant effects. There is no similar products have been approved worldwide. The drug has completed clinical trials phase I and phase II in multiple centers in Europe. The dosage of the drug has been determined through pharmacokinetic studies, and the conclusion that a specific dose can be used to effectively treat metastatic castration-resistant prostate cancer has now passed the FDA The provisions of "506(b) | EMA -CPMP/EWP/2330/99" can expedite the application for clinical Phase III trials of drugs for the treatment of prostate cancer. According to the "Technical Guidelines for Receiving Data from Overseas Clinical Trials of Drugs" issued by the National Medical Products Administration on July 6, 2018, the project can accord with the conditions of the domestic phase III clinical trial.
According to the "Announcement on the Second Batch of New Drugs Urgently Needed for Clinical Use" of the National Medical Products Administration, anti-prostate cancer drugs are included in the announcement. And a well-known domestic oncology medical institution has been selected as the lead institution, and more than 20 medical institutions have participated in the clinical research of this project.