Recently, NT Biopharmaceutical Jiangsu Co., Ltd., an enterprise settled in CMC, brought good news that the company's independently-developed uroacitides injection (Xidike) has been approved by the China Food and Drug Administration (CFDA) as a Category 1 new anticancer drug and is expected to be launched in the market in March.
The uroacitides injection (Xidike) is a non-cytotoxic antineoplastic drug made from the urine of healthy men through acidizing, adsorption, extraction, vacuum drying and other technological processes. It contains hippuric acid, acetyl glutamine and polypeptide, etc. and is mainly used to treat breast cancer and non-small-cell lung cancer. The new indication is for the treatment of myelodysplastic syndromes (MDS). It is currently under Phase II clinical trial for the treatment of MDS. MDS is a malignant hematologic disease that can progress into leukemia in approximately 1/3 of the patients. Experts are optimistic about the prospect of treating MDS with Xidike.
The advent of Xidike brings good news to relevant patients. The product is non-cytotoxic and has no toxic side effect on human normal cells, but it can effectively inhibit tumor proliferation, promote tumor cell apoptosis and induce tumor cell differentiation. Scientific data shows that Xidike is not only effective, but safe and can effectively improve the quality of life of patients. This new anti-cancer drug has been highly praised by industry renowned experts including Wang Zhenyi, an academician of the Chinese Academy of Sciences and the founder of haematology in China.