"Lobaplatin", a new antitumor drug of Yibai pharmaceutical, has obtained clinical approval

Organized and implemented by Guizhou Yibai Pharmaceutical Co., Ltd., the national first-class anti-tumor new drug, patent protection product, and national medical insurance catalog product - "lobaplatin" obtained the approval document for clinical trials of new indications issued by the State Food and Drug Administration on March 3, 2015 Lobaplatin is the third generation of platinum drugs Guizhou Yibai pharmaceutical has its exclusive intellectual property rights The original clinical indications are breast cancer, small cell lung cancer and chronic myelogenous leukemia In clinical use, it is found that lobaplatin has anti ovarian cancer effect, so the enterprise decided to carry out secondary development     In 2011, Guizhou Provincial Department of science and technology approved the "in-depth research and development of a new antitumor drug lobaplatin" as a major scientific and technological achievement introduction, digestion and absorption re innovation project, supported Guizhou Yibai pharmaceutical to carry out the second in-depth re innovation research and development based on the existing indications of lobaplatin, and carried out the improvement and optimization of the preparation process of lobaplatin in accordance with the national drug registration management measures This is the first time that the Department of science and technology has supported the systematic pharmacodynamic research on the antitumor activity in vitro and the therapeutic effect in vivo In 2012, after organization refinement, phase IV clinical research of a class of new antitumor drug lobaplatin was supported by the major new drug development project of the Ministry of science and technology of the people's Republic of China, raising the provincial goal to the national goal With the continuous support of scientific and technological projects, the R & D personnel of Yibai pharmaceutical have carried out R & D in accordance with the urgent need of clinical treatment of the major disease "ovarian cancer" endangering women's health, combined with the clinical pharmacology characteristics of lobaplatin, and achieved phased results: completed the improvement of the preparation process and parameter optimization of lobaplatin, improved the stability and operability of lobaplatin, improved the product yield, and formulated The quality control standard system for the production process of lobaplatin; the main preclinical pharmacodynamics research on the indications of lobaplatin for expanded ovarian cancer; 1 clinical approval document of 1.6 categories (new indications not found at home and abroad) of the State Food and drug administration; 3 patent authorizations In the next step, the research group will focus on the study of lobaplatin crystal form and carry out the international multicenter clinical research on expanding the indications of ovarian cancer After the products are put on the market with new indications, the existing market share will be expanded, and the annual output value is expected to reach 400 million yuan / year.