Application for clinical application of class 3.1 new anti infective drug of Haizheng pharmaceutical

According to the information released by the State Food and Drug Administration on July 29, Haizheng Pharmaceutical Co., Ltd applied for the clinical application of 3.1 new anti infective drug, fidamycin bulk drug and tablet preparation, which was accepted by the drug administration, and became the first domestic enterprise applying for the clinical application of the drug Fedamycin is a macrolide antibiotic, which belongs to a new class of antibiotics It is an oral drug It mainly produces rapid anti refractory Clostridium infection (CDI) effect by inhibiting RNA polymerase of bacteria Its treatment of CDI is better than the existing drugs CDI is a serious disease caused by the infection of Clostridium difficile toxin on the inner wall of the colon The patients have severe diarrhea, sometimes even death 33% of diarrhea related to antibiotic treatment and colitis due to the use of antibiotics are CDI The original manufacturer of fidamycin is optimer company In December 2010, FDA granted the drug the status of rare drug use and approved it to pass the fast track examination and approval On May 27, 2011, it was approved by FDA and the trade name is dificid Haizheng pharmaceutical industry quickly followed up and became the first manufacturer to declare the clinical application of the drug According to the forecast of global industrial analysis company, the global market of anti infective drugs (mainly including antibacterial, antiviral, antifungal and vaccine) will reach 103 billion US dollars in 2015 Haizheng pharmaceutical is a leading API manufacturer in China, and one of the largest production bases of antibiotics and anti-tumor drugs in China At present, it is transforming to high-end preparations In 2013, the profit of Haizheng pharmaceutical preparation business exceeded that of API for the first time, and the transformation has achieved initial results.