Greenchem independent intellectual property rights technology transfer - Tigecycline
release time：2015-10-27 13:27:38
source：Bohai Securities research report
Tigecycline is developed by wyeth drug companies in the United States a new class of antibiotics for add ring element in domestic production of the biggest obstacles is patent wyeth crystal type: CN101248038A, 2005 applications. Including five kinds of crystallization, one crystal shape is more important, generally do a crystal shape. API exports and approval crystal type patent infringement problems in view of this, for our company to add ring element has completed the following studies:
1, got a new crystal type, can break through for API crystal ring element type patent.
2, synthesis process on pilot. Yield is greater than 50% yield, weight (by minocycline hydrochloride raw material), superior to process the yield of 30%.
3, quality: get the purity is more than 99.5% of the products, is superior to the general commercial product purity of 98.5%. The API technology to avoid foreign five kinds of crystal type, with independent intellectual property products.
For added ring element is also called nine uncle Ding Jigan ammonia acyl amino minocycline or Ding Gan minocycline, commodity name TYGACILTM, in June 2005 in the U.S. for the first time. Its structure is similar to tetracycline drugs. Used to treat by gram negative and positive bacteria, anaerobic bacteria; By methicillin-resistant staphylococcus aureus (MRSA) and methicillin sensitive staphylococcus aureus (MSSA) lead to the complexity of the abdominal cavity infection, skin and soft tissue infection (cSSSIs), and complicated intra-abdominal infections in adults (cIAIs), including complicated appendicitis, burn infection, intra-abdominal abscess, infection of deep soft tissue infection and ulcers, etc.
Tigecycline in the United States FDA is preferred way to get approval of the assessment, become a sweet ammonia acyl tetracycline class of antibiotics in the first product approved. According to the FDA regulation, only has compared to the existing treatments have obviously improved drug, to obtain priority evaluation status, which means that the product will be significantly better than existing treatments.
The superbug deaths in July as the Netherlands appeared, Tigecycline once again become a hot point concerned. Tigecycline has broad-spectrum antibacterial effect, and can effectively against drug-resistant bacteria infection. According to ECCMID provided by a study of icu infection, according to data for Tigecycline for most common separation of pathogenic bacteria, including drug resistant strains (except pseudomonas aeruginosa) infection has the very good curative effect. Based on this, Tigecycline undoubtedly will become super antibiotics. Tigecycline is being such attention is Tigecycline set wide antimicrobial spectrum, not easy the creation bears the medicine, easy to use, less adverse reaction and light, and many other advantages in one, has the extremely good marketing, market potential is enormous.