Qilu pharmaceutical passed the consistency evaluation

On March 8, 2019, Qilu pharmaceutical received the approval on the conformity evaluation of tegio capsules approved and issued by the State Drug Administration, which means that the tegio capsules produced by Qilu pharmaceutical passed the conformity evaluation of quality and efficacy of generic drugs in the first batch of the same domestic varieties Up to now, Qilu pharmaceutical has passed the consistency evaluation of 11 products, of which 7 products are the first in China Tegio capsule is a compound antitumor drug composed of tegafur, gemcitabine and otilacy potassium It belongs to a new type of fluorouracil derivative, which is used to treat unresectable local advanced or metastatic gastric cancer Compared with the traditional fluorouracil drugs, tegio capsule can maintain a high blood concentration in vivo, so as to improve the anticancer activity and significantly reduce the gastrointestinal toxicity of the drugs Many years of clinical research and application at home and abroad have fully confirmed the remarkable effect of tegio Capsule on advanced gastric cancer, which is a safe and effective oral anticancer drug, and has been unanimously recognized by medical institutions and patients The original research company of tegio capsule is Dapeng Pharmaceutical Co., Ltd of Japan It was first listed in Japan in 1999, and was imported into China in 2009 At present, only three domestic products are listed In 2017, the domestic sales of the product was 2.8 billion yuan Since 2016, Qilu pharmaceutical has started the consistency evaluation of several oral and injection products With the high attention of the group and the continuous joint efforts of researchers, in 2018, Qilu Pharmaceutical Co., Ltd ranked first in the industry in terms of the number and speed of product applications for conformity assessment Tegio capsule of Qilu pharmaceutical was listed in China in 2010 and is the key product of the company In March 2016, the project was launched as one of the first consistency evaluation projects, which started the race with competitors Adhering to the belief that "ensuring the quality of research is saving time", the researchers strictly follow the design concept of quality, carry out a systematic and comprehensive quality comparison study with the original research drug, work overtime, seize the time, and complete the small trial prescription process research in only four months, solve the problem of product stability, optimize the production process, and greatly improve the production of the product The clinical research team took over the baton and quickly started the recruitment of the subjects, and completed the human bioequivalence (be) research with the original research drug as soon as possible The research departments closely connected, wrote the application materials before and checked at all levels, and submitted the registration materials as soon as possible after the completion of the be research .. Finally, Qilu pharmaceutical's tegio capsule was the first to be approved for consistency with its competitors, which won the market valuable time In the process of the consistency evaluation of tegio capsule, Qilu pharmaceutical always adheres to the concept of high-quality imitation All the quality indexes of the product in vitro are the same as the original research drug, and the internal bioequivalence is the same as the internal bioequivalence The national drug standard, import registration standard and ICH requirements of the product are integrated to establish a more strict internal control standard, effectively control the product quality, and ensure the drug quality Safe, effective and high quality will better meet the clinical drug demand of patients.