Antibiotic leading North China Pharmaceutical accelerates the first imitation and creation

Systemic antibacterials are necessary for the treatment of infectious diseases in clinic, which have the characteristics of wide clinical application and wide variety According to the report "antibacterial drugs: global market forecast 2012-2022" released by visiongain Business Information Research Institute in the UK, the global market size of antibacterial drugs in 2016 was about 43.8 billion US dollars At present, there are mainly β - lactams, macrocyclic lipids and aminoglycosides in China, among which β - lactams are the most widely used According to the data of domestic sample hospitals, β - lactams account for more than 80% of the total antibiotic chemicals These antibiotics contain β - lactam ring, including penicillin and its derivatives, cephalosporins, monoamide rings, carbapenems and penicillin enzyme inhibitors With the long-term and extensive use of antibiotics, the resistance of bacteria to piperacillin tazobactam has gradually increased, which has become a major threat to the clinical efficacy of antibiotics There are many mechanisms for bacteria to produce drug resistance, including changes in target structure or affinity, changes in membrane permeability of bacteria, active membrane efflux system and the production of inactivated enzymes by bacteria Among them, one of the common mechanisms of drug resistance is the production of β - lactamase, which leads to the destruction of β - lactamase hydrolysis of β - lactamase antibiotics, thus inactivating such antibiotics Therefore, researchers began to look for enzyme inhibitors to solve this problem So far, β - lactamase inhibitors are mainly composed of oxacillanes, penicillanesulfones, carbapenems and cephalosporins, which have been used in clinic, including sulbactam, clavulanic acid and tazobactam, all of which are irreversible suicide β - lactamase inhibitors At present, the combination of β - lactamase inhibitor and β - lactamase inhibitor has become an important means to improve the clinical efficacy of β - lactamase antibiotics The compound preparation containing β - lactamase inhibitor has been paid more and more attention, and it has been widely used in primary hospitals, among which piperacillin tazobactam is one of them Piperacillin is a semi synthetic broad-spectrum penicillin, which has the advantages of broad antibacterial spectrum, good tissue permeability and strong action, but it is not stable for β - lactamase Tazobactam is a derivative of sulbactam by adding triazole ring to its structure Its antibacterial spectrum is similar to that of sulbactam, and its enzyme inhibition is stronger than that of sulbactam Tazobactam is a powerful, broad-spectrum and irreversible competitive β - lactamase inhibitor Its inhibition spectrum and inhibition intensity are better than clavulanic acid and sulbactam, and its inhibition of penicillinase and cephalosporinase is 10 times stronger than sulbactam The results showed that the antibacterial spectrum of piperacillin / tazobactam was extended and the antibacterial activity was improved compared with piperacillin, which had the dual characteristics of broad-spectrum antimicrobial agents and β - lactamase inhibitors Among the penicillin antibiotics, piperacillin tazobactam is one of the best compatibility combinations, which can give full play to the advantages of both It is used in the clinical treatment of moderate and severe infections, especially for the enzyme producing Gram-negative bacteria, such as Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae The drug is also safe and effective for children, which provides more choices for clinical children The first strong tazobactam was developed by Dapeng company of Japan in 1984 and then transferred to Lederle company of the United States, which was later merged by Wyeth company The compound preparation of tazobactam and piperacillin is called tazobactam, which was first listed in France in 1992 and approved by FDA in 1993 The sales of tazocillin increased rapidly after its listing, becoming the main product of Wyeth in the field of anti infection In 1995, the global sales reached 94 million US dollars, increased to 638 million US dollars in 2005, and exceeded 1.2 billion US dollars in 2009, with a compound annual growth rate of 20.15% in 14 years Among the semi synthetic penicillins, the sales volume of tazocillin has already surpassed that of amoxicillin and ogmentin, ranking first Tacosillin from Wyeth entered China in 1998 According to the CFDA website, there are 31 manufacturers with the approval documents of domestic generic drugs Huabei pharmaceutical took the lead in developing piperacillin sodium and tazobactam sodium in China It is the first domestic imitator of the product The company established the project in 2005 On October 20, 2008, it obtained the approval numbers of 1.25g and 2.5G specifications of the product, and obtained the new drug certificate, and then submitted for approval of 0.625g specifications Huabei pharmaceutical uses the advanced technology of aseptic freeze-drying to produce It is the proponent of the quality standard of piperacillin sodium and tazobactam sodium North China Pharmaceutical piperacillin sodium and tazobactam sodium, known as qianglintan, are widely recognized clinically for their safety and effectiveness Their market share also ranks first among similar products, and their sales are on the rise year by year At present, the main manufacturers of piperacillin sodium and tazobactam sodium in the domestic market are Wyeth, Huabei pharmaceutical, Zhuhai Union, Qilu pharmaceutical, Zhejiang onlycom and Hainan general Sanyo Since 2011, North China pharmaceutical market share began to follow Wyeth, ranking second In the process of product development and application, Huabei pharmaceutical also obtained the patent of the State Intellectual Property Office for the pharmaceutical use of piperacillin sodium and tazobactam sodium for injection, and applied for the patent for the compound preparation of piperacillin sodium and tazobactam sodium for injection In addition, due to the clinical application value of piperacillin tazobactam products, as well as the excellent technology and brand influence of North China pharmaceutical, the product won the first prize of Hebei Province Science and technology progress in 2014 Rapid upgrade of antibiotic faucet Huabei pharmaceutical is one of the largest pharmaceutical enterprises in China Its predecessor, Huabei pharmaceutical factory, was a key construction project during the "first five year plan" period in China It was built in 1953 and put into operation in 1958 Since then, it has ended the history of China's penicillin and streptomycin dependence on imports, ushered in a new era of antibiotic industrial production, and made great contributions to improving the situation of lack of medicine in New China Now, North China Pharmaceutical has become the largest production base of antibiotic pharmaceutical products in China The total output of antibiotic APIs accounts for about 15% of the total output of the country, and the annual production capacity of powder injection reaches 2.2 billion, ranking the first in the country Among them, the output of penicillin, vitamin B12 and other preparations ranks first in Asia and the world However, in the past two years, under the influence of what is known as the "most stringent anti drug order" in history, the market of systemic anti bacteria drugs in hospitals has been restricted to a certain extent According to the data of mienei.com, in 2012, the total amount of antibacterials used by the sample hospitals in 16 cities in China was 13.35 billion yuan, down 16.34% from the previous year; in 2013, the total amount of antibacterials used by the sample hospitals in 16 cities in China was 13.042 billion yuan, down 2.31% from the previous year The drug market in hospital is stable and declining In the long run, the introduction of the regulatory system of antibacterial drugs will help to reduce the drug resistance of patients in China; in the short run, it will inevitably cause pain in the antibacterial industry The whole industry will enter the stage of shuffling, low-end enterprises will be eliminated, and the industrial structure and product structure will be accelerated Some experts in the industry have reminded that people who have been heavily dependent on antimicrobial drugs need new antimicrobial drugs more urgently than ever Therefore, enterprises must select varieties more scientifically, "who can find a good variety can become a new industry leader." For many antibacterial manufacturers, in order to successfully pass this period of slow-paced growth, the future research and development, sales strategies must be adjusted Experts suggest that products must have the advantages of originality and safety, so as to have the right to speak and reflect the market value In this regard, North China Pharmaceutical has already begun to layout During the 12th Five Year Plan period, it has set up the goal and direction of product structure adjustment: according to the market drug use structure and the actual situation of the company, it plans the industrial development direction, adheres to the principle of "refining, refining and strengthening" in the original business fields such as youth, vitamins, agricultural and veterinary drugs, and focuses on the development of biotechnology drugs, cephalosporin drugs, nutrition and health products, and Chinese patent medicines, so as to accelerate the development The pace of implementation of albumin project, anti-tumor preparation project and immunosuppressant industrialization project is to cultivate a number of advantageous fields and varieties; vigorously develop preparation varieties, especially pay attention to the development of preparation technology and market development, cultivate domestic leading brands, create the advantageous position of domestic preparation market, strive for the preparation products to enter the European and American markets, and build a complete industrial chain, Form a horizontal multi field and vertical multi variety industrial structure In the process of transformation and upgrading, Huabei pharmaceutical has gained a lot Through technological innovation, it not only consolidates the market position in the original advantageous field, but also improves the layout in the new treatment field Since 2011, Huabei pharmaceutical has obtained 7 clinical approval documents for new drugs and 3 national class I new drugs Among them, recombinant human albumin and anti rabies antibody are the first in China.