Such a large market share and such a good development potential have attracted the intervention of many capitals. Many domestic pharmaceutical companies are good at producing antibiotics, so more and more manufacturers share the cake in the cephalosporin market. Fierce market competition is in full swing, from preparations to raw materials and even upstream intermediates. First-generation cephalosporins such as cefazolin sodium were gradually pushed out of the forefront of hospital medication, and advanced third-generation cephalosporins such as ceftriaxone sodium, cefoperazone sodium and cefotaxime sodium also entered the era of meager profit competition. In the era of meager profit, only scale effect can win, so the production of these varieties blooms everywhere and enters the era of centralized production and management again. Manufacturers without cost advantage and scale effect have to withdraw from the competition. Pursuing profit maximization is the essence of constant capital, and some varieties with optimistic profit rate will certainly become the target of chasing again. From this, it is not difficult for us to understand the fact that in 2004, after the national drug price reduction policy was successively issued 10 times, the upsurge of approving new drugs broke out again in the pharmaceutical industry.
With the rapid development of this field, people's attention has been focused on this field. Among many cephalosporin varieties, cefpiramide sodium is especially sought after by everyone, and the popularity is gathered here again. In 2004, there were as many as 10 enterprises, and the approval documents of related APIs will be obtained by Qilu Pharmaceutical, Kangliyuan Pharmaceutical and other manufacturers one after another. Experts in the industry said that the reason why this variety can stand out lies in its own advantages.
The unique advantages of "three generations and a half"
Cefpiramide sodium is a cephalosporin for injection jointly developed by Sumitomo Pharmaceutical Company and Yamanouchi Pharmaceutical Company. According to the principle of cephalosporin discovery age and antibacterial properties, this variety is between the third generation and the fourth generation, and some people simply call it "three and a half generations". Cefpiramide sodium was first listed in Japan on 1985. Its structure is characterized by methyl tetrazolyl at C3 position and hydroxyphenyl and hydroxymethylpyridinyl at C7 position, which greatly improves the antibacterial activity and pharmacokinetic characteristics of the original drug. The patent of this product expired on 1997, and there is no administrative protection in China. Therefore, cefpiramide sodium's research and development is not restricted by patents and administrative protection, which is one of the reasons why this product is sought after by many people.
Cefpiramide sodium is similar to other β -lactam antibiotics. It has strong affinity with pbps (PBP) 1A, 1B and 3. By inhibiting the cross-linking of mucin chain in the process of bacterial cell wall synthesis, bacteria can not form a complete cell wall, induce sensitive bacteria to form filaments, and finally dissolve and die, thus playing a bactericidal role. Cefpiramide sodium has broad-spectrum antibacterial activity against G+ and G- bacteria, especially against Pseudomonas aeruginosa. Clinical evaluation shows that cefpiramide sodium has a good clinical effect on septicemia, respiratory tract infection, biliary tract infection, urinary tract infection and gynecological infection. According to statistics, the total effective rate is 76%, and the clinical curative effect on cases with ineffective antibiotics is 65.3%. Cefpiramide sodium can inhibit 87% of clinical isolates of Pseudomonas aeruginosa at the concentration of 12.5ug/ml, which is basically the same as that of cefsulodin. The sensitivity to Pseudomonas aeruginosa is the same as or even higher than aminoglycosides.
Compared with other third-generation cephalosporins, cefpiramide sodium's antibacterial spectrum is further expanded, and it has strong antibacterial activity against a variety of gram-negative bacteria, Neisseria, Staphylococcus and Streptococcus (except Enterococcus), including Enterobacter, Pseudomonas aeruginosa and Haemophilus. Cefpiramide sodium also showed good antibacterial activity against gram-negative bacilli resistant to the third generation cephalosporins. Based on the antibacterial activity and clinical efficacy of cefpiramide sodium, it can be seen that the efficacy of cefpiramide sodium is comparable to that of ceftazidime and cefotaxime, but its advantage lies in its broader antibacterial activity spectrum in vitro, covering gram-positive bacteria and gram-negative bacteria (including Pseudomonas aeruginosa). Therefore, cefpiramide sodium has improved the poor activity of the third and fourth generation cephalosporins against G+ bacteria, Pseudomonas aeruginosa and anaerobic bacteria, which is in line with the research and development direction of cephalosporins: (1) improving the activity against G+ bacteria, Pseudomonas aeruginosa and anaerobic bacteria; (2) Explore drugs with different antibacterial mechanisms, so as to expand antibacterial spectrum, enhance activity and improve pharmacokinetic characteristics. Therefore, cefpiramide sodium has better market potential and better clinical application prospect than the commonly used third-generation cephalosporins.
Market space bright spot
At present, there are mainly imported products from Lecco and Sumitomo Pharmaceuticals in China, which are expensive, but these two imported products have not occupied the market, so domestic manufacturers still have opportunities. Domestic API manufacturers should act quickly, optimize the production process, improve productivity, reduce production costs, and accelerate the localization process of this variety. At present, the third-generation cephalosporins, which occupy the mainstream position in the market, have strong momentum and fierce competition. Only a variety with obvious clinical advantages like cefpiramide sodium can break the ice.
Qilu Pharmaceutical Co., Ltd. and Kangliyuan Pharmaceutical Co., Ltd. have taken the lead in accelerating the localization process in cefpiramide sodium. According to the product characteristics, they have made a gratifying breakthrough in raw material production technology, and will provide sterile raw materials for preparation manufacturers in the near future, thus fundamentally breaking the bottleneck restricting the development of this variety-looking for acid first, and then looking for a production enterprise with freeze-drying ability and corresponding batches for processing, which is cumbersome, long-term and high in processing cost.
An important feature of cefpiramide sodium is its good stability, which greatly reduces the risk of product quality decline in the process of production and circulation (especially commercial circulation), which is very conducive to the arrival of its modern people. Take cefuroxime sodium as an example, if it were not for its instability (even air transportation requires cooling measures), it would save a lot of trouble in production and commercial circulation. Aside from the curative effect, its instability is an important reason for the slow growth of this variety in recent years.
It is precisely because of cefpiramide sodium's own advantages and good market prospects that it gives people more confidence and courage to look forward to it. At present, some pharmaceutical manufacturers have started to operate this variety, but due to the pressure of cost and the bottleneck of processing, its development speed and level are greatly limited, and it still stays at the level of a small amount of processing. It is believed that with the attention of more manufacturers and R&D institutions, the era of comprehensive competition for such API products will be just around the corner. The determination of the state to control drug prices will also make the price of this variety come soon.