Analysis of the current situation of ofloxacin drug market
Author: Someone's article Source: China Drug Network hits: updated in March 2005-16.
The advent of quinolones has brought good news to patients. With the long-term application of drugs, the drug resistance of bacteria has gradually attracted people's attention and become a hot spot in many countries around the world. Due to insufficient understanding of the side effects of antibiotics, prescription drug abuse and adverse reactions also occur from time to time, which also leads to the breeding of drug-resistant bacteria and serious hospital infection. Facing the new national regulations on antibiotics, the pharmaceutical industry has strengthened the development of new products. In recent two years, many new faces of quinolones appeared in typical urban sample hospitals, such as sparfloxacin, gatifloxacin, lomefloxacin, rufloxacin, pefloxacin, tosufloxacin and moxifloxacin. Therefore, the present situation of serious homogenization of quinolones is changed.
Sparfloxacin: Newborn calf
Sparfloxacin is a product developed by Dainippon Pharmaceutical Co., Ltd., which was first listed in Japan on 1993 under the trade name of Spara. The drug has strong activity on Gram-positive bacteria, Staphylococcus, Streptococcus pneumoniae and Mycobacterium, and has anti-effects on anaerobic bacteria, mycoplasma and chlamydia, and has no interaction with theophylline and non-steroidal anti-inflammatory drugs.
1998 after the successful research and development of sparfloxacin in China, four enterprises, namely Zhejiang Haizheng Pharmaceutical, Chengdu Beite Pharmaceutical, Zhengzhou Yonghe Pharmaceutical and Datong Tianfeng Pharmaceutical, obtained the production registration certificates of APIs and their preparations. In 2002, Dong Rui Pharmaceutical Company of Suzhou successfully developed sparfloxacin lactate and its tablet "Lamber". In recent two years, sparfloxacin's unique mechanism of action has been recognized in clinical application, which indicates that quinolones have made remarkable progress. In 2002, the consumption of drugs in sample hospitals in national key cities increased by 45.54%, and the consumption amount increased by 30.95%, reaching more than 21100,000 yuan.
According to the situation of drug use in urban sample hospitals in June 2003, sparfloxacin has entered the top 200 drugs used in 9 cities, among which Chongqing ranks 33, Chengdu 87 and Xi 85. The main dosage forms of sparfloxacin are tablets, capsules and granules, and the trade names are Bazaar, Haizheng Park Jung Su, Shibaofu and Sennaoxin. Its hospital market is mainly occupied by domestic drugs, and it is expected that the market of sparfloxacin will be better in 2004.
Gatifloxacin: a sharp sword
Gatifloxacin belongs to the third generation of new 8- methoxyfluoroquinolones, which was successfully researched by Institute of Biotechnology of China Academy of Medical Sciences, Anhui Keyu, Changsha Huamei and Chongqing Puhui Pharmaceutical Technology Development Company, and jointly developed gatifloxacin raw materials and preparation products with pharmaceutical companies. In 2003, the State Food and Drug Administration of the United States issued a national first-class new drug certificate, making it the only new quinolone drug in China. Zhejiang Jianfeng Pharmaceutical Co., Ltd., Chongqing Laimei Pharmaceutical Co., Ltd., Chengdu Beite Pharmaceutical Co., Ltd., Anhui Fang Jing Pharmaceutical Co., Ltd. and other 15 enterprises obtained the approval documents for the production of APIs. The main dosage forms are film-coated tablets, capsules, dosage forms for injection, powder injection and glucose injection.
Gatifloxacin is a new drug listed in recent years. It is the third generation of new fluoroquinolones that China, Japanese Xinglin Pharmaceutical and Bristol-Myers Squibb have studied simultaneously. Squibb's product is called "Tian Kun", and it is also the first fluoroquinolone antibiotic approved by FDA. On199965438+February 27th, it was approved by the FDA and listed in the United States. In 2000, the sales revenue was US$ 65,438+US$ 0.365,438+0 billion. In 2003, the global market share rose to US$ 208 million, an increase of 65,438+03% over the previous year.
In the past two years, various dosage forms such as Fesikang from Jiangsu Pharmaceutical Company, Fesikang from Jiangsu Suzhong Pharmaceutical Company, Leo from Zhejiang Jianfeng Pharmaceutical Company, Lai from Chongqing Laimei Pharmaceutical Company, Yan from Hubei Yikang Pharmaceutical Company, Yu Juntai from Shandong Weihai Pharmaceutical Company and Gatifloxacin Glucose Injection from Bristol-Myers Squibb Company have been listed one after another. According to the statistics of drug use in sample hospitals in China 16/2003, gatifloxacin entered the top 200 drugs in1/city by virtue of its good mechanism of action, among which Shenyang and Jinan ranked 30 and 64 respectively, and Shijiazhuang and Zhengzhou ranked 9 1. In 2004, Yitong of Gatifloxacin Injection in Tianqing, Zheng Da, Nanjing and Aoweimei in Si Kang, Yangzhou were also approved by SFDA.
In the first half of 2004, Gatifloxacin ranked in the national list of 16 sample hospitals, and it has entered 58 hospitals from 135 at the beginning of the year. It is predicted that the drug consumption of sample hospitals in 2004 is about 1 100 million yuan. Compared with a series of new fluoroquinolones, gatifloxacin has the least side effects, the widest antibacterial spectrum and the best curative effect, and its bioavailability is as high as 96%. In the next two or three years, gatifloxacin is expected to become a high-profile variety of fluoroquinolones.
Moxifloxacin: It shines brightly.
Moxifloxacin is the fourth generation of quinolones introduced by Bayer Company in Germany. It was first listed in Germany and approved by the FDA in 1999 12 10. At present, it has been used clinically in many countries and regions around the world. In April 2003, moxifloxacin eye drops developed by Alcon Company were also approved by FDA. Many literatures show that moxifloxacin has more advantages in anti-infection than clarithromycin, cefuroxime and levofloxacin.
Although moxifloxacin has not been on the market for a long time, its excellent mechanism of action has promoted market sales, especially in the treatment of respiratory tract bacterial infection, acute bacterial attack of chronic bronchitis, obstructive pulmonary disease, community-acquired pneumonia and so on. Its strong permeability to cells and tissues has been recognized by doctors and patients, thus obtaining a good profit of $65.438+0.22 billion in the second year of product marketing, and increasing to $338 million in 2003.
Foreign manufacturers have great expectations for the China market. Bayer applied for clinical trials abroad, and also applied for clinical trials at home. Thanks to its efforts, moxifloxacin tablets obtained the registration certificate in 2002, and Bayer's moxifloxacin hydrochloride and sodium chloride injection also obtained the registration certificate in 2004, becoming the exclusive drug in China. From the situation of drug use in urban sample hospitals in June, 2003, 65,438 moxifloxacin was sold well in many areas because of its good curative effect, ranking among the top 200 in Chongqing, Jinan and other places. The activity of moxifloxacin against gram-positive bacteria is about 4 times stronger than that of ciprofloxacin. It has the characteristics of anti-anaerobic bacteria, mycoplasma, chlamydia and low photosensitive reaction, and also has a good anti-head effect on some drug-resistant bacteria. With the effective academic promotion, it is sharing the antibiotic market at a faster speed.
Market prospect of quinolones
With the progress of society, the recurrence and resurgence of many diseases and the emergence of drug-resistant bacteria, people attach importance to the clinical application of quinolones and promote the development of new products. The clinical application of sparfloxacin, gatifloxacin, clinafloxacin and moxifloxacin, a new generation of products, shows that their pharmacokinetic properties have been improved a lot, especially for gram-positive bacteria such as staphylococcus, streptococcus pneumoniae and mycobacterium. And has the function of resisting anaerobic bacteria, mycoplasma and chlamydia, thus promoting the progress of quinolones.
In China's pharmaceutical market, the sales of anti-infective drugs have always been in the first place, with an annual sales of about 30 billion yuan, accounting for about 30% of the national pharmaceutical market. At present, in the market of anti-infective drugs, the clinical dosage of quinolones has surpassed that of penicillins, becoming the second largest antibacterial drug. From the market trend of the main ofloxacin drugs in recent years, it is not difficult to see that the sales performance has risen and fallen, and new products have always been the driving force for growth. Senior foreign medical analysts believe that although the growth trend of global drug sales market has slowed down in recent years, the compound annual growth rate of anti-infective drugs has remained at around 1.6% in the past five years, when the sales will reach 28 billion US dollars. Among them, quinolones will be the fastest growing class of drugs, and anti-infective drugs will occupy the mainstream position in developing countries. Further development of drugs for pregnant women and children with high efficiency, low toxicity and low risk will be the expected products.