September 20, September 20, is the twenty-ninth national tooth day in China. This year's theme is "oral health, general health". Effective prevention, treatment and control of oral diseases, and promoting oral health has been one of the top ten health criteria.
On the eve of the national dental day, the minocycline soft paste developed by hainan jianke pharmaceutical co., was awarded the clinical approval of CFDA and opened a new chapter in the treatment of Chinese periodontitis.
In the dental field, periodontal disease and dental caries are associated with higher morbidity. Periodontal disease is a chronic, nonspecific, infectious disease that occurs in tooth support tissues. Periodontitis is the third biggest killer that threatens human health after malignant tumors and cardiovascular diseases. It is also the number one demon that eats away at oral health.
So far, the pipeline of new drug treatments for periodontitis has been far less than that of malignant tumors, cardiovascular vessels and rare diseases, and is a high ground to be conquered. The author will review the market for the treatment of periodontitis.
Periodontitis can not be underestimated, the related treatment medicine is deficient
According to the Journal of Dental Research, according to report on the epidemic condition of severe periodontitis published in the global population aged 15 and severe periodontal disease prevalence was 11%, the prevalence of severe periodontitis in China is about 12.1% ~ 12.1%, the number of new cases per year is 750/10, ten thousand. The 3rd national oral health epidemiological survey showed that the periodontal health rate in China was just over 14%, and most patients with periodontitis did not receive reasonable treatment.
Foreign studies have reported that chronic periodontitis (CP) is a congenital exocrine gland disease of autosomal recessive inheritance. Influenced by genetic factors, physical and environmental health, the majority of patients with periodontitis starting from the age of 30, the lower incisors first attack more, periodontitis affects the gums, the periodontal ligament, alveolar bone and tooth bone chronic infection, after inflammation, bleeding gums, periodontal pocket formation and alveolar bone absorption, decrease alveolar bone height, loose teeth and tooth loss. After more than 20 years, most of the lower teeth are basically tired, almost as an incurable disease of the mouth.
So far, periodontitis has been treated with less drugs and is only a palliative. Numerous studies have confirmed that periodontitis is an independent risk factor for acute coronary heart disease, with significant correlation with acute or total mortality. Into the catalog of national medical insurance in 2017 oral drugs only six varieties, and drugs for periodontitis is just on bran sterol oral often release agent, on behalf of indications and chlorine on external use liquid, its rarity.
In recent years, there have been few new drugs for treating periodontitis, and only Arestin, which was approved by the FDA on February 16, 2001, in OraPharma Inc. Additionally, the approved minocycline preparation is a gel agent Atrix, astra pharmaceutical company's PerioStat and CollaGenex, of the Atrix pharmaceutical company.
The growth of the market of periodontal disease is obvious
According to relevant data show that in 2015 into the global top 500 best-selling drugs of periodontal disease, there is only one is OraPharma Inc/Valeant, sales of periodontitis targeted drug minocycline ointment (Arestin), sales of $151 million, year-on-year growth of 33.63% a year.
According to m Intranet related data in 2016, the domestic focus of the city's public hospital for the treatment of periodontal disease drug market for more than 1150 ten thousand yuan, year-on-year growth of 24.05% a year, its growth rate is significantly higher than other varieties. Need drugs for minocycline ointment, iodine glycerin, compound chlorhexidine gargle containing liquid, strong indications for wash liquid, ammonium chloride ketoneses tyrothricin lozenges, metronidazole mucilage contain gargle fluid and buccal tablet, boron cream and triamcinolone acetonide oral ointment, bran sterol and artificial bezoar metronidazole capsules.
Commonly used systemic use of antimicrobial agents used more anti anaerobe and aerobe united way, although have certain effect, but local targeted drug delivery, drug ACTS on the tooth bag, in the fluid of the gingival sulcus enough bacteriostatic concentration and enough time is the key of the treatment.
Domestic minocycline ointment has been approved for clinical application, and the domestic monopoly will be broken.
Minocycline is a semi-synthetic tetracycline that is efficient, long-term and highly lipid. It has excellent organizational permeability and can be widely distributed in tissues and humors, with high concentration of blood medicine and strong sterilization ability. However, minocycline has certain side effects and limits the use of groups.
With the rapid development of drugs targeting preparation, OraPharma Inc Arestin minocycline ointment was developed, in a patent microsphere technology continuous conveying minocycline directly into the gums periodontal infection under capsule, used in adult periodontitis and tooth and implant treatment.
For the world, periodontal disease is one of the main causes of tooth loss in adults, but periodontal disease has not been fully treated. In April 2001, China approved the treatment of minocycline ointment, a dental treatment drug produced by Japan's Sunstar INC., and the commodity name, Periocline. The drug is injected directly into the periodontal area by the doctor or the patient, avoiding the defects of slow oral administration and serious side effects. It is a targeted preparation for improving the symptoms of periodontal disease and high safety.
In 2016, the market of minocycline soft paste in 16 key cities in China was 88 million yuan, a year-on-year increase of 33.88 percent, according to data from minnet. Pyrio is the exclusive and does not go into the health care directory, which is all self-service medicine, and the performance of the terminal market in retail pharmacy is also considerable.
According to CFDA official website, the minocycline soft paste developed by hainan jianke pharmaceutical has received clinical approval (2017L03197) on August 29, 2017, entering the clinical trial stage. Of the development of hainan jianke ek the slow-release materials as the capsule material, package made microcapsules, minocycline in will contain a slow-release microcapsules for the skeleton cream base, through special injection syringe into the periodontal pocket, ointment in saliva harden and adsorption around the lesions, continued to slow release, so, reach the role of kill periodontitis pathogenic bacteria; The listing will break the country's monopoly of "pylio" in China and ease the use of drugs in patients with periodontitis.
Compound chlorhexine containing gargle liquid is the highest
Compound chlorhexidine gargle containing liquid is composed of glucose acid chlorhexidine acetate and metronidazole, used for gingivitis or pericoronitis oral mucositis caused by bleeding gums, periodontal abscess, and aid in the treatment of oral mucosa ulcer, etc. According to CFDA's official website, six of the compound chlorine has been registered in China.
In 2016, the market for the compound chlorhexine, a public hospital in China's 16 key urban public hospitals, was 5.87 million yuan, up 46.75 percent from the previous year. The mouth of the shenzhen south guangdong pharmaceutical company occupies 46.48% share of the mouths of jiangsu morning brand bond pharmaceutical xin account for 39.98%, jiangsu know the original pharmaceutical compound chlorhexidine gargle containing liquid accounted for 9.62%, Harbin loctite pharmaceutical Su great accounted for 3.92% of the share.
Nitroimidazole, bran sterol, iodide glycerol
Nitroimidazoles are made up of the four major varieties of ornidazole, left ornidazole, metronidazole and tinidazole, and are widely used in the application of anti-anaerobes, trichomonas and amoeba. 16 key cities in 2016, the domestic public hospital nitro imidazoles market 350 million yuan, the year-on-year growth rate of 5.66% in the previous year, the third generation of nitro imidazoles drug ornidazole and left ornidazole is to drive the market growth momentum.
Metronidazole and tinidazole are used for the treatment of periodontal disease, but the whole body has the adverse reaction of digestive tract discomfort and allergy. With the listing of special drugs for dentistry, the methods of oral and external use of the drugs are used in the treatment of severe periodontal disease. The antimicrobial effect of nitroimidazolis in adult periodontitis is particularly strong, and it provides a new and effective choice for the treatment of periodontal disease.
In 2016, the market in the public hospital of the public hospital of the 16 major cities in China was 1.62 million yuan, up 13.29 percent year on year. Zhejiang hangkang pharmaceutical co., which has 93.66% of the company, has a 6.34 percent share of the company.
In 2016, the market of metronidazole dental medicine in public hospitals in 16 key cities in China was RMB 570,000, a year-on-year increase of 16.33%. Apricot fai day force (hangzhou) pharmaceutical metronidazole mucilage contain gargle fluid force ning "day" accounted for 23.50%, shanxi cloud pharmaceutical liquid containing metronidazole gargle account for 18.93%, metronidazole oral buccal tablet of yuanda pharmaceutical (China) "Mr Ann" accounted for 13.86% of the share.
The bran sterol tablets are also known as the extraction of rice bran oil, which is used for oral administration of periodontal disease. It's also been used for more than half a century. It is used for periodontal disease, gum abscess, gingivitis and gingival bleeding. There are 19 enterprises, such as Shanghai qingping pharmaceutical, sichuan otsuka pharmaceutical, etc., which are suitable for mild periodontitis, and the treatment market of periodontitis has been declining year by year.
Iodine glycerin is also an external drug to treat periodontitis. Currently, there are seven registered batches of iodine glycerin in China. In 2016, the market of iodine glycerin in public hospitals in 16 key cities in China was 290,000 yuan, up 4.43% from the previous year. Shanghai yunjia huangpu occupied 98.22 per cent, and Beijing's hedwig accounted for 1.78 per cent. Iodine glycerin is a disinfection antiseptic, its mechanism of action is to make the bacteria protein denaturation, death, effect on bacteria, fungi, and viruses are killing, used for oral ulcer, gingivitis and wisdom tooth pericoronitis disease treatment.
With the improvement of people's economic life, cultural consumption level and awareness of oral health and dental treatment of new drugs and new dosage forms in China will be a rapid development and has a huge potential market.
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