In the past two years on June 21, the state administration of food and drug administration has expanded the green channel for drug review and approval, speeding up the approval process for registered approvals. In 2015, the CFDA approved sodium bromphenate, fluoropprossin, levofloxacin, and brinazide, four eye medications. Two of these are glaucoma treated drugs: the brinamide maleic maleate of Alcon Laboratories in Alcon, and his fluoroprop eye drops from Japan's participating companies.
Market overview
Domestic and foreign drugs have been synchronized
In May 2014, the Chinese medical association branch of ophthalmology published "China inspection diagnosis and treatment of primary glaucoma consensus (2014)", to improve the level of diagnosis and treatment of glaucoma has played an important role in guiding.
In 2017, the national health care drug catalog, which is published in the national health care drug catalog, is divided into nine small, 64 drugs. The number of small classes is the antiglaucoma agent, which takes 12 drugs. Are respectively jaborandi alkali, thiamethoxam parlour, acetazolamide, bei beautiful front element, times he bisoprolol Lin Zuo amine, vinegar, cloth armour thiazole amine, card for parlour, ratan front element, qu fu front element, bromine monie, left a nearly parlour. It is a new addition to the drug in 2017. At present, China and the United States, Europe and the asia-pacific region have basically been in sync with clinical medicines for glaucoma.
The ophthalmic medicine is 20 billion yuan
According to the latest statistics, there are nearly 70 million glaucoma patients around the world, and by 2020 the number will rise rapidly to 796m, with an increase of 13.71 per cent.
In general, older glaucoma accounts for 14.36 percent of eye disease. Glaucoma drugs, laser and surgery is currently the three methods in the clinical treatment of glaucoma, and according to the type of glaucoma and development period, drug treatment is still the first choice, which led to the rapid development of glaucoma drugs market.
According to the data of the HDM system, the amount of ophthalmological medicine in public hospitals in China's major cities has reached 13.6 billion yuan in 2016, up 11.61 percent year on year. About 20 billion yuan of sales were created by 160 manufacturers of ophthalmic drugs in 2016, with anti-glaucoma drugs accounting for 11 to 12 percent.
Large variety review
Glaucoma is the TOP 10 drugs were drug ratan front element, qu fu front element, cloth Lin Zuo amine, bromine monie, card for parlour, bei beautiful front element, ratan thiamethoxam?, vinegar a thiazole amine, left a nearly parlour, nitric acid comospore rue alkali.
TOP 1 lattin:
The only domestic product of the prossin eye drops
Latanoprost is the first anti-glaucoma prostatin drug approved by the U.S. food and drug administration, the product of Pfizer, called Xalatan. Ratan other prostaglandin F2 alpha analogue, is a kind of selective prostaglandin agonists, can increase the grape membrane sclera of aqueous humor outflow and reduce intraocular pressure, small dose, has good effects in effect, clinical is mainly used for primary open-angle glaucoma and high intraocular pressure. Since 1999, we have imported the product, which is called the fitlida, which is a first-line medicine for the clinical treatment of glaucoma in the domestic hospital.
2001 Pfizer development of compound ratan any other thiamethoxam bisoprolol (latanoprost/Timolol) preparations for FDA approal, reducing primary open-angle glaucoma and high intraocular pressure, disease patients elevated intraocular pressure, and is suitable for the beta blockers and local treatment the effect not beautiful, in 2008 to enter the Chinese market, commodity called comfortable together.
In 2004, the drug and its eyedrops, developed by the drug company lunan bette, were allowed to go public. Then chengdu hengrui, huarun zizhu and Shanghai xinyi jinzhu's latan eye drops are also listed. In December 2015, the tianming tianyin drop eye drops listed in hubei province. In addition, the chemical pharmaceutical shares in Taiwan, and the Taejoon Pharm of South Korea, have been registered in China.
According to the HDM data, the amount of drug used in the public hospital in China's major cities in 2016 was 3.24 million yuan, up 7.89 percent year on year.
It is worth noting that in July 2015, the CFDA approved the release of his fluorostatin, a drug called Tapros, in Japan. In the domestic market, there have been several varieties of prolactin, and the only one has achieved localization. As a result, lantoprop is one of the focal points of domestic anti-glaucoma eye drops and moorings.
TOP 2:
Alcon is the market for tannin
The eye drops are a new breed developed by Alcon Universal. In September 2006, the FDA approved the product, called Travatan. In 2004, alcon's lycana drool was introduced into the Chinese market, which was listed as a commodity. In October 2014, the CFDA approved the use of the product name, DuoTrav, which has entered the domestic hospital market.
Down the front element is isopropyl precursor, through the absorption of the cornea, were hydrolyzed to possess biological activities of free acid, in the body metabolism, qu fu other oxidative metabolism of the free acid can be to inactive metabolites. Fully activating the FP receptor, which causes the water to flow out sufficiently, provides a powerful reduction in intraocular pressure and protects the patient's vision. It is used to reduce the intraocular pressure therapy for patients with open-angle glaucoma or hyperophthalmia.
According to the HDM data, the amount of drugs used in public hospitals in China's major cities in 2016 was 28.13 million yuan, up 0.54 percent year on year. At present, the clinical medicine for the treatment of the eye drops in the home is controlled by alcon, and the compound eye is still in its infancy.
TOP 3 brinamide:
The domestic market is over 100 million yuan
Carbonic anhydrase inhibitor (CAI) is the treatment of glaucoma and high intraocular pressure and a class of drugs, local use of carbonic anhydrase inhibitor has become the beta blockers have taboo and can't tolerate pupil reduction agent of choice for patients with drug use. This kind of drug mainly is to restrain the carbonic anhydride activity of the ciliary epithelium directly, thereby reducing the production of the water and reducing the pressure of the eye. Acetazolamine oral tablets and injections are used for years, but they are less selective and have a poor response to the digestive system. As carbonic anhydrase inhibitor, amine drugs cloth Lin Zuo listed, vinegar a thiazole amine, acetazolamide and double chloride than that amine oral medicine is not chosen by doctors and patients, showing a downward trend year by year, and so did the carbonic anhydrase inhibitor drugs.
In 1998, the F.D.A. approved the release of alcon's bulinolamine, the name Azopt. Cloth Lin Zuo amine is a kind of selectivity and high affinity and significantly inhibit the activity of CA Ⅱ drugs, can reduce aqueous humor production, thus effectively reduce intraocular pressure, have strong effects in effect, stable effect, small side effects and good tolerance, suitable for primary open-angle glaucoma and high intraocular pressure and intolerance to beta blockers in patients with glaucoma. The alcon eye company's brinzo eye drops have been approved for listing in our country, and the name of the product is posted. In 2015, alcon's brinazine tirol was registered with the name of the product.
According to the HDM data, the amount of the drug used in public hospitals in China's major urban public hospitals in 2016 has reached 65 million yuan, up by 3.53 percent from the previous year, and the market for the domestic brinsoamine market is over 100 million yuan.
Database data by retrieving human medicinal center, 2015-2016 at the end of the year, nanjing huawei cloth Lin Zuo amine. Consult a parlour eye drops, chengdu sdsensor tartrate cloth Lin Zuo amine bromide monie eye drops, qilu cloth Lin Zuo amine eye drops, hubei great day dawn any more with amine/maleic acid thiamethoxam bisoprolol eye drops have been submitted to the human medicinal center, becoming the latest window of glaucoma CAI drugs market.
TOP 4 bromine:
Dominate the adrenaline drip market
It was approved by the U.S. food and drug administration in 2001 as Alphagan. Bromine harmony is a kind of selective alpha 2 agonists, optic nerve protection, can avoid alpha 1 - receptor mediated the side effects of the cardiovascular system, it had no effect on cardiopulmonary function almost, can be used as a beta blockers taboo patients preferred drugs. The clinic showed that bromine was slightly less effective than prostaglandin, but it could be used as a combination drug or alternative medicine as an additional drug for thionolol and lantopolin. The FDA has approved the release of the bromine moniteine/thiolol drops, the brinzoamine/bromine and the eye drops, etc.
Currently, the domestic bromine market import drug has al's Alphagan and alcon's Brimocon. Domestic bromine monocine is the "kqingling" of the hang seng in nanjing, "jie lida" of lunan bette, and in 2016, the new approval of the PBR, which was approved by Beijing huienland, has been approved.
According to the HDM data, the amount of the drug in the public hospital of the public hospital in 2016 was 19.4 million yuan, up 12.73 percent year on year. Bromine dominates the market for the epinephrine droplet.
TOP 5 cartirol:
The highest rate of growth of the single side of the monotherapol eye drops
In 1990, the U.S. food and drug administration approved the listing of the U.S. food and drug administration. Beauty and cheerful belongs to nonselective beta blockers, for beta 1 and beta 2 receptor are blocking effect, with minimal or no have local anesthesia effect, and can make the intraocular pressure by 22% ~ 25%, and the primary open-angle glaucoma has good effect of lower intraocular pressure.
In 2016, according to HDM data key cities for the domestic card for public hospital parlour drug amount has reached 9.3 million yuan, year-on-year growth of 28.93% a year, is the highest in unilateral prostanoid drugs eye drops.
Replacement of new drugs
The research and development pipeline follows
Since the 1990s, global anti-glaucoma drug development has reached its peak, and dozens of drugs have been developed, with more than 20 different types of drugs treated with open-angle glaucoma. With the replacement of drugs, the development of new anti-glaucoma drugs is an eternal topic.
In February 2012, the F.D.A. approved Merck's treatment of keratoid glaucoma, an eye hyperbaric drug called "Tafluprost," and a product called Zioptan. He was similar to the treatment of ratan prostaglandin, but alleviated the advantage of long, small side effects.
In April 2013, the FDA approved alcon's anti-glaucoma drug brinamide tartrate and the product name Simbrinza.
On July 28, 2014, the commission approved Simbrinza on sale in the European market and to single-agent therapy is not fully reduce the intraocular pressure of primary open-angle glaucoma therapy of adult patients with disease or high intraocular pressure, the drug can reduce the intraocular pressure of 25% ~ 37%.
In recent years, as foreign drugs have been used in clinical practice in China, the proportion of anti-glaucoma products has changed over the years. Prostaglandin drugs are important in the treatment market for glaucoma and have gradually replaced traditional medicine.
(author: Beijing jilin pharmaceutical) |
