Foreign companies continue to sing high prices for imported antibiotics

Business Club December 31 News Recently, the National Development and Reform Commission adjusted the price of the original research drug in foreign companies. The drug price adjustment was the 26th price adjustment made by the Development and Reform Commission since 1997. For individually priced drugs, it is the first time a larger range of "moving knife." Previously, some people thought that this was the prelude to further price cuts for Medicare drug catalogs. At the 64th Pharmaceutical Fair forum held in Nanchang recently, many insiders thought that this was a pave for domestic drug price cuts. However, in the face of tendering, foreign drugs and individually priced varieties still have strong advantages.

In recent years, anti-infective drugs have been the most frequently used and the most severely reduced. Of the 48 generic drugs that were price-cut in December 2010, the average retail price of drugs that were individually priced on 174 items fell by an average of 19%. Among them, anti-infective drugs are 14 generic drugs, accounting for approximately 30%.

13 antibiotic-based drug price adjustments The Ministry of Health of the People's Republic of China announced on August 18, 2009, in the “National Essential Drugs List (Part of Basic Medical and Health Institutions Equipped with Use)”, there are 34 antimicrobial drugs, and this time adjustment of prices has amoxicillin. Piperacillin, amoxicillin/potassium clavulanate, cephalexin, cefuroxime, ceftriaxone, azithromycin, fosfomycin, ciprofloxacin, ofloxacin, levofloxacin, miconazole, fluconazole Thirteen generic drugs were used, which accounted for 38% of the National Essential Drug List.

According to data released by the Southern Food and Economic Research Institute of the State Food and Drug Administration, in 2009, the sales volume of medicines in the hospital market in China was 369 billion yuan, an increase of 22%, and the sales volume in the pharmaceutical retail market was 148.7 billion yuan, an increase of approximately 14.8% year-on-year. . Anti-infective drugs are the most widely used clinical products in China, the fastest replacement, and the most products. The market for anti-infective drugs in China has reached RMB 92.539 billion. Therefore, the price adjustment of such drugs has attracted attention.

In the past two years, the pharmaceutical market and retail market in our country have developed rapidly. According to the data provided by the China Pharmaceutical Association Science and Technology Development Center, the total amount of drugs used in the 22 cities in 2008 sampled was 53.192 billion yuan, an increase of 24.7% from the previous year. In 2009, the total amount of drugs used by hospitals reached 65 billion yuan, an increase of 22.2% year-on-year. Among them, systemic anti-infective drugs were 15.733 billion yuan, accounting for 24.20%.

The performance of the drug market is stable. From the perspective of China's pharmaceutical market, generic drugs dominate the market, and the original research drug (including patented drugs) only accounts for 5% of the drug market, but its market share has increased from 12% in 1997 to the current 30%. With the rapid development of import, joint venture pharmaceutical companies, and sales of their products are inseparable. With the improvement of medical diagnosis, high consumption in the medical field has become a heart disease for patients.

After the price revision of the original research drug by the National Development and Reform Commission for foreign companies, the overall response was relatively calm. The main reason is that many imported drugs and individually priced drugs in China are relatively high in price, and their profits are relatively high. Therefore, this price cut has little effect on many companies. The first is that companies have had a comprehensive understanding of price cuts and have enough capacity. On the other hand, the original research drug is different from the domestic drug, and the original research drug has a large profit margin. Therefore, the space for this price reduction does not produce too much deterrence for foreign drugs. Foreign drug manufacturers are fully tolerated, and many foreign-funded enterprises still occupy the market in China. They value long-term interests.

From an insider familiar with Nanchang Lijian Pharmaceuticals, the author learned that although the price of the original research drug in foreign companies has been adjusted, domestic drugs with the same quality are still many times cheaper than imported drugs. Relatively speaking, domestic production enterprises are still in the tendering process. Weak. In this regard, Lijian Pharmaceutical has a certain degree of representation.

In December 2010, the price cuts for antibiotic drugs mainly included 13 semi-synthetic penicillins, first-generation cephalosporins, second-generation cephalosporins, third-generation cephalosporins, third-generation quinolones, new-generation macrolides, and antifungal drugs. Generic drug. Cephalosporins are the most commonly used anti-infective drugs in clinical practice, especially the price reduction of cefuroxime and ceftriaxone. In 2009, the amount of drug use in 22 sample hospitals reached 471 million yuan and 356 million yuan respectively. It is predicted that after the price reduction, the growth in the amount of medication will slow down in 2011, while the amount of medication will continue to grow.

The price of cefuroxime is further suppressed by cefuroxime. It belongs to the second generation of broad-spectrum cephalosporins and is an antibiotic drug sold in many countries and regions around the world. Due to its exact curative effect, wide antibacterial spectrum, low toxicity to the kidney, strong permeability, and stability to β-lactamase, adverse reactions rarely occur in clinical applications.

According to the 2009 China Pharmaceutical Statistics Annual Report of the Ministry of Industry and Information, there are 27 domestic manufacturers of cefuroxime sodium, and the total output is 462 million. Among them, the top five are Shenzhen Zhijun Pharmaceutical, Nanchang Lijian Pharmaceutical, Shandong Luoxin Pharmaceutical, Guangzhou Baiyunshan Tianxin Pharmaceutical, Shanxi Weiqida Pharmaceutical, and 5 companies account for 63.50% of the total statistical output, while others 22 homes account for only 36.50% and have gradually formed a high degree of industrial concentration.

In 2005, when the National Development and Reform Commission announced the reduction of the maximum retail price of 22 drugs, the price of cefuroxime sodium injections fell by an average of 23.42% from 2004 prices in the separate pricing and temporary maximum retail prices of the original research drugs. This time, the price adjustment in 2010 was only A decrease of 11.65%. Cefuroxime axetil tablets declined by 20% in 2005 and by 10% in 2010.

The same specification of domestic cefuroxime sodium injection has dropped by 44.05% in 2005, the price is 18.80 yuan, and cefuroxime sodium (Xilinxin) for injection of GlaxoSmithKline brand drugs is still 78% more expensive than domestic drugs. This is also an important factor in the overall response of the National Development and Reform Commission after the price adjustment of the original research drug by foreign companies. When the author discussed with Nanchang Lijian Pharmaceutical Industry, the second largest manufacturer of cefuroxime sodium for injection in China, the market manager Xu Hongliang believes that there is no “floor price” for basic drug bidding and the price will increase. The lower, even lower than the cost price, prevents companies from maintaining production. Many people in the industry also believe that at such low prices, how to ensure that the overall strength of pharmaceuticals, production, and reputation will become a source of waterlessness.

The market of ceftriaxone sodium is ceftriaxone which is the largest species of cephalosporins in the market. It is a long-acting antibiotic drug in the third generation cephalosporins. It was marketed by Swiss Roche Pharmaceuticals and has been widely marketed. Its excellent mechanism of action promotes market development. At present, in the world, whether it is raw materials or preparations, competition is fierce, and it has become a major indicator of the market for cephalosporin antibiotics.

In 1991, China's pharmaceutical companies successfully developed ceftriaxone preparations and obtained production approvals. In 1995, China approved the production of ceftriaxone sodium by Shanghai Roche under the trade name of "Rossin". After the patent expired in 1996, ceftriaxone entered the growth stage in China. As of September 2009, SFDA has approved 379 production approvals, of which 36 production raw materials and 110 production of ceftriaxone injection for injection.

According to statistics published by the China Pharmaceutical Industry Association, in 2009, China's ceftriaxone production of raw materials was 2,646 tons, an increase of 29.07% over the previous year. Under the expansion of downstream product expansion, it also stimulated the growth of foreign trade exports. In 2009, the export supply was 175 tons, an increase of 36.66% year-on-year.

Ceftriaxone sodium drugs have the basic requirements of large market demand, outstanding clinical efficacy, and high value-added products, which has led to the rapid growth of this product, making ceftriaxone sodium a core product in the antibiotic market. In the past five years, in the sample hospital cephalosporin antibiotics ranking list, has been in a leading position. With the adjustment of antibiotic prices in the country, the amount of ceftriaxone sodium used has also fluctuated, but the ranking is always within 50 of the sample hospital medication.

According to the 2009 China Pharmaceutical Statistics Annual Report by the Ministry of Industry and Information, there are 43 domestic producers of ceftriaxone, with a total output of 1.904 billion. Among them, the top five are Yuekang Pharmaceutical Group, Harbin Pharmaceutical Group, Shandong Luoxin Pharmaceutical Co., Ltd., Shijiazhuang Pharmaceutical Group and Kaifeng Pharmaceutical (Group). The five productions account for 56.41% of the total output of ceftriaxone.

Ceftriaxone sodium for injection has been used in the Chinese market for nearly 20 years. The public believes that ceftriaxone sodium has been used as a generic drug from new drugs. However, from the perspective of the highest government-directed retail prices, there is a big gap between individual-priced and domestically produced drugs. The data shows that in 2005, Roche's average price was reduced by 22.14%; after 5 years, in 2010, Roche's average price was reduced by 29.10%.

Taking 1 g of ceftriaxone sodium for injection as an example, the maximum retail price of the individually-priced drug Robust is 557% higher than that of domestic drugs. The domestic drug is only 15.22% of Robust, showing a wide range of price differences. Industry insiders believe that domestic pricing for ceftriaxone for injection has been very low and competition is extremely weak. Under the influence of local protectionism and non-standard bidding, profits are even lower. It is understood that the overall profits of domestic drugs are basically 7% to 8%, while foreign drugs are generally 30% to 40%. The profitability of high-priced drugs is even higher. The drugs that are individually priced have a great impact on domestic companies and may even cause many products to quit production line.

The drug-based drug procurement standard solves the mystery. At present, despite the fact that the national unified drug tendering document is late, if it can truly implement centralized procurement and unified distribution in provinces (regions, cities), and adheres to the combination of government-led and market mechanisms, It will undoubtedly make many domestic companies see a glimmer of hope by capitalizing on the advantages of centralized bulk procurement, minimizing corporate costs, realizing safe and effective basic medicines, good quality, reasonable prices, timely supply, and promoting the production and supply of essential drugs.

Xu Hongliang believes: "For large clinical doses, after several centralized purchases, prices have been basically stable and adequate supply of some basic drug types, such as cefuroxime sodium for injection, ceftriaxone for injection and other antibiotics and some proprietary Chinese medicines, It is recommended to study and formulate documents similar to the bid 'base price' as soon as possible. Each province should refer to the formulation of the province's unified pricing and optimize the production enterprises."

“In order to avoid unpredictable factors in the supply, production, and transportation links, the basic drugs cannot be fully supplied. For some of the basic drug types with large clinical dosage and many manufacturers, the number of successful bidders should be 5-8. It is advisable to use homes instead of adopting a single source of supply that is more risky,” said Xu Hongliang.

In short, in the bid-standard procurement bidding for basic drugs, the technical indicators of the “double envelope” are basically indicators related to the company. In particular, indicators such as production scale, sales, and industry rankings are actually repeated scores. It is true that the quality of large-scale enterprise varieties is relatively stable, but basic drug bidding involves drugs, large enterprises have small varieties, and small enterprises also have large varieties. We should see that a considerable number of domestic companies are taking the route of “strengthening and refining”, and the sales scale may not be large, but a certain basic pharmaceutical product can become the leading domestic product in terms of quality and production. It is recommended that provinces increase the rankings of production and sales of single varieties, safety evaluations (adverse reaction occurrences), and other indicators related to the drugs themselves in the evaluation system, fully embodying the preferred role of the “technical standard”.

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