Ministry of Health rectifies abuse of antimicrobial cephalosporins

The public comment for “the strictest in history” of the “Administrative Measures for the Clinical Application of Antibacterial Drugs” (draft for solicitation of comments) will end on September 5, and antibiotic production companies will feel the autumn cool ahead of schedule. According to an industry analyst who asked not to be named, the current antibiotic market for about 100 billion yuan will likely shrink by 20-30 billion yuan. He believes that the period of the worst decline in the growth rate of antibiotic companies has passed, and the second half of the year may still be It will slide down.

New rule refers to antibiotic misuse

According to the Exposure Draft, the level of antibacterial drugs in tertiary medical institutions shall not exceed 50 in principle, and no more than 35 in secondary hospitals. There shall be no more than two types of injections and oral dosage forms of the same generic name. 2 kinds. In addition, antibiotic drugs are clinically divided into three levels of non-restricted use, restricted use, and special use. According to the patient's condition and antibiotic efficacy, each antibiotic drug has different levels.

The second draft was solicited for comments. In April this year, the Ministry of Health issued the first round of the “Administrative Measures for the Clinical Application of Antibacterial Drugs (Draft for Solicitation of Comments)”. According to industry sources, the “2011 National Special Program for the Clinical Application of Antibacterial Drugs” issued by the Ministry of Health in July meant that the curtain for regulating the use of antibacterial drugs in China has been opened.

For listed companies, "all the antibiotics companies in the first round will be affected, and companies that produce more or less cephalosporins in the third or fourth generation will be more affected," said a pharmaceutical analyst. The market generally believes that anti-infective Chinese medicine preparations that are not within the scope of management exist to a certain extent, while listed companies such as Baiyun Mountain, Yunnan Baiyao [61.28-0.92%] and Hongri Pharmaceutical [26.99-0.04%] have related antibacterial agents. product.

However, some analysts expressed his disagreement: “The first draft did not mention anti-infective preparations of Chinese medicines, and the market may associate them with restrictions on the use of Chinese medicines; but the second draft clearly excludes traditional Chinese medicines, so the benefits of Chinese medicine are only relative to the first draft. The new regulations for antibacterial drugs will not affect the amount of antibacterial drugs used for Chinese medicines, mainly to limit abuse."

The irrational use of antibiotics is widespread worldwide. The theme of World Health Day 2011 is “No action today. There will be no medicine available tomorrow.” According to WHO standards, the average use rate of antibiotics in hospitals should be less than 30. %, however, the current utilization rate of antibiotics in China is approximately 46.5%, the average use rate of antibiotics in hospitalized patients is as high as 70%, and the use rate of surgical patients is even 97%-100%.

Due to the high degree of abuse, antibacterial drugs have become China's largest drug use. This phenomenon is extremely unreasonable. The Director of the Department of Medical Affairs Jiao Yahui of the Ministry of Health once told the media that the Ministry of Health will use three years to rectify the irregular use of antimicrobial drugs. The new rules that will be released this year will show that the Ministry of Health is working hard to resolve the abuse of antibacterial drugs.

Cephalosporins raw material prices down

Listed companies that produce antibiotics all said that the new regulations have not yet been issued official documents and it is not convenient to comment. However, some analysts pointed out that the decrease in antibiotic orders and the decline in sales growth have been revealed in the first half of this year. According to the 2011 mid-year report of Accord Pharmaceutical, the revenue of cephalosporin products was 800 million yuan, a year-on-year increase of 15.69%; and in the first half of 2010, the revenue of cephalosporin products was 692 million yuan. The year-on-year increase rate was 75.28%, and the sharp drop in growth rate was very obvious. In the first half of 2011, the company's respiratory relieving cough medicines accounted for only 124 million yuan, but the increase was 39.21%, which was far more than that of cephalosporins. The cephalosporin products of Huabei Pharmaceutical [11.15-0.18%] achieved revenue of 541 million yuan in the first half of this year, down 4.45% year-on-year.

From the details, the new regulations also require that doctors not only have to undergo clinical training for the use of antibacterial drugs but also pass tests, and they also specify the prescription authority of each doctor for the corresponding antibacterial drugs. It is reported that restricted-level antibiotics can only be prescribed by the deputy chief physician. People in the industry believe that because of the relationship between taking medicine for medical care, hospitals still prefer to use high-volume varieties, and the impact on sales of large quantities of antibiotics that are already on the market is limited.

Some analysts said: “From the three indicators of drug resistance, price, and efficacy, cephalosporins have high prices and high resistance levels in the third and fourth generations of cephalosporins, leading to increased abuse, so the NDRC's 2009 list of drugs There are many second-generation cephalosporins inside, and three generations of cephalosporins are basically not involved.” Wu Huifang, general manager and chief researcher of Beijing Oriental Bit Technology Co., Ltd. (Health Network) also believes that the most affected species will be homogenized efficacies and drug resistance. Strong varieties and varieties with the same product too many manufacturers, which are mainly concentrated in the second, third and fourth generation cephalosporins and quinolones drugs.

Upstream antibiotic companies are also implicated. Currently, some raw materials are falling in price. For example, the price of 7-ACA, an important intermediate of cephalosporins, has fallen below 500 yuan/ton from the high of 860 yuan/ton last year, while the price of penicillin intermediate 6-APA has gone down. Also from 225 yuan / ton to 190 yuan / ton, ceftriaxone raw material prices fell from 1,000 yuan / ton to 600 yuan / ton. The Qilu Securities Research Report showed that downstream distributors began to reduce orders and try to avoid inventory. Some hospitals have begun to restrict the use of antibiotics, and the amount of antibiotics used and varieties used have dropped significantly.

Qilu Securities research report shows that the current antibiotic industry is facing unprecedented challenges, and the advantages of the original high-end products no longer exist. Restricted use means that many products are very likely to withdraw from some high-end markets, while low-end products are too small to be profitable, and the profitability of the industry is facing Inflection point. From the perspective of the entire industry, the proportion of sales of anti-infective drugs has dropped from 30.73% in 1999 to 23.10% in 2010.