"Nimesulide" dispute escalation: Canchi sued Johnson to do the bureau

Canchi Pharmaceutical Industry (300086) to the National Drug Administration SFDA The latest statement to respond.　　As "Nimesulide" the largest domestic production enterprises, the current "nimesulide" all kinds of drug safety questions and disputes, will Canchi pharmaceutical industry at the cusp.　　The National ADR Monitoring Centre (ADR), originally scheduled to issue the results of the "nimesulide" evaluation on February 20, has remained silent. The incident of Nimesulide, which began in the year of the Rabbit, is now involved in more and more enterprises.　　February 19, Canchi blamed the US Johnson for planning and directing attacks against Nimesulide, and began organising similar production companies to deal with Johnson. Changshu Yu Pharmaceutical sales director Cheng told reporters: "Canchi contact me, hope to be able to unite against Johnson unfair competition." "Cheng said that Yu pharmaceutical products accounted for 50% of the pharmacy market, Canchi pharmaceutical industry accounted for 70% of the hospital market, both basically control the domestic nimesulide market," the other dozens of companies in fact, production is not large.　　"The incident" international Forum, a small "international forum" brewing the storm. November 26, 2010, "2010 Years International Forum on Child Safety Medication" held in Beijing.　　The meeting was small and had only one theme: the advantages and disadvantages of antipyretic and analgesic drugs, and the recommendation of ibuprofen and paracetamol. Cheng Introduction: "Paracetamol, ibuprofen, Nimesulide is the three main types of child antipyretic drugs, Nimesulide is the most effective." The declining sales of ibuprofen in recent years can prove that. In 1998, Nimesulide was first sold in China for 13 years. Cheng said: "The National Drug Administration in the 5-year monitoring period did not detect serious adverse reactions, we have been collecting data, also did not find problems." If you follow the instructions to take the medicine, no problem. "Nimesulide formulations have always been prescription drugs, and ibuprofen and paracetamol are mostly over-the-counter drugs," he said. But in reality, domestic pharmacies often buy prescription drugs without a prescription. Cheng said: "Patients abuse of prescription drugs caused adverse reactions, can not be said to be a drug problem."　　"The forum is directed at the high toxicity of nimesulide in the liver and kidney, claiming that children are banned from foreign countries and recommending paracetamol and ibuprofen." Chinese experts said at the meeting: "Nimesulide is now the third largest pediatric drug sales, from January 2004 to April 2010, a total of 4703 adverse reactions, including 3 deaths." Of course this information has not been published publicly, but the death case is true. "Johnson's two children's Fever medicine Tylenol and Merrill Lynch are the ingredients of paracetamol and ibuprofen, respectively. 2010 Johnson These two products in overseas encounter multiple rounds of recall, seriously affect its brand image.　　Canchi pharmaceutical industry is to point out that Johnson intends to combat competition products, to restore market decline. One participant said: "The sponsor of this forum is Johnson, the sponsorship fee is 1 million." In addition to the professional media, Johnson also invited a central-level TVMedia。　　"After the meeting, it is the television media on the adverse reactions of nimesulide, the continuous report, only to roll up the current turmoil."　　There is a dispute about adverse reactions. It is worth mentioning that, as early as the Canchi pharmaceutical industry listed at the beginning, there is the main product Rui Zhi Qing ("nimesulide" granule) "Poison rural children" and other remarks to see the network, the adverse reaction of nimesulide dispute, long-term presence in the industry.　　After the cessation of the sale of Nimesulide in 2002 in Spain and Finland, the European Drug Administration's commission for drug use has made a positive assessment of nimesulide, and Spain and Finland resumed sales of Seretide in 2004.　　In April 2004, the EU formally adopted the European Drug Evaluation Agency (EMEA) evaluation of Nimesulide, and again affirmed that nimesulide treatment of a wide range of inflammation and pain has good benefit/loss characteristics, is safe and effective drugs. The High Court of Delhi, India, on March 10, 2004, considered the safety of Nimesulide, agreeing with the Drug Technology Advisory Committee (DTAB) that the medical community was well received; the overall data failed to confirm that it should be banned; paediatric disabling of nimesulide is not justified; this medicine should be allowed for adults and children. The Indian Academy of Pediatrics also signs that nimesulide can continue to be used in pediatrics.　　2004 India resumed sales. May 15, 2007 Ireland discontinued nimesulide for 6 liver injury reports and asked the European Drug Administration Commission to review the relationship between nimesulide efficacy and risk.　　September 21, 2007 the European Drug Administration's Commission on human Drugs assessed the efficacy of nimesulide and limited its duration to no more than 15 days, and did not require other European countries to suspend the sale of Nimesulide. Also in 2007, the European Union's Drug Review agency issued a comprehensive ban on the use of Seretide in children under 12 years of age and highlighted in the manual a special warning of the risk of serious liver damage.　　In the United States, the use of nimesulide in children has never been approved.　　In other words, at the international, the use of nimesulide has a different opinion of the discussion, there is a lot of controversy, but there are no more after the sale of the case of re-listing.　　In this regard, the state Food and Drug Administration Drug Evaluation Center, Professor Sun Zhongxi, said that any drug has adverse reaction risk, according to the existing clinical literature at home and abroad, nimesulide and ibuprofen, acetaminophen and other drugs, compared to adverse reactions.　　Professor Ceng of the Institute of Clinical Pharmacology, Tongji Medical College, has been engaged in research on Seretide pharmacology for many years, and he believes that the incidence of nimesulide liver adverse reactions is not significantly higher than that of other nonsteroidal anti-inflammatory drugs.　　Canchi declared war on Hainan Canchi Pharmaceutical industry, the overwhelming doubts and accusations, even from the end of the shelf, so that its Charybdis.　　February 14, Canchi Pharmaceutical emergency suspension of the announcement clarified that the media mentioned "Nimesulide granules" will lead to serious liver damage, death cases and other content and the fact that serious discrepancy, and Hainan Canchi Pharmaceutical Co., Ltd. production of "Rui Zhi Qing" has nothing to do. and CanchiShares in the pharmaceutical industry have also been affected, with prices falling for several days since the opening of 15th. "This species accounted for 80% of the profits of Canchi pharmaceutical industry, the impact is unlikely."　　"A securities analyst said that if the Canchi drug industry could be a catastrophe."　　Canchi Medicine in the prospectus clearly given the data, Rui Zhi Qing in 2007, 2008, 2009 sales of gross profit accounted for the same period sales of gross profit of 72.89%, 84.67% and 89.54% respectively, Rui Zhi Qing's production and sales situation basically determines the company's income and profitability level.　　19th, Hainan Canchi Pharmaceutical Co., Ltd. submitted to Hainan Trade and Industry Bureau "Johnson company through unfair competition means to suppress the Hainan pharmaceutical leading enterprises complaint letter."　　At present, Hainan Trade and Industry Bureau has officially accepted the case, Hainan Bureau of Medicine has also begun to intervene investigation. According to the complaint material submitted by the Canchi pharmaceutical industry, the company "has distorted, exaggerated facts, deliberately fuelled, and maliciously attacks against rivals" in this incident of "nimesulide children's adverse drug reactions".　　Canchi said the company also reserves the right to further legal recourse. "This is the Canchi drug industry's declaration of war on Johnson Pharmaceuticals, which will be followed by legal means to solve the problem."　　said the person. He said Canchi pharmaceutical industry has communicated with the FDA, is willing to the Swiss and Merrill Lynch to do drug safety evaluation of the comparison, scientific assessment. "If the results prove that the adverse reaction of Rui Zhi Qing is higher than the abnormal, the company is willing to take the initiative to withdraw.　　"Commercial means?"　　Whether or not Johnson is the mastermind behind the incident, its flagship drug Merrill Lynch and Rui Zhi Qing have obvious competition.　　At present, in the domestic child antipyretic drug market, with Nimesulide as the main ingredient of "Rui Zhi Qing", with ibuprofen as the main ingredient of Johnson "Merrill Lynch", with acetaminophen as the main ingredient of Johnson Tylenol has been a large market share, is the main variety of antipyretic and analgesic drugs.　　Tylenol was recalled several times in 2010, and Johnson lost a lot of market share, but Johnson has said that the recalled products are not related to the Chinese region.　　Merrill Lynch has been mainly used in high-end markets such as big cities and level three hospitals, and the main position of Rui Zhi Qing is in the two or three-line market as well as primary medical institutions. Canchi said that, compared to Merrill Lynch, Rui Zhi Qing's price is very cheap. Most of China's pharmaceutical companies produce children's acetaminophen products are mainly "nimesulide" as the main ingredient, international pharmaceutical manufacturers to ibuprofen or acetaminophen, such as the main ingredient.　　Because of the price advantage Rui Zhi Qing in recent years the market growth is very rapid. As of January this year, Canchi pharmaceutical industry has been listed 3 billion bags of Rui Zhi Qing (nimesulide granules), which in the field of children Fever Medicine has exceeded Merrill Lynch, in the child acetaminophen market share in the first.　　At present, Rui Zhi Qing (nimesulide granule) segment market share of more than 50%.　　Johnson has not said that the "planning attack" to make any statement, as if also waiting for the final ruling of the FDA. 19th, the State administration of drugs and Drug Administration for the first time to open their position, said that the current nimesulide is still approved by the National Drug Administration, allowed for children's antipyretic drugs.　　The safety monitoring of Nimesulide showed that the benefit of the drug was greater than the risk.　　The FDA said that Nimesulide has always been closely monitored by the National ADR Monitoring Center, and its safety issues will be further demonstrated.　　This January, Johnson and the National Drug Administration International Exchange Center signed the 2011-Year strategic Cooperation Agreement, to carry out cross-border exchanges, drug safety training and other aspects of cooperation. For "Nimesulide caused 4703 cases of adverse reactions," the ADR did not positively deny, but said: "Thousands of cases will certainly be wrong, now we can not identify." The release of information must be responsible, so it will take some time. "Adverse reaction data from the provincial ADR summarized to the National Drug Supervision Bureau of the national ADR, not published before, only insiders can know." Because of the abuse of drugs in Nimesulide, ADR can not give a clear answer to the market. But people familiar with the matter said: "The data credibility is relatively high." "February 21, ADR insiders said:" To make a conclusion on nimesulide need to remove unreasonable medication and other factors, ADR will be more cautious. But you can see how the previous cases were handled.　　The so-called "previous case" refers to the October 2010 FDA moratorium on sibutramine (trimebutine). At that time the situation and now similar: the foreign frame, public opinion hot discussion, ADR evaluation, announced the sale of the moratorium. The nimesulide may await the same outcome as sibutramine.