Medical network May 24 - "the kore is no approved indications of children at home, but there is no other alternative drugs in patients, many doctors still take risks in use, the so-called 'label to apply. Used if the problem is that doctors unlucky, but no words may be more trouble." 

 

In recent days, there have been concerns that Actelion pharmaceutical trade (Shanghai) co., LTD. Has illegally promoted unlicensed drugs. Intentionally conceals the adverse events of the drugs; Illegally accessing patients and collecting patient information; Full access to health care in the form of commercial bribery. 

 

On May 4th, he asked, "we have reported to the public security bureau that this is a smear." But for all the children of indication whether in China or other global markets, approved, adverse reaction mechanism of feedback channel, into the procedure of the negotiations directory, as of the time, love can not reply tyrone. 

 

It was founded in December 1997 in Switzerland and its IPO on the Swiss stock exchange in 2000. The founding team used to work for roche, a rare disease drug, especially in the area of pulmonary hypertension. All of these are drugs that treat pulmonary hypertension. 

 

Actelion started to make money, as Tracleer, the world's first publicly traded pulmonary hypertension drug, went public in late 2001. Actelion's products in the high pressure area of the pulmonary artery are also known as Opsumit, Selexipag (Uptravi) and so on. 

 

On January 26, 2017, Johnson & Johnson announced a $30 billion deal to buy Actelion, as part of the deal, the research and development department of the post-acquisition Actelion will become a new independent listed companies, and its shares as a dividend distributed to shareholders Actelion, Johnson & Johnson will hold 16% stake in the company. 

 

When the deal is completed, j&j will receive a combination of Actelion's Tracleer, Opsumit and Uptravi, which treat pulmonary hypertension. According to the 2016 Actelion report, the three drugs are estimated to have annual sales of $1.02 billion, $831 million and sfr245 million, with total sales of 24.1.2 billion Swiss francs. 

 

Treatment is expensive 

 

Pulmonary hypertension refers to the pulmonary artery pressure exceeds a certain boundary value of a state of hemodynamic and pathological physiology, leads to right heart failure, can be an independent disease, complications or syndrome, morbidity and mortality are very high. 

 

World of pulmonary hypertension, Spain on May 5, every year is the countries as pulmonary hypertension, the current worldwide, about 25 million patients with pulmonary hypertension. 

 

Pulmonary hypertension is a late development in our country, and there is still no specific epidemiological statistics. Jing-yu Chen, vice President of the National People's Congress, in wuxi city people's hospital after an interview with the media said, according to the data of the United States centers for disease control and prevention, the incidence of idiopathic pulmonary hypertension is estimated in 10 to 20 / one million. Based on this data, the estimated number of cases in China is between 14, 000 and 28,000, based on 1.4 billion people in China. 

 

Question in the context of the content is loved by tyrone drugs can all raw temple (wave), are "star" in the treatment of the pulmonary hypertension targeted drugs, it is because of its curative effect is distinct, suitable for many kind of patients with pulmonary arterial hypertension, is 2015 released by the European society of cardiology ESC in pulmonary hypertension treatment guidelines recommend one of drugs; The second is because of its expensive price, which was previously used for a month's use in each box of 19980 yuan, which is called "the blockbuster drug". 

 

In early 2016, the company announced that it would cut its price by 80%, from $19980 / box to 3996 yuan/box (the spec is 125mg by 56 / box). Have the personage inside course of study thinks the move is in response to the wave born patents expire in October 2015, the generic drugs have entered clinical trials, also is in order to enter the health care and made adjustments. 

 

Jing-yu Chen on this year's two sessions proposed include targeted drugs for the treatment of pulmonary hypertension in special drug reimbursement directory, serious illness insurance "pulmonary hypertension, there is no radical therapy but targeted drugs has obvious therapeutic effect, can improve the patient's quality of life and prolong the life of patients. But the targeted drugs are all imported drugs, the price is very expensive, and not within the scope of coverage, the average patient family can't afford to." 

 

According to Chen, it is important to include the medical treatment for the medical treatment of pulmonary hypertension. In the past 10 years, domestic patients have had a 3-year survival rate of 39 per cent without treatment and only 21 per cent for five years. With the advent of targeted drugs for pulmonary hypertension, patients were significantly improved after treatment, with the survival rate of 92.1% and 75.1% respectively in the first and third years. 

 

On April 14, people club department released "2017 national basic medical insurance, industrial injury insurance and maternity insurance drug catalogue" negotiations scope, could be included a total of 44 species, including the wave born of love can tyrone. Prior to this, cities such as shandong, shenyang and shenzhen have incorporated bosheng into the local insurance special medicine catalogue. 

 

Child indications 

 

According to love tyrone information, on the official website of the kore (TRACLEERR) in the global more than 60 sales on the market, including the United States (November 2001), the European Union (May 2002) and Japan (since April 2005). 

 

", according to the above question for indications for approval of product promotion in China and around the world of the law is not allowed, illegal behavior. The drug full of love can tyrone company the raw temple (wave) on the leaflet despite children dosage, but the drug didn't pediatric indications permission in China." 

 

According to the 21st century business herald, the company did not have any child indications in China, but it has been approved in Europe. On May 5, the reporter contacted aittenon and asked for the official eu documents to be approved by the European Union. 

 

In October 2006, the food drug safety administration of China approved the kore market in mainland China, in the clinical use of the pulmonary hypertension and children but is not yet approved indications. Children's medicine is a special medicine used by minors under the age of 14. In wave in the instruction of China, the clear medicine for children in the aspects of "has not yet been established wave was born in the safety and efficacy in children, not recommended for children". 

 

But the love can tyrone's website information, "a quarter of the Tracleer, 32 mg dispersible tablet formulation has been approved in the eu for children. In addition, Tracleer approved for the treatment of children aged 1 PAH." 

 

21st century business herald reporters access to European drug administration (EMA) official data, in a 2015 public release for Tracleer drugs public assessment report (EPAR), specify the Tracleer usage, dosage, risk and research progress, and so on. Usage of these instructions for: "adult should begin with a dose of 62.5 mg, twice a day, four weeks, and then to the routine dose of 125 mg twice a day. In one year of age and above, in children with PAH, recommend starting and maintaining dose for 2 milligrams per kilogram of body weight, 2 times a day." 

 

Love can tyrone in December 2008 and China charity federation launched a charity aid to low-income families of patients with pulmonary hypertension, "the purpose is to make more patients need to have the opportunity to obtain all the effective treatment, has been in full can treat the benefit and cannot continue to afford expensive costs of treating patients to continue to get full kore treatment. Patients must conform to the requirements of the project application of medical and economic standards to achieve full kore drug donations." 

 

According to the official China charity federation, according to the content of the "whole kore charitable aid project from its inception 14 patients to expand project aid, 2010, 2011 increase children indications, in 2012 to carry out the total pay mechanism, by 2016 for new drugs of patients only for patients with low free aid medicine." 

 

On May 3rd, kore projects all staff reporter confirmed into the 21st century economy, "the project by the end of April this year. Each phase of the aid model and the object is different, but from the perspective of the data of project audit, we've funded juvenile patients." 

 

Domestic children's medicine commonly has the problem that "adult can use but not to children". 

 

On November 29, 2016, roche pharmaceuticals announced the CFDA approval for its biological agents to treat arthritis yami ROM indications of new type "systemic juvenile idiopathic arthritis" (" sJIA), yami ROM become China's first listed approved biological agents for the treatment of sJIA. When yamamiro entered China as an adult patient two years ago, paediatricians were forced to risk giving the children of sJIA a chance to use it. 

 

"All kore is no approved indications of children at home, but there is no other alternative drugs in patients, many doctors still take risks in use, the so-called" label to apply ", "a heart doctor with the economy of the 21st century reporter said," this is a gray area. Because abroad have been used, with the if the problem is that doctors unlucky, but no words may be more trouble." 

 

So-called "label" refers to the indications to use drugs without approval or without approval of age group, the dose or method, most of the labels in use of the study focus on prescription drugs. "Drug labels to clinical use at home and abroad, but at the same time may cause health risks and the corresponding legal responsibility, regulators will ban usually label use of drug marketing," the doctor says, "but all available to children generally have more side effects than adults, because dosage is very small. All can be listed for many years, is a drug with higher security, but the doctor when in use for patient shall explain the corresponding risk." 

 

For rare diseases drugs research and development enterprise, because of fewer patients, drug profit ability is low, but high r&d, lead to a rare disease of drug pricing is very high. Apply new indications to do clinical trials, "certainly no expensive new drug research and development, but involve two phase 3 clinical trials may also need the investment of several million," a drug firms r&d staff reporter said to the 21st century economy, "plus the patient data collection difficult, approved for a long time, doctors and patients in the use of the drug to the risk under the condition of the presenter, drug companies are tend to provide drugs for support."