The first prescription!This rare disease "life -saving medicine" landed in China

As the original research medicine that was temporarily imported by clinical needs for clinical urgently needed medicines, clotal Zhan recently issued the first prescription in the country at the Beijing Union Hospital. This is a drug that treats children with rare and difficult epilepsy. It can be said to be a "life -saving medicine" for the treatment of such diseases. According to the news, the first domestic medicine for the treatment of related diseases has been approved recently. How is its price? Can it meet the needs of patients?

The chloropharic prescription in the country has the first prescription in the country.

Cobra is a drug for rare cure for children with epilepsy, which plays a very important role in adjuvant therapy. However, because chipuba occupies the second type of psychotropic drugs in my country and is addictive, it has not been approved in China before.

In order to meet the patient's demand for a small amount of specific clinical urgently needed drugs that have been listed abroad and have no supply in China, in June of this year, the State Health and Health Bureau and the State Drug Administration jointly formulated and released the "clinical urgent need for temporary imports of drugs for drugs. "And" Cobra Temporary Import Work Plan ". The "Plan" states that the imports of desertzhan will be implemented one after another at 50 third -level hospitals across the country in Beijing Union Hospital. Children and their families can buy chorica through eligible doctors.

Recently, the Beijing Union Hospital opened the first chlorba cubes in the country. Ms. Mao's son was the first child to use the original drug chinenia after prescribing prescriptions in domestic hospitals.

Ms. Mao's son suffered from baby spasm at the age of two. She has been taking chrysea for nearly 5 years. She has been purchasing from abroad by friends, and often faces the risk of drugs. Ms. Mao said that if such diseases cannot be taken for a long time, it is easy to repeat and even bring complications.

"It turned out to be purchased online, but I was always worried about buying fake medicines. It is convenient now because I don't have to worry about buying fake medicines. After all, the hospital will definitely be a regular way, and don't worry about the drug break."

Doctor: Provide a solution for the availability of other rare diseases

Zhang Bo, director of the Department of Pharmacy Department of Peking Union Hospital, said that the impact is very serious in terms of children or families. "For example, the impact on the intellectual development of the child, the damage to his body, and the mental stress are very great."

Zhang Bo pointed out that with the import of chloropa occupation of the original drug, the problem of drug use of drugs in domestic refractory epilepsy has been effectively relieved, and it provides a solution for the availability of other rare diseases.

Shao Rong, Executive Dean of the Academy of Pharmaceutical Supervision Science of China Pharmaceutical University, said that the measures to solve the problem of rare disease families mainly include imported original drugs, localization of imported drugs, and imitation. According to Shao Rong, the registration and approval of imported drugs need to go through multiple strict procedures. In recent years, for rare disease medications, the state drug supervision department also reduces the time of listing approval as much as possible while strictly benefiting the risk benefits. Patients and families saw the dawn as soon as possible.

Shao Rong said that directly imported medicines from abroad, that is, products listed abroad, drug holders are interested in coming to the Chinese market and applying to the drug supervision bureau. Pathopathy, surrounding children's medication, its procedures will be appropriately accelerated. "It depends on how its clinical data is, whether there are data differentiated data, etc., and also involve the problem of rare disease samples. It depends on the number of samples if there is clinical research? The approval of drugs is relatively flexible under the premise of ensuring safety. "

Enterprise: Domestic drugs are expected to be cheaper than imported drugs in October

In addition, the first domestic medicine for the treatment of related diseases has been approved recently. Liao Zongquan, deputy director of the enterprise development center, said, "In September, we obtained the" (Drug) Registration Certificate "approved by the State Drug Administration and obtained our production approval. Our company expects this product to be listed in October."

Liao Zongquan revealed that there are relatively few drug audiences used in such rare diseases. There are not many companies engaged in R & D and production in China, and it is not difficult.

"The research and development of psychiatric drugs is more requirements for the management links in the management links. Whether it is materials or actual production, there are some special requirements, such as requesting two people operations. Among them, the process we first obtained, its income, environment, etc. are relatively poor and do not meet the needs of commercial production. How to design new synthetic routes to avoid these adverse effects, while increasing the final production of the final production Out of the time to guarantee the medicines later, this is a huge challenge to the raw material process route. "

Regarding the price issue that everyone is concerned about, Liao Zongquan said that the company has not finally determined the sales price, but it can be determined that it will definitely be cheaper than imported drugs.

Disclaimer: This article is transferred from the Voice of China (ID: ZGZS001) of the Central Radio and Television Station, thanks here!

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