It is difficult to relieve medication for children with epilepsy. The domestic first imitation of chloropa is approved to be listed.

On September 22, Blue Whale Finance reporters learned from Renfu Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Renfu Pharmaceutical") that recently, its holding subsidiary Yichang Renfu Pharmaceutical Co., Ltd. (hereinafter referred to as "Yichang Renfu" ) Received the chloropa occupied "Drug Registration Certificate" approved by the State Drug Administration.

Shimcz is a broad -spectrum antiepile seizure drug that treats rare epilepsy. In more than 100 countries, it is used for antiepileptic drugs. As early as May 2017, chopcimstan was "not yet registered in mainland China and was not yet registered and listed and listed and listed and listed. "Children's medication that is urgently needed clinically" was included in the "Second Batch of Encouraging R & D and Application for Children's Medicine Suggestions" by the former National Health and Family Planning Commission and other institutions, but at that time, my country has not been listed in China. Many children of children can only from abroad. "Illegal" purchasing regularly listed clippling.

"It is believed that the listing of chorima in China will provide new medication for domestic clinical epilepsy treatment, and it will also bring new hope for the treatment of patients with epilepsy." People said.

In recent years, patients with rare diseases have attracted increasing attention from the national and society. What are the current difficulties of China ’s rare medical medication?

It is difficult to relieve medicine for children with epilepsy

Chopstra occupies the second type of psychiatric control drugs in my country. In July last year, the purchaser "Iron Horse Glacier" was detained by the Zhongmu County Public Security Bureau. It was suspected of smuggling drug crimes and caused social attention. Family.

Since then, in December last year, the "One -meter Sunshine Patient Group" of rare epilepsy diseases and more than 1,000 patients drafted an open letter with more than 1,000 patients, sending "our children to need chlorine occupation" for help, calling on the whole society to pay attention to rare epilepsy "life -saving medicine" The shortage of medication for chine occupation.

In this context, in June of this year, the National Health and Health Commission and the State Drug Administration jointly formulated and issued the "Temporary Import Work Plan for Clinical Urgent Pharmaceuticals" and "Clotic Temporary Import Work Plan". Clarify the application process, drug use management, prescription physician's qualification conditions and management requirements, relevant party and responsibility for the application process of temporary imports. At the same time, 50 hospitals across the country are used as medical institutions that use clotal occupation, of which there are 6 in Beijing, and at least 1 medical institutions that use clotal zhan in other provinces (municipalities).

Public information shows that the overall prevalence of epilepsy in my country is 4 ‰ ~ 7 ‰, and it is estimated that about 6 million patients with activity epilepsy. Epilepsy treatment is to control seizures and improve the quality of life. Drug treatment is the main goal. Studies have shown that most patients with epilepsy have been standardized or relieved by standardized drug treatment. Seizure repeated seizures are called refractory epilepsy. Research on domestic and foreign guidelines, consensus and clinical evidence -based medical studies show that barbaric epilepsy is recommended for children and adults.

According to Renfu Pharmaceutical, the specific matters such as the price and time of the chlorophage is still determined. "It is believed that the listing of chorima in China will provide new medication for domestic clinical epilepsy treatment, and it will also bring new hope for the treatment of patients with epilepsy."

It is reported that at present, the 仿. In December last year, the State Drug Administration stated that eight companies have been allowed to develop chloropham in accordance with relevant regulations. In addition to Renfu Pharmaceutical's industry, Jinan Kehui Pharmaceutical Technology Co., Ltd. has also been relatively high. The company stated last year that the pharmacy work of chinenzhanzhanic drugs has been completed, and the research and development progress has been reported to the pharmaceutical regulatory department.

What are the difficulties of rare diseases?

What are the current dilemma of rare medicine in China? According to Renfu Pharmaceutical reporters, the Blue Whale Finance reporter was that first of all, there were still some rare medical drugs that were not listed in our country. As of March 31, 2021, of the 121 rare diseases involved in the rare disease catalog, 46 diseases have no targeted treatment drugs worldwide, and 168 drugs in 75 diseases have been listed globally. Among the 75 rare diseases with "medicines", 19 treatment drugs with 16 rare diseases were not registered and listed in mainland China.

In addition, in terms of payment, compared with common diseases, rare medical insurance coverage is less, the proportion of medical insurance reimbursement is low, the patient's disease burden is relatively heavy, and there are differences in the level of protection in each region. Third, in terms of diagnosis and treatment, the prognosis and treatment effect of different individuals are very different. At the same time, compared with common diseases, it is more difficult to establish a specific, sensitive and stable clinical and PRO (patient results) of the disease.

Huang Rufang, the founder and director of the CORD (CORD) of Rou Dehan, pointed out that it is not uncommon for rare patients who cannot obtain treatment in China because of the impact of admission policies. In terms of policies, rare diseases are paying more and more attention, but there are few types of drugs available, and problems such as small medicines are still the biggest obstacles on the path of diagnosis and treatment of rare diseases.

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