Rare epilepsy "life -saving pills" Domestic clotal occupation is approved!Patient: Finally see hope

Author:Red Star News Time:2022.09.21

↑ The official website of the State Drug Administration shows that desert accounts for drug approval

Red Star News reporter ｜ Wang Jianqiang

Editor of Deng Yiguang Edit ｜ Wang He

On September 21, Red Star Journalists learned from Yichang Renfu Pharmaceutical Co., Ltd. (hereinafter referred to as "Yichang Renfu") that recently, the company received the chlor etcocalist "Drug Registration of Pharmaceutical Registration for the National Drug Administration's approval of the State Drug Administration. Certificate".

Red Star reporter also learned on the official website of the State Drug Administration, and in the "September 19, 2022 September 19, 2022 Drug Approval Certificate to Receive the Information Release", Yichang Pharmaceutical Apply for two chlor essiles The number is "Chinese Medicine Performance H20223657", "Chinese Medicine Quanda H20223658", and the approval date is September 14, 2022.

According to Red Star News previously reported, chloropham is a broad -spectrum antiepile seizure medicine that treats rare epilepsy. In more than 100 countries, it is used as antiepileptic drugs; At that time, it was not approved to be listed in China. The family members of the children could only purchase regularly listed chlorophara from foreign countries. As the customs increased the investigation of chlorotia drugs, many children were facing the risk of drug disconnection.

↑ Chleako is a broad -spectrum antiepile seizure medicine that treats rare epilepsy. In more than 100 countries, it is used as antiepileptic drugs

In November 2021, Red Star News released an exclusive report "Drug Traders" Mother "disclosed that several rare epilepsy mothers were charged as" smuggling, transportation, drug trafficking "because of helping buyers to collect overseas clotal parcels. After the report was published, the shortage of specific drugs of the rare epilepsy group began to be concerned about the public.

In December 2021, the State Health and Health Commission publicly responded that it was organizing the cosmetic group to understand the needs of the diseased group, understanding the demand for the amount of drugs, and coordinating the relevant institutions and departments in accordance with the relevant provisions of the Drug Management Law, and organized a centralized application and import to meet patients to meet patients to meet patients to meet patients with patients. Demand demand.

On March 29, 2022, the State Health and Health Commission issued the "Cobra occupation Work Plan" publicly soliciting opinions, "In order to meet the urgent needs of clinical drugs, in accordance with the relevant provisions of the" Clinical Expressive Pharmaceutical Import Work Plan ", Formulate a temporary import work plan. "

On June 29, 2022, the State Drug Administration issued the "Notice on Printing and Distributing the" Temporary Import Work Plan for Clinical Urgent Pharmaceutical Import "and " stated that it was the The masses have a small amount of specific clinical urgently needed drugs that have been listed abroad and have no supply of drugs in the country abroad, and take this as an opportunity to form a relatively complete clinical urgent need of drug temporary import solutions. The "Temporary Import Work Plan for Clinical Urgent Pharmaceuticals" and "Jamca Temporary Import Work Plan" are issued.

At the same time that the relevant national departments actively carried out the import work of chlorophara, the listing of domestic club occupation also ushered in a major breakthrough.

On September 21, the relevant person in charge of Yichang people introduced to the Red Star journalist that rare epilepsy is characterized by childbirth. Most of them are epilepsy encephalopathy. The causes are complicated and diverse. Sexual epilepsy; chorus is aimed at the effective effect of rare epilepsy. Compared with traditional drugs, there are fewer adverse reactions in sedatives and hubs, less drug interaction, and better tolerance.

"Although patients have an urgent clinical needs for chloropa, because their orphan drugs and national second type of psychiatric drugs are dual attributes, the market is small, large in investment, and low income. The long -term listing in the country was not listed in China.

The relevant person in charge of Yichang Renfu also introduced that in 2017, the company decided to apply for clotal occupation projects in the "Second Batch of Encouraging R & D and Application for Children's Medicine Suggestions" issued by the former National Health and Family Planning Commission and other institutions, and decided to apply for the project.

The relevant person in charge also said that the company will put the protection of drugs first, bringing better treatment opportunities to domestic children; for the parents' demands of the parents, the company is preparing to start the desertham in 2023 to enter the national medical insurance to enter the national medical insurance The application for the directory will also prepare for cooperation with third -party public welfare funds in the later stage to conduct pharmaceutical assistance for patients with economic difficulties.

"I can't wait to go to the hospital for prescribing medicine!" On September 21, a family member of a rare epilepsy disease told Red Star Journalist that after the problem of shortage of clotal, "every one or two months, there will be any one or two months. The good news came over, and the relevant national departments made a solemn statement that it carried out the import work and domestic pharmaceutical companies' declaration ... Although the work process has been fast, we have been waiting for the family members of the child for too long. "

Min Wen, the owner of another patient and the patient group "One -meter Sunshine Patient Group", told the Red Star reporter that he finally saw hope that domestic clotca was approved to be listed, overseas chopstorms also began to be imported. The problem of medication can be solved soon.