Health Times reporter Chen Linhui
The family members of children with epilepsy who have attracted much attention purchase "life-saving drugs" and are accused of drug trafficking, "Clopajan", is expected to usher in the first imitation in China.
The Health Times reporter inquired about the drug clinical registration and information publicity platform of the Drug Evaluation Center (CDE) of the State Food and Drug Administration and found that there are currently 3 clinical trial registration information of clobar tablets. The applicants for clinical trials are Yichang Renfu Pharmaceutical Co., Ltd. The status of the three clinical trial registration information is: in progress, completed and actively terminated. Among them, the completed clinical trial has a completion date of September 20, 2021, and the drug indications are for the treatment of seizures in patients aged 2 years or older with Lennox-Gastaut syndrome (LGS).
According to the information of the China Drug Clinical Trial Publicity Library of The InnerNet: Yichang Renfu Pharmaceutical Co., Ltd. submitted a clinical application for clobazan tablets in 2020 for the combined treatment of seizures in patients aged 2 years and older with Lennox-Gastaut syndrome (LGS), which was approved for clinical trials in February 2021, completed bioequivalence trials in August of the same year, and declared 3 types of generic listing in March 2022.
Previously, because the family of the child with epilepsy purchased and managed the drug Chlobarjan, he was prosecuted for the crime of smuggling, trafficking, transporting and manufacturing drugs, and the drug Chlobarjan also attracted attention. Clobazan is suitable for the treatment of refractory epilepsy that is ineffective against other anti-epileptic drugs, and is an old drug widely approved for use internationally, but at present, neither imported drugs nor generic drugs have been approved for marketing in China. Yichang Renfu Pharmaceutical Co., Ltd. is the first domestic production enterprise to report the product, which is expected to solve the dilemma of imitation of the "life-saving drug" for children's epilepsy.
According to the official website of the pharmaceutical company, Yichang Renfu Pharmaceutical Co., Ltd. is one of the leading enterprises of domestic nervous system drugs, and in recent years, it has developed a series of products in the field of children's drug shortage, and in 2021, it won the first imitation of midazolam oral solution and successfully entered the 2021 version of the national medical insurance negotiation directory. If the tablets are successfully approved, it will not only bring hope to children with epilepsy in China, but also strengthen the company's competitive strength in the field of pediatric drugs.
"At present, the company's chlorappa project research and development investment is more than 20 million yuan, has completed the pharmacological research of chlorappal cham, plans to complete BE and other studies, on the basis of meeting the declaration requirements as soon as possible to apply for listing, and strive to benefit patients as soon as possible." In January this year, Yichang Renfu Pharmaceutical Co., Ltd. said in an interview with the "China Business Daily" reporter that the research and development of rare disease drugs has the characteristics of high difficulty, long cycle and large investment, which is also the three mountains in front of the research and development of rare disease drugs by domestic enterprises. According to the Measures for the Administration of Drug Registration, the registration classification of the chlorpalcan project belongs to the 3 categories of chemical drugs, and under normal circumstances, it is necessary to complete the pharmacy, human biological equivalent test (BE) and confirmatory clinical practice before submitting a listing application to the State Food and Drug Administration. The pharmacy development of the chlorpalcan project is difficult, and it is a rare disease for children, and the patient population is special, and it is difficult to recruit and enroll subjects. This is the reason why domestic pharmaceutical companies imitate and introduce chlorpha account for low motivation.
According to the Catalogue of Varieties of Narcotic Drugs and Psychotropic Substances, psychotropic substances are divided into the first category of psychotropic substances and the second category of psychotropic substances. Clopazar belongs to the second category of psychotropic drugs and is strictly controlled. According to the "Dependency Conversion Table of 100 Controlled Varieties of Narcotic Drugs and Psychotropic Substances" issued by the Office of the National Narcotics Control Commission in 2017, 1 gram of clobas is equivalent to 0.1 mg of heroin.
"Psychotropic drugs are indeed addictive and will have a great impact on the human body, so the control of such drugs is indeed relatively strict." Kang Zhen, deputy director of the National Licensed Pharmacist Development Research Center of China Pharmaceutical University, once said in an interview with the Health Times reporter that it cannot be denied that some patients do need to take such drugs, and it is recommended that the relevant departments of the state establish a green channel, apply to the relevant government departments by the hospital, and then authorize the relevant enterprises and hospitals from the national level, give them a certain special channel procurement right, and according to the actual needs, the corresponding procurement amount is stipulated, put into the relevant national drug library, to ensure the medication of such children.