The first domestic imitation antiepileptic drug clobazam was approved, and Renfu Pharmaceutical responded: it is expected to be launched within this year, and it is expected to enter the medical insurance in 2023
2022-09-23: [Article Link] Source: Times Weekly by Wang Dandan
From the time that imports are permitted to the first generic drug on the market, the road against epilepsy is finally through the country.
On 20 September 2022, the Ichang Pharmacy Company Ltd. (hereinafter referred to as “the Human Pharmacy Industry”) released a message stating that it had recently received approval from the National Drug and Monitoring Service for the issuance of the Certificate of Registration for Drugs for Chlorpa-occupions (hereinafter referred to as the “Certificate”).
The issuance of the certificate means that our country is about to have its first chlor-pascadoxin pharmaceutical product, and that the company is also qualified to sell it on the domestic market.
In this regard, the director of the Pharmacy for Favour, a correspondent for Times Weekly, said that the follow-up company would place chlorine tablets on the market as soon as possible and was expected to do so in the course of the year.
Chlorpa-occupancy is a new type of anti-eclampsia drug, and the Network of Human Favourists has shown that its treatment for children as young as 2 years of age and adults with the Lennox-Gastaut syndrome (hereinafter referred to as LGS) is accurate for epilepsy compared to traditional drugs, with fewer sedatives and related adverse central effects, with fewer drug interactions and better tolerance, has been used as anti-epile treatment in more than 100 countries and has been unanimously endorsed by a wide range of clinical experts. The chlorinated cerebral ailment is a rare form of epileptic encephalitis in LGS, which is prone to early childhood and is manifested as a persistent epilepsy in childhood, with symptoms of epileptic cerebral disease accompanying the patient for life, with a prevalence rate of approximately 2/100.000. Until last June, the National Health Council and the National Drug Control Service issued the Temporary Programme for the Importation of Clinical Emergency Medicines and the Temporary Programme for the Import of Chlorpacasia, which identified 50 hospitals throughout the country as health-care institutions that use chlorbacha, and at least one health-care facility in each province (directly under the Central Government). Source: Imagine.
“It's like I've been taking pills since I remember, and every weekend of primary school is in a hospital. When I first took debakin, I didn't know it had hormones, so when I was a kid, I was fat, and the whole person was so ashamed. When you get to junior high school, you may have had an epileptic seizure, twice in an ambulance, and fortunately, teachers and classmates don’t look at me differently. “When are these days the 21-year-old Xiaoji said to the Times journalist that he was diagnosed as an epileptic from childhood, that he has been suffering from medication, and that when he is stressed, he is sick, and he never dares to fall in love?” In addition to Xiaoji, Guo is also an epilepsy patient in his 40s this year, and he is not sure what caused the disease, but he has indeed tortured one third of his life. “As a child, being stigmatized on a train is a thief, when there are no relatives to support him, and when he returns home, he has had an epileptic seizure.” Guo-Sang is not sure if he was suffering from the disease because of the incident, but then, as long as he is stressed and nervous, he will have an epileptic seizure. With regard to the use of medicines, Mr. Guo, having heard that the disease is very difficult to cure, does not want to waste money on expensive drugs, and has therefore been eating the “student medicine” distributed by the nearby clinic.
Many believe that epilepsy is uncontrollable and incurable, and therefore that the number of visits to epilepsy patients in the country is very low. According to a previous article published by the then Vice-President of the Beijing Institute of Functional Neurosurgery, the rate of visits to epilepsy in the country was less than 40 per cent.
According to public sources, epilepsy is the most common chronic neurological disease in the brain, with children and the elderly at two peaks. According to the World Health Organization, there are about 500,000 epilepsy cases worldwide, of which there are about 9 million in China, and 6 million cases continue to occur every year, with 400,000 new cases occurring every year. In contrast to the rare problem of epilepsy, as a life-saving drug for people suffering from the LGS syndrome, the CCP is now approved for anti-epile treatment in more than 100 countries, or even as a first-line drug for paediatric epileptic treatment. However, before this year, the country had neither approved imports of chlor-papazine nor home-grown generics. Patients had to rely on overseas purchases, which, according to the Catalogue of Varieties of Narcotic Drugs and Psychotropic Substances, were addictive and included in the second category of psychopharmaceuticals and were strictly regulated. During the second half of 2021, widespread concern was raised over the problem of chlor-pacasia seizures and the difficulty of purchasing medicines for children suffering from epilepsy, and in December, the National Health Board, in an open response to media concerns, stated that it was organizing a mapping of the sick population and coordinating the organization of centralized applications and imports by the relevant agencies and departments, in accordance with the relevant provisions of the Law on the Administration of Drugs. In June of this year, the National Health Board and the National Institute of Medicine issued the Work Programme for the Temporary Import of Clinical Emergency Medicines and the Work Programme for the Temporary Import of Chlorpacca, which clarified the application process for the temporary import of chlorpacca, the management of the use of medicines, the qualifications and management requirements of prescription physicians, and the responsibilities and responsibilities of the parties concerned. A total of 50 hospitals throughout the country have been identified as health-care facilities using chlor-paccasia, of which six are in Beijing and at least one in other provinces (municipalities directly under the Central Government). Impostorials on the market
In addition to allowing imports, we have adopted two routes of “temporary import + imitation” to address the domestic shortage of chlorine papaz.
According to the Human Pharmacy Industry, in 2017, in the national catalogue of medicines that are in short supply to encourage research and development, the company paid attention to the use of chlorine. “At that time, we took note of the demand for medicines for this segment of the country’s rare patients, and it is our responsibility, as a company that has developed drugs in the central nervous field for long periods of time, to promote the marketing of the drug. As a follow-up, in collaboration with a wide range of actors, the chlorine-pap film was approved as “fast speed”.
In 2018, the Pharmacy Industry approved the approval of the National Institute of Pharmacy, which in the same year began researching literature and craft routes; on 4 March 2022, the Chinese Pharmacy Industry's chlorine-paste film was officially submitted to the market; and in May, the drug received the support of the National Institute of Pharmacy's priority CDE review and entered the “green corridor” on the market. According to the National Drug Monitoring Authority's Government Service Portal, which was released on 19 September, information is pending on the confirmation of pharmaceutical approvals, which was approved on 14 September.
With regard to the timing of the marketing of chlorinated tablets, the head of the HFP industry said to the Times Reporter that the exact time was still being determined, but that it had now been approved and should soon be expected to be marketed in the course of the year.
In terms of sales prices of most public concern, the current level of imports of chlorine papaz is 50 grains x 20 mg/box with a selling price of approximately 350-550 Yuan yuan/box, and patients have one pill per day, but the amount of medication used will increase according to age and weight increase. In response, the Pharmacy Industry stated to the Times Journalist that the price of the company's chlor-painted tablets needed to be discussed with a wide range of parties, but that the guaranteed availability of medicines would always be paramount in order to effectively address the problem of the use of medicines by patients. It has been reported that the HPV industry has invested approximately 200.000 Yuan in the CCP project and that as the country's first imitation of the CCP, it may have a market monopoly period in the future for some time.
The founder and chief attorney of Beijing Hong's law firm, Ma Song, in an earlier interview with the Times Journal journalist, stated that the Patent Dispute Resolution, which was introduced in July 2021, provided for a market monopoly period for the first successful generic challenge, and no further approval was granted for the same type of generics to be placed on the market within 12 months of their first approval. This means that once marketed, or for some time, there will be an exclusive market advantage in the human drug industry.
Currently, there is more than one Pharmacy company in the generic industry of chlor-papazine. Last December, according to the National Drug Control Service, eight enterprises have been authorized to develop chlor-papazine in accordance with the relevant regulations. In addition to the human-favourables industry, research and development has been relatively advanced by Synanco Pharmaceuticals and Technology Ltd., which stated last year that the pharmaceutical work on the chlor-Papamic pharmaceutical has been completed and that the progress of research and development has been reported to the Pharmacy Department. In the future, with the introduction into the market of chlor-pap-occupancy medicines, the problem of the use of drugs for epilepsy patients in our country will be substantially improved and breakthroughs will be made.
Xiaoji Wen and Shun Guo are aliases