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Epilepsy is one of the common neurological diseases.
Strengthening the development of anti-epileptic drugs is of great significance to patients
.
Data shows that there are 8 new drugs on the market in the world, but only 3 new drugs have been marketed in China, namely Lacosamide, Perampanel, and Pregabalin
.
Although China has relatively few new drugs in the field of antiepileptic drugs, it is undeniable that China's pharmaceutical companies are making continuous innovation and efforts in this area
.
As recently, CSPC's anti-epileptic drug Enrivi (lacosamide tablets) was launched nationwide
.
According to reports, as a new product launched by CSPC in the field of nervous system, Enliwei has two specifications of 50mg and 100mg.
It was approved by the State Food and Drug Administration on May 26 and August 25 this year.
Consistency evaluation of the quality and efficacy of generic drugs
.
Some people said that among the third-generation anti-epileptic drugs, lacosamide, a representative of slow inactivation of sodium channels, has the following main characteristics: 1.
Lacosamide is refractory to treatment Both monotherapy and additive therapy for epilepsy are very effective; second, lacosamide is well tolerated, and the incidence of rash is very low; third, monotherapy for partial seizures in epilepsy patients 4 years and older has been obtained in China Indications for treatment and combination therapy
.
For another example, the CDE website in July showed that the Levetiracetam tablets of Nanjing Hailing Pharmaceutical of Yangtze River Pharmaceutical Group were accepted for application for listing in 4 categories of imitations
.
Data show that Levetiracetam tablets are developed by UCB (UCB) for the treatment of partial seizures (with or without secondary generalized seizures) in adults and children over 4 years of age with epilepsy; for adults And add-on treatment for general tonic-clonic seizures in adolescents over 16 years of age with epilepsy
.
At present, there are 9 manufacturers of Levetiracetam tablets, including Zhejiang Jingxin Pharmaceutical, Zhejiang Prokangyu Pharmaceutical, and Shenzhen Xinlitai Pharmaceutical
.
In terms of consistency evaluation, 7 companies have been evaluated
.
It is worth mentioning that in recent years, the sales of Levetiracetam tablets in physical pharmacies in Chinese cities have grown rapidly.
For example, sales in 2020 will reach 173 million yuan, a year-on-year increase of 9.
67%..
In addition, in June, the State Food and Drug Administration issued a new drug approval document, and Renfu Pharmaceutical's carbamazepine tablets had been evaluated for consistency
.
Data show that carbamazepine is a dibenzazepine anticonvulsant and antiepileptic drug, suitable for the treatment of epilepsy and trigeminal neuralgia
.
At present, there are 92 domestic companies that have been approved to list carbamazepine tablets, involving 113 production approvals
.
Three pharmaceutical companies, Shanghai Fuhua Pharmaceutical, Shanghai Pharmaceuticals, and Renfu Pharmaceuticals, have applied for consistency evaluation
.
Nowadays, new types of anti-epileptic drugs and medication evidence continue to emerge; anti-epileptic seizures and drug resistance targets are gradually becoming clear, but industry insiders have pointed out that it is still necessary to further promote the standardization of drugs in China
.
In addition, some people pointed out that with the strengthening of national and private attention, the drug market in the field of epilepsy has increased by 8.
5 times in the past 9 years.
The current scale may exceed 5 billion yuan, but drug research and development are still difficult
.
However, the person also pointed out that some medical companies have seen the potential of innovative treatments for epilepsy and have begun to explore the use of technologies outside the biological field to develop digital therapies, which may bring good news to patients
.
Strengthening the development of anti-epileptic drugs is of great significance to patients
.
Data shows that there are 8 new drugs on the market in the world, but only 3 new drugs have been marketed in China, namely Lacosamide, Perampanel, and Pregabalin
.
Although China has relatively few new drugs in the field of antiepileptic drugs, it is undeniable that China's pharmaceutical companies are making continuous innovation and efforts in this area
.
As recently, CSPC's anti-epileptic drug Enrivi (lacosamide tablets) was launched nationwide
.
According to reports, as a new product launched by CSPC in the field of nervous system, Enliwei has two specifications of 50mg and 100mg.
It was approved by the State Food and Drug Administration on May 26 and August 25 this year.
Consistency evaluation of the quality and efficacy of generic drugs
.
Some people said that among the third-generation anti-epileptic drugs, lacosamide, a representative of slow inactivation of sodium channels, has the following main characteristics: 1.
Lacosamide is refractory to treatment Both monotherapy and additive therapy for epilepsy are very effective; second, lacosamide is well tolerated, and the incidence of rash is very low; third, monotherapy for partial seizures in epilepsy patients 4 years and older has been obtained in China Indications for treatment and combination therapy
.
For another example, the CDE website in July showed that the Levetiracetam tablets of Nanjing Hailing Pharmaceutical of Yangtze River Pharmaceutical Group were accepted for application for listing in 4 categories of imitations
.
Data show that Levetiracetam tablets are developed by UCB (UCB) for the treatment of partial seizures (with or without secondary generalized seizures) in adults and children over 4 years of age with epilepsy; for adults And add-on treatment for general tonic-clonic seizures in adolescents over 16 years of age with epilepsy
.
At present, there are 9 manufacturers of Levetiracetam tablets, including Zhejiang Jingxin Pharmaceutical, Zhejiang Prokangyu Pharmaceutical, and Shenzhen Xinlitai Pharmaceutical
.
In terms of consistency evaluation, 7 companies have been evaluated
.
It is worth mentioning that in recent years, the sales of Levetiracetam tablets in physical pharmacies in Chinese cities have grown rapidly.
For example, sales in 2020 will reach 173 million yuan, a year-on-year increase of 9.
67%..
In addition, in June, the State Food and Drug Administration issued a new drug approval document, and Renfu Pharmaceutical's carbamazepine tablets had been evaluated for consistency
.
Data show that carbamazepine is a dibenzazepine anticonvulsant and antiepileptic drug, suitable for the treatment of epilepsy and trigeminal neuralgia
.
At present, there are 92 domestic companies that have been approved to list carbamazepine tablets, involving 113 production approvals
.
Three pharmaceutical companies, Shanghai Fuhua Pharmaceutical, Shanghai Pharmaceuticals, and Renfu Pharmaceuticals, have applied for consistency evaluation
.
Nowadays, new types of anti-epileptic drugs and medication evidence continue to emerge; anti-epileptic seizures and drug resistance targets are gradually becoming clear, but industry insiders have pointed out that it is still necessary to further promote the standardization of drugs in China
.
In addition, some people pointed out that with the strengthening of national and private attention, the drug market in the field of epilepsy has increased by 8.
5 times in the past 9 years.
The current scale may exceed 5 billion yuan, but drug research and development are still difficult
.
However, the person also pointed out that some medical companies have seen the potential of innovative treatments for epilepsy and have begun to explore the use of technologies outside the biological field to develop digital therapies, which may bring good news to patients
.