A few days ago, the marketing application (the relevant acceptance No. is CYHS2100147) of class 3 generic drugs "Eslicarbazepine Acetate" submitted by Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd. has entered the administrative examination and approval stage, and it is expected that it will be officially approved in a few days, becoming the first generic drug of this class in China.
Eslicarbazepine acetate is a prodrug of S-licarbazepine acetate, which can inhibit the repeatedly abnormal discharge of brain neurons and control epilepsy seizure by cutting the conduction of action potential. The drug is well tolerated after long-term administration, and has high efficacy and safety. It is reported that no new problems have been found in the safety data of 10 years after its marketing. Compared with carbamazepine, the blood lipid analysis show that the patients' blood lipids have been improved after using eslicarbazepine.
Developed by Bial-Portela, Eisai and Sumitomo Dainippon Pharma, the original eslicarbazepine acetate was approved as a monotherapy or adjuvant therapy for the treatment of partial seizures in adults, adolescents and children (aged 4 and above). It was first approved in Europe in 2009 under the trade name Zebinix, and then in the United States in 2013 under the trade name Aptiom.
In China, the original eslicarbazepine acetate has not been approved for marketing, but it has been included in the market of Second Batch of Suggested Generic Drugs published on the website of the National Health Commission of the People's Republic of China in March 2021.
At present, many enterprises and medical supplies manufacturers in China have entered the generic drugs market of eslicarbazepine. In addition to Yangtze River Pharmaceutical Group, Sihuan Pharm is carrying out BE test, and six enterprises including Changzhou Pharmaceutical Factory and HUAWE have been approved for clinical treatment.
Epilepsy is one of the three major diseases of human central nervous system. According to the report of WHO, there are more than 50 million patients with active epilepsy in the world, accounting for nearly 8.2% of the world's population. There are about 9 million epilepsy patients in China, accounting for about one fifth of the global epilepsy patients, and there are more than 400,000 new epilepsy patients every year.
According to the data of Menet, the sales volume of antiepileptic drugs in public hospitals in key provinces and cities in China were 1.327 billion yuan in 2020. Based on the above data, the sales scale is expected to exceed 6 billion yuan across China. The top five antiepileptic drugs sold in Chinese hospitals are sodium valproate, levetiracetam, oxcarbazepine, lamotrigine and topiramate. These five drugs were approved earlier in China, and many generic drugs have been approved at present.
In addition to eslicarbazepine, three antiepileptic drugs, vigabatrin, brivaracetam and fycompa, are also included in the market of encouraged generic drugs.
As an analogue of γ-aminobutyric acid (GABA), vigabatrin can be used as adjuvant therapy for patients who are ineffective against other antiepileptic drugs, especially for patients with partial seizures (mainly used to control complex partial seizures) and infants with West syndrome (infantile spasms). Manufactured by Sanofi, the original vigabatrin was launched in the United States in 2018. It is one of the few effective drugs approved by FDA to treat infantile spasm (IS) and complex partial seizures (CPS) of some adults who cannot control their seizures after using various epilepsy therapies. In June this year, Aucta has obtained the production approval for first generic drugs of vigabatrin powder.
Brivaracetam, also known as briviac, is similar in structure to levetiracetam, and the binding capacity of SV2A is enhanced by 10 times, 15-30 times than that of levetiracetam, which reduces its dosage by about 10 times...
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