国产氯巴占片申请上市获受理

On April 12, 2022, Yichang Renfu Pharmaceutical Co., Ltd. issued a document stating that the 10mg and 20mg tablets developed by its company have submitted a marketing authorization application and successfully accepted it (acceptance number: CYHS2200435 country, CYHS2200436 country). Yichang Renfu Pharmaceutical Co., Ltd. stated in the release that the company received project approval for the development of clobazam tablets in 2018 and began research and development. It applied for clinical application in November 2020 and obtained clinical approval in February 2021. Currently, the company is accelerating the research and development process in response to the urgent needs of the society and has submitted a product marketing authorization application to CDE (Center for Drug Evaluation of the State Food and Drug Administration). The company will continue to follow up on the product process to ensure a smooth launch.

Epilepsy is one of the common neurological diseases, affecting approximately 0.7% of the world's population. It is also one of the important neurological diseases that contributes to the disease burden of patients when measured in terms of disability-adjusted life years. Drug treatment is the basic treatment for epilepsy, and controlling epileptic seizures is the key. However, even after regular drug treatment, about 1/3 of epilepsy patients still cannot fully control their seizures, which is called drug-refractory epilepsy. Since there are many different types of epilepsy, more drugs are needed to control different types of epilepsy. For drug-refractory epilepsy, a combination of multiple drugs is often required.

Clobazam binds to the BZD site on the γ-aminobutyric acid type A (GABA,) receptor, enhancing the inhibitory effect of GABAergic nerves and exerting its anti-epileptic and anti-anxiety effects. A meta-analysis indirectly compared the therapeutic effect of clobazam and 4 other anti-seizure drugs on fall attacks in patients with LGS. The results of the study found that high-dose 1.0 mg/(kg·d) and medium-dose 0.5 mg/(kg·d) clobazam were superior to lamotrigine, topiramate, rufinamide, and felbamate in reducing fall attacks.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

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