Class 1.1 new drug dp-vpa of Enhua pharmaceutical was approved for clinical application

The new drug dp-vpa (API and tablet) of Jiangsu Enhua Pharmaceutical (sz002262) was declared in February 2014 and approved for clinical application on March 16, 2015 The evaluation time of the drug is 13 months in total, and the current processing status is "under approval", involving acceptance No.: cxhl1400017 and cxhl1400018 Dp-vpa, a new antiepileptic drug, is a phospholipid derivative of valproic acid, which is used to treat epilepsy, migraine and bi-directional affective disorder As a prodrug of valproic acid, it can show better safety and pharmacokinetic characteristics, and is expected to replace the first-line drug valproic acid for epilepsy treatment Enhua pharmaceutical has the exclusive right to develop Enhua pharmaceutical focuses on central nervous drugs and cardiovascular drugs In central nervous drugs, compared with anesthetics and psychotropic drugs, Enhua pharmaceutical only has one kind of neurodrugs, gabapentin In order to enrich the product line of central nervous drugs, Enhua signed a cooperation agreement with Israeli d-pharm company in 2011, and spent US $2.4 million to obtain the exclusive license of dp-vpa If dp-vpa goes on the market smoothly, it can make up for the short board of Enhua pharmaceutical in neurodrugs According to the agreement, when the sales amount exceeds the agreed amount, Enhua will also pay d-pharm a 5% commission of the total sales amount There are disputes on the research and development prospects of dp-vpa There are many disputes on the research and development prospects of the new antiepileptic drug dp-vpa, mainly due to its few patent periods and interrupted research and development history The patent period of dp-vpa's core patent zl01815173.6 in China is still 6 years, and there seems to be a surplus However, according to the statistics of insight database, the time from clinical application to approved listing of class 1.1 new drugs in China is at least 6 years, and the time of market review is on the rise Therefore, when dp-vpa is successfully listed, its market benefit time is not much left Moreover, before dp-vpa was licensed to Enhua pharmaceutical, the product was licensed to shire for development, but prior to the start of phase III clinical practice, shire announced the termination of the project, and the specific reason has not been disclosed by shire On the one hand, Enhua pharmaceutical has the leading advantage in the domestic central nervous drug market, but on the other hand, the research and development prospect of dp-vpa is not clear enough Can dp-vpa, the second class 1.1 new drug of Enhua pharmaceutical, bring new market growth? It's too early to make a conclusion, and let's wait and see.