The first "butyl benzene injection" improved drug Nanjing Yuke 2.2 new drug was reported to the market.

On June 2, the CDE website showed that Nanjing Ucodinbenzene injections were registered for classification 2.2 and submitted to the cDE for improvement of neurological impairment in patients with acute ischemic stroke.
as early as April this year, insight database shows that Nanjing Yuke started a human bioequivalence test of butyl benzene injection, the control drug is the stone drug emp (butyl sodium phenylene injection), currently showing a completed state.
photo source: Insight Database () butyl benzene, which was first isolated from water celery seeds by the Institute of Pharmacology of the Chinese Academy of Medical Sciences in 1978 and first chemically synthesized in 1980. the
are divided into three main structures: l-butyl benzene, right-handed butyl benzene and transcyclic butyl benzene.
the structure of butyl benzene compounds (source: Wikipedia) In September 2002, The Stone Pharmaceutical Group's butyl benzene softgels (commodity name: Emp) obtained a new drug certificate and trial production approval, and in 2005 it became the third innovative drug with independent intellectual property rights in China after artemisinin and bicyclinol, mainly for the treatment of light and moderate acute ischemic stroke.
oral often-release form of butylbenzene was successfully included in the annual national health insurance directory in 2009, and sales increased significantly in 2010, while in April 2010, the sodium butyl phenylene chloride injection was approved for sale in acute ischemic stroke patients with an improved neurological defect, greatly enriching the product pipeline.
2017, sodium phenylene chloride injections were successfully included in the national health insurance directory, which played a positive role in the promotion of emergency medication spent on stroke treatment and the promotion of the drug in soft capsule recovery.
According to IVQIA data, Emppur's two dosage forms generated sales of 2.9 billion in 2017, of which 1.4 billion were softgels and 1.28 billion were injected, and injections were a strong driver of The Emp market.
Stone PharmaceuticalGroup is expanding on Empp's new indications, with public data indicating that a total of 134 research projects (basic 69 and 65 clinical) are ongoing research projects, and insight databases show that the phase III clinical study of butyl phenyles for the treatment of vascular dementia was first published in December 2019 and is currently being recruited to include 700 patients in the group.
Photo Source: Insight Database () In addition, the butyl benzene injection of the stone drug was listed in the 2014 report and has not been approved to date. according to the
Insight database, Nanjing Yuke and Zhuhai Bonded Area Lizhu Synthetic Pharmaceutical Company filed a listing application for butyl benzodiazepine sphenyl sage in 2017 and are currently under review in supplementary information and are expected to be approved this year.
image source: Insight Database () Nanjing Uco's declared class 2.2 butyl benzene injectionwas was approved for clinical use in October 2019, and Class 2.2 refers to new dosage forms containing known active ingredients (including new dosing systems), new prescription processes, new approaches to administration, and formulations with significant clinical advantages.
the first study of bioequivalence in Nanjing Youke to carry out bioequisability research on the control drug with nbipu (sodium titylbenzene injection) as a control drug, and the first to be reported to the market, is a potential danger for the stone drug Enbipu.
according to public data, Empis is stone pharmaceutical group's fist products, sales in 2019 reached 5.6 billion yuan, up 35.8% year-on-year, accounting for about 25% of the group's total revenue.
it is understood that Ishiguro does not have a patent for a compound for butyl benzodiazepines, a patent for acute ischemic stroke that expires in 2019.
in order to preserve Themarket position of Enbipu, Ishiguro has also developed butyl benzene tablets, l-butyl benzene tablets, l-butyl benzene injections, have been approved for clinical treatment;
new indications and the continuous development of new markets will bring new growth opportunities for Empp, see in the short term other enterprises will be difficult to shake its market position, but the exclusive large varieties will always face the impact of generic drugs, how to expand through indications, the introduction of new products and other ways to maintain the profits of patented drugs will be another big challenge for enterprises.
original title: Entering the domestic market of nearly 6 billion, the first "butyl benzene injection" improved new drug reported to the market.