Home Qilu Pharmaceutical Secures Approval for Esmolol Hydrochloride Injection, Adding to Over 40 Products Passing Consistency Evaluation This Year

Qilu Pharmaceutical Secures Approval for Esmolol Hydrochloride Injection, Adding to Over 40 Products Passing Consistency Evaluation This Year

Nov 26, 2021 15:23 CST Updated 15:23
Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Recently, the official website of the National Medical Products Administration showed that Qilu Pharmaceutical's Esmolol Hydrochloride Injection was approved for supplementary application. Data from Mi Network showed that in 2020, the sales revenue of Esmolol Hydrochloride Injection in China's public medical institutions exceeded 700 million yuan, with a year-on-year increase of over 50% in the first half of 2021. Since this year, Qilu has had more than 40 products approved.

Information on Pending Drug Approval Documents Released on November 24, 2021

Data show that esmolol is an ultra-short-acting β-adrenergic receptor blocker and an ideal drug for treating supraventricular tachyarrhythmia, acute myocardial ischemia, postoperative hypertension, etc.

Sales of Esmolol Hydrochloride Injection in Chinese Public Medical Institutions in Recent Years (Unit: Billion Yuan)

Source: Competitive Landscape of Terminal Public Medical Institutions in China

Data from MiNe Network shows that in recent years, the sales of Esmolol Hydrochloride Injection at the terminals of China's urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (referred to as Chinese public medical institutions) have grown rapidly. It surpassed the 700 million yuan mark in 2020, with year-on-year growth exceeding 50% in the first half of 2021. Qilu Pharmaceutical has the largest market share.

Esprolol Hydrochloride Injection has production approval from 10 companies. In terms of consistency evaluation, three companies have passed the evaluation. Among them, Qilu Pharmaceutical (Hainan) and Qilu Pharmaceutical Co., Ltd. have both been approved through supplementary applications.

Source: MiNei MED2.0 China Drug Evaluation Database

To date, Qilu Pharmaceutical has had over 90 products pass the evaluation, among which there are seven cardiovascular system drugs. The Levosimendan Injection is the exclusive product to have passed the evaluation, while the Isosorbide Mononitrate Sustained-Release Tablets, Fasudil Hydrochloride Injection, and Trimetazidine Hydrochloride Sustained-Release Tablets were the first to pass. Notably, since the beginning of this year, Qilu Pharmaceutical has had more than 40 products pass the evaluation.

Source: Official website of the National Medical Products Administration, Methyl Network Database