Qilu Pharmaceutical's $700M Esmolol Hydrochloride Injection Passes Consistency Evaluation

On August 10, the official website of the NMPA indicated that Qilu Pharmaceutical's Esmolol Hydrochloride Injection has passed the consistency evaluation. Esmolol is a β-receptor blocker. In 2020, its sales at public medical institutions in China exceeded RMB 700 million, representing a year-on-year increase of 24.75%. To date, Qilu Pharmaceutical has had 84 products pass the consistency evaluation.

Esmolol Hydrochloride Injection is an ultra-short-acting selective β-blocker, which can be used for lowering blood pressure in perioperative hypertension and for reducing heart rate in sinus tachycardia.

Data from Menet shows that in recent years, the terminal sales of esmolol injection at urban public hospitals, county-level public hospitals, urban community health centers, and township health centers in China (collectively referred to as Chinese public medical institutions) have continued to rise, exceeding RMB 700 million in 2020, a year-on-year increase of 24.75%. Among them, Qilu Pharmaceutical holds a 94.4% market share.

Terminal Sales of Esmolol Injection in Public Medical Institutions in China (Unit: RMB 10,000)

Source: Menet Terminal Competitive Landscape of Chinese Public Medical Institutions

Currently, in the Chinese market, Esmolol Hydrochloride Injection from 10 manufacturers has been approved for production, including Qilu Pharmaceutical, China Resources Double-Crane, Aosaikang Pharmaceutical, Lukang Pharma, Lingkang Pharmaceutical, Baxter Healthcare, and others.

On June 16, 2021, Baxter Healthcare's Esmolol Hydrochloride Injection, submitted for production approval as a Class 3 generic drug, was granted manufacturing approval and is deemed to have passed the consistency evaluation. On August 10, the official website of the NMPA indicated that Qilu Pharmaceutical's supplementary application for the consistency evaluation of Esmolol Hydrochloride Injection had been approved.

It is worth noting that, apart from Baxter Healthcare and Qilu Pharmaceutical, no other companies have currently initiated the consistency evaluation for Esmolol Hydrochloride Injection.

As of now, Qilu Pharmaceutical has had 84 drug products (155 specifications) pass or be deemed to have passed the consistency evaluation.

Data source: Menet Database, NMPA