Qilu Pharmaceutical's Duloxetine Hydrochloride Enteric-Coated Capsules Enter Administrative Approval Stage for Consistency Evaluation

Recently, Qilu Pharmaceutical’s duloxetine hydrochloride enteric-coated capsules, filed under Category 4 generic drug regulations, have entered the administrative approval stage. Duloxetine is an antidepressant that generated a combined sales revenue of RMB 1.2 billion in 2019 across public medical institutions and urban physical pharmacy terminals in China. Data from Menet shows that Qilu currently has four additional psychostimulant drugs that have either been submitted for marketing approval or approved for clinical trials.

Source: Official Website of the National Medical Products Administration

Duloxetine is a selective serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor developed by Eli Lilly, primarily used clinically for the treatment of depression.

Sales of Duloxetine in Public Medical Institutions and Urban Physical Pharmacy Terminals in China

Source: Menet Database

Data from Menet shows that in recent years, the market size of duloxetine in China has continued to expand, with growth rates consistently remaining in double digits. In 2019, the total sales revenue from urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as Chinese public medical institutions), as well as physical retail pharmacies in Chinese cities, amounted to RMB 1.2 billion, with capsules accounting for more than 50% of the share.

Status of the Consistency Evaluation Application for Duloxetine Hydrochloride Enteric-coated Capsules

Source: Menet MED2.0 China Drug Review Database

Currently, 12 companies have submitted supplementary applications for the consistency evaluation of Duloxetine Hydrochloride Enteric-coated Capsules or filed for production under the new classification system. Products from six companies have passed or are deemed to have passed the consistency evaluation, and Qilu Pharmaceutical’s product has entered the administrative approval stage.

Psychostimulants with Marketing Applications Submitted or Clinical Trial Approvals Granted by Qilu Pharmaceutical

Source: Menet MED2.0 China Drug Evaluation Database

In the field of psychostimulants, in addition to Duloxetine Hydrochloride Enteric-coated Capsules, Qilu Pharmaceutical has one Class 3 generic drug and one Class 2 improved new drug application for market approval, as well as two new drugs approved for clinical trials.

Source: Menet Database, Official Website of the National Medical Products Administration