Qilu Pharmaceutical Advances with New Class 1 Drug and Nears Approval of Its First Orally Disintegrating Film

On January 9, the clinical trial application for Qilu Pharmaceutical’s Class 1 new drug, QLS31901 for Injection, was accepted by the Center for Drug Evaluation (CDE), with the acceptance number CXSL2100012. QLS31901 for Injection is the first Class 1 new drug submitted for clinical trials by Qilu Pharmaceutical in 2021. In recent years, Qilu Pharmaceutical has made significant strides in the field of innovative drugs; in 2020, it submitted clinical trial applications for four Class 1 new drugs, all of which were therapeutic biological products.

Class 1 New Drug Submitted for Clinical Trial by Qilu Pharmaceutical in 2020

Qilu Pharmaceutical has long been strategically positioning itself in the field of Class 2 improved new drugs, which are now approaching the harvest period. Data from Menet shows that Qilu Pharmaceutical has submitted marketing applications for five Class 2.2 new drugs, namely tadalafil orally disintegrating films, olanzapine orally disintegrating films, montelukast sodium orally disintegrating films, memantine hydrochloride orally disintegrating films, and aripiprazole orally disintegrating films, all of which are orally disintegrating film formulations. Among them, the registration status of olanzapine orally disintegrating films has been updated to “under review,” with expectations for imminent approval and market launch, marking it as the company’s first orally disintegrating film product.

Marketing Application Status of Qilu Pharmaceutical's Olanzapine Oral Dissolving Film

Source: Menet One-Click Search

Olanzapine is primarily used for the treatment of schizophrenia. Data from Menet shows that in 2019, sales of olanzapine at terminal outlets of Chinese public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded RMB 4 billion. Currently marketed olanzapine products in China include olanzapine tablets, orally disintegrating tablets, and orally dissolving films. Hansoh Pharmaceutical is the only company approved for olanzapine orally dissolving films, while Qilu Pharmaceutical is poised to become the second domestic manufacturer.

Source: Menet Database, CDE