Qilu Pharmaceutical Submits Sixth Class 1 Biologic New Drug Application of the Year: QLP31907 Injection

On July 8, Qilu Pharmaceutical submitted an IND application for QLP31907 injection, a Class 1 new therapeutic biological product, which was accepted by the Center for Drug Evaluation (CDE). Since 2021, Qilu has submitted IND applications for six Class 1 new biological drugs, two of which have been approved for clinical trials.

Figure 1: Overview of Qilu's New Biologic Drug Submissions in 2021

Source: CDE Official Website

Data from Menet indicates that QL1779 injection and QLS31901 for injection have been approved for clinical trials, with QLS31901 for injection indicated for advanced solid tumors and currently in Phase I clinical trials.

Table 1: Overview of Qilu Pharmaceutical's Independently Developed Class 1 Biologic New Drugs Approved for Clinical Trials

Source: Menet China Drug Clinical Trial Public Database

Qilu Pharmaceutical's marketed biologics include Recombinant Human Interleukin-11 for Injection, PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor Injection, Bevacizumab Injection, and Recombinant Human Granulocyte Colony-Stimulating Factor Injection. Among the Class 1 new biological drugs currently under development, Recombinant Human Thrombopoietin Mimetic Peptide-Fc Fusion Protein for Injection and Recombinant Anti-HER2 Humanized Monoclonal Antibody-DM1 for Injection have entered Phase III clinical trials and are expected to become new breakthroughs for the company in the biologics sector.

Figure 2: Overview of Marketed Biological Products by Qilu Pharmaceutical

Source: Menet MID Comprehensive Drug Index Database

Source: CDE Official Website, Menet Database