Qilu Pharma Advances Two Class 1 Biologics Targeting Billion-Dollar Oncology Market

After its hydroxyurea tablets became the first antitumor drug to pass the consistency evaluation, Qilu Pharmaceutical's oncology innovative drug pipeline has also welcomed good news. On September 28, the official website of the Center for Drug Evaluation (CDE) showed that Qilu Pharmaceutical's Class 1 biologics, QLF32004 for injection and QLP31907 injection, have received deemed approval for clinical trials, intended for the treatment of advanced malignant solid tumors and B-cell malignancies. This year, Qilu Pharmaceutical has already obtained clinical trial approvals for eight Class 1 new drugs.

The Class 1 biological drug QLF32004 for injection is intended for the treatment of advanced malignant solid tumors, and QLP31907 injection is intended for the treatment of B-cell malignancies.

Antineoplastic drugs represent a major R&D focus for both domestic and international pharmaceutical companies, with their market size continuing to expand steadily. According to data from Menet, in 2020, terminal sales of antineoplastic drugs across China's public medical institutions—encompassing urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as public medical institutions in China)—exceeded RMB 100 billion, marking a year-on-year increase of 9.63%.

Terminal Sales of Antineoplastic Drugs in China's Public Medical Institutions (Unit: 10,000 RMB)

Source: MENET - Competitive Landscape of China Public Medical Institutions Terminal

Since the beginning of this year, Qilu Pharmaceutical has obtained clinical trial approval for 8 Class 1 new drugs, including QLF32004 for Injection, QLP31907 Injection, QLF31907 for Injection, QL1706 Injection, QLS31905 for Injection, QL1779 Injection, VB4-845 Injection, and QLS31901 for Injection.

Notably, all eight Class 1 innovative drugs are focused on the oncology therapeutic area.

Class 1 New Drugs Approved for Clinical Trials by Qilu Pharmaceutical Since 2021

Regarding R&D progress, VB4-845 injection has initiated Phase III clinical trials. VB4-845 injection is an antibody-drug conjugate (ADC), a novel bladder cancer drug that Qilu Pharmaceutical in-licensed from Sesen Bio in July 2020 for $35 million. Additionally, QLS31901 for injection, QLS31905 for injection, and QL1706 injection have all initiated Phase I clinical trials.

Data source: MENET Database, CDE