Qilu Pharmaceutical Launches Multiple Class 1 New Drugs Targeting the Billion-Dollar Oncology Market

Review Progress of Some New Drugs by Qilu Pharmaceutical

QLC5513 for Injection and QL2302 Injection are respectively the first IND application of Class 1 and Class 3.3 new drugs by Qilu Pharmaceutical, both belonging to therapeutic biological products. Biologics is one of the key areas that Qilu Pharmaceutical focuses on. Currently, the company has one Class 1 new drug approved for marketing, which is Eparaliber-Tovorolimumab Injection (PD-1/CTLA-4 bispecific antibody), as well as more than 10 biosimilars approved for marketing, including Pertuzumab Injection, Ranibizumab Injection, Trastuzumab for Injection, and Denosumab Injection.

Abemaciclib tablets, developed by Eli Lilly, were first approved for marketing in China in 2020 for locally advanced or metastatic breast cancer, etc. In 2024, the sales revenue in China's three major terminals and six major markets (the statistical scope is detailed at the end of this article) exceeded 1 billion yuan. Recently, the IND application for Qilu Pharmaceutical's Abemaciclib Tablets as a Class 2.4 new drug was accepted. Prior to this (December 2024), the company had submitted a generic Class 4 marketing application for this product, which is expected to be the first generic version.

QLH12016 capsule, a Class 1 innovative drug independently developed by Qilu Pharmaceutical, is intended for the treatment of advanced prostate cancer. The clinical application of this new drug (application number: CXHL2500547/8) was accepted by the CDE in June 2025 and subsequently received tacit approval for clinical trials in August this year.

Data from MiNe Network shows that in 2024, the sales of anti-tumor drugs (chemical + biological) in China's three major terminals and six major markets surpassed 150 billion yuan for the first time, with a year-on-year increase of 8.74%; In Q1 2025, it continued to grow by 9.7% to exceed 42 billion yuan. In terms of therapeutic subcategories, antibody drugs (chemical + biological) and protein kinase inhibitors (chemical) are leading the market, with market shares exceeding 40% and 30%, respectively.

In recent years, Qilu Pharmaceutical has prioritized innovation, actively engaging in various forms of research and development to accelerate its transformation towards innovation. According to data from the Menet database, since 2025, the company has received clinical approvals for at least 11 Class 1 new drugs, primarily anti-tumor medications and immunosuppressants.

In terms of the highest R&D progress, Injectable QLS31905 (pancreatic cancer) has entered Phase III clinical trials, Injectable QLS32015 (multiple myeloma) and QLP2117 Injection (advanced cancer) are in Phase II clinical trials, and QLC1101 Capsules (advanced solid tumors) are currently conducting Phase Ib/II clinical trials. In addition, new products such as QLS12010 Capsules (atopic dermatitis), QLS1304 Tablets (solid tumors), QLS1209 Tablets (solid tumors), Injectable QLS5132 (advanced solid tumors), and Injectable QLS5133 (advanced solid tumors) have been approved for clinical trials for the first time this year.