Qilu Pharmaceutical's Innovative Pipeline Surges with 12 First-in-Class Drugs Granted IND Approval in 2026

　　【Pharmaceutical Network - Product Information] The core competitiveness of the pharmaceutical industry stems from continuous innovation, with high-intensity R&D investment serving as the solid foundation for breakthroughs. In recent years, Qilu Pharmaceutical has been continuously transforming towards innovation, with its R&D investment gradually increasing. Data shows that in 2025, the company's R&D expenditure increased by 23% year-on-year, reaching RMB 5.37 billion, accounting for 14.5% of its revenue. Driven by sustained R&D investment, the company has built a robust pipeline of innovative drugs, currently comprising 120 projects under development. Since 2026, Qilu Pharmaceutical’s innovative drug pipeline has seen a concentrated surge, with 12 Class 1 new drugs receiving initial approval for clinical trials.
 

On June 4, Qilu Pharmaceutical’s Class 1 new drug, QLS2311 injection, received its first approval for clinical trials. Data indicate that this product is Qilu Pharmaceutical’s first Class 1 new drug in the antithrombotic field, with indications specifically targeting acute ischemic stroke. The market scale for antithrombotic chemical drugs and biologics is substantial; data show that in 2025, domestic sales across all terminal hospital markets increased by 2.81% year-on-year, exceeding RMB 37 billion, reflecting sustained and stable clinical demand.
 

On May 19, Qilu Pharmaceutical’s Class 1 new drug, QLC1101 tablets, received initial approval for clinical trials, intended for the treatment of advanced solid tumors harboring KRAS G12D mutations. It is reported that in China’s “three major terminals and six major markets,” the sales scale of anti-tumor drugs (chemical and biological) has continued to expand in recent years, surpassing RMB 160 billion in 2025, a year-on-year increase of 7.86%.
 

On May 12, QLS1413 tablets, a Class 1 innovative small-molecule drug independently developed by Qilu Pharmaceutical, received implicit approval for clinical trials from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug is intended for the treatment of advanced solid tumors with FGFR2 genetic alterations. As a highly selective FGFR2 inhibitor, QLS1413 features a clear differentiated development strategy. In terms of safety, compared with pan-FGFR inhibitors, QLS1413 is expected to significantly reduce the incidence and severity of hyperphosphatemia and diarrhea, thereby improving patient safety and tolerability. Regarding efficacy, the antitumor activity of FGFR2 inhibition has been fully validated in clinical studies of cholangiocarcinoma, providing a solid theoretical basis for the development of QLS1413. In terms of application potential, beyond cholangiocarcinoma, FGFR2 amplification/mutations are also present in various other solid tumors, such as gastric cancer and breast cancer, offering new therapeutic options for these patient populations.
 

On April 22, QLS7320 injection, a Class 1 innovative drug independently developed by Qilu Pharmaceutical, received implicit approval for clinical trials from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration for the first time. Clinical studies targeting paroxysmal nocturnal hemoglobinuria (PNH) will soon be conducted in China. This complement-targeting therapy with a novel mechanism of action is expected to provide patients with cutting-edge treatment options.
 

In addition, the innovative drugs newly approved for clinical trials by Qilu Pharmaceutical this year also include QLS-2322 injection, QLS-5212 for injection, QLS-1317 tablets, QLS-5308 for injection, QLH-2405 injection, QLS-7305 injection, QL-2401 for injection, and QLS-5316 for injection.
 

It is reported that oncology drugs are one of the key strategic focus areas for Qilu Pharmaceutical. Among its novel anti-tumor drug pipeline, candidates with advanced development progress include QLC5508 for injection (B7-H3 ADC), daratumumab injection (CD38 monoclonal antibody), and QL2107 injection (PD-1 monoclonal antibody). All have entered Phase III clinical trials for the treatment of esophageal squamous cell carcinoma, multiple myeloma, and non-small cell lung cancer, respectively, with New Drug Applications (NDAs) expected to be submitted imminently. Notably, QLC5508 is a novel B7-H3-targeting antibody-drug conjugate (ADC) characterized by high cell-binding activity and internalization efficiency. Its payload, SuperTopoi™, exhibits potency 5 to 10 times greater than that of Dxd.
 

By continuously increasing R&D investment and building a robust innovative pipeline, Qilu Pharmaceutical has charted a course for high-quality, innovation-driven development. In the future, as multiple innovative drugs are successively launched and made available, the company will continue to provide domestic patients with superior, accessible innovative therapies, injecting strong momentum into the innovation and upgrading of China’s pharmaceutical industry. It is reported that, to date, Qilu Pharmaceutical has received approval for the market launch of several Class 1 new drugs, with their commercial value being steadily realized.
 

Disclaimer: Under no circumstances shall the information contained herein or the opinions expressed constitute investment advice to any person.