Qilu Pharmaceutical's Innovation Surge: Multiple IND Submissions and Clinical Trial Registrations in March 2026

　　【Pharmaceutical Network Corporate NewsSince 2026, driven by the high R&D investment from pharmaceutical companies, there has been an explosive growth in drug clinical trials in China. According to statistics, in March, the CDE publicly registered a total of 498 clinical trial registrations. Among the sponsors of these drug clinical trials, the name Qilu Pharmaceutical frequently appeared, with numerous trials covering different types of clinical studies, including both new drug clinical trials and bioequivalence trials.
 

On March 31, according to the disclosure on the CDE website, the indication for the combination therapy of Qilu Pharmaceutical's Class 1 new drug, QLS5132 Injection, for the treatment of advanced solid tumors received tacit approval for clinical trials. QLS5132 is an antibody-drug conjugate (ADC) independently developed by the company that targets CLDN6. This product can accurately identify and efficiently kill CLDN6-positive tumor cells, offering the potential to provide a new treatment option for patients with advanced solid tumors.
 

On March 20, the CDE website announced that Qilu Pharmaceutical's self-developed Class 1 new drug, QLS1317 tablet, received clinical trial implied permission for the targeted treatment of microsatellite-highly unstable (MSI-H) driven solid tumors. Preclinical studies showed that, for MSI-H solid tumors, the drug demonstrated strong anti-tumor activity in multiple in vivo efficacy models.
 

On March 17, the website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that Qilu Pharmaceutical registered a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single, subcutaneous injections of escalating doses of QLH2405 injection in healthy participants as well as those with mild cognitive impairment and mild Alzheimer’s disease of Alzheimer's origin. The study is randomized, double-blind, and placebo-controlled.
 

News on March 17: Qilu Pharmaceutical Co., Ltd. has launched a multi-center, randomized, double-blind, positive-controlled, parallel-design Phase III clinical study comparing the efficacy and safety of QL1207H Injection with Eylea®/Eylea® (specifications: 114.3mg/mL (70μl containing 8mg Aflibercept)) for the treatment of neovascular age-related macular degeneration.
 

On March 11, Qilu Pharmaceutical Co., Ltd. initiated a Phase I clinical trial in healthy male subjects to compare the pharmacokinetic characteristics, safety, and immunogenicity of QL2109 Injection and DARZALEX®. This is a randomized, double-blind, single-dose, parallel-controlled study. QL2109 Injection is a biologic product indicated for multiple myeloma.
 

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Industry analysis suggests that since 2026, the dense registration of clinical trials by Qilu Pharmaceutical is mainly due to the high-intensity R&D investment in recent years, which is being translated into continuous breakthroughs in cutting-edge technology platforms. In recent years, based on high-intensity investment and oriented by clinical value, Qilu Pharmaceutical has built a product line covering areas such as oncology, autoimmune diseases, metabolism, cardiovascular, and central nervous system through precise pipeline layout.
 

In addition, it is worth mentioning that in order to accelerate innovation and R&D, Qilu Pharmaceutical is also actively deploying AI-driven drug discovery. On January 27, 2026, Insilico Medicine reached a drug R&D strategic cooperation with Qilu Pharmaceutical and its subordinate Shanghai Qilu Pharmaceutical Research Center, with a total amount exceeding 931 million Hong Kong dollars. According to the agreement, Insilico Medicine will utilize its self-developed Pharma.AI platform to focus on the design and optimization of novel small molecule drugs in the field of metabolic diseases, while Qilu Pharmaceutical Group will be responsible for subsequent development and commercialization.

 

Overall, the intensive layout of differentiated pipelines, the entry of multiple cutting-edge new drugs into clinical trials, the market explosion of already listed products, and AI-driven next-generation drug research and development fully demonstrate that Qilu Pharmaceutical is steadily moving from being a "generic drug leader" to joining the "innovative drug top tier." In the near future, its innovation transformation will undoubtedly enter a "golden harvest period."
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.