Qilu Pharmaceutical's Innovation Pipeline Surges with 8 First-in-Class Drugs Granted Clinical Trial Approvals
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
In less than a month,Qilu PharmaceuticalTwo important clinical advances were successively achieved. On April 22, 2026, a product independently developed by the companyClass 1Innovative DrugQLS7320 InjectionReceived CDE clinical trial implied permission for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). On April 13, another Class 1 new drugQLS5212 for InjectionAlso approved for clinical trials, with the indication being advanced solid tumors, and entered Phase I clinical trials on April 21.
Screenshot source: NMPA
01
QLS7320 Approved for Clinical Trials for the First Time, Development Progresses Efficiently
QLS7320 InjectionIt is a product delivered via GalNAc.(N-Acetylgalactosamine)siRNA drug conjugated for liver-targeted delivery. The drug's clinical trial application was first submitted on February 9, 2026, and it was approved for clinical use by April 22, demonstrating highly efficient progress in development.
Screenshot source: Global Drug R&D Database (More clicksMini ProgramView)
The indication PNH approved for clinical use this time is a rare acquired hemolytic disease driven by abnormal activation of the complement system. Its clinical features include intravascular hemolysis, thrombosis, and bone marrow failure. The condition can be life-threatening in some patients, and current treatment options are limited or show poor response. Targeting the complement pathway is one of the fundamental strategies for treating such diseases, but innovative therapies in this field are still relatively scarce in China.QLS7320The clinical advancement is expected to offer new therapeutic hope for such patients.
02
New Member Added to the ADC Pipeline, Targeting Advanced Solid Tumors
QLS5212 for InjectionIt is an antibody-drug conjugate (ADC) independently developed by Qilu Pharmaceutical, intended for the treatment of advanced solid tumors.QLS5212InFirst clinical application on January 29, 2026, first approved for clinical use on April 13, entered Phase I clinical trial on April 21.
Screenshot source: Global Drug R&D Database (More clicksMini ProgramView)
This drug is designed to combine the targeting ability of antibodies with the cytotoxic capacity of small-molecule toxins, aiming to address common clinical challenges such as drug resistance, recurrence, and toxicity in the treatment of advanced solid tumors. Preclinical studies have shown,QLS5212With good anti-tumor activity and controllable safety.
In recent years, Qilu Pharmaceutical has been continuously expanding its presence in the ADC field. WithQLS5212The addition enriches the company’s ADC product portfolio, expands the range of targets covered, and provides more innovative options for solid tumor treatment. Currently, Qilu Pharmaceutical Co., Ltd. has seven ADC drugs in clinical research, gradually demonstrating the R&D strength of its platform.
03
Innovation pipeline advances intensively, with strong sales growth of newly launched drugs
Qilu Pharmaceutical currently has over 100 innovative drugs in development, with more than 30 novel class 1 drugs in clinical development stages, covering multiple disease areas such as oncology, autoimmune disorders, metabolism, cardiovascular and cerebrovascular diseases, and central nervous system conditions. In the field of oncology, the company has established a product portfolio incorporating cutting-edge technologies such as ADCs, bispecific antibodies, and small molecule targeted therapies.
According to the statistics from the Mosentropy Medical Database, since 2026, Qilu Pharmaceutical(Including Subsidiaries)Eleven Class 1 new drugs have been approved for clinical trials, eight of which were approved for the first time, indicating that the innovative pipeline has entered a period of accelerated harvest.
Screenshot source: China Drug Evaluation Database (morePointMini ProgramView)
More notably, the two Class 1 new drugs that the company has launched in recent years have demonstrated strong market explosiveness. The Class 1 new chemical drug approved in 2023Iruak Tablets, with total terminal hospital sales exceeding 1.25 billion yuan in 2025, representing a year-on-year increase of up to 654.02%; and the Class 1 new biologic drug approved in 2024.Aipalolitovorelimab Injection, with total terminal hospital sales reaching 147 million yuan in 2025, representing a year-on-year growth rate of 6647%. The rapid sales growth of the two products not only validates the company's commercialization capabilities but also provides strong support for the advancement of subsequent innovative pipelines.
Since 2026, Qilu Pharmaceutical(Including subsidiaries)Eight novel Class 1 drugs have been approved for clinical trials for the first time, marking that the company's innovative pipeline has entered a period of concentrated effort. From siRNA drugs to ADC therapies, from complement targeting to solid tumor treatments, Qilu Pharmaceutical is building an innovative product matrix covering major disease areas through diversified technological layouts.
With the continuous increase in R&D investment, the constant acceleration of clinical progress, and the gradual validation of commercialization capabilities, Qilu Pharmaceutical is expected to occupy a more significant position in the competition among China's innovative pharmaceutical companies, bringing more breakthrough treatment options to patients.
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