Qilu Pharmaceutical's Class 1 New Drug QLS5132 Advances in Combination Therapy, Targeting the RMB 140 Billion Anti-Tumor Market
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On March 31, the Center for Drug Evaluation of the National Medical Products Administration（CDE）Official website announcement,Qilu PharmaceuticalSubmittedClass 1New DrugQLS5132 for InjectionThe indication for combination therapy in the treatment of advanced solid tumors has received clinical trial approval by default. This is another key milestone for the product following its first clinical approval in 2025, marking a further acceleration in Qilu Pharmaceutical's布局 in the field of innovative anti-tumor drugs.
Screenshot source: CDE official website
01
Focus"Golden" Target, Aiming at the Billion-Dollar Anti-Tumor Drug Market
QLS5132 for InjectionYesQilu PharmaceuticalA self-developed antibody-drug conjugate targeting CLDN6（ADC）CLDN6, as a tight junction protein, shows specific high expression in various solid tumors such as ovarian cancer and non-small cell lung cancer, while it is almost "invisible" in normal tissues, making it a highly promising new anti-tumor target. The product, designed like a "biological missile," can precisely identify and efficiently kill CLDN6-positive tumor cells, offering potential new therapeutic options for patients with advanced solid tumors.
Currently, the anti-tumor drug market is experiencing explosive growth. Data from Maxent Pharmaceuticals shows that by 2025, the total sales in the hospital market across all terminals have exceeded 140 billion yuan, with a year-on-year growth rate of 6.51%. In this vast and rapidly growing blue ocean market, Qilu Pharmaceutical Co., Ltd. has gained an advantage through...QLS5132The rapid advancement has already secured a significant first-mover advantage in the CLDN6细分赛道, which is still in the early stages of competition.
Screenshot source: All-terminal Hospital Sales Database (Check Data. Find Moxone)
02
Innovation Pipeline Fully Explodes, 9 Class 1 New Drugs Approved for Clinical Use Within the Year
This timeQLS5132The progress is not an isolated case. According to the database of Mose Pharm, since the beginning of this year, Qilu Pharmaceutical(Including subsidiaries)Nine Class 1 new drug candidates have been approved for clinical trials, six of which were approved for the first time, indicating a "surge" in the innovative pipeline. In recent years, Qilu Pharmaceutical has adhered to high R&D investment, promoting differentiated innovation guided by clinical value, and has built a rich pipeline covering areas such as oncology, autoimmune diseases, metabolism, cardiovascular and cerebrovascular diseases, and central nervous system disorders.
This fully demonstratesQilu PharmaceuticalThe innovative transformation has moved from the early "single-point breakthrough" to "comprehensive layout," achieving substantial returns on the commercialization front. Two of its new drugs have performed remarkably since their market launch: the Class 1 chemical drug newly launched in 2023.Iruak TabletsIn 2025, the total sales of all-terminal hospitals exceeded 125 million yuan, with a year-on-year increase of up to 654.02%; in 2024, the first-class new biological drug was approved.Aipalolitovorelimab InjectionIn 2025, sales reached 147 million yuan, with an astonishing year-on-year growth rate of 6647%. The market explosive power of the two new drugs continues to strengthen the company's market competition barriers.
WithQLS5132The clinical advancement of combination therapy has further expanded Qilu Pharmaceutical's footprint in the billion-dollar anti-cancer market. In the future, Qilu Pharmaceutical stated that it will continue to uphold the mission of "expressing our love through technology," accelerate the development of innovative drugs, and is committed to providing global patients with more drug options that are "globally new" and "globally excellent."
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