On April 22nd, QLS7320 injection, a Class 1 innovative drug independently developed by Qilu Pharmaceutical, officially obtained implied clinical trial approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration for the treatment of paroxysmal nocturnal hemoglobinuria (PNH)! This milestone progress marks a crucial step for Qilu Pharmaceutical in the research and development of small nucleic acid drugs, and its independently innovated small nucleic acid technology platform is accelerating the release of innovative momentum.

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QLS7320 injection is a small interfering RNA (siRNA) drug that uses GalNAc coupling technology. This technology achieves efficient targeted delivery of drugs to liver cells by precisely coupling siRNA with GalNAc ligands. GalNAc can specifically recognize and bind to the sialic glycoprotein receptor (ASGPR) on the surface of liver cells, and deliver drugs into cells through endocytosis, thereby achieving silencing regulation of pathogenic genes. This technology not only significantly improves the targeting and stability of drugs, but also greatly reduces off target risks, making it the mainstream delivery strategy for small nucleic acid drug development worldwide.

QLS7320 is mainly targeted at a disease called paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare, acquired, chronic intravascular hemolytic disease, in which patients often experience severe complications such as anemia, thrombosis, and renal dysfunction due to red blood cell destruction, resulting in extremely low quality of life and urgent treatment needs. At present, targeted therapeutic drugs for PNH are still relatively limited globally, especially small nucleic acid therapies that can be injected subcutaneously for a long time and managed conveniently, which are still at the forefront. The approved clinical trial of QLS7320 is expected to provide a new, efficient, and convenient treatment option for PNH patients in China, filling the clinical gap.

This approval is a reflection of the continuous cultivation of Qilu Pharmaceutical’s small nucleic acid drug research and development platform. In recent years, the company has proactively entered the forefront of small nucleic acid technology, systematically building a complete technical chain from target discovery, sequence design, chemical modification to GalNAc delivery system development. As a representative achievement of the platform’s independent research and development, QLS7320 has successfully entered clinical practice, fully verifying the platform’s technological maturity and innovation capabilities.

It is worth noting that Qilu Pharmaceutical’s layout in the field of small nucleic acid is not an isolated case. Previously, the company collaborated with Ruibo Biotechnology to introduce the GalNAc siRNA drug QLC7401 (RBD7022) targeting PCSK9. The drug started phase III clinical trials in February 2026 for the treatment of hypercholesterolemia, demonstrating strong lipid-lowering potential. The addition of QLS7320 further enriches the company’s product matrix in the field of small nucleic acid, covering two major directions: rare diseases and chronic diseases, demonstrating its strategic effectiveness of “self-developed+cooperative” dual wheel drive.

As a leading enterprise in China’s pharmaceutical industry, Qilu Pharmaceutical has continuously increased innovation investment in recent years, focusing on major disease areas such as tumors, autoimmune diseases, metabolic diseases, central nervous system and rare diseases, and accelerating the construction of an innovative drug pipeline with global competitiveness. Since 2026, the company has received clinical approval for 8 Class 1 new drugs for the first time, covering ADC, dual antibody siRNA、 Various cutting-edge technologies such as biopharmaceuticals have entered a period of concentrated research and development.

In the future, with the clinical advancement of QLS7320, Qilu Pharmaceutical is expected to become an important participant in the global siRNA field, bringing more precise, long-lasting, and accessible innovative therapies to Chinese patients, and injecting new vitality into Chinese biopharmaceutical innovation.

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