On May 14, LY103 for Injection, a project under the “Blue Drug Storage” development program with wholly independent intellectual property rights, passed the review of the National Medical Products Administration (NMPA) and received Notice of Approval for Drug Clinical Trial (Approval Nos. 2026LP01521 and 2026LP01522). The drug is jointly developed by Ocean University of China (OUC), the Marine Biomedical Research Institute of Qingdao (MBRI), and Qingdao Haiji Biomedical Co., Ltd., and is the fourth marine innovative drug under OUC’s major “Blue Drug Storage” innovation initiative to be approved for clinical trials. Intended for the treatment of sepsis-induced coagulopathy (SIC), the drug is expected to provide a new therapeutic option for this critical clinical condition.
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Each year, more than 11 million people worldwide die from sepsis-related conditions. SIC is a coagulation disorder caused by sepsis. It is a common and serious complication of sepsis, as well as one of the major contributors to organ dysfunction and death in patients with sepsis. According to the Chinese Expert Consensus on the Diagnosis and Treatment of Sepsis-Induced Coagulopathy (2024 Edition), SIC occurs in 24.0%-60.0% of patients with sepsis worldwide, and the incidence is as high as 67.9% in China. If not properly managed, SIC may progress to disseminated intravascular coagulation (DIC), doubling the mortality rate. Safe and effective therapeutic agents are therefore urgently needed in clinical practice to control the progression of SIC and reduce the risk of death in critically ill patients.
Marine polysaccharides have good biocompatibility and safety, making them a major research focus in innovative drug development. However, their complex pharmaceutical and pharmacological properties, together with unclear in vivo metabolic processes, remain key bottlenecks restraining their clinical translation. LY103 is a safe, effective, and quality-controllable marine carbohydrate compound derived from seaweed polysaccharides through targeted molecular modification. It is an important, highly active molecule in OUC’s “marine glycan library”. To overcome the challenges in clinical translation, systematic studies have been conducted on LY103, covering raw material selection, preparation processes, quality control, and mechanisms of action. On the basis of clarifying the material basis for new drug development and elucidating its pharmacological characteristics and mechanisms of action, the project has completed systematic preclinical studies in pharmaceutical development, pharmacodynamics, and pharmacology and toxicology. Relevant research data show that LY103 can exert dual therapeutic effects by regulating coagulation responses and blocking the interaction between inflammation and thrombosis, while carrying a lower risk of bleeding. It is therefore expected to provide a new approach and solution for the prevention and treatment of SIC.
The clinical approval of LY103 is an important demonstration of OUC’s sustained efforts to develop the “Blue Drug Storage” initiative and strengthen support for the translation of innovative research outcomes. Drawing on the solid foundation and scientific leadership of Academician Guan Huashi’s team in marine glycodrug development, and under the planning and guidance of Academician Du Guanhua, chief technical expert of the “Blue Medicine Talent” program, OUC has deepened industry-university-research collaboration and built a full-chain innovation platform for the “Blue Drug Storage” initiative, providing full-process support for the project’s research and development. This achievement further highlights OUC’s distinctive strengths in marine drugs and consolidates and demonstrates its comprehensive research capacity and leading role in the marine pharmaceutical sector.
