Grand Pharmaceutical (00512): The Phase Ib clinical trial of the global innovative product STC3141 for the treatment of sepsis in Australia and Belgium has completed the enrollment and administration of all patients
(00512) announced that the group's wholly-owned subsidiary Grand Medical Pty Ltd. (an innovative drug research and development center established by the group in Australia) is developing a global innovative drug STC3141 for the field of severe anti-infection, which is being launched in Australia and Belgium The phase Ib clinical trial (REFINE) for the treatment of sepsis recently successfully completed the enrollment of all patients, and successfully completed the 72-hour continuous intravenous administration of the patients. The clinical study report is expected to be completed in the next 4 months . This is another major R&D progress of the Group in the field of severe anti-infection, and STC3141, as a blockbuster product of which the Group has global rights, has been patented in 12 countries or regions around the world.
REFINE is an open-label, multi-center, dose-escalating phase Ib clinical study, which was approved in Australia and Belgium in April 2020 and April 2022, respectively. The study enrolled 26 patients requiring intensive care ( In patients with sepsis treated in ICU), the safety, drug metabolism characteristics and preliminary effectiveness of STC3141 in the treatment of sepsis patients with different degrees of renal impairment in the ICU were studied and evaluated in a dose-escalating manner. Previously, STC3141 has completed Phase Ia clinical research on healthy volunteers in Australia, and initially confirmed the safety and metabolic characteristics of the drug in healthy humans. This Phase Ib clinical study aims to further evaluate the safety of the drug in patients with sepsis and the impact of different renal impairments on drug metabolism, and provide more information for late-stage clinical trials and development directions, so as to accelerate the global development of the product process.
The field of severe anti-infection is one of the Group's core strategic areas. STC3141 is a global innovative product with a new mechanism of action. It reverses organ damage caused by the body's excessive immune response by neutralizing extracellular histones and neutrophil traps. A serious indication, such as sepsis and acute respiratory distress syndrome (ARDS) and other diseases with high clinical mortality and lack of specific therapeutic drugs. The product has an innovative mechanism of action, and the relevant preclinical research results have been published in the top academic journal "Nature Communications" in February 2020, which has far-reaching academic influence. In terms of clinical research, in addition to the Phase Ib clinical research for the treatment of sepsis conducted in Australia and Belgium, the product was approved by the National Medical Products Administration (NMPA) of the People's Republic of China in early March 2021. In patients with ARDS Conducted Phase Ib clinical study and successfully reached the clinical endpoint in October 2022; Phase IIa for the treatment of severe new coronavirus infection (COVID-19) was approved in Belgium, Poland and the United Kingdom in April, September and October 2021, respectively Clinical research, and successfully reached the clinical endpoint in July 2022; The success of STC3141 in clinical research for the treatment of ARDS and severe COVID-19 reveals the good safety and potential clinical benefit trend of this product in the treatment of severe patients , providing positive data support for the subsequent clinical development of this product in the critical care field. At present, the project has been approved for seven clinical approvals in four indications of sepsis, ARDS, severe COVID-19, and ARDS caused by COVID-19 in five countries on three continents: China, Australia, Belgium, the United Kingdom, and Poland. The comprehensive advancement of multi-center clinical trials demonstrates the continuous improvement of the Group's global innovation and R&D capabilities. The clinical progress achieved in the Phase Ib clinical study in Australia and Belgium is another important milestone in the Group's overseas clinical research.
In addition, GS221, another oral small-molecule anti-COVID-19 3CL protease (3-chymotrypsin-like protease, 3CLpro) inhibitor of the Group in the field of severe anti-infection, has also successfully carried out clinical research in China, and has completed clinical trials The test results showed that the subjects were safe and well tolerated after taking the drug, and no serious adverse events or adverse events leading to drug withdrawal were observed. At the same time, it showed the trend of improving clinical symptoms, shortening the negative time of nucleic acid and reducing the viral load. , suggesting that GS221 has potential clinical benefits for patients. GS221 and STC3141 are expected to cover the mild, moderate and severe treatment of COVID-19 patients, and provide more treatment services for patients with unmet clinical needs.
The Group has always attached great importance to the research and development of innovative products and advanced technologies, focusing on the needs of patients, driven by technological innovation, and increasing investment in global innovative products and advanced technologies for unmet clinical needs, enriching and improving product pipelines and industries The layout adopts the strategy of "globalized operation layout, dual-cycle operation and development" to form a new pattern of domestic and international double-cycle linkage development and mutual promotion, give full play to the group's industrial advantages and R&D strength, and quickly launch technologically innovative products to the market, serving the world Patients are provided with more advanced and diverse treatment options.
