Grand Pharma’s Global Innovative Product STC3141 Approved for Phase Ib Clinical Study in Belgium, Another Milestone of Global Innovative Products and Continues the Globalization Development Process
(April 26, 2022 - Hong Kong) Grand Pharmaceutical Group Limited (“Grand Pharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce 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 treatment of sepsis which has recently been approved in Belgium to conduct a phase Ib clinical study for the treatment of sepsis.
The field of severe disease and anti-infection is one of the core strategic areas of the Group. The Group always puts focus on the R&D of innovative products and advanced technologies. Sticking to patients-centered and innovation-driven, the Group continuously increases its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs, and enrich product pipeline and improve supply chain.
The STC3141 was approved in Belgium to carry out phase Ib clinical study for the treatment of sepsis this time, on one hand, it will further evaluate the safety and metabolic properties of the drug in patients with sepsis, and on the other hand, it will also accelerate the global R&D layout of STC3141 and commercialization progress. Previously, STC3141 has completed the Phase Ia clinical study in healthy volunteers in Australia, preliminary determined the safety and metabolic properties of the drug in humans, and has entered the Phase Ib clinical study. The first patient administration was completed in December 2020.
STC3141 is a global innovative product with a new mechanism of action. It neutralizes extracellular protein and neutrophils trap net to reverse the body organ damage caused by the excessive immune response and can be used for a variety of severe indications, such as sepsis and acute respiratory distress syndrome ("ARDS") and other diseases which have clinically high-mortality rate and no effective treatment method. This product has a novel mechanism of action and the results of related pre-clinical research were 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 study for sepsis approved in Australia and Belgium, the product was approved by the National Medical Products Administration of the People's Republic of China (NMPA) in early March 2021 for phase Ib clinical trials in patients with ARDS, and the first patient administration was completed in November 2021. Phase IIa clinical trials for the treatment of severe COVID-19 infection were approved in Belgium, Poland and the UK in April, September and October 2021, respectively, and all patients were enrolled and dosed in December 2021. At present, the project has received seven clinical approvals for four indications that including sepsis, ARDS, severe COVID-19 infection, and ARDS caused by COVID-19 infection in five countries on three continents, namely China, Australia, Belgium, the United Kingdom, and Poland. The comprehensive promotion of multi-center clinical practice demonstrates the continuous improvement of the Group's global innovation and R&D capabilities.
The Board of Grand Pharmaceutical Group Limited, commented, “The field of anti-virus and anti-infection is one of the core strategic areas of the Group. The progress of the project being approved for Phase Ib clinical trials in Belgium this time is another important milestone in the Group's overseas clinical research process. Looking ahead, the Group will continue to deepen the strategic plan of the three innovative strategic directions of ‘cerebro-cardiovascular precision interventional diagnosis and treatment’, ‘intervention, nuclear medicine and immunotherapy anti-tumor’ and ‘severe disease and anti-infection’, adopts the strategy of ‘global expansion and dual-cycle operation’, and make full use of its industrial advantages and R&D capabilities, to accelerate commercialization process for innovative products and provide patients with more advanced and diverse treatment options in the world.”