GP (HK)’s Global Innovative Drug STC3141 Successfully Completed the Enrolment and Dosing of All Patients in Phase IIa Clinical Trial for COVID-19 in Europe, Another Milestone in Global Clinical Trial, and Consolidating the Strategic Plan in the Field of Severe Anti-infection
(December 14, 2021 - Hong Kong) Grand Pharmaceutical Group Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that the global innovative drug STC3141, which is developed for the field of severe infections by Grand Medical Pty Ltd (the Group’s wholly-owned subsidiary and an innovative drug R&D centre established by the Group in Australia), has successfully completed the enrollment of all patients in the phase IIa clinical trial for the treatment of severe Coronavirus Disease 2019 (“COVID-19”) in Europe, and has successfully completed the 72-hour continuous intravenous dosing of the test patients. The observation period is 30 days after medication. The clinical research report is expected to be completed within the next 6 months.
The field of severe anti-infection is one of the core strategic areas of the Group. The Group has deployed 3 global innovative drugs in this field. 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 phase IIa clinical trial of STC3141 in Europe for the treatment of severe COVID-19 infection aims to research and evaluate the safety, preliminary efficacy and optimal dosing strategy for the treatment of patient with severe viral pneumonia caused by COVID-19 infection, and accumulate more data to comprehensively evaluate the risks and benefits of later clinical trials in order to accelerate the global development process of the product.
The clinical research of STC3141 conducted in Europe is progressing smoothly. After submitting the clinical trial application (CTA) in March 2021, the clinical trials were approved in Belgium in April 2021 and the first patient was enrolled in May 2021, approved in Poland in September, approved in the United Kingdom in October 2021, and all patients were successfully enrolled and dosed in December 2021. The is also the first clinical research of the Group’s First-in-class innovative drug in Europe.
STC3141, a global innovative product with a new mechanism, can neutralize 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, acute respiratory distress syndrome (“ARDS”) and other diseases with high clinically mortality and lack of effective therapy. The product has a novel mechanism and the results of related preclinical research 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 IIa clinical research for the treatment of patients with severe COVID-19 infection conducted in Europe, the product has been approved in Australia in May 2020 to conduct phase II clinical study for the treatment of ARDS in patients infected with COVID-19 and phase Ib clinical research for the treatment of sepsis, and the first patient has been dosed in December 2020. In March 2021, the product has been granted clinical approval by the National Medical Products Administration of the People’s Republic of China (NMPA) to conduct phase Ib clinical research in patients with ARDS, and the first patient has been dosed in November 2021. At present, this project has been granted 6 clinical approvals in four indications of sepsis, ARDS, severe COVID-19, and ARDS caused by COVID-19 in five counties around three continents, China, Australia, Belgium, the United Kingdom, and Poland. Its international multi-centre clinical trials are comprehensively advancing, demonstrating the continuous improvement of the Group’s global innovative R&D capabilities. The clinical progress of this project in the European Phase IIa clinical trial is also another significant milestone in the Group’s overseas clinical research process.
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 Group has forward-looking strategic plan in respect of sepsis, ARDS, COVID-19 and other diseases that pose a major threat to human health. The clinical progress of STC3141 in the European Phase IIa clinical trial is also another significant milestone in the Group’s overseas clinical research process. It is also expected to provide more data support for the commercialization of this product. 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, nuclear medicine and gene intervention therapy of tumor and anti-viral 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.”