GP (HK)’s Global Innovation Product STC3141 Enrolled and Dosed Four Patients for the Phase IIa Clinical Trial of Covid-19 in Belgium Rapidly Advance the Global Development Process
(May 24, 2021 - Hong Kong) China Grand Pharmaceutical and Healthcare Holdings Limited (“GP (HK)” 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 field of severe infections, which recently successfully enrolled four patients for the phase IIa clinical trial for the treatment of severe Coronavirus Disease 2019 (“COVID-19”) infection in Belgium, and successfully completed continuous dosing.
The Group always puts focus on the research and development (“R&D”) of innovative products and advanced technologies. Sticking to patients-centered and innovation-driven, the Group will continue to increase 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 Group adopts the strategy of “global expansion and dual-cycle operation”, forming a new pattern of domestic and international cycles that synergize with each other. In this way, the Group can 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.
The enrollment and dosing of four patients for STC3141 Phase IIa clinical trial for the treatment of severe COVID-19 infection in Belgium, aiming to study and evaluate the safety, efficacy and optimal dosing strategy of STC3141 in the treatment of severe viral pneumonia caused by COVID-19 infection. It will further expand the scope of application of the product, accumulate more data to comprehensively evaluate the risks and benefits of late-stage clinical trials, and accelerate the global development process of the product.
The field of severe anti-infection is one of the core strategic areas of the Group. 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 clinically high-mortality diseases without effective treatment. The product has a novel mechanism of action and the results of related pre-clinical 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, the product has been approved in Australia in May 2020 to carry out phase II clinical research for the treatment of ARDS in patients infected with COVID-19 and phase Ib clinical research for the treatment of sepsis. In early March 2021, the product obtained approval from the National Medical Products Administration of the People's Republic of China (NMPA) to carry out phase Ib clinical research in patients with ARDS. In April 2021, the product was approved for phase IIa clinical research for the treatment of patient with severe COVID-19 infection in Belgium.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “Only within one month after the approval of the clinical trial of the project, the enrollment and dosing of four patients with severe COVID-19 infection for Phase IIa clinical trial in Belgium were successfully completed, representing that the Group’s R&D efficiency has been further improved. At the same time, this clinical progress of the project is another significant milestone in the Group’s overseas clinical research process. In the future, the Group will continue to deepen the strategic plan in the field of severe infections, strive to provide patients with more diverse treatment options to benefit more patients, and create greater returns for shareholders.”