GP (HK)’s Global Innovation Product STC3141 Receives Approval for a Phase IIa Clinical Trial of COVID-19 in Belgium ，OncoSec’s Gene Electrotransfer Device GenPulse™ Receives the CE Mark Certification from EU
(April 19, 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 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 has recently received approval for a phase IIa clinical trial in Belgium for the treatment of Coronavirus Disease 2019 ("COVID-19"). At the same time, the Group’s associate OncoSec Medical Incorporated (NASDAQ: ONCS) (“OncoSec”, the Group’s research and development (“R&D”) platform in tumor immunotherapy and DNA technology), has received the European Union’s (“EU”) CE mark certification for its next generation gene electrotransfer device GenPulse™ recently.
The Group always puts focus on the R&D of innovative products and advanced technologies, and continues to expand its strategic planning in anti-tumor field. Sticking to patients-centered and innovation-driven, the Group will continue to increase its investment in the world-class innovative products and advanced technologies, and introduce world-class innovative products for different cancer indications in response to unmet clinical needs, dedicating itself into building world-leading radiopharmaceuticals platform and Immunotherapy platform. 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.
Global innovative product STC3141 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 this year, the product obtained approval from the National Medical Products Administration of the People's Republic of China to carry out phase Ib clinical research in patients with ARDS. STC3141 Phase IIa clinical trial for the treatment of COVID-19 approved in Belgium aims to study and evaluate the safety and efficacy of STC3141 in the treatment of severe viral pneumonia caused by COVID-19 infection. This clinical trial 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.
GenPulse™ is a part of the OncoSec Medical System (“OMS”) electroporation device platform for the treatment of solid tumors. GenPulse™ applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increases the uptake of anti-cancer agents into these cells. TAVO™, OncoSec’s core product, is a global innovative cytokine-based intratumoral immunotherapy product that delivers DNA-based interleukin-12 (“IL-12”) encoding in the tumor and its microenvironment. Through OMS electroporation technology, IL-12 is expressed locally in the tumor microenvironment to stimulate the immune response to react, and target and attack tumor cells, in order to inhibit the growth of the tumor cells. The CE mark certification from EU demonstrates that OncoSec has the capability to develop and manufacture devices that meets quality and safety requirements in the EU, and further augments the OncoSec's OMS standard in the design, development, manufacture and distribution to the International Organization for Standardization's (“ISO”) 13485 standard. The CE mark certification also indicates the OncoSec’s electroporation device complies with standard of the European Commission (“EC”) and therefore can be marketed within the 31-nation European Economic Area (“EEA”) and Switzerland, paving the way for the subsequent commercial deployment in the U.S. and the EU.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “The fields of severe anti-infection and anti-tumor are core strategic areas of the Group. The approval of the global innovative product STC3141 Phase IIa clinical research of COVID-19 in Belgium is another important milestone in the global development of the project. The CE mark certification for gene electrotransfer device GenPulse™ marks a significant milestone in OncoSec’s commercialization in Europe. Looking forward, the Group will continue to enrich product pipeline and industrial strategic plan, accelerate commercialization processes for innovative and international products and provide patients with more advanced and diverse treatment options in the world.”