GP (HK)’s Global Innovative Drug STC3141 Successfully Dosed the First Patient of its Phase Ib Clinical Trial for ARDS In China, Deepen the Dual-Cycle Development Strategy and Continues the Global Development Process
(November 9, 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 global innovative drug STC3141, which is developed for the treatment of acute respiratory distress syndrome (“ARDS”) by the Grand Medical Pty Ltd, the Group’s wholly-owned subsidiary and an innovative drug research and development center established by the Group in Australia, has been dosed to the first patient for its phase Ib clinical trial conducted in China.
The Group always puts focus on the R&D of innovative products and advanced technologies and has deployed 3 innovative global drugs in the field of anti-virus and anti-infection. The Group is sticking to patients-centered and innovation-driven, with the strategy of “global expansion and dual-cycle operation”, continuing to increase its investment in world-class innovative products and advanced technologies to meet unmet clinical needs, and enrich product pipeline and improve the supply chain. The Group has implemented the innovative strategy of “Missile, Nuclear Bomb and Satellite” in the field of “cerebro-cardiovascular precision interventional diagnosis and treatment”, “anti-tumor” and “anti-virus and antiinfection”, dedicating itself into building a world leading pan-interventional diagnostic and therapeutic platform and strive to develop as the international first-class leader in terms of technology in the fields of treatment platform of tumor and severe anti-infection.
The conduct of phase Ib clinical trial of STC3141 for the treatment of patient with ARDS in China aimed to study and evaluate the safety, tolerability and metabolic characteristics for treatment of ARDS patients, and to collect more data to comprehensively evaluate the risks and benefits of late-stage clinical trials and accelerate the global development process of the product.
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, ARDS and other diseases with clinically high-mortality and lack of effective treatment drugs. 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, STC3141 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, and the first patient has been dosed in December 2020. In April 2021, the product was approved for phase IIa clinical research for the treatment of severe COVID-19 patients in Belgium, and the first patient has been dosed in May. In March 2021 the product has been granted clinical approval in China by the National Medical Products Administration of the People's Republic of China (NMPA) to carry out phase Ib clinical research in patients with ARDS, passed the ethics review of leader entity in May and gained verification from Human Genetic Resource Administration of China* (中国人类遗传资源管理办公室) in July, and has successfully enrolled the first patient recently, which indicated that the Group’s research and development efficiency is further enhanced.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “The field of severe anti-infection is one of the core strategic areas of the Group, the STC3141 dosing of the first patient for Phase Ib clinical trial for the ARDS treatment in China is another significant milestone in the global development of the project. In addition, APAD, another global innovative product deployed by the Group in this field, is complementary to the STC3141 on antagonizing the excessive immune response of the body to treat sepsis, which brings along with synergy for the treatment of severe sepsis patients in the future. The Group will continues to expand and reach a new business growth point, with the vision of internationalization and technological innovation, fully capitalising the Group's 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.”