GP (HK)’s First-In-Class Drug STC3141 for Sepsis has been Granted  A “Notice of Approval for Clinical Trial of Drugs” Issued by the NMPA and Approved to Carry out Phase Ib Clinical Trial on ARDS Highlights its Ability to Implement the Commercialization of R&D Results

GP (HK)’s First-In-Class Drug STC3141 for Sepsis has been Granted A “Notice of Approval for Clinical Trial of Drugs” Issued by the NMPA and Approved to Carry out Phase Ib Clinical Trial on ARDS Highlights its Ability to Implement the Commercialization of R&D Results

(March 3, 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 STC3141, a first-in-class drug (first-in-class) for the treatment of sepsis, is being developed by Grand Medical Pty Ltd, a wholly-owned subsidiary of the Group and an Australia based antiviral and anti-infection innovative drug research center. It has been granted a “Notice of Approval for Clinical Trial of Drugs” issued by the National Medical Products Administration of the People's Republic of China (“NMPA”) and approved to carry out Phase Ib clinical trial in another indication for acute respiratory distress syndrome (“ARDS”). This will focus on assessing the safety, tolerability, and metabolic characteristics of the drug in patients with ARDS and accumulating more data to comprehensively assess the risks and benefits of later-stage clinical trials so as to accelerate the global product development process.

The Group always puts focus on the R&D of innovative products and advanced technologies, and adopts the strategy of “global expansion and dual-cycle operation”, continuing to increase its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs. The Group has already predicted that anti-virus and anti-infection may become one of the key focuses to counter diseases that pose a great threat to human health following malignant tumor, and thus, the Group sets anti-virus and anti-infection as one of the focus areas in strategic planning. STC3141 has now completed a Phase Ia clinical trial of healthy volunteers in Australia, which has preliminarily determined the safety and metabolic characteristics of the drug in human. In May 2020, Phase II clinical trial for the treatment of ARDS in patients with 2019 coronavirus disease (“COVID-19”) and Phase Ib clinical trial for the treatment of sepsis were approved.

Sepsis, commonly known as blood poisoning, is an immune system disorder caused by infection, which can lead to life-threatening organ dysfunction. It is a common fatal complication of patients with tumors and severe infections such as burns, trauma and major surgery. Sepsis affects more than 31.5 million people worldwide each year, of which over 19.4 million patients are with severe sepsis. ARDS is a non-cardiogenic clinical syndrome characterized by progressive dyspnea and refractory hypoxemia, which leads to hypoxia and respiratory distress. According to a survey of nearly 30,000 patients in 459 intensive care units (“ICUs”) in 50 countries, the prevalence of ARDS is 10.4% among critically ill patients. Currently there are limited access to treatment for ARDS, with an overall mortality rate of 34% in hospital and 60% in severe cases. In the COVID-19 pandemic, ARDS and sepsis are also important causes of death. There is a clear relevance between the two pathogenic mechanisms. However, there is a lack of drugs targeted for sepsis in the market, indicating an urgent clinical demand and tremendous market prospect.

With clear therapeutic mechanism, STC3141 is used to treat sepsis by reversing organ damage which is caused by the body's excessive immune response through neutralizing extracellular histones and neutrophil trapping nets. The results of STC3141 were published in the top academic journal “Nature Communications” in February 2020, with profound academic influence. The Phase Ib clinical study of ARDS in China is also an important milestone in the global development of the project.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: “The Group sets antiviral and anti-infection as one of the focus areas in strategic planning. The approval for STC3141’s clinical trial in the indication for ARDS has further highlighted our ability to implement the commercialization of R&D results. Meanwhile, the approval helps to accelerate the Group's commercialization process of technological innovation pipelines worldwide and further enhance the Group's innovative competitiveness in the field of emergency medicine. In the future, the Group will continue to make full use of its industrial advantages and research and development capabilities, to accelerate commercialization process for innovative products and provide patients with more advanced and diverse treatment options in the world.”