First Patient Dosed in the Phase 1b Clinical Trial for Sepsis of GP (HK)’s World-Class Innovative Drug STC3141 Promote Commercialization of Technological Innovation Pipelines Globally at Full Speed First-mover Advantages in Anti-virus and Anti-infection Area Come into Play

First Patient Dosed in the Phase 1b Clinical Trial for Sepsis of GP (HK)’s World-Class Innovative Drug STC3141 Promote Commercialization of Technological Innovation Pipelines Globally at Full Speed First-mover Advantages in Anti-virus and Anti-infection Area Come into Play

(December 13, 2020, 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 first patient has been dosed in Australia in a Phase 1b clinical trial of STC3141, a world-class innovative drug for treatment of sepsis developed by Grand Medical Pty Ltd, a wholly-owned subsidiary of the Group and an Australia based innovative drug research centre.

The Group always puts focus on the research and development (“R&D”) of innovative products and advanced technologies and increases its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs. 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. 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 and has commenced research and development of multiple innovative products.

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. It is expected to become an innovative first-in-class drug for treatment of sepsis. STC3141 has completed the phase 1a clinical trial in healthy volunteers, and the primary results proved its safety, tolerability and pharmacokinetic. This time, the 1b clinical trial in Australia will further evaluate the safety, tolerability and pharmacokinetic of this product in sepsis patients. Up to now, the patent of this product has been filed in many countries and regions including Europe, US, Japan and South Korea, and has been approved in several places.

Sepsis, commonly known as blood poisoning, is an immune system disorder caused by infection. 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[1] people worldwide each year, of which over 19.4 million patients are with severe sepsis. It has a fatality rate higher than a quarter, becomes the leading cause of mortality following heart disease in intensive care units. Furthermore, sepsis is the most expensive hospital condition to treat and consumes considerable medical resources. According to statistics, sepsis accounts for 40% of the total cost of treatment for patients in the intensive care units, which costs 6 times more to treat than non-sepsis patients. Sepsis has posed a huge threat to human health and is a major contributor to the global burden of disease. However, there is a lack of targeted drugs for sepsis on the market, indicating an urgent clinical demand and tremendous market prospect.

At present, the Group has owned several blockbuster world-class innovative products for indications including (but not limited to) sepsis, acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients, and parainfluenza. Professor Chris Parish, one of the inventors of STC3141, is the group leader of the Cancer and Vascular Biology Group, in the Department of Immunology at The John Curtin School of Medical Research, Australian National University. He was awarded the Clive and Vera Ramaciotti Medal for Excellence in Biomedical Research in recognition of his scientific achievements. Moreover, the Group has the global license of new parainfluenza drug and its related technologies, which is co-developed with Professor Mark von Itzstein, inventor of Zanamivir and director of the Institute for Glycomics, Griffith University. Also, the Group has established the Australian Research and Development Centre, and reached long-term and in-depth cooperation with the Australian National University and Griffith University, continuing to co-develop world-class innovative products and therapies in the field of anti-virus and anti-infection.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: “Since the outbreak of COVID-19, antiviral and anti-infective drugs have again become the focus of pharmaceutical companies around the world, setting off a new wave of research and development. The Group’s forward-looking strategic planning in the field has gradually achieved favourable results, and the first-mover advantage has come into play.”

“The Group always believes that the technological innovation is the core factor of corporate competitiveness. In the event of public health incident, the value of anti-virus and anti-infection area has become more evident. The Group’s early strategic planning in the area is precisely focused on the demands of long-term operation and development of the Company. In the future, the Group will continue to adhere the strategy of ‘global expansion and dual-cycle operation’, increase its investment in the world-class innovative products and advanced technologies, and together with the synergistic effects from multiple domestic and international centres, to enrich product pipeline and improve supply chain. In this way, the Group can make full use of its and its associates’ industrial advantages and R&D capabilities at home and abroad, to accelerate commercialization process for innovative products and provide patients with more advanced and diverse treatment options in the world.”