GP (HK) Enters into Investment and Strategic Cooperation Agreements with FastWave, a High-end Medical Device Development Company in the United States, Jointly Developing an Innovative Intravascular Shock Wave Calcification Treatment System, Establishing an Overseas R&D Platform for High-end Medical Devices

GP (HK) Enters into Investment and Strategic Cooperation Agreements with FastWave, a High-end Medical Device Development Company in the United States, Jointly Developing an Innovative Intravascular Shock Wave Calcification Treatment System, Establishing an Overseas R&D Platform for High-end Medical Devices

(August 2, 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 and FastWave Medical Inc (“FastWave”) has entered into a series of investment and strategic cooperation agreements. Among which, the Group will acquire 100% equity of FastWave with up to total USD72 million by phases, and will invest up to total USD8 million for supporting and jointly developing an innovative medical device, intravascular shockwave calcification treatment system, for the treatment of moderate to severe arterial calcification. After fulfilling the relevant conditions, FastWave will become the Group’s wholly owned subsidiary in the field of cerebro-cardiovascular precision interventional devices, and overseas high-end innovative medical devices research and development (“R&D”) platform.

The Group always puts focus on the 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 core members of FastWave have worked in well-known interventional devices R&D companies for many years, with experience in the founding of multiple medical technology companies and rich experience in the field of cerebro-cardiovascular precision intervention. The solid manufacturing process and technology precipitation of high-end innovative medical devices will lay the foundation for the R&D of the Group’s innovative medical devices.

Vascular calcification is the common pathological manifestations of atherosclerosis, hypertension, diabetic vascular disease, blood vessel damage, chronic kidney disease, and aging etc. Its mainly manifested as increased stiffness of vascular wall and decreased compliance, which can easily lead to myocardial ischemia, ventricular hypertrophy and heart failure. It is one of the important factors for the high morbidity and mortality of the cerebro-cardiovascular diseases. Coronary artery calcification is the most common type of vascular calcification. Epidemiological data shows that coronary artery calcification increases with age. The incidence in the population aged 40 to 49 is about 50%, and in the population aged 60 to 69 is about 80%. According to the relevant data from the Journal of the American College of Cardiology (JACC), the proportion of moderate to severe calcification lesions exceeds 30% in patients who received coronary intervention therapy. Vascular calcification can also involve peripheral vessels, especially for the people with diabetes and chronic kidney disease. In the United States, there are more than 9 million people suffer from peripheral vascular diseases every year, of which 30%-50% of patients have varying degrees of calcified lesions in the vascular walls. It has become a heavy medical burden. At present, products for the treatment of intravascular calcification lesions in China rely on imports, and there is a huge unmet clinical demand.

The intravascular shock wave calcification treatment system to be developed by the Group applies extracorporeal shock wave lithotripsy for the treatment of nephrolithiasis into vessel. Using the universal balloon dilatation catheter platform, integrating shock wave lithotripsy technology and balloon catheter angioplasty technology, it delivers catheter into vascular cavity of the lesion through interventional method, to destroy the calcification without damaging the vascular inner wall/intima soft tissue, and reduce complications of balloon expansion and stent implantation. The product has low difficulty in use, short learning curve, and high application versatility, therefore can be a new treatment method for calcified lesions. Intravascular lithotripsy is not only effective on superficial calcification, it is also the only technology that has therapeutic effect on deep calcification, and is the latest generation of vascular calcification treatment method. At present, Europe and the United States have approved the Shockwave coronary artery and peripheral intravascular lithotripsy system for the treatment of calcified lesions.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “The establishment of strategic cooperation relation with FastWave will help the Group build an overseas R&D platform for high-end medical devices. With FastWave’s rich experience in medical device development, the development of the intravascular shock wave calcification treatment system is expected to bring new treatment methods to patients with intravascular calcification lesions in China, and will further enrich the product pipeline of the Group in the field of vascular intervention and set up a product cluster of technologically innovative high-end medical devices. The field of cerebro-cardiovascular precision interventional diagnosis and treatment of the Group covers five directions, i.e., vascular intervention, neurointervention, structural cardiac disease, electrophysiology and heart failure. The Group now have seven products covering four directions, two of them have been approved for commercialization in the PRC, and the remaining five are expected to be approved for commercialization in the PRC before the end of 2025.”

“In the future, regarding ‘introduction and landing’ and ‘synchronously independent and localized R&D’ as its development direction, the Group will realize the construction of a dual system of local + global R&D and production, as well as accelerate product launches and improve its own R&D capability, provide patients with more advanced and diverse treatment options in the world, as well as creating greater returns for shareholders.”