(May 30, 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 has entered into a cooperation and exclusive product licensing agreement with CardioFocus, Inc. (the “CardioFocus”). The Group will introduce the new generation HeartLight X3 laser ablation platform of HeartLight® Endoscopic Ablation System, an innovative medical device for the treatment of atrial fibrillation from CardioFocus with a milestone payment of not more than USD 20 million and a certain percentage of sales commission to obtain the exclusive commercialization rights and conditional transfer of the core technology in Mainland China, Hong Kong and Macau (the “Licensed Region”), and the priority cooperation rights of other products of CardioFocus in the Licensed Region.
The Group always puts focus on the research and development (“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 field of cerebro-cardiovascular precision interventional diagnosis and treatment is one of the Group’s core strategic areas. It covers five directions, i.e. vascular intervention, neurointervention, structural cardiac disease, electrophysiology and heart failure. For the purpose of a comprehensive deployment, a product cluster of technologically innovative high-end medical device is in place. After the completion of this transaction, the Group will 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.
HeartLight X3 is another global innovative product introduced by the Group in the field of cerebro-cardiovascular precision intervention, following the drug-coating balloon that specialize in vascular intervention, neuro-interventional stent retriever, and intravascular and cardiac diagnostic equipment. It is an important strategic plan of the Group in building a world-leading cerebro-cardiovascular precision interventional diagnosis and treatment platform. HeartLight X3 has been approved for commercialization by the U.S. Food and Drug Administration (FDA) in May 2020. It is the only product in the world that can achieve circumferential ablation in the treatment of atrial fibrillation (“AF”). CardioFocus has been working in this field for more than 20 years and its related technologies are at the leading level in the industry worldwide.
CardioFocus is a medical device company in the United States dedicated to the development of ablation therapy for heart diseases such as AF. Its first, second and third generation Heart Light Systems have been approved for commercialization in the United States and Europe and in Japan the first generation HeartLight System is approved. It has cooperated with more than 100 medical institutions, and the products have more than 10,000 clinical procedures with remarkable clinical effect. HeartLight X3 laser ablation platform is the third generation AF ablation technology product. Utilizing the unique RAPID mode of the platform, it uses direct tissue visualization, adjustable laser energy, and compliant balloon technology to achieve accurate and continuous energy delivery, reducing the manual overlap processing of individual lesions, and more confidently performing complete pulmonary vein isolation. HeartLight X3 laser ablation platform has the point-to-point adjustable energy precise ablation characteristics of traditional radiofrequency catheter ablation, and at the same time has the characteristics of simple operation and short procedure time of cryoablation, while greatly reducing the dependence on the operator, which are all included in the latest generation of the HeartLight System. HeartLight X3 is expected to be approved for commercialization in China in 2025.
According to the research data of National Health Commission Arrhythmia Intervention Quality Control Centre (中國國家衛生健康委員會心律失常介入質控中心) and Frost&Sullivan, the number of electrophysiological surgery for catheter ablation patients in China has continuously increased in recent years, from 117,000 cases in 2015 to 180,000 cases in 2019, with a CAGR of 11.3%. The market size of electrophysiological devices in China increased from RMB1.48 billion in 2015 to RMB4.67 billion in 2019, with a CAGR of 33.2%. It is expected that the market size of electrophysiological device in China will reach RMB18.78 billion by 2024, with CAGR of 32.1% from 2019 to 2024, driven by the increasing ageing population and increasing number of patients with arrhythmia, the popularization of ablation surgery, and the upgrading of ablation surgical consumables, etc. The field of electrophysiological will become a fast-growing device subdivision track in the future.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “The introduction of the global innovative HeartLight X3 platform has further strengthened the Group’s strategic planning in the field of cerebro-cardiovascular precision interventional diagnosis and treatment, and enriched our innovative products reserve, marking another important footprint in our global development.”
“Looking forward, 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. It is the Group’s target to build this segment into a leading “cerebro-cardiovascular precision interventional diagnosis and treatment platform” in the PRC and even the world. The Group will strive to provide patients with more diverse treatment options to benefit more patients in the globe and create greater returns for shareholders.”
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