GP (HK) Introduces A Global Innovative Mitral Valve Replacement Medical Device – Saturn, Continue To Deepen The Product Pipeline Strategic Plan In The Field Of Precision Interventional Diagnosis And Treatment

GP (HK) Introduces A Global Innovative Mitral Valve Replacement Medical Device – Saturn, Continue To Deepen The Product Pipeline Strategic Plan In The Field Of Precision Interventional Diagnosis And Treatment

(November 28, 2021 - Hong Kong) Grand Pharmaceutical Group Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that the Group recently has entered into equity investment and product introduction strategic cooperation agreement with InnovHeart S.r.l. (“InnovHeart”). The Group will acquire approximately 17.8% equity interests of InnovHeart and obtain the exclusive development, manufacturing and commercialization rights of Saturn, a global innovative medical device for mitral valve replacement, in Greater China Region (including Mainland China, Hong Kong, Macau and Taiwan) with EUR43.8 million consideration.

The field of cerebro-cardiovascular precision interventional diagnosis and treatment is one of the Group’s core strategic areas. Saturn is another global innovative product of the Group in the field of precision intervention following drug-coated balloon for coronary artery and peripheral vascular intervention, neuro-interventional stent retriever, intravascular and cardiac diagnostic equipment, laser ablation platform, and heart failure therapeutic system. This strategic cooperation is also an important strategic plan of the Group in building a world-leading cerebro-cardiovascular precision interventional diagnosis and treatment platform.

The Group has achieved the comprehensive strategic plan of innovative products in the six major directions in this field: coronary artery vascular intervention, peripheral vascular intervention, neurointervention, structural cardiac disease, electrophysiology and heart failure. After the completion of this transaction, the Group will have 10 innovative products. Among them, 2 products have been approved for commercialization in Mainland China, and the clinical registration of the other 8 products in China are also being actively advanced, striving to realize the commercialization of innovative products in phases and echelons, and driving the business in this field to achieve leap-forward growth. Since now, the Group has achieved the comprehensive strategic plan of innovative products in the six major directions in this field, has successfully completed the development planning objectives formulated at the beginning of this year as scheduled, and has become one of the companies with the broadest product layout and the most comprehensive disease coverage in the field of cerebro-cardiovascular precision interventional diagnosis and treatment.

Located in Italy, InnovHeart is a medical device company focusing on the development of medical systems for innovative transcatheter mitral valve (“TMV”) intervention therapy, devoted to provide innovative treatments for patients with valve diseases. Its founding team has deeply involved in the field of heart valve diseases for more than 10 years, with very rich experience in product development. InnovHeart’s core product Saturn implanted by transseptal intervention, which minimizes surgical trauma and shortens postoperative recovery time. Its innovative combination of annulus reconstruction technology and valve replacement technology will improve the adaptability of the device and will be suitable for various mitral valve structures. The introduction of the Saturn product is expected to enable the patient with mitral regurgitation (“MR”) in China to simultaneously benefit the world’s most advanced transcatheter mitral valve replacement (“TMVR”) therapy.

Valvular heart disease is caused by the damage or defects in one or more of the four heart valves (i.e. aortic valve, pulmonary valve, mitral valve, and tricuspid valve). It is a common structural heart disease. According to Frost&Sullivan’s data, there were approximately 210 million patients with valvular heart disease around the globe in 2019, causing approximately 2.6 million deaths. Among them, MR is the most common type of heart valve disease, accounted for 45.4% of patients with heart valve disease worldwide. The number of MR patients has increased from 9.6 million in 2015 to 10.6 million in 2019, and is expected to reach 12.1 million in 2025. Due to the prevalence of rheumatic fever and degenerative diseases, together with the improvement of living standard and the increasing aging population, patients with valvular disease over 65 years old in China become more common, and treatment needs are much more urgent.

If patients with severe MR cannot receive effective treatment, the 5-year mortality rate can reach 50%. For patients with severe MR, the standard treatment is to replace or repair the mitral valve under extracorporeal circulation by thoracotomy. But surgical thoracotomy is very traumatic and with high surgical risk, the number of patients that received surgical treatment is limited. As an alternative therapy to surgeries, TMV technology uses minimally invasive pathways through atrial septum to complete the repair or replacement of the mitral valve under the guidance of imaging techniques, without the need for cardiac arrest and extracorporeal circulation assistance. Due to the complex structure of the mitral valve, currently the mitral valve edge-to-edge repair technology that has been commercialized can only temporarily solve some of the problems, and TMVR is expected to become a standard general treatment solution of various types of mitral valve disease. However, due to the difficulty of research and development, currently there are no transseptal interventional mitral valve replacement products that have been successfully commercialized. According to Frost&Sullivan’s report, it is estimated that by 2030, the global mitral valve intervention market will reach USD17.4 billion. According to Huatai Securities’ research on the TMV market, the market capacity of China TMV is approximately RMB11.8 billion by 2030

The Group has entered into the field of cerebro-cardiovascular high-end medical devices since 2015. Adhering to the treatment concept of “intervention without implantation”, the Group has deployed three drug-coated balloon products, two of them, RESTORE DEB and APERTO OTW, have been approved for commercialization in China in 2019 and 2020 respectively. The performance of the products has been highly confirmed by the industry experts. Among them, the clinical research results of RESTORE DEB have been published on the important journals in the field of cardiovascular diseases “JAAC (Journal of the American College of Cardiology) Cardiovascular Interventions”. Its clinical status has also been confirmed in the guidelines and experts consensus such as “Chinese Guideline for Percutaneous Coronary Intervention and Chinese Experts Consensus on the Clinical Application of Drug-coated Balloons* (藥物塗層球囊臨床應用中國專家共識)”. The clinical research results of APERTO OTW were published on the important journals in the field of renal disease treatment “American Journal of Kidney Diseases”, and its commercialization brought a new treatment method to patients with arteriovenous fistulas stenosis in dialysis access. Since the commercialization of the two products, the sales team has continued to expand, and hospital access has been accelerated. At present, there are more than 100 sales personnel, and over 700 hospitals coverage. In 2017, the Group obtained the innovative intracavitary imaging diagnostic device NOVASIGHT Hybrid, forming the pattern of a precision intervention platform integrated diagnosis and treatment. This product is expected to be launched in China in the fourth quarter of 2022. In 2020, the Group deployed a global innovative neurological stent retriever through the establishment of a R&D and production base, completing the strategic plan of “treating the heart and brain with the same therapeutic method” in the field of devices. In 2021, the Group strategically accelerated the expansion of the high-end device product pipeline, has cumulatively invested for more than USD160 million. It has strategically planned HeartLight X3, a new generation of laser ablation platform for atrial fibrillation, the innovative CoRISMA series products for the treatment of heart failure, and the intravascular shockwave calcification system for the treatment of arterial calcification, and has established an overseas high-end innovative medical device R&D platform. The mitral valve replacement product Saturn this time will complete the strategic plan of the Group in the field of structural cardiac disease, further enrich the Group’s pipeline of innovative products under development in the field of cerebro-cardiovascular interventional diagnosis and treatment, and continuously promote the comprehensive establishment of “active + passive” innovative device platform.

At present, in the field of cerebro-cardiovascular precision interventional diagnosis and treatment, the Group has established overseas R&D platforms and overseas production bases in both North America and Europe, continuously developing innovative products, and has established R&D and production bases for passive products and active products in Changzhou and Wuhan Optics Valley, respectively. The Changzhou R&D and production base has been put in use, and the Wuhan Optics Valley R&D and production base is expected to be officially put in use in 2022, continuously enhancing Chinese R&D and production capabilities. In this field, the Group now has 50 R&D personnel, nearly 40% of them hold master or doctorate degrees. It has more than 30 families of patents, Chinese patent applications and international patent applications under the Patent Cooperation Treaty (PCT), with solid industrial foundation and R&D capabilities, escorting the Group to establish its leading position in various directions in the field of cerebro-cardiovascular precision interventional diagnosis and treatment, and establish high-end medical device innovative product clusters featuring “intervention without implantation, treating the heart and brain with the same therapeutic method, and active + passive”, thereby achieving the continuous improvement of the Group’s core competitiveness.

At the same time, the Group will continue to focus on innovative business development in the six directions of coronary artery vascular intervention, peripheral vascular intervention, neurointervention, structural heart disease, electrophysiology and heart failure, and adopt a combination of internal and external R&D to accelerate the pace of R&D. Relying on the Group’s deep global R&D strength and continuous capital investment, it will constantly explore global cutting-edge technologies thereby providing continuous momentum for the Group’s long-term development.

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 innovative product launches and improve our internal R&D capability. The Group will further promote the development of global platforms, with the belief of “persistence is the key to success”, targeting to build this segment into a leading “cerebro-cardiovascular precision interventional diagnosis and treatment platform” in China and throughout the world.

The Board of Grand Pharmaceutical Group Limited, commented, “The Group always puts focus on the R&D of innovative products and global advanced technologies in the field of cerebro-cardiovascular precision interventional diagnosis and treatment. The global innovative Mitral Valve Replacement Medical Device – Saturn will further improve the Group's comprehensive strategic plan of innovative products in the six major directions in this field. In the future, The Group will continue to stick to patients-centered and innovation-driven, adopt the strategy of 'global expansion and dual-cycle operation', increase its investment in global innovative products and advanced technologies, and enrich and improve product pipelines and improve supply chain. The Group will further deepen the innovative strategy of 'Two Bombs, One Satellite' in the three directions of cerebro-cardiovascular precision interventional diagnosis and treatment, nuclear medicine and gene intervention therapy of tumor and anti-viral and anti-infection, dedicated to build a world leading precision interventional diagnosis and treatment platform, and to develop into an international first-class nuclear medicine and genetic interventional tumor diagnosis and treatment platform, and a leading technology company in the field of severe anti-infection.”