Grand Pharma Enters into Strategic Cooperation with XELTIS, Introduced A Global Innovative Endogenous Tissue Repair Product

Grand Pharma Enters into Strategic Cooperation with XELTIS, Introduced A Global Innovative Endogenous Tissue Repair Product

  • In addition to aXess and other new products under the same technology platform, the Group also has the pre-emptive negotiation right for products of XELTIS developed in other indication areas in the Greater China region.
  • As the product with the world’s leading technology for establishing AVG access for dialysis patients, aXess is conducting the FIM trial overseas and is progressing smoothly.
  • The Group will reserve 11 innovative products in this field, among them, 2 products have been approved for commercialization in China, 5 products are in the clinical development stage, 1 product is in the registration application stage.

(July 18, 2022 - Hong Kong) Grand Pharmaceutical Group Limited (“Grand Pharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that the Group and XELTIS AG (“XELTIS”) have entered into a strategic cooperation agreement on equity investment and product introduction. The Group will use EUR 15 million, after meeting specific terms and conditions, to acquire approximately 11% equity interests in XELTIS, and obtain the exclusive development, production and commercialization rights of aXess, a global innovative endogenous tissue repair product for hemodialysis treatment of Arteriovenous Graft (“AVG”) patients with End Stage Renal Disease (“ESRD”), and the other new products in the field of hemodialysis developed under the same technology platform in the Greater China region (Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan Region). According to the agreement, the Group also has the pre-emptive negotiation right for products of XELTIS developed in other indication areas in the Greater China region. This strategic cooperation will deepen the Group’s product layout in the field of hemodialysis in peripheral vascular intervention.

XELTIS, based in the Netherlands, is a medical device company focused on development of supramolecular polymer-based Endogenous Tissue Restoration (“ETR”) devices for vascular-related treatments. The ETR technology of XELTIS can design and implant the absorbable biomaterials into the body to function as blood vessels or tissues in the body. The absorbable biomaterials can be absorbed or digested by the body after the body’s self-healing system grows corresponding tissues from the material as a skeleton and becomes functional. As the product with the world’s leading technology for establishing AVG access for dialysis patients, aXess product is conducting the First-in-Man (FIM) trial overseas, and it is progressing smoothly. The introduction of this product will benefit many Chinese hemodialysis patients.

Chronic kidney disease (“CKD”) is a disease of chronic kidney structure and function caused by various reasons, which has become one of the important public health problems in the world. According to the report of China Kidney Disease Network (CK-NET), there are about 700 million CKD patients in the world, among which China has the largest number of CKD patients, about 130 million (including about 1 million ESRD patients). Dialysis is the most common method for the treatment of ESRD. At present, the total number of patients using dialysis in China is about 675,000, of which 580,000 are using hemodialysis, and it will grow at a compound growth rate of about 15% in the next 5 years. At present, arteriovenous fistula (“AVF”) is the main access of hemodialysis access. However, AVF technology often suffers from complications such as fistula failure, long time for internal fistula maturation, internal fistula stenosis and thrombosis. According to statistics, more than 40% of dialysis patients who establish AVF access will develop arteriovenous fistula stenosis within one year. With the prolongation of access time, the proportion of stenosis will further increase, so there is an urgent need for a vascular access that can mature rapidly and have fewer complications for hemodialysis. aXess is expected to provide a safer and more effective blood access for dialysis patients by providing an infrastructure for patient autologous tissue repair, accelerating the establishment of dialysis access, and reducing the incidence of thrombosis and associated complications.

The field of cardiovascular and cerebrovascular precision interventional diagnosis and treatment is one of the core strategic areas of the Group, which has carried out an all-round layout in three directions: access management, structural heart disease, electrophysiology and heart failure. After the completion of this transaction, the Group will reserve 11 innovative products in this field, among them, 2 products have been approved for commercialization in China, 5 products are in the clinical development stage, 1 product is in the registration application stage, and the R&D of other products are also actively advancing.

In this field, the Group now has 50 R&D personnel, nearly 40% of them hold master or doctorate degrees. The Group has established overseas R&D platforms and overseas production bases in both North America and Europe, continuously developing innovative products. And it has established R&D and production bases for passive products and active products in Changzhou and Wuhan Optics Valley, respectively, and both of them have been put in use, continuously consolidating R&D and production strength in China, and actively promoting the localization of imported products, thereby benefiting more Chinese patients.

The Board of Grand Pharmaceutical Group Limited, commented, “Sticking to patients-cantered and innovation-driven, the Group will enhance its strategic plan 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’ and focuses on the high-quality innovative products at home and abroad, to further strategically plan in its existing sectors. By the dual-cycle development in China and abroad, the Group will provide more advanced and more diverse treatment options for patients around the world.

In the future, the Group will continue to adopt the development path of ‘introduction and implementation’ and ‘simultaneous localization and independent R&D’ to realize the dual system construction of local + global R&D and production, accelerate the launch of products and improve its own R&D capabilities. The group aims to build a leading ‘precise interventional diagnosis and treatment platform for cardiovascular and cerebrovascular diseases’ in China and even the world, and bring greater return to shareholders and society.”