TH MEDICAL-B (02697): Completed preclinical experiments of extracorporeal cross-circulation perfusion using gene-edited pig livers in 6 cases, the world's first validation of long-duration efficacy

TH MEDICAL-B (02697) announced that, leveraging its independently developed organ perfusion system, it has successfully completed six preclinical experiments of extracorporeal cross-circulation perfusion support therapy using gene-edited pig livers to assist non-human primate acute liver failure models. The experiments were conducted in accordance with the relevant requirements of the State Council Order No. 818 regarding the filing guidelines for clinical research on new biomedical technologies and clinical translation of new xenotransplantation technologies. In collaboration with research teams from Yunnan Agricultural University, Kunming First People's Hospital, and the First Affiliated Hospital of Anhui Medical University, the company set a record for stable liver function perfusion support therapy lasting up to 144 hours, with all six cases exceeding 72 hours, marking the world's first validation of the long-duration efficacy of this technology. Experimental results showed that during the experiments, the animals' vital signs remained stable, the donor livers continuously secreted bile, and core biochemical indicators remained generally stable, effectively compensating for liver physiological functions. At the same time, immune rejection reactions were controllable, with no hyperacute or acute rejection injury observed, effectively overcoming the core technical challenges of xenogeneic liver transplantation. This research relied on the independently developed organ perfusion system of Zhenjiankang Medical, combined with 8-gene-edited medical donor pig livers developed by Yunnan Agricultural University, to construct a safe and stable extracorporeal liver perfusion support therapy system. The system is a modular organ medical device platform that adopts a technical architecture of a universal core main unit paired with replaceable dedicated tubing, organ chambers, perfusion fluids, and other consumables and configuration modules. Without replacing the main unit, it can conduct research and applications related to normothermic perfusion preservation and extracorporeal life support for multiple organs including liver, kidney, heart, and lung, and possesses the technical potential to expand from isolated organ perfusion preservation to extracorporeal perfusion support therapy research. Liver failure is a severe disease with a relatively high mortality risk. Existing artificial liver support technologies still have limitations in fully replacing the complex physiological functions of the liver, while liver transplantation is constrained by factors such as donor liver resources, patient condition, and transplantation timing. The gene-edited pig liver extracorporeal perfusion support therapy technology aims to explore the use of an extracorporeal perfusion system connected to a biologically active isolated liver to achieve potential liver function support, buying time for patients with severe liver failure to recover liver function or receive a liver transplant. Related technical research conducted based on the organ perfusion system is expected in the future to explore applications in various diseases related to severe liver dysfunction and clinical scenarios, including but not limited to: acute liver failure, subacute liver failure, acute-on-chronic liver failure, severe liver function decompensation and related critical liver diseases, critically ill patients awaiting liver transplantation, and severe liver dysfunction after liver transplantation. These applications are currently all exploratory research directions and are not approved clinical indications. The Board hereby reminds that the six experiments described in this announcement are preclinical studies, and their completion does not mean that the relevant technology has been proven safe and effective in humans, nor does it mean that the relevant products have obtained medical device registration certificates or clinical application permits. The relevant potential indications, clinical translation directions, and commercialization prospects are all subject to uncertainty. Shareholders and potential investors are advised to exercise caution when dealing in the company's securities.