Zielend auf die Reparaturbedürfnisse von Transplantationsorganen hat „Qinghan Medical“ ein eigenentwickeltes Normaltemperatur-Perfusions-NMP-System entwickelt | Frühes Projekt

When it comes to organ transplantation, the huge disparity between supply and demand has always been a global challenge. A piece of data from the World Health Organization once showed that the total number of organ transplants worldwide each year is less than 10% of the demand. In China, although organ donation pilot programs started in 2010, in the approximately 14 - year period up to the end of 2024, there were only 55,000 cases of organ donation after citizens' death in the country, with about 170,000 donated organs.

 Meanwhile, given the already insufficient supply - to - demand ratio, the problem of "a relatively high discard rate during organ transplantation surgeries" has also begun to attract industry attention. 

Recently, at the Global Health Industry Innovation Conference jointly hosted by Tsinghua Industrial Development Research Institute and the Global Health Industry Innovation Center (GHIC), Zhang Xiangjun, CEO of Qinghan Medical, told 36Kr that one of the reasons for this phenomenon is that due to limited protection and repair technologies, many organs "are discarded during the processes of extraction, transportation, storage, or surgery and cannot be reused". 

Specifically, after obtaining transplant organs, domestic medical institutions mainly use static cold storage technology (SCS) for storage. That is, after extracting the organ, it is immediately placed in a suitable perfusion fluid for irrigation, rapidly and uniformly cooled to between 0 - 4°C, and then transported to the surgical site. The advantage is that it is simple and easy to use, but the drawback is that it can cause organ damage. 

Therefore, in recent years, a method called normothermic machine perfusion technology (NMP) has begun to gain popularity in the industry. Simply put, the NMP device uses blood as a carrier, adds nutrients, biotin, etc. to the circulatory system, and uses an external oxygenator to simulate the normal human body environment, so as to better monitor the organ quality and evaluate the transplantation efficiency outside the body. A previous statistics from the University of Oxford on more than 200 liver transplant patients showed that compared with SCS, the NMP method can reduce the overall organ discard rate by about 50%. At the same time, there is less liver damage and the average preservation period is increased by about 54%. 

However, limited by the high - difficulty development barriers, currently, only products from 3 overseas companies in the world have obtained the US FDA or EU CE certification, and no domestic equipment has been registered and approved. 

To solve this problem, Qinghan Medical was established with the support of the Precision Medicine Research Institute of Tsinghua University, focusing on the development of a full range of high - end extracorporeal circulation medical equipment. In 2020, the company, together with Peking Union Medical College Hospital and other units, undertook the ECMO localization research project of the Ministry of Industry and Information Technology. 

Zhang Xiangjun introduced that although the history of machine perfusion technology can be traced back to the 1930s, it didn't start to be commercialized in the form of equipment until around 2018. From the perspective of technical development barriers, multiple factors such as the configuration of the perfusion fluid, oxygenator technology, and perfusion strategies directly affect the perfusion effect. In addition, during the perfusion process, the organ microcirculation also affects organ vascular perfusion, oxygen supply, metabolism, and organ repair. "The core is to make the liver think that it is still 'alive' in the human body, so a suitable temperature and blood environment must be created." 

In response to this, Qinghan Medical has carried out technological innovation in the development of NMP equipment mainly from three aspects: First, in the perfusion module, based on the concept of the microcirculation model, the company adopts a pulsatile perfusion design to achieve the perfusion effect of microvessels, ensuring that blood can be quickly delivered to the microvessels; 

In the oxygenation module, since the oxygenation indicators of different organs vary, the company has self - developed a full range of oxygenators dedicated to each organ; 

In addition, to achieve intelligent oxygenation and facilitate the observation and evaluation of the perfusion effect, in addition to displaying hemodynamic indicators, Qinghan Medical's NMP system also monitors blood gas indicators in real - time. At the same time, the system is embedded with intelligent algorithms for the temperature control system and oxygen supply system, enabling the isolated liver organ to achieve "survival and repair in the optimal bionic environment". 

It is understood that Qinghan Medical's normothermic machine perfusion system for the liver was officially launched in November 2024 and has successively received research orders. In addition, the company is also exploring the application of the NMP system in the fields of kidneys, hearts, lungs, etc. 

It is worth mentioning that based on the technical concept of microcirculation and the research accumulation of the founding team in the three core technical fields of micro - flow interface/flow field design, bio - coating technology, and hollow fiber membrane preparation, in addition to organ medicine, Qinghan Medical has also laid out corresponding product lines in the field of life support, such as extracorporeal membrane oxygenation systems and artificial uterus systems; and in the field of dissolved gas control, such as medical oxygenation membranes and medical heat exchange membranes.

Zhang Xiangjun mentioned that the reason for planning the product development idea in this way is that the team believes that all organs in the human body rely on the interaction with blood and exchange substances through microcirculation. For example, the heart drives blood circulation through bio - electricity and mechanical means, the lungs transfer substances through the alveolar membrane, and the kidneys filter plasma components through the thin - walled capillaries of the glomerulus.

  "Just as we can't eat, chat, and interact with the outside world on the highway, but we can stop and enjoy life on the country road. The same is true for life. Large blood vessels are like highways, which only transport blood. Only when blood flows into the microcirculation (country road) can it reach different organs and exchange different substances. Therefore, Qinghan Medical hopes to start with microcirculation research and gradually enter the full - range R & D and innovation of pulmonary circulation, systemic circulation, and even circulation power technology and equipment." Zhang Xiangjun said.