Technology Research and Development

In the past decade, these hospitals and individuals have achieved many innovations that enabled the growth of the transplant industry and made it possible to achieve its present-day scale. These achievements include prolonged organ preservation, lower rejection rates, and shortened operation times.

Immunosuppressants

As transplant patients rely on post-transplant immunosuppressants to avoid organ rejection, the rapid development of China’s immunosuppressant technology has greatly contributed to the unprecedented growth of China’s organ transplant industry.

The Chinese government incorporated organ transplantation into its national strategy and listed the research and development of immunosuppressants as national key scientific research projects. For example, the High Technology Research and Development Program (863 Program), National Program on Key Basic Research Projects (973 Program), “985 Project” of the State Key Universities, and China National Natural Science Fund all invested heavily in promoting immunosuppressant research and development. Many domestic transplant related institutions engaged in R&D early on.

Such ample government funding produced fruitful results:

• Ciclosporin, the first domestic immunosuppressant was, was made by the North China Pharmaceutical Group¹
• “A novel immunosuppressant Fingolimod: research advances”² and “Research advances in the application of immunosuppressant in organ transplantation” published by the Institute of Basic Medical Sciences, Academy of Military Medical Sciences³
• A project on research and development of organ transplant immunosuppressant series products conducted by the Lunan Pharmaceutical Group
• Research in immunosuppressant withdrawal after liver transplantation by the Guangdong Provincial Organ Transplant Center, Sun Yat-sen University Institute of Organ Transplantation⁴
• Studies in basic immunology for organ transplantation conducted by the Fudan University Organ Transplant Center⁵

By 2004, domestic drug development began to catch up, taking almost half of the market share from imported and joint-stock drugs. This greatly lowered the cost of immunosuppressant medications and lifted an economic barrier for many patients who otherwise could not afford to receive organ transplants. It thereby contributed to a rapid growth in transplant volume in China before 2004.⁶

In 2004, Professor Zhang Yuhai, director of the Urology Department of the Beijing Friendship Hospital, said that over half of kidney transplant patients chose to use domestic immunosuppressants, including not only self-funded patients but also many with free medical service or insurance.⁷

In 2006, Health Times (owned by People’s Daily) interviewed Yan Lvnan, the director of the liver transplantation center at West China Hospital of Sichuan University. Dr. Yan said that West China Hospital was able to keep the cost of post-transplant maintenance at 30,000 yuan in the first year and an average of 10,000 yuan per year thereafter by using immunosuppressants reasonably, which greatly reduced the cost.⁸

In March 2006, just before the exposure of forced organ harvesting, the Southern Medicine Economic Institute under the China Food and Drug Administration published a report in its own publication, Medicine Economic Reporter, which said the domestic immunosuppressant market at the time was nearly 10 billion yuan with more than 100 manufacturers of nearly 30 drugs.⁹

If each patient pays an average of 30,000 RMB per year for immunosuppressants, a10 billion RMB market in 2006 would have supported approximately 333,000 post-transplant patients. Since organ transplantation grew significantly only after 2000, the size of the immunosuppressant drug market in 2006 implies an average of 50,000 to 60,000 transplants were performed each year since 2000.

According to the 2011 “China Science and Technology Development Report,” China has established a series of new demonstration bases for piloting the production of raw materials and preparations of immunosuppressants. China has also improved its research capacity and development and manufacturing of domestic immunosuppressants, achieved the localization of new immunosuppressive products, reduced medical costs for transplant patients, realized earnings from exports, and strengthened the international competitiveness of the Chinese organ transplant immunosuppressant industry.¹⁰

As the patents of several major imported drugs expired, China began to produce a large volume of imitation products in addition to domestically developed drugs. These producers have achieved the same efficacy as imported immunosuppressants but at much lower prices. This increased the market share of domestic drugs. Major producers include Huadong Medicine Co., Ltd, North China Pharmaceutical Group Corporation, and Zhejiang Hisun Pharmaceutical Co., Ltd.¹¹

As transplant hospitals and pharmaceutical companies have widely deflated public transplant data for tax evasion and inability to explain organ sources, it is difficult to determine accurate statistics for domestic immunosuppressant usage. Nevertheless, our research finds that along with the momentous development of China’s organ transplant industry, the immunosuppressant market grew by an average of 13% every year between 2008 and 2014.¹²

International drug sales data, such as those from IMS Health indicating a 2.3 billion RMB market in 2009,¹³ reflect only part of the actual size of the Chinese immunosuppressant market. China’s actual immunosuppressant market should be far more than the 10 billion figure in 2006 with its scale reflected by current IMS Health data.

Improved Organ Matching

Professor Tan Jianmin at Fuzhou General Hospital of Nanjing Military Command pioneered HLA and amino acid residue matching technology in China, enabling donors and recipients to be genetically matched before transplantation and significantly improving transplant outcome quality. He was the second-place recipient of the 2001 National Science and Technology Advancement Award.¹⁴

Tan also established an anti-HLA antibody screening method that significantly reduced acute rejection events. This technique has since been applied all over the country with Fuzhou General Hospital establishing collaborative relationships with more than 100 hospitals in 19 provinces and cities and organ sharing relationships with 15 transplant centers.¹⁵

Prolonged Organ Preservation

Among the hundreds of transplant-related patents in China, about half are related to anti-rejection drugs and organ preservation solutions.

Shanghai Changzheng Hospital of the Second Military Medical University was one of the first in China to perform kidney transplants. Zhu and his team completed research on kidney and multi-organ preservation solutions. After 20 years of clinical application, this product is propelling China to the forefront of this field internationally.¹⁶ An archived webpage of Changzheng Hospital stated, “95% of hospitals in China use the organ preservation solution we developed.”¹⁷

Shortened Operation and Hospitalization Times

At No. 107 Hospital of Jinan Military Command, deputy director Du Yingdong of the liver transplant center claimed, “Over 10 years ago, it took us over 10 hours to complete a liver transplant surgery. Now our technology has matured, and a liver transplant only takes 4 to 5 hours. Sometimes, 3 to 4 surgeries can be completed in one day. The speed of development has caught up to that of high-speed rail.”¹⁸ In April 2012, the hospital opened a new ward building, increasing its bed count from 600 to over 1,000.¹⁹

Shen Zhongyang, the director of Tianjin Oriental Organ Transplant Center, set a world record for the fastest liver transplant surgery in 2003, taking 2 hours and 4 minutes between making the incision and closing the abdomen. No blood transfusions were used during the operation. The previous record was 3 hours.²⁰

Zhongshan Hospital of Shanghai Fudan University performed its first liver transplant in 1978. Since 2001, liver transplantation at this hospital has seen rapid development, with increased variety, more innovations, shorter operating times (4 to 6 hours on average), less bleeding, and fewer complications. Some patients are discharged 9 days after their operation. Transplant recipients include patients with liver cancer as well as other end-stage liver diseases. Its quantity and success rate of liver transplantation lead both the Shanghai region and the country.²¹

Zhongshan Hospital’s Liver Surgery Department recently started accelerating the transplant process time by performing surgery on patients immediately after their initial outpatient examination and hospital admission, This has attracted patients from more than 10 countries and regions, including the United States, the United Kingdom, Japan, Canada, South Korea, Hong Kong, Macau, and Taiwan.²² Even with a conservative two-week hospitalization stay, this hospital’s annual liver transplant volume can reach 5,000.

References