The involvement of the same-species allogeneic bone used for orthopedic patients in the black market trade of human remains has caused public astonishment. The urgent treatment of patients requires a more transparent and compliant source of consumables, which has become a topic of concern.
On August 8th, lawyer Yi Shenghua posted a case material on Weibo, stating that Shanxi Aorui Biological Materials Co., Ltd. (referred to as "Shanxi Aorui") is suspected of illegally purchasing thousands of corpses and bones from hospitals and funeral homes in Shandong, Sichuan, and other places, processing them into same-species allogeneic bone products after dissection, cleaning, and irradiation, and selling them to hospitals across the country for illegal profits. During the period of the case, the company had a revenue of 380 million yuan, and the police seized more than 18 tons of human bone raw materials and semi-finished products, as well as 34,077 finished products, with a total of 75 people involved. The Taiyuan Procuratorate responded to the media, stating that the case involves a wide range and has not yet been concluded.
Same-species allogeneic bone products are a type of bone repair material, which is bone tissue from the same species but different individuals. They are used in neurosurgery, oral medicine, and orthopedics, and there are already dozens of certified products on the market.
There is a huge demand in the bone repair material market. According to Frost & Sullivan's analysis, there are currently more than 3 million orthopedic surgeries in China each year, of which nearly one-sixth of orthopedic surgeries require the use of bone repair materials. Spinal and joint surgeries may require a large amount of bone repair materials. In addition, nearly 50% of dental implant surgeries in China, as well as some craniotomy surgeries, require the use of bone repair materials.
Frost & Sullivan estimates that from 2017 to 2022, the market size of bone repair materials in China will increase from 1.9 billion yuan to 2.86 billion yuan, with a compound annual growth rate of 8.5%. It is expected that by 2028, the market size of bone repair materials in China will grow to 7.68 billion yuan, with a compound annual growth rate of 17.9%.
In addition to same-species allogeneic bone, autogenous bone and artificial bone can also be used for bone defects. However, the former has limited availability and high acquisition risks, while the latter has poor biological activity and cannot perfectly match the speed of new bone formation. Currently, same-species allogeneic bone products have advantages in clinical applications, while seeking safer and more effective artificial bone materials is the goal pursued by regenerative medicine.
Same-species allogeneic bone is widely used in clinical practice and requires donation. Same-species allogeneic bone is divided into several categories, including deep-frozen bone (removing fresh allogeneic bone tissue and designing it into different sizes, shapes, and dimensions of graft materials, cleaning the periosteum and bone marrow under high pressure, and deep-freezing under cooling conditions), freeze-dried bone (deep-frozen bone subjected to dehydration and drying treatment, controlling the tissue moisture content within 5%, vacuum packaging, and sterilization), and decalcified bone matrix (a series of chemical treatments such as decalcification and defatting of bone tissue, retaining various osteogenic factors, and inducing bone formation).
A doctor from a top-tier hospital's orthopedics department told Caixin that he commonly sees two types of same-species allogeneic bone products in clinical practice, namely partially demineralized bone granules and injectable bone powder. The former is used to fill bone defects in trauma orthopedics, while the latter is more common in spinal orthopedics, such as in posterior lumbar interbody fusion surgery for treating diseases such as lumbar disc herniation.
Although artificial bone materials have undergone several iterations, they still cannot replace same-species allogeneic bone. The key issue is that the degradation process of materials in the body cannot perfectly match the speed of new bone formation, and the formed biomaterial and bone mixture cannot completely rebuild the bone tissue under physiological conditions. In addition, there is a balance issue with the bone conductivity, bone inductivity, and vascular inductivity of the materials, which severely limits the timeliness and regional specificity of material repair for bone defects, making it difficult to quickly and effectively reconstruct large bone defects.
Compared with other high-value orthopedic consumables, such as artificial bone, the pricing of same-species allogeneic bone products is not outstanding. The price of 1 gram of bone powder is approximately 2,000 yuan; a box of 5 grams of freeze-dried cancellous bone strips is about 2,500 yuan; and a 15cm freeze-dried cortical cancellous bone strip is about 15,000 yuan.
Currently, the bone implant consumables included in the national centralized procurement system include artificial joints, spinal implants, and sports medicine, but same-species allogeneic bone has not been covered. The National Joint Procurement Office for High-Value Medical Consumables stated that same-species allogeneic bone is not procured through the volume-based procurement method but through a bidding process to determine the price.
According to the official website of the National Medical Products Administration, in addition to Shanxi Aorui, there are more than 10 other domestic production companies of same-species allogeneic bone products, including Daqing Bio, Beijing Yikang Hengye, Hubei Lianjie, Nanjing Yitebo, and Shanghai Anjiu. Artificial bone products are produced by companies such as Aojing Medical, Jiuyuan Genetics, and Shanghai Ruibang. The market is relatively fragmented.
Same-species allogeneic bone comes from bone banks, also known as tissue banks, mainly from deceased donors and requires the consent of the donor or their family before donation.
Tissue banks have strict criteria for selecting donors, as there are safety risks associated with the illegal purchase of corpses and bones. Generally, donors cannot be individuals with active systemic or local infections, malignant tumors, sexually transmitted diseases, infectious hepatitis, AIDS, autoimmune diseases, poisoning, long-term use of ventilators, hormone treatment, bone lesions or injuries at the bone harvesting site, or unknown cause of death. When bone is used for structural support, the age of female donors should be less than 50 years old, male donors should be less than 55 years old, and both should be over 18 years old. Bone materials with articular cartilage should be below 35 years old.
The involved company is the first enterprise tissue bank in China
Currently, the management of tissue banks in China is chaotic and their nature varies. According to incomplete statistics, there are about 44 existing tissue banks, with more than half of them being enterprise tissue banks, which are almost equivalent to medical device companies. The second is hospital-based tissue banks, which belong to internal departments of hospitals and do not have independent legal person status, accounting for about one-fourth. Finally, there are private non-profit organization tissue banks, which belong to social organizations, accounting for about 20%.
Shanxi Aorui, involved in this case, has a good reputation in the industry. It is the first enterprise tissue bank in China and is backed by the China Institute of Radiation Protection.
The China Institute of Radiation Protection has mastered the irradiation technology for preparing same-species allogeneic bone products. In 1994, the Shanxi Provincial Health Department approved the establishment of the Shanxi Provincial Medical Tissue Bank, which was incorporated into the health system and engaged in the development, production, and supply of same-species allogeneic bone. In 1999, same-species allogeneic bone products were classified as Class III medical devices. In order to provide products for clinical use, the Shanxi Provincial Medical Tissue Bank had to obtain a production license and legal person status in physical form. Li Baoxing, the director of the tissue bank at the time, established Shanxi Aorui.
In 2000, Shanxi Aorui's same-species allogeneic bone products obtained certification and became the first domestically approved product. Shanxi Aorui also cooperated with the Chinese Association of Surgeons and the Chinese Orthopedic Association to hold two national bone transplantation symposiums, with nearly 200 domestic and foreign orthopedic experts and tissue bank practitioners participating and sharing thousands of clinical cases of same-species bone and other bone substitute materials.
In 2001, Shanxi Aorui's annual production of same-species allogeneic bone exceeded 15,000 pieces, which was five times higher than the previous years, reaching 20,000 pieces in 2002. By 2005, Shanxi Aorui's market share of same-species allogeneic bone products had reached 80%, making it the largest same-species bone material production base in the Asia-Pacific region.
Currently, Cong Maoyi is the largest shareholder of Shanxi Aorui, holding 54.08% of the shares and serving as the chairman; Su Chengzhong holds 45.92% of the shares and serves as the general manager; Li Baoxing is responsible for the company's operations.
Shanxi Aorui has three categories of products: deep-frozen, freeze-dried, and demineralized bone. It has four series of same-species allogeneic bone products: general, bone cages, bone nails, and large bone joints. According to public information, its same-species allogeneic bone products during the period of the case have been awarded contracts for procurement by Dongguan Traditional Chinese Medicine Hospital, Inner Mongolia Medical University, Hohhot Municipal Health Commission, Sun Yat-sen University Affiliated Eighth Hospital, Sichuan Provincial Orthopedic Hospital, Sichuan Provincial People's Hospital, Xinjiang Medical University First Affiliated Hospital, Leshan People's Hospital, Southern Medical University Integrated Chinese and Western Medicine Hospital, Wuhan Fourth Hospital, and Chengdu Medical College First Affiliated Hospital.
The Shanxi Provincial Medical Tissue Bank, which is closely related to Shanxi Aorui, is also highly recognized in the industry. It not only drafted and formulated industry standards for same-species allogeneic bone but also participated in the drafting and review of tissue bank industry standards, and completed more than ten national defense scientific research, national natural science fund, and provincial-level fund projects.
According to an article published by Bai Yulong et al. in 2022 titled "Development History, Current Situation, and Prospect of China's Medical Tissue Banks," there is currently no specialized department for the certification and regulation of tissue banks in China. It relies more on the industry guidance of social organizations such as the China Human Body Health Science and Technology Promotion Association. It is urgently needed to establish and improve a unified regulatory framework for tissue banks in China and form Chinese tissue bank standards.