The exposure of allogeneic bone used for orthopedic patients’ transplants involving black market transactions of corpses has caused public astonishment. It is urgent to treat patients, and how to make the source of consumables more transparent and compliant has become an issue of concern.
On August 8, lawyer Yisheng Hua released a case material on Weibo, claiming that Shanxi Aorui Biomaterials Co., Ltd. (hereinafter referred to as “Shanxi Aorui”) was suspected of illegally purchasing thousands of corpses and skeletons from hospitals and funeral homes in Shandong, Sichuan and other places, dismembering, cleaning, and irradiating them, and processing them into allogeneic bone products for sale to hospitals across the country, illegally profiting. The company’s revenue during the case was 380 million yuan, and the police seized more than 18 tons of human bone raw materials, semi-finished products, 34,077 finished products, and a total of 75 people were involved. The Taiyuan Municipal Procuratorate responded to the media that the case involved a wide range of issues and has not yet been concluded.
Allogeneic bone products are a type of bone repair material, which is bone tissue of the same species but different individuals, and is used in neurosurgery, oral medicine, and orthopedics, with dozens of products approved for market launch.
The market demand for bone repair materials is huge. According to Frost & Sullivan analysis, China currently has more than 3 million orthopedic surgeries every year, of which nearly one-sixth of the orthopedic surgeries need to use bone repair materials, and a large amount of bone repair materials may be needed in spinal orthopedic surgery and joint orthopedic surgery. In addition, nearly 50% of dental implant surgeries in China, as well as some craniotomy surgeries, also have the need to use bone repair materials.
Frost & Sullivan estimates that from 2017 to 2022, the market size of China’s bone repair materials increased 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 China’s bone repair materials will grow to 7.68 billion yuan, with a compound annual growth rate of 17.9%.
In addition to allogeneic bone, bone defects can also use autologous bone and artificial bone, but the former has limited material acquisition and high acquisition risk, while the latter has poor biological activity and cannot perfectly match the new bone formation rate. At present, allogeneic bone products have advantages in clinical practice, and seeking safer and more effective artificial bone materials is the goal that regenerative medicine is pursuing.
Widely used in clinical practice, requiring donation
Allogeneic bone is divided into several categories, including deep-frozen bone (after removing fresh allogeneic bone tissue, it is designed into transplant materials of different sizes, shapes and dimensions, and the periosteum and bone marrow are washed clean with high pressure, and deep-frozen treatment under low temperature conditions); freeze-dried bone (dehydration and drying treatment of deep-frozen bone, controlling its tissue moisture content within 5%, vacuum packaging and sterilization); decalcified bone matrix (decalcification, defatting and other series of chemical treatments of bone tissue, retaining various osteogenic factors, and then inducing bone formation).
A chief orthopedic surgeon at a tertiary hospital told Caixin that he often sees two types of allogeneic bone products in clinical practice, namely semi-demineralized bone granules and injectable bone powder. The former is used in trauma orthopedics to fill bone defects, and the latter is often seen in spinal orthopedics, such as in the intervertebral fusion surgery of the posterior lumbar vertebrae in the treatment of diseases such as lumbar disc herniation.
Although the materials of artificial bone have been iterated several times, they still cannot replace allogeneic bone. The key problem is that the degradation process of the material in the body cannot perfectly match the new bone formation rate, and the resulting biomaterial and bone mixture cannot completely reconstruct the bone tissue under physiological conditions. In addition, there is also the problem that the bone conductivity, bone induction, and vascular induction activity of the material cannot be well balanced, leading to severe limitations in the timeliness and regionality of the material’s repair of bone defects, and it is often difficult to quickly and effectively reconstruct for large bone defects.
Compared with other high-value orthopedic consumables, such as artificial bone, the pricing of allogeneic bone products is not prominent. A 1g bone powder is priced at about 2,000 yuan; a box of 5g 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 orthopedic implant consumables included in the national centralized volume-based procurement include artificial joints, spine, and sports medicine, and do not yet cover allogeneic bone. The National Organization for the Joint Procurement of High-Value Medical Consumables Office said that allogeneic bone does not adopt the volume-based procurement method, and the price is formed through bidding.
According to the official website of the National Medical Products Administration, in addition to Shanxi Aorui, there are more than 10 domestic production enterprises of allogeneic bone products, including Daqing Bio, Beijing Yunkang Hengye, Hubei Lianjie, Nanjing Yitebo, and Shanghai Anji. Artificial bone products include Aojing Medical, Jiuyuan Gene, and Shanghai Ruibang Bio. The market pattern is relatively scattered.
Allogeneic bone comes from bone banks, also known as tissue banks, which mainly come from deceased donors and require the donor’s consent or the consent of their family members.
Tissue banks have strict requirements for the selection of donors, and the illegally purchased corpses and skeletons have safety risks such as the spread of diseases. Generally speaking, donors cannot choose those with active infections of the whole body or local areas, patients with malignant tumors, patients with sexually transmitted diseases, patients with infectious hepatitis, AIDS patients, patients with autoimmune diseases, patients with poisoning, those who have been using ventilators for a long time, those undergoing hormone therapy, those with lesions or injuries in the bone collection site, and those with unknown causes of death. In addition, when the bone is used for structural support, the donor’s age should be less than 50 years old for women and less than 55 years old for men, and older than 18 years old, and the bone material with articular cartilage should be less than 35 years old.
The involved enterprise is the first tissue bank in China
At present, the management of tissue banks in China is chaotic and of different nature. According to incomplete statistics, there are about 44 existing tissue banks, more than half of which are enterprise tissue banks, which are almost equivalent to medical device enterprises; the second is the tissue banks within hospitals, which belong to the internal departments of the hospital and do not have independent legal person qualifications, accounting for about a quarter; the last is the non-profit tissue banks, which belong to social organizations, accounting for about 20%.
Shanxi Aorui, which is involved in this case, is well-known 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 masters the irradiation technology for the preparation of allogeneic bone products. In 1994, the Shanxi Provincial Health Department approved the establishment of the Shanxi Provincial Medical Tissue Bank, which was included in the health system and engaged in the development, production, and supply of allogeneic bone. In 1999, allogeneic bone products were classified as Class III medical devices. The Shanxi Provincial Medical Tissue Bank must obtain a production license and legal person qualification in the form of an entity to provide products for clinical use. Li Baoxing, the then director of the tissue bank, established Shanxi Aorui.
In 2000, Shanxi Aorui’s allogeneic bone products were approved for market launch, which was the first in China. Shanxi Aorui also cooperated with the Chinese Society of Surgery and the Chinese Orthopedic Association to hold two national bone transplantation seminars, with nearly 200 orthopedic experts and bone bank practitioners from home and abroad participating, and sharing thousands of clinical application cases of allogeneic bone and other bone substitute materials.
In 2001, Shanxi Aorui’s annual output of allogeneic bone exceeded 15,000 pieces, five times that of the previous years, and reached 20,000 pieces in 2002. In 2005, Shanxi Aorui’s market share of allogeneic bone products had reached 80%, making it the largest production base of allogeneic bone materials 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 actually responsible for the company’s operation.
Shanxi Aorui has three major categories of allogeneic bone products: deep-frozen, freeze-dried, and demineralized, and four series of general, bone cage, bone nail, and large bone joint. According to public information, its allogeneic bone products during the case were once awarded the bid for procurement by Dongguan Traditional Chinese Medicine Hospital, Inner Mongolia Medical University, Hohhot Health and Health Commission, the Eighth Affiliated Hospital of Sun Yat-sen University, Sichuan Provincial Orthopedic Hospital, Sichuan Provincial People’s Hospital, Xinjiang Medical University First Affiliated Hospital, Leshan People’s Hospital, Southern Medical University Traditional Chinese and Western Medicine Hospital, Wuhan Fourth Hospital, and the First Affiliated Hospital of Chengdu Medical College.
The Shanxi Provincial Medical Tissue Bank, which is one with Shanxi Aorui, is also highly recognized by the industry. It not only drafted and formulated the industry standard for allogeneic bone, but also participated in the drafting and review of the industry standard for tissue banks, and undertook and completed more than ten defense scientific research, National Natural Science Foundation, and provincial and ministerial fund projects.
According to the article “Development History, Current Situation and Prospect of China’s Medical Tissue Bank” published by Bai Yulong et al. in 2022, China does not yet have a dedicated tissue bank certification and regulatory department, and relies more on the industry leadership of social organizations such as the China Human Health Science and Technology Promotion Association. There is an urgent need to establish and improve a unified regulatory framework for tissue banks in China and form China’s tissue bank standards.
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