The involvement of the same-species allograft bone used for orthopedic patients in body black market transactions 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, and processing them into same-species allograft bone products for sale to hospitals across the country, making illegal profits. The company had a revenue of 380 million yuan during the period of the case, and the police seized more than 18 tons of human bone raw materials and semi-finished products, as well as 34,077 finished products. A total of 75 people were involved in the case. The Taiyuan Procuratorate responded to the media, stating that the case involves a wide range and has not yet been concluded.
Same-species allograft 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. There are already dozens of certified and listed products.
The demand for bone repair materials in the market is huge. According to Frost & Sullivan 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 allograft 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 allograft bone products have advantages in clinical practice, while seeking safer and more effective artificial bone materials is the goal pursued by regenerative medicine.
Same-species allograft bone is widely used in clinical applications and requires donations. Same-species allograft bone is divided into several categories, including deep-frozen bone (after removing fresh allograft bone tissue, it is designed into different sizes, shapes, and dimensions of graft materials. The bone membrane and bone marrow are thoroughly cleaned under high pressure and then deep-frozen), freeze-dried bone (deep-frozen bone is dehydrated and dried, and the tissue moisture is controlled within 5%. It is vacuum-packed and sterilized), and decalcified bone matrix (a series of chemical treatments such as decalcification and defatting are performed on bone tissue to retain various osteogenic factors, thereby inducing bone formation).
A doctor from a top-tier hospital's orthopedics department told Caixin that he commonly sees two types of same-species allograft bone products in clinical practice: partially demineralized bone granules and injectable bone powder. The former is used to fill bone defects in trauma orthopedics, while the latter is commonly used in spinal orthopedics, such as in posterior lumbar interbody fusion surgery for treating diseases such as lumbar disc herniation.
Although the materials for artificial bone have been iterated several times, they still cannot replace same-species allograft bone. The key problem is that the degradation process of the material in the body cannot perfectly match the speed of new bone formation. The formed biomaterial and bone mixture cannot completely rebuild the bone tissue under physiological conditions. In addition, there is a balance issue with the material's bone conductivity, bone induction, and vascular induction activity, which severely limits the timeliness and regional effectiveness of material repair for bone defects. It is often 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 allograft 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, spine, and sports medicine, but same-species allograft bone is not covered. The National Joint Procurement Office for High-Value Medical Consumables stated that same-species allograft 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 allograft bone products, including Daqing Bio, Beijing Yikang Hengye, Hubei Lianjie, Nanjing Yitebo, and Shanghai Anjiu. Artificial bone products are produced by companies such as OsteoGen, Jiuyuan Gene, and Shanghai Ruibang. The market is relatively fragmented.
Same-species allograft 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 active infection carriers, malignant tumor patients, sexually transmitted disease patients, infectious hepatitis or AIDS patients, patients with autoimmune diseases, poisoned patients, long-term ventilator users, patients undergoing hormone therapy, patients with lesions or injuries in the bone harvesting area, or those with unknown causes of death. When bone is used for structural support, the donor's age should be less than 50 for females and less than 55 for males, and over 18. Bone materials with articular cartilage should be below 35.
The involved company is the first enterprise tissue bank in China
Currently, the management of tissue banks in China is chaotic and diverse. 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 prestigious 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 allograft 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 allograft bone. In 1999, same-species allograft 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 allograft bone products obtained certification and were listed, making it the first in China. 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 bone experts and tissue bank practitioners participating and sharing thousands of clinical cases of same-species bone and other bone substitute materials.
In 2001, the annual production of same-species allograft bone by Shanxi Aorui exceeded 15,000 pieces, which was five times higher than the previous years, reaching 20,000 pieces in 2002. By 2005, Shanxi Aorui's same-species allograft bone products had a market share of 80% and became 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 allograft bone products: general, bone cages, bone nails, and large bone joints. According to public information, its same-species allograft bone products during the period of the case were once awarded contracts for procurement by Dongguan Traditional Chinese Medicine Hospital, Inner Mongolia Medical University, Hohhot Health Commission, Sun Yat-sen University Affiliated Eighth Hospital, Sichuan Orthopedic Hospital, Sichuan People's Hospital, Xinjiang Medical University First Affiliated Hospital, Leshan People's Hospital, Southern Medical University 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 allograft 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 foundation, and provincial-level fund projects.
According to an article titled "Development History, Current Situation, and Prospect of China's Medical Tissue Banks" published by Bai Yulong and others in 2022, China currently does not have a dedicated department for the accreditation and supervision of tissue banks. It relies more on the industry leadership 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.