At present, there are 25 enterprises in Xiamen that have obtained foreign certification for COVID-19 test reagents and entered the "white list" for export, among which 20 are in Haicang, including Baotai Biology, Anbang (Xiamen) Biology, Wantai Biology, Boditai Biology, and Merrill Lynch Maybong Biology.
In 2021, Haicang District will export more than 17 billion yuan of COVID-19 antigen detection reagents, accounting for about 1/3 of the national export volume of COVID-19 antigen detection reagents, leading the country and contributing to the global epidemic resistance.
During the epidemic, many domestic leading enterprises of nucleic acid detection kit, detection equipment manufacturers, third-party detection institutions and other related enterprises have "stepped out of the circle". And those who serve as the "gatekeepers" behind the scenes to provide IVD manufacturers with COVID-19 testing materials are also worth seeing. They persevere in the ordinary, and they are extraordinary in the persistence.
In vitro diagnostic reagent raw materials are like liquid "chips". In the field of in vitro diagnostic reagents, due to the late start of raw material research and development in China and the high degree of dependence on imports, most of the market shares are occupied by foreign enterprises. However, as domestic IVD products go overseas, it is the responsibility of IVD reagent raw material enterprises to ensure the safety of raw material supply for domestic IVD manufacturers. Through independent innovation, reagent raw materials with completely independent intellectual property rights are developed to achieve import substitution.
In Haicang District Biomedical Industrial Park, there is such an IVD upstream active raw material manufacturer. Since its establishment seven years ago, through independent innovation, it has achieved the market layout of antigen antibody raw materials required by nearly 100 reagent products. Among them, Taq enzyme antibody detected by nucleic acid and COVID-19 antibody raw materials of immunochromatography occupy an important market share, providing high-quality and comprehensive raw material support for IVD midstream production enterprises.
Xiamen Tongrenxin Biotechnology Co., Ltd
Xiamen Tongrenxin Biotechnology Co., Ltd. is mainly engaged in the research, development and preparation of bioactive proteins, including antigens, antibodies and industrial enzymes。
As a high-quality supplier of bioactive raw materials for many nucleic acid reagent giants in China, Tongren Xinbo has supplied 1600g of Taq enzyme antibody in total during the epidemic period. These active raw materials can be used to produce nucleic acid detection reagents for 1.2 billion people. At the same time, Taq enzyme antibody products have obtained national invention patent technology。
Compared with traditional C-line system, DNP system can reduce the interference of C-line system to T-line detection, and there will be no weakening of C-line signal when detecting strong positive samples。
As of May 30, 2022, there are more than 300 IVD detection manufacturers cooperating with Renxin Biotech, and the products of the cooperative manufacturers have performed well in epidemic prevention and control at home and abroad。
Compared with the performance of the domestic market, Tongrenxin Bio's raw materials have performed better in the global epidemic resistance. The COVID-19 reagent of the cooperative manufacturer has passed the CE self-test certification and FDA/EUA certification, and has gained access to the United States, Europe, Southeast Asia, Australia, Japan and other regions。
Adhering to a serious scientific attitude and the product concept of keeping improving, Tongrenxin Bio is willing to provide high-quality core raw materials and technologies for in vitro diagnostic reagent manufacturers worldwide。