Innovative Works, a well-known domestic venture capital institution, invested tens of millions of US dollars in Xiamen Zhishan Biotechnology Co., Ltd. (referred to as “Zhishan Bio”), and has become one of the major shareholders of Zhishan Bio. In the field of viral nucleic acid detection, Zhishan Biotechnology has developed an innovative “fist product”-the fully automatic integrated medical PCR analysis system Sanity 2.0 (hereinafter referred to as Xiamen Sanity 2.0), which is a major national science and technology project. The Supervision Bureau gives priority to approval, and on June 4, 2021, it was approved by the National Medical Products Administration for Class III medical device registration. Zhishan Biologics, once known as the “drug inspection artifact”, is finally officially certified. On duty. The Sanity 2.0 is based on the principle of real-time fluorescent PCR detection, equipped with dedicated reagents and consumables, and uses a high-precision full touch system, which can automatically complete nucleic acid extraction, preparation of reaction systems, and PCR amplification with just one button start. The whole process of testing and reporting results without any manual intervention is done in one go.
The light of import substitution domestic products Nowadays, the internationally emerging medical PCR all-in-one machines mainly include GeneXpert Ⅳ from Cyper from the United States, Filmarray 2.0 from Mérieux in France, and cobas Liat from Roche in Switzerland. The PCR integrated machine Sanity2.0 approved by Zhishan Biologics for the three-class medical device registration certificate is the first fully automatic integrated medical PCR analysis system with independent intellectual property rights in Fujian Province, and all core components have been made domestically. , Broke the technological monopoly of the international head biotechnology company, and filled the gap in the subdivision of the domestic PCR detection integrated machine. This product is suitable for various scenarios such as disease prevention and control centers, clinical laboratories, community hospitals, shelter hospitals, bedside testing, outpatient clinics, and emergency clinics. Particularly prominent is that Sanity 2.0 can be equipped with a full range of kits from ZHIBIO, which can treat respiratory pathogens such as new coronary pneumonia and tuberculosis, reproductive tract pathogens such as HPV, genetic diseases such as hereditary deafness and thalassemia, as well as individualized medications, etc. Nucleic acid detection for various types of diseases and molecular diagnosis in the whole field. As an imported alternative “drug-checking artifact”, Xiamen Sanity 2.0 has five significant advantages, one of which is “intelligence + automation”: one-key start, full-process automatic, local machine directly prints reports, and connects to hospital information Management system; the second is “high-quality nucleic acid extraction and purification”: magnetic bead extraction, suitable for multiple samples, anti-cross-contamination, 10-20 times concentrated and purified nucleic acid; third, high-precision temperature control of the PCR module to ensure The high sensitivity and specificity of the amplification results; the fourth is in the form of freeze-dried reagents, which can be transported at room temperature without freezing at -20 degrees; the fifth is the unique and complete multi-color melting curve analysis function, which can detect at most simultaneously in a single run 1728 targets. Deep ploughing technology has broad prospects R&D and innovation strength has increasingly become a benchmark for the competitiveness of a biopharmaceutical company. Founded in June 2010, Zhishan Biology has developed deep technology in the past 11 years and is a national high-tech company with a patented technology for PCR detection. Technology companies provide one-stop solutions for nucleic acid testing for hospitals, disease control centers and other units. As a leading domestic molecular diagnostic company, Zhishan Biological always adheres to the close integration of scientific research and industrialization, and transforms the latest molecular diagnostic technology into clinically demanded products, serving the prevention and control of infectious diseases and the precise diagnosis of major diseases. The innovation, leadership and huge market potential of Zhishan Biotechnology (compared with international giants and is expected to replace them) deeply attract investors. Recently, Innovation Works invested tens of millions of dollars in Zhishan Biotechnology, which has become the mainstay of Zhishan Biotechnology. One of the shareholders. At the same time, relying on the reputation and influence of the innovative workshop, it will help the products developed by Zhishan Biological to be promoted to the market, and consolidate the leading position of Zhishan Biological in the domestic molecular diagnostic field. According to statistics, at present, there are estimated to be about 8,000 medical institutions in China with PCR laboratories (which can provide new crown nucleic acid testing), and there are still more than 900,000 medical institutions that have not yet established PCR laboratories, including public and private hospitals. There are more than 17,000 and more than 900,000 primary-level medical institutions. In response to the needs of large-scale primary-level testing during the epidemic period and the need for other molecular testing at the grass-roots level in the future, the fully-automatic integrated machine overcomes the obstacles to the construction of PCR laboratories, so it is very popular. It is the focus of attention of the industry, especially the all-in-one system with powerful functions and complete supporting reagents is a rare product that is generally optimistic and has a broad blue ocean market. Not only the market is broad, but it also has huge advantages compared with traditional PCR detection. In particular, the fully automatic integrated machine can greatly reduce the input cost. The use of the fully automatic and integrated Sanity 2.0 of Xiamen Zhishan all-in-one machine eliminates the need for three laboratories for traditional PCR testing. The laboratory construction investment is reduced by at least 2/3, the instrument investment is reduced by about 1/2, and the personnel investment is also reduced. About 2/3. Guangzhou Daily·Xinhuacheng reporter: Xiao Huanhuan, correspondent Wu Jian Guangzhou Daily·New Flower City Editor: Cai Lingyue