Shenzhen New Industries Biomedical Engineering Co., Ltd.
新产业
300832
Shenzhen Stock Exchange
Company Profile
1. Strengths in Complete R&D System of the Industry Chain Having specialized in research and development of in-vitro diagnostic products for 30 years, we have built four major technical R&D platforms for magnetic nanospheres, critical raw materials of reagents, diagnostic instruments and reagents. The complete R&D platforms of our industry chain can effectively increase the efficiency of new product R&D, speed up upgrading/iteration of existing products, and constantly improve product quality and performances, so as to satisfy the end users'needs. 2. Competitive Advantages in a Series of Products Adopting R&D strategies for serializing our instruments, we supply 12 types of automatic chemiluminescence immunoassay analyzers, which include low-speed, medium-speed and high-speed models for satisfying different customer requirements. The MAGLUMI X10 analyzer can perform 1000 tests per hour.The reagents for chemiluminescence immunoassay sold by us worldwide include multiple varieties and 239 types, which are specific to tumor markers, thyroid, fertility, infectious diseases, inflammation monitoring, hepatic fibrosis, bone metabolism and glyco metabolism. 196 out of these 239 types of reagents have been registered in China. As chemiluminescence immunoassay system is closed, diverse instruments and complete reagent menus will effectively enhance our product competitiveness. 3. Strengths in the Worldwide Marketing Network Having constructed a marketing network which covers the key markets at home and abroad.So far, we have sold our products to 1,875 tertiary hospitals of China. The sustained growth of our installed capacity will lay a solid foundation for driving our future sales of reagents. After approximately 10 years of continuous hard work in the overseas markets, we have occupied striking leading advantages in our chemiluminescence products. Up till now, we have cumulatively sold instruments in 161 countries and regions. Our stable customer base has also driven steady increase in our overseas sales revenues of reagents. 4. Strengths in Professional and Timely after-sales Services High-quality after-sales services are important guarantees for our product competitiveness. Through years of efforts, we have constructed a nationwide after-sales service network which covers Xinjiang and Tibet. This network has enabled us to promptly respond to customer needs for services within 48 hours and guarantees quality of after-sales services. In addition, we establish our professional training system dependent upon R&D platforms to perform systematic skills training for our after-sales service engineers, who are managed according to their skill level, so precise services are provided for customers based on how difficult the services are, in order to promptly and accurately solve all after-sales problems. 5. Strengths in Reserves of Technical Talents Upholding the core values of “shouldering heavy missions bravely, enjoy challenging and pursuing excellence”, we have cultivated multidisciplinary, hierarchical and well-structured talents for research, development, technical production, product promotion and after-sales services after 30 years of independent research and development. Having established a polycentric skill level evaluation system, we have built and reserved an echelon of professional talents for supporting our continuous development. Our R&D team has made prominent achievements in technology and process innovations.
Full description
1. Basic Businesses and Products We are mainly engaged in research, development, production and sales of in-vitro diagnostic products as well as provision of related services. Since our establishment, we have been customer-centered and market-oriented and continuously making product and technology innovations to provide customers with better products and services. Our products are mainly used for providing medical terminals with diagnostic information for prevention, diagnosis, treatment, surveillance and prognostic observation of diseases, health status assessment and prediction of genetic diseases. Having specialized in the in-vitro diagnostics industry for 30 years, we have built four major technical R&D platforms for magnetic nanospheres, critical raw materials of reagents, diagnostic instruments and reagents. In the leading immunodiagnostic product line, we sell 12 types of automatic chemiluminescence immunoassay analyzers and 239 types of supporting agents globally. We have registered 196 types of chemiluminescent reagents in China (with 281 registration certificates in total). The supporting reagents cover tumor markers, thyroid, infectious diseases, fertility, cardiac markers, inflammation monitoring, glyco metabolism, bone metabolism, Hepatic Fibrosis, autoimmune antibodies and other test items. In the actively expanded biochemical diagnosis product line, we sell 6 types of automatic biochemical analyzers and 72 types of supporting reagents. We have registered 72 types of biochemical reagents in China. These supporting reagents involve renal functions, hepatic functions, special protein, lipid and other test items. In the molecular diagnostic product line, we have developed some types of nucleic acid detection reagents which have obtained CE access permits. In 2021, we additionally developed fully-auto nucleic acid purification system and extraction kits.In March 2024, the company's fully automated nucleic acid testing and analysis system, Molecision R8, obtained the EU market access approval and is currently undergoing domestic product registration. We have established stable sales and after-sales service systems at home and abroad. Dependent upon our strengths in products, technologies and services, we have supplied our products to 1,835 domestic tertiary hospitals at the end of 30th June 2025. In the overseas markets, we have served medical end users of 161 countries and regions with our products. 2. Production Management Model We strictly carry out our production activities within the scope of the production licenses for medical equipment issued by National Medical Products Administration. With complete and systematic quality management systems, we have passed the certifications of TÜV SÜD (a notified body of the European Union) about ISO 9001 and ISO 13485. As China’s first manufacturer of chemiluminescence analyzers passing the EU’s IVDR CE certification and admitted by FDA, we constantly improve our services and customer satisfaction in research, development, production and sales in strict compliance with the requirements of the quality management systems for medical devices, in order to realize our quality objectives. Meanwhile, we constantly collect and offer feedback on customers’ requirements and opinions for our products in the sales process, to assist our research, development and production departments in improving the products. 3. Sales and Profit Models We develop our business by “focusing on distribution and integrating it with direct selling”. So far, we have generally constructed a marketing network which covers the key markets at home and abroad. Profit model: We profit from our business model for “driving reagent sales by selling instruments and impelling instrument sales by selling reagents”. We gain trust in customers with stably reliable products and timely efficient after-sales services, to promote sustained growth of our sales revenues.