To create an industrial chain, Huibang Biological will increase the research and development of IVD innovative products with its original ability, and continue to develop the raw material market

Recently, Anhui Huibang Bioengineering Co., Ltd. (hereinafter referred to as "Huibang Bio") , an IVD manufacturer , announced the completion of the second strategic financing. This round of financing was jointly completed by Jiaxing Qihui and Saizhi Capital. The proceeds from the financing will be used to accelerate product development. Post-launch marketing.

 

Founded in 2013 , Huibang Biotechnology is located in Hefei National High-tech Development Zone. It is a collection of chronic disease prevention detection reagents, tumor cell detection reagents, maternal and child health care diagnosis and treatment reagents, cardiovascular disease detection reagents, POCT diagnostic reagents and diagnostics . , A high-tech enterprise integrating R&D, production and sales of monoclonal antibody raw materials with independent intellectual property rights for treatment. The company adheres to innovation-oriented, strong research and development strength, has obtained more than 10 medical device registration certificates, more than 30 various patents , and created a complete IVD industrial chain.

 

Huibang biological new factory

 

The domestic IVD industry is developing rapidly, and the upstream raw material market is promising

As one of the most important diagnostic methods in clinical diagnosis and treatment, in vitro diagnosis can provide 80% of the information for clinical diagnosis. Since the development of in vitro diagnosis industry, it has gradually become the largest subdivision field in the medical device industry.

Wang Zhongliang, the founder of Huibang Biotechnology, studied clinical medicine at Anhui University of Traditional Chinese Medicine in his early years, and entered a hospital as a clinician after graduation. After entering the Institute of Biophysics of the Chinese Academy of Sciences in 2000, Wang Zhongliang founded biomedical companies in Beijing, Hebei, Anhui and other places, and accumulated a lot of experience in product development, marketing and team management .

 

Years of experience in the medical industry has made Wang Zhongliang aware of the rapid development of the in vitro diagnostic industry and the lack of domestic in vitro diagnostic market compared with foreign countries.

 

According to relevant data, the market size of the global in vitro diagnostic industry has risen from US$ 53.3 billion in 2013 to US$ 72.5 billion in 2019 , and will continue to grow at a compound annual growth rate of about 5% . From the perspective of regional market distribution, the global in-vitro diagnostic demand market is mainly distributed in North America, Europe, Japan and other developed economies, which together account for more than 70% of the global in-vitro diagnostic market . It is estimated that in emerging markets represented by China, the growth rate of the in vitro diagnostic market will remain at around 15-20% . In the IVD raw material market, China is also facing the problem that foreign companies occupy more than 90% of the market share, which also affects the development of the entire IVD industry to a certain extent .

 

Based on this, in 2013 , Wang Zhongliang led a research and development team and a team of experts to devote himself to the research and development of in vitro diagnostic reagents and equipment. At the same time, he made efforts in the field of IVD raw materials to prepare and develop various key raw materials, forming an industrial chain development and replacing imports with independent innovative products. product.

 

At present, Huibang Biotechnology has built three core technology platforms around the in vitro diagnostic industry, including IVD R&D and manufacturing platforms, testing equipment R&D and manufacturing platforms, and medical monoclonal antibody R&D and preparation platforms. market.

 

In terms of team, the core team members of Huibang Biotech are all senior professionals in the medical industry, and their professional capabilities cover product development, marketing and other aspects. The chief scientist of the team, Professor Yang Jinkui, has a doctorate in medicine and is currently the director of the Department of Endocrinology of Beijing Tongren Hospital affiliated to Capital Medical University and the director of the Department of Endocrinology and Metabolic Diseases of Capital Medical University. He focuses on clinical research on diabetic microangiopathy and islet function and molecular markers The basic research provides a solid medical foundation for Huibang Biotechnology's product development.

Professor Yang Jinkui, Chief Scientist of Huibang Biotechnology

 

 

Focus on innovative technology to create a non-invasive detection system for type II diabetic nephropathy

my country is a big country with diabetes. Diabetic nephropathy is the main complication of diabetes, and its incidence has been increasing in recent years. Currently, invasive renal biopsy and non-invasive detection of urinary microalbumin and creatinine are commonly used clinically for the detection of diabetic nephropathy. In addition, indicators such as urine glucose and urinary sediment nuclide renal dynamic glomerular filtration rate are available for detection. refer to.

 

Usually, renal biopsy has the most differential diagnosis value for various chronic kidney diseases, but it is not recommended for routine examination because of its high degree of invasiveness. Urinary microalbumin is widely used in clinical examination, but there are also problems such as long observation time and insufficient specificity for the diagnosis of type Ⅱ diabetic nephropathy. In order to improve the accuracy of diagnosis, Huibang Biotech innovatively applied urinary haptoglobin ( HP) to the detection of diabetic nephropathy based on cutting-edge scientific research technology. It is known that the increase of urinary HP concentration is related to the acute injury and active inflammatory reaction of the kidney, and it can be used as an early biological detection marker of early diabetic nephropathy, especially for type Ⅱ diabetic nephropathy .

 

In the process of product development, Huibang Biotechnology adopts a multi-channel composite detection method, combines urine HP, urine microalbumin, and creatinine indicators and develops a kit, and can obtain five results within 10 minutes through a dry urine analyzer , compared with a single urine microalbumin test, it is more sensitive and early, and can ensure the detection efficiency while obtaining multiple test results. It is reported that this non-invasive detection system for type Ⅱ diabetic nephropathy has been officially launched to the market.

 

 

               

Horizontally expand the field, launch maternal and child health care, urine iodine detection and other products

Combined with the untapped demand of the market, Huibang Biology focuses on product innovation, and has developed a series of core products for the maternal and child health care system, including four items of child care and a dual quantitative dynamic monitoring system for premature birth and premature rupture of membranes. Products, escorting children and pregnant women in China, and promoting the healthy growth of fetuses and infants.

 

 

 

child care

Rickets, anemia (iron deficiency anemia) and viral hepatitis are common diseases that affect the normal growth and development of children. In recent years, there are many detection and screening methods for such diseases. The combination of kits has developed a children's health analysis and detection system, which solves the problem of children's disease detection in one stop, replacing the workload that can only be completed by four different machines and four different kits.

 

In terms of operation, the product can automatically complete the detection only by medical staff collecting peripheral blood, which simplifies the detection operation process of medical staff, greatly improves work efficiency, and saves space and labor costs for the hospital.

 

Surveillance of preterm birth and miscarriage during pregnancy

 

                

Premature rupture of membranes is the most common perinatal complication of pregnant women. It occurs before labor and can lead to increased rates of premature birth and increased perinatal mortality. When the membranes rupture, the insulin-like growth factor binding protein -1 (IGFBP-1) present in the amniotic fluid leaks from the amniotic membranes into the cervix and vagina along with the amniotic fluid, which can be used as a marker for the diagnosis of premature rupture of membranes.

 

When pregnant women are 22-35 weeks pregnant, the content of fetal fibronectin (fFN) in cervical secretions is extremely low, which indicates that the fetus is developing well, and the content of fFN will gradually increase after full-term, so fFN is negative. The test can be used to diagnose preterm labor in pregnant women (fFN is more negative than positive in predicting preterm birth).

 

In this regard, Huibang Biotech combined the two markers of IGFBP-1 and fFN to prepare a kit, which can simultaneously detect two indicators through the analyzer with only one sampling. At the same time, according to the dynamic monitoring analysis table, medical staff can have a more accurate assessment of amniotic fluid leakage and premature birth risk, escort the growth and development of the fetus, and provide a reference for subsequent treatment plans.

 

In addition, Huibang Biotechnology has also developed a urine iodine quantitative detection system around policy concerns and social hotspots, which is suitable for infants, pregnant, parturient, lactating women and women of childbearing age. During the COVID-19 epidemic, Huibang Biotech also developed a COVID-19 detection kit and an ear thermometer for the epidemic, and successfully obtained CE certification.

Combined with market demand, synchronous development of multiple product lines

For a long time, Huibang Biotech has always adhered to the differentiated innovation model in the product research and development process, avoided homogeneous competition, seriously considered patients and clinical needs, attached importance to independent research and development of core raw materials, and contributed its own strength to promote the development of the domestic in vitro diagnostic market.

At present, Huibang Bio is promoting the development and implementation of products in the fields of neonatal cerebral palsy, autism in children, and pulmonary embolism detection. Combining with the hot spots of family self-test in the field of general health at this stage, Huibang Bio is also carrying out a series of research . It is reported that next, Huibang Biotechnology will rely on innovative technology to launch home self-test series products, quantum dot automatic detection series, dry chemiluminescence detection series and other products.

 

In terms of raw materials, Huibang Biotech currently mainly conducts research and preparation of monoclonal antibody raw materials. In the future, Huibang Biology will also launch antigen and targeted drug raw materials to the market according to market demand.

 

For the next step of development, Huibang Biotech will also further strengthen the R&D strength of the team, introduce more high-end technical talents, continue to make efforts in monoclonal antibody research, diagnostic and therapeutic raw materials for tumor products, and increase in vitro diagnostics. R&D layout of raw materials.