Brief Introduction of International Cooperation
The promotion of medical technology relies on the support of strong academy and technology. In recent years, NKY has established some formal and informal cooperative relations with the top medical college, renowned professors and doctors both at home and abroad. In March 2016, NKY, Beijing Breast Disease Society and China Woman’s Development Foundation co-hosted China-Sweden Breast Cancer Premium Conference. The conference invited dozens of foreign experts including Prof. Gert Auer from Karolinska Institute, and dozens of Chinese experts including Prof. Xu Binghe. Both sides carried out a efficient academic exchanges. In November of 2016 and 2017, NKY sponsored two consecutive Beijing Breast Cancer Precision Medicine and Translational Medicine Forum, and invited Prof. Gert Auer and Prof. Christof Sohn to make academic presentations of MammaScreen technology, which were highly praised by hundreds of Chinese experts.
At present, NKY has registered some subsidiaries in America, Germany and Sweden, and has established great relations with world’s top medical college including Heidelberg University Hospital and Karolinska Institute. In the future, NKY will establish an authoritative bridge of academy and technology in biomedicine field in China and overseas.
Breast cancer is the most common cancer among women in the world. The main cause of death in breast cancer is the distal metastasis associated with the diagnosis of delay. Around 95% of breast cancer patients can be cured if breast cancer can be diagnosed in the early stage, and it can greatly reduce the cost of medical care. According to figures, each person can save 200-500 thousand RMB for the cost of treatment. Although breast cancer screening has been widely applied, the current screening method based on mammography and B-mode ultrasound is inefficient for the detection of early breast cancer. In European and American countries, although it costs nearly 8 billion U.S. dollars a year to carry out breast cancer screening and 50 billion U.S. dollars for breast cancer treatment, around 3% of women die from breast cancer metastasis caused by delayed diagnosis. At present, the market of global breast cancer screening is about 8 U.S. dollars billion, mainly for women over 50 years old. The market is still expanding and it’s main growth points are emerging economies, such as China, India, Brazil and Russia. If women over 30 years old are considered, the potential of global breast cancer screening market will reach about 20 billion U.S. dollars.
A simple and reliable method to achieve early breast cancer screening will lead a revolution of global breast cancer screening and bring the gospel to breast cancer patients, which will greatly reduce the cost of social health-care. If the method is in vitro diagnosis, without side effects, without distinction among all types of breast cancer screening, without distinction for all age group women while the result is objective and efficient, thus there is no doubt that this method will possess huge market potential. The MammaScreen test in this project meets all the above standards.
MammaScreen test is a new generation of tumor in vitro screening method developed by Heidelberg University Hospital, which ranks No. 1 in Germany. MammaScreen is a kind of blood test that uses a series of independent patented molecular markers to achieve high precision screening for breast cancer. MammaScreen can effectively screen out the first phase of breast cancer and precancerous lesions. The test provides high detection efficiency for patients of different ages. Meanwhile, the test can detect all types of breast cancer with no difference, and is not affected by the size and location of tumor. The objective analysis of the whole process is not restricted by doctor’s medical level and does not depend on subjective judgment. Molecular markers are stable and reliable, blood samples can be transported for long distance, which can realize the diagnosis of different places and completely break the imbalance of medical resources.
MammaScreen's main competitor is radiological technology, including mammography, B-mode ultrasound, MRI, CT and PET-CT, while mammography is insured by European and American countries. The above radiological technologies have many weakness to overcome, for example, the breast cancer detection rate of mammography for women under 50 years old is only 30%-70%, while it also has radioactive side effects (CT and PET-CT is about 500 times more than mammography). The diagnostic efficiency and accuracy of all radiological methods are relied on tumor size, shape, location and inspector’s subjective judgment.
According to the market survey in November 2017, the cost of a single mammography detection in Beijing area is about 500 RMB, the cost of a single breast color ultrasound detection is about 120 RMB, the cost of a single breast MRI detection is about 1700 RMB, and the cost of Pet-CT is about 9200 RMB. If we control the cost of MammaScreen’s clinical detection, it will possess bright market competitiveness and profit space.
Chinese Market Development Plan:
NKY Medical Group has received the authorization of Heidelberg University Hospital, and has the sole license of this technology in China. NKY plans to develop detection kits for Chinese people and obtain CFDA certification in the near future.
NeoDynamics AB (formerly called Navigation Dynamics AB) was founded in 2015. Its predecessor was founded in 2004 and its headquarter is located in Stockholm, Sweden. Focusing on improving the accuracy of breast cancer detection through the optimization of detection techniques, NeoDynamics AB is a cancer diagnosis enterprise to reduce the pain of patient detection. The company’s core technology was developed by several famous professors at Karolinska Institute in Sweden.
The company has obtained many patents since it was established. The scientific research team of the company has published research results in many academic journals, which has gained universal recognition from experts and scholars in the industry. Based on years of technology accumulation, the company has developed NeoNavia Biospy System (NeoNavia breast cancer biopsy system). The difficulties of current breast cancer biopsy techniques and the advantages of NeoNavia Biospy System are as follows:
Today it is generally accepted that the final diagnosis of breast malignancy suspicious lesions has to be confirmed using percutaneous biopsy techniques. Currently the most common biopsy cells and tissue sampling method is Core Needle Biopsy (hereinafter referred as CNB). CNB use the puncture needle with spring installation. However, the puncture needle is too long and moves too fast, so that even with the help of auxiliary imaging instrument, it still could not reach the suspected lesion location. Doctors usually increase living tissue sampling volume or use the bigger size of needle to overcome above weakness, which will increase the suffering of patients and also leads to more blood loss. On the other hand, with the increasing demand for personalized adjuvant therapy, more biomarkers need to be detected in biopsies, which further improves the accuracy of biopsy. NeoNavia Biospy System has the core technology to securely solve the above difficulties:
1) NeoNavia Biospy System is equipped with Fourier Micro-pulse Technology to solve the problem of hard location. Its advantages are as follows:
● Help the sampling needle to move accurately in the suspicious lesion.
● Human Enhancement Technology help doctors accurately put sampling needle or treatment electrodes at any location of human body.
2) In view of the large size of biopsy needle and endoscopic equipment as well as too many biopsy samples to increase the pain of patients, NeoNavia Biospy System adopted Cytotest professional puncture technology, which has passed the European Union CE Certification in the end of 2015. Its advantage is as follows:
● Ensure the most reasonable sampling amount of biopsy.
3) The current biopsy technology could not sterilize the biopsy needle, so that there is a potential risk of disseminating cancer cells. NeoNavia Biospy System has adopted the world's unique anti-vaccination technology. Its advantages is as follows:
● The heating needle and guideway with radiofrequency pulse could reduce the risk of disseminating cancer cells during biopsy sampling.
The first phase of clinical research of NeoNavia Biospy System has been completed, and obtained the European Union quality and safety CE certification in July 2016 (Certification Number: 41319283). The second phase of clinical trials is now being conducted in Sweden, Germany and the United Kingdom. In addition to breast cancer, NeoNavia Biospy System will also expand in biopsies for other cancers, such as lympha cancer and prostate cancer.
Chinese Market Development Plan:
As the largest shareholder of NeoDynamics, NKY Medical Group will be exclusively responsible for introducing the NeoNavia Biospy System to China and its market development in the future.
3. NKY Acquired BioVision, Inc., a leading Life Science company in U.S.
BioVision, Inc., is a Life Science company headquartered in the beautiful San Francisco Bay area and founded in 1999. BioVision develops, produces and sells a wide variety of products including assay kits, recombinant proteins & enzymes, antibodies, small biological molecules, etc. Focusing on the field of bioanalysis related to disease and after years of accumulation, the company currently produces and sells more than 6000 kinds of products, which fully and systematically covers the biological research field such as cell metabolism, cell apoptosis, cell proliferation, cell stress, cell damage and repair, diabetes, obesity and metabolic syndrome, stem cell biology, gene regulation, gene signal transduction, etc. to provide global coverage of more than 70 of national life science researchers rich. BioVision is well known in life science industry to provide research tools to scientists in more than 70 counties worldwide to expedite their research. The cell metabolic kits and apoptosis kits developed by the company are highly specific, sensitive, fast and convenient, which has outstanding influence in related research fields. In the field of cell metabolism research, the company has the most complete product line containing sugar metabolism, lipid metabolism, protein and amino acid metabolism, enzyme activity and cofactor analysis. In the field of apoptosis, Annexin V kits enjoys a good reputation in global scientific research institutions. Meanwhile, the Caspase series provides the most complete types of products such as Caspase activity assay kit, Caspase protein kit, Caspase enzyme, Caspase inhibitor and substrate, etc. All kinds of research tools provided by the company could be applied to the study on the etiology and pathology, pharmaceutical effects of new medicine and pharmacological screening, development of diagnostic reagents, food nutrition analysis and environmental monitoring, etc. It’s mainly for research institutes, universities, hospital research department, biotechnology companies, pharmaceutical companies, drug testing companies, diagnostic reagents manufacturers, food manufacturers and environmental services company, etc.
The company has more than 60 employees, over 70% possess doctoral degrees, including over a total of 30 R & D technical staff, who come from global famous laboratory respectively, basically possessing doctoral degrees or above and deep academic foundation and research experience, and once published papers in core journals such as Nature, Journal of Biological Chemistry of Cell Biology, Journal of Cell Biology. Strong R & D strength supports the company to keep the leading R & D speed in the industry. The company can develop 100-200 new products and successfully launch them into the market every year, and always keep up with the latest research and development trend.
Focusing on the field of reagent for scientific research, the company has accumulated rich R & D experience of thousands of products, and has built up an efficient R & D system. Under the guidance of this system, the company's product development become orderly and systematized, which greatly improves the development efficiency. The company has accumulated a wealth of plasmid library, independently developed Pg-ProbeTM technology and various unique freeze-drying technologies, which make products more accurate, sensitive and convenient to use, forming a strong competitiveness.
Through establishing a solid cooperative relationship with world famous enterprises such as Sigma, Abcam and Fisher Scientific, the company has formed a sales network which radiates the main countries and regions in the world. Brand reputation has been continuously accumulated, and a batch of loyal customers has been developed. With the increasing importance on medical research attached by global governments and enterprises, the future market will be much wider.
Chinese Market Development Plan:
NKY Medical Group is acquiring BioVision, and will use BioVision's scientific research ability, production capacity and market channels to further develop its own biological medical business.