Wu Sheng: Positioning in vitro diagnosis of upstream active antibody raw materials, speed up the localization of imported reagents.

Guide: This is an industry driven by technological innovation and requires deep technological accumulation.
in recent years, due to the rapid growth of domestic medical services demand, in vitro diagnostics (IVD) industry has also been rapid development, the diagnostic industry is expected to maintain an annual growth rate of nearly 20% in the next few years, by 2019 the overall size of the industry is expected to exceed 70 billion yuan.
at the same time, many reagent/raw material manufacturers still face many challenges, including high imported raw materials, fierce competition in the market, etc.
" this is a technology-driven industry, need a profound accumulation of technology, in order to be in a large number of importers, and then break the monopoly of raw materials imports.
" said Mr. Wu Sheng, vice president of Kingsley's In vitro Diagnostics division, in a recent interview.
as an important source of information for clinical diagnosis, in vitro diagnosis affects about 70% of medical decisions.
in recent years, with the renewal of in vitro diagnostic technology and the improvement of the level of public medical services, the IVD industry has developed significantly, involving biochemical diagnosis, immunodiagnosis, molecular diagnosis, microbial diagnosis, urine diagnosis, clotting diagnosis, hematology and flow cell diagnosis and other sub-sectors.
foreign IVD market is relatively mature and stable, on the contrary, there is still a lot of room for development at home.
" domestic per capita in vitro diagnostic consumption of about 2-3 Dollars, while developed countries reached about 30 Dollars, china's in vitro diagnostic market development space is huge.
, " Mr. Wu Sheng said intuitively.
1, positioning upstream active raw materials as the industry's well-known CRO company, Kingsley has 14 years of antibody and protein preparation history, has a profound technical accumulation.
company has more than 7000 square meters of independent constant temperature and humidity animal room, is the only domestic IVD raw materials in the field of the international AAALAC and OLAW dual certification company.
company has built an integrated macromolecule drug development platform from drug target development to animal model testing, and the development and production of diagnostic antibodies is also developed using this antibody drug platform technology.
16 years, the technology innovation company from "gene synthesis" is moving towards "diversification", with major business segments including life sciences research services, preclinical drug research and development, in vitro diagnostic active raw material products, life sciences research catalog products, synthetic biological products and cell therapy research and development.
's Hong Kong Stock Exchange listing in 2015 (stock code: HK01548) broke through the market value of 50 billion for the first time last year.
at the same time, in order to expand its strength and add a new engine, In vitro Diagnostics (IVD) Bioactive Raw Materials Business was officially launched in March 2017 , the upstream raw material seq.com, which is positioned in vitro diagnostics to provide bioactive raw materials to customers in the lower and middle reaches (diagnostic reagent developers, third-party medical testing agencies, etc.).
", "focusing on upstream, aiming to break the monopoly of foreign companies on the industry.
our service model is very flexible, including antibody, antigen product line, antibody customization outsourcing, foundry production and antibody antigen joint development cooperation win-win.
," Wu Sheng said in an interview.
2. Seizing market opportunities Since 2011, the Chinese government has gradually implemented the "pay-as-you-go" medical reform, which is an important means to control the unreasonable growth of medical expenses and reduce the burden on patients.
", "in the case of comparable quality, this favorable policy helps to highlight the cost-effective advantages of domestic reagents."
" Wu Sheng said, "This is to promote the development of the domestic IVD industry has a great role in promoting."
" in June this year, the National Health and Health Commission issued a "notice on further reform and improvement of medical institutions, physician s/he approval work" to promote the medical field", "decentralization" (short for decentralization, decentralization, optimization of services) reform.
this policy clearly states that, under the premise of ensuring the quality and safety of medical care, medical institutions may entrust independently set up medical examination laboratories, pathology diagnostic centers, medical imaging diagnostic centers, medical disinfection supply centers or other medical institutions with conditions to provide medical examination, pathological diagnosis and other services.
", "this outsourcing will create more outsourcing needs, thereby facilitating more capital and enterprises entering the sector."
with the number of third-party independent laboratories, reagents and raw materials companies will share the market boom.
this is a virtuous circle, product quality rise, price decline, the ultimate benefit will be the masses of the people.
" Wu Sheng has great confidence in industrial development, he believes that enterprises should be based on innovation, with high-quality products to win more market share.
3, to meet the challenges of the industry compared with international manufacturers, the proportion of domestic IVD manufacturers market share is relatively low, upstream industry importers are still strong and industrial concentration is not high.
" At present, The Hospital of Sanjia is still mainly imported instruments and reagents.
in the promotion of core competitiveness, domestic manufacturers are facing a great challenge, imported reagents localization still has a long way to go.
" Wu Sheng analysis, "in the upstream of the industry in the core raw materials, the advantages of importers are still obvious."
As a bioactive raw material manufacturer, is willing to work with the vast number of peers, for the development of domestic reagents to make their own contribution.
" talk about the advantages in the IVD industry, Wu Shengdi is full of gas, Kingsley's active raw materials are expressed through in vitro recombination, with an industrial-grade mass production platform, can successfully deliver large-scale orders.
"Our primary nuclear expression platform has a flux of 1000L and a eukaryotic expression system flux of 250L, and is expanding."
eukaryoeuic expression of antibody yield up to 2g/L, the purity of the antibody is verified by HPLC to ensure purity of more than 95%, while the antibody will pass 3 weeks of thermal stability accelerated experiments, each batch of products will undergo multiple verification to ensure that the delivered products meet the needs of customers.
, he said, "Compared to foreign companies, Kingsley's production capacity in China, can directly connect customers, without worrying about the impact of intergovernmental tax and customs clearance policies and other international situations, and the speed of shipments is more advantageous."
" In the field of IVD, Kingsley will continue to focus on the production and development of in vitro diagnostic active raw materials, further expanding our product line.
at the same time, we will strengthen the construction of the verification platform.
the current tomography platform has been built, than the turbid platform is about to be completed, the light-emitting platform will be built in the near future.
in the near future, we plan to launch fluorescent-labeled CD molecular antibodies for TBNK thin species, as well as a variety of specific target antibodies for in vitro tumor diagnostics.
on the way to product development, Kingsley is willing to accompany everyone along the way.
"There's a lot of planning for the next step, Wu Sheng."
he believes that new detection indicators and platform technology will bring new flashpoints.
.