There is such a scene in the famous British drama “Downton Abbey”. Miss Sybil of died of eclampsia shortly after giving birth to his daughter, which shocked and regretted the audience. What kind of disease is eclampsia? What are the prevention and control methods and treatment methods? Recently, Arterial Network (Wechat: vcbeat) contacted Ningbo Aucheer Biotechnology Co., Ltd. (hereinafter referred to as “Aucheer Bio”), a high-tech biological company focusing on accurate diagnosis of preeclampsia in pregnant women.
When it comes to preeclampsia (PE), Zhou Yi, founder of Aucheer biology, is professional and rigorous. For more than ten years, he and the Aucheer biological team have continued to dig deep into the field of IVD immunodiagnostics, established a complete series of accurate preeclampsia (PE) diagnostic products, and obtained relevant registration certificates, which are sold on the market for accurate preeclampsia. Diagnosis, convenient monitoring, and effective prevention provide the “Aucheer solution”.
The creation of Aucheer Bio began with a marketing experience. As the founder of Aucheer Bio, Zhou Yizheng recalled: “In 2003, I entered the biomedical industry. In the field of marketing gynecology and cardiovascular disease and communicating with clinicians, I learned that preeclampsia is the incidence of maternal and perinatal infants. And one of the leading causes of mortality. Globally, approximately 76,000 women and 500,000 babies die each year from preeclampsia. These numbers were really shocking, and I was thinking, at this time, can I do something to solve this problem? Provide help as much as you can. ”
However, doctors now basically diagnose preeclampsia through clinical features such as blood pressure / urinary protein levels, thrombocytopenia, liver and kidney damage, and pulmonary edema. If the disease is not treated in time, it will be present in both pregnant women and fetuses. Fatal danger. The traditional screening method is to identify the risk factors from the maternal demographic characteristics and medical history (maternal risk factors), but the detection rate is low, and the risks cannot be ruled out to the maximum. Scientific predictions and effective prevention of preeclampsia-related issues are social issues that lie ahead.
“This pain point needs to be overcome.” Zhou Yizheng is keenly aware that the market urgently needs an in vitro diagnostic product that can accurately, quickly and conveniently detect early pregnancy hypertension and preeclampsia, so as to facilitate timely and effective early intervention and reduce The occurrence of early-onset eclampsia improves maternal and infant outcomes and eugenics. Secretly determined in Zhou Yizheng’s heart, this is a professional responsibility and a mission in life.
“The IVD market is an emerging market. Whether 10 years ago or now, the annual growth rate of the IVD market is about 20%, which is very rare, and it also shows that there are many gaps in this market. As long as we uphold science, down-to-earth, and persist in innovation, there must be opportunities for Aucheer to develop. “Zhou Yizheng said. In 2009, Aucheer Biological landed in Ningbo, Zhejiang Province, and began to explore and research in the field of hypertension and preeclampsia of pregnant women for more than ten years.
In 2019, the “Healthy China Action (2019-2030)”, formulated by the National Health and Health Commission and co-ordinated by the State Council’s Health China Action Promotion Committee, clearly states that in 2022 and 2030, China’s maternal mortality rate will drop to 18, respectively. 100,000 and below and 12 / 100,000 and below; prenatal screening rates of 70% and above and 80% and above, respectively; require medical institutions at all levels to effectively implement pregnancy risk screening assessment, high-risk project management, and critical illness Five systems of treatment, maternal death case reports and interviews, strengthening the capacity building of critical care pregnant women and newborns, and improving mechanisms for consultation and referral.
For Aucheer, the development of the “ten-year sword-sharpening” ushered in an unprecedented spring. From Zhou Yizheng’s point of view, everything from the sale of pharmaceutical products to the development of detection technology platforms and in vitro diagnostic reagents is “let it be,” because of responsibility to urge, policy support, and teamwork.
A breakthrough to hit the pain points of preeclampsia
July 11, 2019 is an unforgettable day for Aucheer Bio. The team’s independently developed placental growth factor detection kit (PLGF) was approved by the NMPA for marketing. This domestic breakthrough based on preeclampsia has aroused strong response from gynecologists and prenatal screening market.
As we all know, preeclampsia (PE) is a multi-system disease that is idiopathic to women during pregnancy. It is clinically characterized by clinical symptoms such as hypertension and proteinuria after 20 weeks of pregnancy. Preeclampsia can affect placental blood supply, cause fetal growth restriction in the uterus or premature delivery, which can cause pregnant women and fetal death. At the same time, preeclampsia is the source of cardiovascular disease in the two generations of mother and child. To date, termination of pregnancy is the only effective treatment. Coupled with the implementation of the “full two-child” policy, the aging of pregnant women has contributed to the rapid increase in the incidence of preeclampsia in China.
In recent years, international studies on preeclampsia have gradually deepened, and some practical research results have been introduced one after another. For example, the International Obstetrics and Gynecology Alliance (FIGO) published the “Practical Guide to Preeclampsia Screening and Prevention in Early Pregnancy (2019)”, and the American Association of Obstetricians and Gynecologists (ACOG) issued the “Pregnancy Hypertension and Preeclampsia Guidelines ( 2019) “and the” Guidelines for the Diagnosis and Treatment of Hypertensive Diseases During Pregnancy (2015) “issued by the Pregnancy Hypertension Diseases Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association have laid the foundation for the diagnosis and treatment of hypertension and preeclampsia in China during pregnancy- By detecting the combination screening of placental growth factor, maternal risk factors, MAP and UTPI, the detection rate of early-onset PE can be 88%.
Early combination screening for eclampsia
The combined screening and testing of pregnant women with high-risk factors in the first 11 to 13 weeks of pregnancy will allow medical staff to carry out targeted prevention and management, effectively reducing the incidence of preeclampsia and maternal mortality. In order to make “Aucheer contribution” in this field, Zhou Yizheng and his team of 100 people also worked hard. The construction of bases, group inspections, fundraising, and independent research and development have been done for more than ten years.
In 2014, Aucheer Bio achieved its first five-year plan-to establish an immunodiagnostic detection technology platform. Since the listing of fluorescent immuno-placental growth factor detection reagents, the national distributor sales network has covered more than 20 provinces, and the significance of clinical detection has been highly recognized by clinical and patients.
“In the development of reagent products, raw materials are the key, especially for immunodiagnostic products. The quality of antibodies is directly related to the stability of the product.” Asked about the problems encountered, Zhou Yi was introducing to Arterial Network. “For a long time, the raw materials of antibodies have been monopolized in the hands of international giants. This has also restricted the development of many large domestic companies. The expansion of scale and the expansion of overseas markets have been constrained by others. I saw this situation many years ago, and then I decided Determination: We must follow a path of independent development. To this end, I often exchange and cooperate with international biomedical teams. I have visited many well-known laboratories and scientists, and some of them have reached cooperation so that our company can quickly solve some technical problems and also master It’s the core technology we need to make Aucheer more stable and sustainable. ”
The pursuit is endless. Aucheer Bio has a clear product vision, the first of which is: “Committed to providing leading clinical diagnostic solutions for maternal and child health”. Therefore, in addition to the introduction of the core product of placental growth factor detection reagents, Aucheer Bio has now established an immunodiagnostic technology platform based on fluorescent immunochromatography, microfluidic chips, magnetic microparticles acrylate, full-automatic chemiluminescence, and antibody materials. A series of products developed around the disciplines of maternal and child health, cardiovascular, infection, and kidney disease. And has obtained 2 registration certificates for fluorescence detectors, 1 180-speed magnetic particle acryl ester full-automatic chemiluminescence detector, 14 registration certificates for fluorescent immunoassay products.
A chip to broaden the field of microfluidics technology
In 2019, Aucheer Biology independently innovated the “Time-Resolved Fluorescence Immunoassay Chip”, which broke through four core technologies:
The first is to carefully design the micro-scale functional structure to precisely control the flow of blood samples in the chip;
The second is to break through the pre-encapsulation, release, and fixation processes of biological reagents in microfluidic chips;
The third is to chemically modify the surface of the microfluidic chip to provide a stable environment for blood sample flow and reagent reaction and precise flow rate control within 12 months;
Fourth, the uniformity of micron precision injection molding is good.
“In 2021, Aucheer Bio’s related products with this microfluidic chip as its core will be officially launched in the Chinese market, realizing the whole process of whole blood sampling, reaction, and detection without any external drive, and high accuracy and sensitivity.” With microfluidic chip, Zhou Yizheng is full of confidence. This confidence comes from the first try of Aucheer creatures. Microfluidic technology is one of the most cutting-edge technologies in the field of in vitro diagnostics. It entered China from abroad in the early 21st century. Although it has only gradually become known in recent years, Aucheer Bio has accumulated five years of R & D experience in this technology.
Zhou Yizheng said that there are also many difficulties in the development of microfluidic chips, such as the uniformity of chip processing, chip material hardness, hydrophilic and hydrophobic processing, air bubbles in the flow channel, release of fluorescent microspheres, filtration of whole blood into serum, long-term A series of issues such as whether the stable detection time is controllable, how to minimize the amount of protein fixation, how to improve the sensitivity, and how to prevent the double detection and triple detection from interfering with each other. However, these problems have been effectively solved by Aucheer Bio by conducting a large number of experiments by combining domestic and foreign talents. At present, the application field of Aucheer biological microfluidic chip is mainly around a series of maternal and child health products such as the detection indicators PlGF and PlGF / sFLt-1 for preeclampsia during pregnancy and the detection indicator AMH for ovarian evaluation before pregnancy.
“In today’s medical environment, only professional academic promotion can lead companies to success.” Zhou Yi introduced Artucher’s business promotion ideas to Arterial Network. “Professional academic promotion ideas are widely used in foreign companies. Marketing methods. At present, it is relatively mature in the domestic drug marketing field, but it is less used by companies in the field of in vitro diagnostics. We have become the true transmitter of the medical value of our products. Our products can really help patients and a certain disease in the hospital. Only by building a diagnosis and treatment system can the development of medicine be promoted. ”
At present, Aucheer has developed 6 equipments including three platforms: fluorescence immunochromatography, microfluidics, and chemiluminescence. There will be nearly 30 product pipelines in the future. Regarding the future, Zhou Yizheng said that Aucheer Bio aims to create “a smart medical solution based on a detection technology platform and big data.” At the same time, Aucheer Bio is also introducing high-end talents in bioinformatics and artificial intelligence and software, and has established cooperation with many well-known medical institutions and universities across the country to add value to existing technology platforms. The implementation and advancement of these achievements are sufficient to achieve Aucheer’s Brand positioning of maternal and child health clinical diagnostic solutions.