Milestone for Biowin’s Rapid COVID-19 Nucleic Acid Detector

BEIJING, Aug 6, 2020 – (ACN Newswire) – Changzhou Biowin Pharmaceutical Co., Ltd. (“Biowin”), a Chinese biotech company focusing on diagnostic product R&D and high-tech biomedical manufacturing, has announced that their rapid COVID-19 nucleic acid detection kit has passed the laboratory evaluation tests. Designed for individual use at home or in the office, the RT-LAMP nucleic acid and easy-sample test kit is fast, portable and affordable.

Early detection is of primary importance to the prevention and control of COVID-19. Rapid detection reflects in the efficacy of follow-on events including treatments following diagnosis and isolation or quarantine to prevent further transmission. At the ‘Two Sessions’ in May, Premier Keqiang Li spoke about detection in the battle against coronavirus, and encouraged the industry to develop a nucleic acid technology that was fast, accurate and convenient, with no lab, as soon as possible.

As expected, Biowin’s “Novel Coronavirus (COVID-19) Nucleic Acid Test Kit (RT-LAMP)” can be carried anywhere and used at any time, allowing individuals privacy and an accurate, real-time understanding of their status, so they can return to work, business and markets with ease. For completion of the full development process, Biowin is in discussions with its partners in relevant countries and regions regarding clinical trials.

Biowin entered an LOI on July 27 with Beijing-based Shineco, Inc (Nasdaq: TYHT), a producer and distributor of Chinese herbal medicines, and organic agricultural and hemp products in China. Shineco is to acquire a 73.7% interest, and join Biowin as it steps into the market for COVID-19 nucleic acid detection. On August 4, the BoD appointed Dr. Fengming Liu, CEO and Chief Scientist of Shienco, Inc, to guide the company through this strategic transformation,

INTERVIEW with Dr. Fengming Liu, CEO and Chief Scientist, Shienco, Inc.

– Q: Biowin Pharmaceutical Co., Ltd. is known for quality biotechnology development and industrial operation team. Can you mention your personal experience, as a nationally distinguished expert and leading returnee?

– Dr. Liu: I obtained my doctoral degree in cardiovascular medicine from Peking Union Medical College, and later received my post-doctoral training at Dartmouth College in the USA. In business, I successfully operated a number of bioengineering technology enterprises before becoming the General Manager of Biowin. I presided over 5 national projects and 8 local projects, contributing in the fields of biopharmaceutical, clinical diagnostic reagents and functional food development. I have organized more than 60 patent applications, and have obtained 48 market approvals for new drug and in vitro diagnostics from the Chinese FDA.

– Q: It has been nearly half a year since the worldwide outbreak of COVID-19, and it has not been effectively controlled yet. What are the main reasons for this situation now?

– Dr. Liu: The main reason is that some countries or regions are currently facing a variety of problems, which can not be effectively solved. I think there exists 4 main problems. First, insufficient detection capacity: virus nucleic acid detection is the main method currently used, but it needs to be operated by specialized instruments and professionals, so the current detection capacity is short of actual requirements; Second, the legal system is not ready to deal with epidemic disease like Covid-19: effective isolation and control for mild and asymptomatic infected people is an important measure to reduce or prevent the spread of the disease. However, many western countries can not implement the unified isolation control for the undiagnosed and latent infection population due to the lack of legal support.

Therefore, timely detection of mild and asymptomatic infections and isolation and control according to the law is an effective means of epidemic prevention and control; Third, insufficient public cooperation: for mild and asymptomatic infected people, especially in other countries, there are such phenomena as unwilling to inspect, unwilling to report, deliberately concealing and not cooperating with the follow-up prevention and treatment management, which leads to the continuous increase of infectious sources; Fourth, the contradiction between returning to work and epidemic prevention and control: a large number of undiagnosed mild and asymptomatic infected people largely exist in the group who have returned to work, which will lead to further spread of the disease, and make it harder to be controlled.

– Q: The world is facing insufficient detection capacity, can you give us a detailed introduction of this home nucleic acid detector in a language that is easy for the public to understand?

– Dr. Liu: Our detector is based on the nucleic acid test kit (RT-LAMP) and developed by using genetic engineering and immune detection technology. It is mainly used for the detection of various viral nucleic acids, especially for the current nucleic acid detection of coronavirus, which can be used at home. It has the advantages of small size, convenient use, low price, high detection sensitivity, low risk of cross infection and broad detection coverage. It can also be used as a screening tool for large sample centralized detection. We just finished the laboratory research test and require further clinical trials to be fully approved..

– Q: What are the characteristics of this domestic nucleic acid detector compared with other existing nucleic acid detection technologies?

– Dr. Liu: Nucleic acid detection is the only way to recognize the coronal virus. The existing fluorescent PCR detection reagents must be operated by professionals in specific molecular laboratories and corresponding large-scale instruments, which greatly limits the detection progress and cannot cover all the population in the control area in a short time. By using at-home nucleic acid detector produced by our company and accompanied by our sampling technology and our nucleic acid detection reagent, ordinary people can complete sampling and testing independently at home without the help of professional testing personnel. Compared with other existing nucleic acid detection technologies on the market, it is more convenient, faster with higher sensitivity and accuracy, and low average detection cost. It can thoroughly help our society solve problems like difficulty in appointment, expensive detection and cross infection risk, etc., and is suitable for effective monitoring of coronal virus in companies or communities.

– Q: The current situation of the epidemic situation is still not optimistic, especially in foreign countries. A large number of ordinary people are still dominated by the fear brought about by coronavirus. So we need a quick and effective easy-taken nucleic acid detector. When can your nucleic acid detector be put on the market to meet the huge demand?

– Dr. Liu: The home nucleic acid detector is progressing well in clinical trials, and will soon contribute to international efforts at prevention and control of COVID-19 . In terms of reagents, Biowin has developed 3 nucleic acid testing products: a novel coronavirus (COVID-19) IgG/IgM antibody test kit (colloidal gold) has already received the CE certification, while the novel coronavirus (COVID-19) nucleic acid test kit (fluorescence RT-PCR), and novel coronavirus (COVID-19) nucleic acid test kit (RT-LAMP) are applying for the process. With respect to testing instruments, we are applying for the registration certificate of medical devices and preparing for trial production. At present, the self collecting disposable nucleic acid detection sampler has obtained the approval certificate of medical device registration, and is in production.

Biowin’s home nucleic acid detector is composed of two main parts: self sampling technology and nucleic acid testing instrument. It requires no laboratory environment and does not rely on medical staff. With it, people can easily complete the detection at home and get results within 30 minutes. It is expected that everyone can achieve scientific and accurate prevention and control of COVID-19 in the process of returning to work and production. We hope that this product will enter the market quickly, and that the world will win in its fight against COVID-19 through technological innovation.

About Changzhou Biowin Pharmaceutical Co., Ltd

Established in Changzhou, China in 2012, Changzhou Biowin Pharmaceutical Co, Ltd focuses on R&D, manufacture and distribution of point-of-care diagnostic test kits (POCT). The Company currently has 33 in vitro diagnostics products with marketing approval, 12 Chinese patents, and 28 Chinese patent applications, covering a variety of diseases including heart disease, infectious diseases, stroke, kidney function, diabetes, cancer and bone metabolism disorders. Biowin has a well-established diagnostics R&D laboratory and five technology platforms, and a rapid response system for the delivery of emergency-use in vitro diagnostics products. For more information, please visit http://www.czbiowin.com/.

About Shineco, Inc.

Incorporated in Delaware in August 1997 and headquartered in Beijing, Shineco is a holding company. Through its subsidiaries and related entities, Shineco undertakes vertically- and horizontally-integrated production, distribution, and sales channels to provide health and well-being focused plant-based products in China. Utilizing modern engineering technologies and biotechnologies, Shineco produces, among other products, Chinese herbal medicines, organic agricultural produce, and specialized textiles. For more information, please visit http://tianyiluobuma.com.

Media contact:
Changzhou Biowin Biopharm Co., Ltd
Contact Person: Yue Liu
Telephone: +86 18850050087
Website: http://www.czbiowin.com

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